Home

DISCOVR-e USER MANUAL Vanderbilt University Human

1. Radiation Procedures and Radioactive Drugs 2 anmnint The pre review comment will appear below the item To revise an answer to align with the request simply select the appropriate response or revise the text in the dialogue box as necessary As all pre review comments are suggestions please add a comment providing a rationale for any requested changes not made Version Date 04 29 2015 34 Please identify ALL applicable recruitment methods must provide value Changes made to the application will be recorded in the change history H Change History 1 w Comments 1 Please confirm if flyers will be used for recruitment 2015 03 30 14 56 17 straznkh Add comment N A Flyers Internet Letter Departmental Research Boards Mass E mail Solicitation Newspaper Posters ResearchMatch IRB 090207 Radio Telephone Television Social Media Other Requested changes will be included in the comments box for the specific item Add a comment for any changes requested but not made If revisions are necessary to study documents attach any documents with pre review requested changes in the document uploads tab Please ensure that all changes are tracked Documents can be uploaded by dragging and dropping the document into the corresponding box or using the standard upload method to find the document on your computer Main KSP Funding Application Document Uploads Attach Study Fil
2. within the Draft Submissions region 4 22 2015 AMENDMENT 4 21 2015 AMENDMENT 4 13 2015 AMENDMENT Version Date 04 29 2015 31 If you need to revise any information within your submission navigate to the appropriate tab of your submission and update where necessary Dashboard Submissions Studies Home Draft Submissions Submission New Study Title New Study Title Main KSP Funding Study Title New Study Title Principal Investigator Is the Pl a student resident or fellow Navigate through your study tabs to edit any information within your submission Study Coordinator Department Chair Division Chief If you want to delete the submission ES simply click the i gt Delete button Delete If you would like to delete your submission simply click the Delete button After making your edits select the Save and Continue button to save your changes and to advance you back to the Submit tab Click the Submit button to re route your submission for the appropriate signatures Home Draft Submissions Submission New Study Title New Study Title Main KSP Funding Application Document Uploads Submit Reviews After making your Your submission is ready to be submitted edits and saving your l l work advance to the Click the submit button to start the signature process Once all required parties have signed off on the Submit
3. A Phase and Randomized Double Blinded 150014 1 21 2016 Test Standard 140026 A Phase 1 Study to Evaluate the 150080 4 1 2016 Test Repository 140916 IRMH Recruitment Repository 150071 4 1 2016 IRB Training expiration can be easily viewed on the Investigator Dashboard using the gauge displaying days until expiration Submissions Welcome This is your investigator dashboard From here you can respond to action items manage approved studies and create new study submissions Training expires in oO 397 Submissions Submissions Draft requiring my requiring a CAL submissions signature response View IRB Training Clicking on the link under the gauge titled View IRB Training will open the view of your training status Version Date 04 29 2015 13 Submissions Studies Welcome This is your investigator dashboard From here you can respond to action items manage approved studies and create new study submissions Training expires in 39 Submissions Draft requiring my requiring a CAL submissions signature response This view displays your IRB Training status and expiration date Dashboard Submissions Studies Home Training Summary I IRB Training Summary Name Training expires in IRB Training Status REQUIREMENT IS MET Expiration Date 10 21 2022 View Latest IRB Training Certificates View your five most recent IRB training certificates New study submission are the only submissions
4. Amendment Non compliance with Protocol Adverse Event Continuing Review Version Date 04 29 2015 55 Enter the description of the Non compliance and the date of the event or problem Click Save Dashboard Submissions v Studies Home Draft Submissions Submission Test Standard 140026 A Phase 1 Study to Evaluate the Test Standard 140026 A Phase 1 Study to Evaluate the IRB 150080 PI Noncompliance with Protocol 4 13 2015 DRAFT Submission ID Noncompliance Document Uploads Submit Reviews Description of the Noncompliance with the Protocol Date of event problem 2015 Apr 7 13 Delete Once you have saved the Main tab click the Non Compliance tab to continue Dashboard Submissions v Studies v Home Draft Submissions Submission Test Standard 140026 A Phase 1 Study to Evaluate the y Test Standard 140026 A Phase 1 Study to Evaluate the IRB 150080 PI Noncompliance with Protogol 4 13 2015 DRAFT Submission ID Noncompliance Document Uploads Submit Reviews Description of the Noncompliance with the Protocol Date of event problem 2015 Apr 7 13 ft Delete Version Date 04 29 2015 56 Complete all questions on the Non Compliance form The Wizard will not allow you to submit if a questions is not answered Once all questions have been answered Click Save at the bottom of the page Did the Noncompliance with the Protocol a
5. 2732 YP A d a u View IRB Training My studies Studies listing me as KSP ki Approved Studies Study Title Study Contact Study Expiration J2 ECOGGIEA2131 A Phase and Randomized Double Blinded 5 1 21 2016 Test Standard 140026 A Phase 1 Study to Evaluate the 50081 4 1 2016 Test Repository 140916 IRMH Recruitment Repository S 1 4 1 2016 Grant Review Test 140279 Cardiac structure and function Grant Review Test 140067 HDL Function in Human Disease Test Expedited 140050 Retrospective Review of Coagulation Test Study A randomized study of the effect of chocolate New Tools for Assessing Fracture Risk Investigating immune responses in patients with advanced Test A multi center randomized prospective open label Clicking on Dashboard will return you to your investigator Dashboard Dashboard Submissions Studies Clicking Submissions will display a drop down menu This menu holds items corresponding with the buttons on the dashboard as well as other study views Version Date 04 29 2015 9 Dashboard Submissions Studies Drafts Requiring my signature ra This is your investigator dashboard From here you can respond to action items ived studies and create new study submissions Pre review requests CAL responses Submissions In route Training expires in Submissions I ve signed 39 ICON Submissions Submissions Draft requiring my requiring a CAL submissions signat
6. 615 322 2918 Study Coordinator YES HUBBARM o Myler Hubbard Human Research Protect MD 615 875 8716 Research Clinical YES ARRINGJG James Arrington Human Research Protect BA 615 875 8961 Research Non Clinical YES cyrc Ciara Cyr Human Research Protect MS 615 875 9704 Research Clinical _ Y YES Add another tart typing to search by name ema i Save KSPs l Em Hit the Save KSPs button to save your changes Version Date 04 29 2015 21 The history tab allows you to see the date KSP were added removed You can also see who added deleted KSP Dashboard Submissions v Studies v Hutchins Erin L Home Approved Studies Study IRB test 150036 MEL 1460 Stand Up To Cancer Consortium IRB test 150036 MEL 1460 Stand Up To Cancer Consortium IRB 150148 PI Vigil Karen Info Approved Documents Submissions O cre The history tab allows you to see the date KSP were added removed You can also see who added deleted KSP Current KSA VUNetID First Name Last Name Deleted By 04 22 2015 ARRINGJG James Arrington HUTCHIEL NA 04 27 2015 CYRC Ciara Cyr HUTCHIEL NIA 04 10 2015 HUBBARTM Tyler Hubbard SYSTEM NIA 04 10 2015 HUTCHIEL Erin Hutchins SYSTEM NIA 04 10 2015 04 27 2015 JOHNSTB7 Tiara Johnson SYSTEM HUTCHIEL 04 22 2015 04 22 2015 PFLUMAE Amy Pflum HUTCHIEL HUTCHIEL 04 22 2015 04 22 2015 TURNERC9 Chasiety Turner HUTCHIEL HUTCHIEL 04 10 201
7. CITI training they can be added to the study My PI deleted his her link to sign off on a study submission now what do I do You can instruct your PI to log in to DISCOVR E through the IRB website If they have any submissions that require their signature they will see a section called Submissions Requiring My Signature at the very top of the page They can access and sign off on all submissions that may require their signature by clicking the button or link under the menu at the top of the page Will be able to add photos or diagrams to my application At this time photos and diagrams cannot be added to the application wizard itself However you are free to attach them as supporting documents or reference their location in the protocol Will be able to use standard formatting such as bold italics super sub scripts At this time the system does not support text formatting in the wizard responses You may refer to the appropriate sections in the protocol for this information i e references Please also consider if the additional information that requires formatting answers the question being asked by the IRB application Can access a collective list of all my currently approved study documents Version Date 04 29 2015 68 Yes by clicking on the link in the approved studies dashboard for that study Select the Approved Documents tab There you will see a tab for Current Documents that includes links f
8. Please indicate type of report Initial Report of Event Problem Follow Up Report ES gt Save and Continue On the Adverse Event tab you will complete additional Adverse Event questions Required items are marked with must provide value Please complete all of the requested items on the form The Wizard system will not allow incomplete forms to be submitted The following types of events are required to be reported to the IRB If the event does not fit the categories shown the event is not reportable to the IRB However the event may need to be reported to the sponsor If you have any questions please call the IRB 615 322 2918 of check with your sponsor Was this an event that requires prompt reporting to the sponsor in accordance with the protocol 2 g serious adverse events musi provide value Unanticipated An event is unanticipated when it was unforeseeable at the time of its occurrence must provide value Serious An event is serious if it adversely alters the risk benefit relationship of the research musi provide value Related An event is related if it is likely to have been caused by the research procedures Version Date 04 29 2015 48 Delete In this section please indicate the Participant ID or initials Please do not include a name or any other personal identifiers Participant Identifier NOTE GO NOT idete a name or ANY personal identifiers P
9. Project HIPAA Expire VIGILKM Karen Human Research Protect MD 615 875 9905 Principal Investigator YES eg HUTCHIEL Erin Hutchins Human Research Protect MD 615 322 2918 Study Coordinator YES a JOHNSTB7 Tiara Johnson Human Research Protect MD 615 322 2918 Research Clinical Y YES ca HUBBARTM Tyler Hubbard Human Research Protect MD 615 875 8716 Research Clinical Y YES_ p B ARRINGJG James Arrington Human Research Protect BA 615 875 8961 Research Non Clinical YES cad cyrc Ciara Cyr Human Research Protect MS 615 875 9704 Research Clinical 7 YES_ ea Start typing t Save KSPs Click the restore icon to restore a person s name If you do not have any other KSP to add delete please click the Save KSPs button and proceed to the next section Z IRB test 150036 MEL 1460 Stand Up To Cancer Consortium IRB 150148 You have the option of PI Vigil Karen clicking the Restore button in the event you choose the Info KSP Approved Documents Submissions Create Submission wrong member of KSP to remove from the study AcCurrentKSP W History Print Accessing PHI Training VUNetID First Name Last Nam Department Credentials Phone Pager Role in Project HIPAA Expire VIGILKM Karen Vigil Human Research Protect MD 615 875 9905 E Principal Investigator YES HUTCHIEL i Hutchins Human Research Protect MD
10. accessed via the drafts submission button on your Investigator Dashboard Note The submission portal will not allow an incomplete submission to be submitted or routed for signature You may choose to download an electronic version of the IRB Application by clicking the Download Application button as shown in the example above To proceed to the next section of the submission process click the Continue button Version Date 04 29 2015 26 Document Uploads The Documents Uploads section is where you will attach upload additional study documents such as consent forms protocols questionnaires and any other study related documents or materials Uploading documents is easy You may upload attach documents from locations saved on your computer by dragging and dropping the item s into the proper field or by browsing your computer for the appropriate file and attaching the document the standard way To utilize the drag and drop feature click the Drag and Drop button to activate it Next select the document you wish to upload and drag it to the proper field and release the document Multiple uploads may be dragged and dropped at a time if they will be uploaded to the same field Otherwise attachments must be uploaded one at a time As you load additional items a list will build showing what has been attached to your submission Home Draft Submissions Submission New Study Title New Study Title Main KSP Funding Applic
11. approved studies and create new study submissions Training xpires in Submissions Submissions Draft requiring my requiring a CAL submissions signature response My studies Studies listing me as KSP b Approved Studies Study Title IRB Study Contact Study Expiration Jz ECOGGIEA2131 A Phase and Randomized Double 150014 1 21 2016 Test Standard 140026 A Phase 1 Study to Evaluate the 150080 4 1 2016 Test Repository 140916 IRMH Recruitment Repository 150071 4 1 2016 Grant Review Test 140279 Cardiac structure and function 150068 4 1 2016 Grant Review Test 140067 HDL Function in Human Disease 150058 4 1 2016 Test Expedited 140050 Retrospective Review of Coagulation 150087 4 1 2016 Test Study A randomized study of the effect of chocolate 150103 4 2 2016 New Tools for Assessing Fracture Risk 150110 4 5 2016 IRB 130808The Establishment of the Genotype Phenotype 150113 4 5 2016 Investigating immune responses in patients with advanced 150109 4 8 2016 Test A multi center randomized prospective open label 150145 4 8 2016 Test Using patient data to transform care and improve 150133 4 8 2016 Version Date 04 29 2015 46 From the study page click Create Submission Home Approved Studies Study Test Standard 140026 A Phase 1 Study to Evaluate the est Standard 140026 A Phase 1 Study to Evaluate the IRB 150080 PI Info KSP Approved Documents Submissions Create Submission i Test St
12. as outlined previously for selecting a Principal Investigator or Faculty Advisor All new study submissions require a department chair and or a division chief signature The process for indicating this individual is the same as previously outlined If you experience trouble identifying the department chair and or a division chief for your research save your work and contact the IRB at 322 2918 for assistance Dashboard Submissions Studies Back to submissions New Study Study Title Principal Investigator Is the PI a student resident or fellow No Yes Study Coordinator Department Chair 2 Division Chief Create New Study Click on the Create New Study button at the bottom of the page to advance in the new study creation process Version Date 04 29 2015 17 Selecting Key Study Personnel Under My studies Click on the title of study you wish to add KSP NOTE If a KSP s requirement for annual VU IRB Human Subjects Training is not current the individual may not be added to the KSP listing at this time Those individuals may access the CITI Basic and Refresher Courses at https www citiprogram org Dashboard Submissions Studies v Hutchins Erin L v Welcome Erin This is your investigator dashboard From here you can respond to action items manage approved studies and create new study submissions Create a new study Training expires in Pre review Submissio
13. at the bottom of the page UR EVENT Thal t5 SDS ead Sed MSE TO Darkibants or othe ae Wie Pos Sc related bo the reses procedues KOTE Events that do not St into the abowe categories da not raguire reporting ta the IRE at this time However the event may require reporting ta the spammar or data nmanitaring plan This event problem is Choose one Currently described as a risk in the informed consent document and does not require submission of an amendment mEt provide walue Net listed as a risk in the informed consent document and requires submission of an amendment Net listed as a risk in the informed consent document and submission of an amendment is not recommended at this time This study choose one has a Data and Safety Monitoring Committee Board DSMC DSMB or Data Safety Monitor DSM Muss provide walu does not have a Data and Safety Monitoring Committee Board DSMC DSMB or Data Safety Monitor DSM Has te Pl been notified of this event problem and D Yes received a copy of this report No Mus provide waue The PI should be notified of all noncompliance with the protocol Adhere ewes and or unanticipated problems imwohwing risks to participants or others The PI E neqpons ible for the accurate doocunventation inwsstigation and tolloe up of all noncompliance with the grotecal adverse events and or unanticipated problems involving rikr bo participants ar others that are posadbty related ta study partipation Ha
14. be prompted to begin your new study submission in StarBRITE s UBER Project Tracker This feature provides a central location to view the status of your study s approval regulatory requirements To proceed in UBER click the Start in UBER button To bypass this feature click the Continue New Submission button Before you begin We recommend starting your study using StarBRITE s UBER Project Tracker UBER provides a central location where you can view the status of your study s approval regulatory requirements including e IRB Billing Plan e Contracts Grants VICTR continue new submission Start in UBER Version Date 04 29 2015 16 You will begin your new study submission by typing in a title for the study Next enter the Principal Investigator PI for the study You can search for the Investigator by first and or last name or even do a partial name search Click the name of the PI you want to use If you are not able to find the Investigator in the database save your work and contact the IRB at 322 2918 for assistance Indicate whether or not the Principal Investigator is a student If the answer is yes you will be prompted to identify a Faculty Advisor Selecting a Faculty Advisor follows the same process as choosing a Principal Investigator If applicable select a Study Contact by choosing the appropriate contact person from the database The process for indicating a study contact is the same
15. by the Vanderbilt University Institutional Review Board understand that should use the project described in this application as a basis for a proposal for funding either intramural or extramural it is my responsibility to ensure that the human participants involvement as described in the funding proposal s is consistent in principle to that contained in this application will submit modifications and or changes to the IRB as necessary in the form of an amendment to ensure these are consistent agree to comply with all VU policies and procedures as well as with all applicable federal state and local laws regarding the protection of human participants in research including but not limited to Ensuring all investigators and key study personne have completed the VU human subjects training program Ensuring the project is conducted by qualified personnel following the approved IRB application and study protocol Implementing no changes in the approved IRB application study protocol or informed consent document without prior IRB approval in accordance with VU IRB policy except in an emergency if necessary to safeguard the well being of a human participant and will report to the IRB within 5 days of such change Obtaining the legally effective informed consent from human participants or their legally responsible representative using only the currently approved date stamped informed consent documents and providing a copy to the partic
16. created from the Investigator Dashboard Clicking the green Create a new study button will begin the process of creating that new study submission Submissions Studies Welcome This is your investigator dashboard From here you can respond to action items manage approved studies and create new study submissions Training expires in Submissions L E N oe Days requiring my requiring a CAL signature response X A A 2732 NY a View IRB Training Version Date 04 29 2015 14 Throughout the website and application you will find small black circle icons with an i inside These are information buttons Hovering your mouse over these icons will display helpful information about that item For example hovering over this icon next to the Approved Studies heading displays information regarding the use of the Approved Studies view Training expires in Submissions requiring my signature Click on the study title below to View IRB Training access the study dashboard where you can manage KSP download documents or create an amendment continuting review adverse event or report of non compliance roved Studies R Study Contact Study Expiration Jz ECOGGIEA2131 A Phase and Randomized Double Blinded 1 1 21 2016 Test Standard 140026 A Phase 1 Study to Evaluate the 4 4 2016 Test Repository 140976 IRMH Recruitment Repository 1 4 4 2016 Grant Review Test 140279 Cardiac structure and funct
17. search box on the right My studies Studies listing me as KSP Study Title Study Contact Study Expiration Jz ECOGGIEA2131 A Phase and Randomized Double Blinded 1 21 2016 Test Standard 140026 A Phase 1 Study to Evaluate the 5008 4 1 2016 t Repository 140916 IRMH Recruitment Repository 501 4 1 2016 Grant Review Test 140279 Cardiac structure and function 150068 4 1 2016 Grant Review Test 140067 HDL Function in Human Disease 50058 4 1 2016 t Expedited 140050 Retrospective Review of Coagulation 5008 4 1 2016 Test Study A randomized study of the effect of chocolate 4 2 2016 New Tools for Assessing Fracture Risk 150111 4 5 2016 IRB 130808The Establishment of the Genotype Phenotype 15 4 5 2016 Investigating immune responses in patients with advanced 5011 4 8 2016 Test A multi center randomized prospective open label 0145 4 8 2016 The views accessed on the Dashboard can also be accessed at any point via drop down menus These drop down menus can be accessed on any screen allowing you to access submissions without returning to your dashboard Dashboard Submissions Studies Welcome This is your investigator dashboard From here you can respond to action items manage approved studies and create new study submissions Training expires in o os 4 gt Submissions Submissions ae ae f Osys requiring my requiring a CAL signature response AN 4 A
18. select the study that requires an amendment Dashboard Submissions Studies Welcome Kristin This is your investigator dashboard From here you can respond to action items Create a new study manage approved studies and create new study submissions Submissions requiring my signature My studies Studies listing me as KSP b Approved Studies Q Study Title IRB PI Study Contact Study Expiration Jz A Phase 1b Open Label Dose Finding Study to Evaluate 150007 Straznicky Kristin 1 21 2016 3 13 2015 CAL testing Preliminary Assessment 150035 Straznicky Kristin 3 11 2016 Expedited Study Test Study of Prophylaxis 150055 Straznicky Kristin 3 30 2016 Do those with generalized neck pain also have undiagnosed 150077 Straznicky Kristin 3 31 2016 This will open the study page Using the Create Submission tab on the study page select to create a new amendment submission IRB 150007 PI Straznicky Kristin Info KSP Approved Documents Submissions Review Create Submission Create a new submission for this study i ae Amendment Non compliance with Protocol Adverse Event Continuing Review Begin by completing the main page of the amendment Save your changes at the bottom of the page before moving forward Changes that are not saved before moving to a new tab may be lost Version Date 04 29 2015 37 Amendment Funding Application Document Uploads Submit Reviews g description or Number mendment Da
19. tab and submission it will be sent to the IRB for review submit your submission to re route ma for appropriate LS signatures Debug info Vanderbilt University Institutional Review Board discovere vanderbilt edu Nashville TN 37232 4315 Version Date 04 29 2015 32 How to Respond to a Pre review The Principal Investigator and Study Contact will receive an email when a pre review request has been received The link in this email will lead to the submission These submissions can also be accessed on the dashboard The pre review requests button will contain a counter listing the number of items with pre review requested changes Welcome Kristin This is your investigator dashboard From here you can respond to action items manade approved tudies and create new study submissions This item will reflect the number of items with preview requested changes Select this item to Submissions access all pre review requiring my requests signature The pre review requests are sorted by two categories My Submissions studies in which you are the PI or Study Contact and Submission for studies listing me as KSP Dashboard Submissions Studies Home Submissions in Pre review ES ubmissions for studies listing me as KSP Submissions in Pre review Q Study Title IRB Last Updated J Type PI Status Umbrella Test IRB 141738 Autonomic Angiotensin 1 7 150093 4 1 2015 NEW STUDY Kristin Straznicky REQUES
20. this selection Respond to Data and Safety Monitoring Report investigator s Brochure IB WITH changes in safety Consent Form changes Protocol changes Changes to recruitment materiais Submission of new documents all questions and save ag to continue the submission Does this amendment involve ionizing radiation ves wst provide vaise No NIA Does this amendment change the billing plan Yes Mus prov ce vaie No N A a Save Making Changes to the IRB Application In the IRB application wizard review each tab and make changes as necessary The changes made will be tracked under each item Since the application builds based on the information input some new questions may appear as you make revisions Include answers to each new question that appears and save your changes before moving on to the next section of the application Version Date 04 29 2015 38 Main Amendment Funding Application Research Activities Procedures and Schedule of Events for Study Participants Document Uploads Submit Reviev VS f Summary Please check all that apply to your study and Behavioral Observation Study Type and describe each below Performance Site must prowide value 2 a zai Information Surveys Interviews Questionnaires Document and Artifact Collection Study Purpose and Description Research Activities sore oe D Procedures and sed to Schedule of Events for Study Participants Data an
21. this manual Review all tabs for completeness and submit the continuing review in the Submit tab The submission will now route for signature before being sent to the IRB for review Continuing Review 4 3 2015 DRAFT Submission ID STRAZNKL04032015105547 Main Continuing Review Funding Application Document Uploads Submit Reviews Your submission is ready to be submitted Click the submit button to start the signature process Once all required parties have signed off on the submission it will be sent to the IRB for review Debug info The Continuing review has now been routed for signature The IRB will receive the submission after the Principal Investigator signs the submission Submissions that are awaiting signature Submissions in route can be located in the submissions drop down menu at the top the screen Version Date 04 29 2015 44 Submitting an Adverse Event On the Dashboard Approved Studies can be found in the list at the bottom of the screen Approved studies for which you are the PI Study Coordinator or Faculty Advisor are found on the My Studies tab This is the default view for the dashboard Studies for which you are listed as KSP are found on the Studies listing me as KSP tab Submissions Studies Welcome mem This is your investigator dashboard From here you can respond to action items manage approved studies and create new study submissions Training expires in oO 35 HCN Submissions
22. 067 HDL Function in Human Disease 150058 4 1 2016 Test Expedited 140050 Retrospective Review of Coagulation 150087 4 1 2016 Test Study A randomized study of the effect of chocolate 150103 4 2 2016 New Tools for Assessing Fracture Risk 150110 4 5 2016 IRB 130808The Establishment of the Genotype Phenotype 150113 4 5 2016 Investigating immune responses in patients with advanced 150109 4 8 2016 Test A multi center randomized prospective open label 150145 4 8 2016 Version Date 04 29 2015 7 Studies listing me as KSP will display only studies in which you are listed as other KSP not PI Study Contact or Faculty Advisor My studies Studies listing me as KSP i Approved Studies Study Title IRB Study Contact Study Expiration ECOGGIEA2131 A Phase and Randomized Double Blinded 150014 1 21 2016 Test Standard 140026 A Phase 1 Study to Evaluate the 150080 4 1 2016 Test Repository 140916 IRMH Recruitment Repository 150071 4 1 2016 Grant Review Test 140279 Cardiac structure and function 150068 4 1 2016 Grant Review Test 140067 HDL Function in Human Disease 150058 4 1 2016 Test Expedited 140050 Retrospective Review of Coagulation 150087 4 1 2016 Test Study A randomized study of the effect of chocolate 150103 4 2 2016 New Tools for Assessing Fracture Risk 150110 4 5 2016 IRB 130808The Establishment of the Genotype Phenotype 150113 4 5 2016 Investigating immune responses in patien
23. 148 y wir 4 8 2016 Days 7 iS y Mii 5 Y NCT ID ClinicalTrials gov registry number The PI Study Coordinator and Faculty Advisor if applicable identified in the Info tab will be the first to populate into the Key Study Personnel KSP tab Version Date 04 29 2015 19 Hutchins Erin L Under the Current KSP tab begin typing the name email or VUnetID in the Add another search field You will be required to enter credentials pager number role in project and whether the KSP will be accessing Protected Health Information These fields must be completed in order to advance to the subsequent sections of the Application Wizard Repeat this process until you have identified all of the individuals that will help in the conduct of your research IRB test 150036 MEL 1460 Stand Up To Cancer Consortium IRB 150148 PI Vigil Karen whether the member of Select the role in the Info Approved Documents Submissions Create Submission Please list your staffs project highest degree level CurrentKSP Jf History If someone does not at have a degree you Pager numbers will be auto filled if available If we cannot find one for a Clinical KSP is KSP who has a pager Non Clinical accessing please provide the number in case of Investigator urgent issues amp Print may enter N A Training VUNetiD First Name Last Name Department Credentials Phone Page
24. 29 2015 29 How to Retract a Submission You may choose to retract a submission if you wish to make additional edits or if you wish to delete the submission all together Please note you can only retract submissions that have not been formally submitted to the IRB Only once a submission has been routed for additional signatures such as those from a department chair and or a division chief signature shall it be retracted To retract the submission after it has been signed off on by the PI select the Submissions dropdown menu at the top of the screen and click the Submissions in Route button Dashboard Submissions Studies Drafts Submission signature successful Requiring my signature Pre review requests CAL responses E I ve S Submissions In route Submissions l ve signed Pi Status O e Tr a PENDING DEPT CHAIR SIGNATURE 4 21 2015 NEW STUDY SUBMITTED 4 16 2015 CONTINUING REVIEW SUBMITTED 4 15 2015 NEW STUDY SUBMITTED 4 9 2015 NEW STUDY SUBMITTED 4 8 2015 NEW STUDY SUBMITTED 4 8 2015 NEW STUDY SUBMITTED 4 6 2015 NONCOMPLIANCE WITH THE SUBMITTED PROTOCOL Locate the submission you wish to retract by selecting the study title of that submission Dashboard Submissions Studies Home Submissions In Route My submissions Submissions for studies listing me as KSP Submissions In Route Q Study Title IRB Last Updated 7 Type PI Status New
25. 3 2648 www mc tedu rb April 2 2015 RE IRB 150061 Test Repository 140841 Idiopathic Pulmonary Fibrosis Prospective Outcomes IPF PRO Registry Dear E Er Submission Reviews Updated On Meeting Date Committee Review Type Review Outcome Letter HS1 Full Committee Approve Pending Changes Download CAL Version Date 04 29 2015 62 Once the CAL is downloaded review the changes and concerns expressed by the Committee in the letter Changes requested within the Wizard can be addressed by clicking the tab corresponding with the concern Vanderbilt IRB Dashboard Submissions Studies Home Submissions Submission Test Repository 140841 Idiopathic Pulmonary Fibrosis Test Repository 140841 Idiopathic Pulmonar Fibrosis g Reviews Main KSP Funding Application Document Uploads Submit Test Repository 140841 Idiopathic Pulmonary Fibrosis Prospective Outcomes IPF PRO Registry Latest IRB Review Info Committee concerns regarding this submission can be found in the Committee Action Letter below Please review the letter and select the corresponding tabs at the top of this page to begin addressing these concerns Download CAL Vanderbilt Universi Institutional Review Board 504 Oxford House Nashville Tennessee 37232 4315 615 322 2918 Fax 615 343 2648 vwawwme vanderbilt edu irb April 2 2015 Please limit your changes to only those requested by the Committee If the IRB has not requested an
26. 3 4 5 2016 Investigating immune responses in patients with advanced 150109 4 8 2016 Test A multi center randomized prospective open label 150145 4 8 2016 Test Using patient data to transform care and improve 150133 4 8 2016 Version Date 04 29 2015 53 If you see the study that the non compliance with the protocol is related to click the study title to go to the study page If you cannot find the appropriate study you can use the search field by typing the IRB number sponsor number part of the title or another relevant piece of study information Submissions Studies Welcome This is your investigator dashboard From here you can respond to action items manage approved studies and create new study submissions Training xpires in O 35 x Submissions Submissions Draft i requiring my requiring a CAL submissions signature response e 2739 d d My studies Studies listing me as KSP Study Title IRB Study Contact Study Expiration Jz ECOGGIEA2131 A Phase and Randomized Double i 150014 1 21 2016 tandard 140026 A Phase 1 Study to Evaluate the 150080 4 1 2016 t Repository 140916 IRMH Recruitment Repository 150071 4 1 2016 Grant Review Test 140279 Cardiac structure and function 150068 4 1 2016 Grant Review Test 140067 HDL Function in Human Disease 150058 4 1 2016 Test Expedited 140050 Retrospective Review of Coagulation 150087 4 1 2016 Test Study A randomized study of the effect of chocola
27. 5 VIGILKM Karen Vigil SYSTEM N A Version Date 04 29 2015 22 Adding a Funding Source Indicate whether the study is funded by external support VICTR funding support use of VICTR facilities internal funds or not funded Main KSP Funding Application Document Uploads Submit Reviews Funding Questions Indicate whether the study involves check all that apply W External Support of any kind funding drug supplies equipment or personnel from Government Foundation or Industry LJ VICTR funding support or use of VICTR facilities LJ Internal funds O No funds Please specify this study s funding sources E Bay i Marie ie peret a vk Next specify the study s funding source by clicking the Add Funding Source button Add Funding Source Funding Type Department Funds Donor Gift Federal Foundation Funder Industry Personal Funds VICTR To add a funding source for your study select the funding type within the dropdown menu Version Date 04 29 2015 23 Add Funding Source Funding Type DeparmentFunds Funder Vanderbilt Y Add the funder for your research and select Accept ard Submissions Studies v bjehi lpi E p hy UM y Funding Questions Funding Sources Indicate whether the study involves check all that apply DEPARTMENT FUNDS 4 W External Support of any kind funding drug supplies equipment or personnel from Government Foundation or Ind
28. Creating an NCP Report ccccccccccssseeececeeeeeceeeceeeeecececaeaseceeseeaaeeeesessaaeeeesssaageeeessaaaaes 55 Completing the NCP FOrin ccccccccssseseceeceeseceeecseeeceeecseeseeeeseeaaeeessesaaseeeseeuaeeeeesaaaass 57 PU AC TIN FINS inturusccataimawncecmeactemaunentnnannenteneeterRadaieneRiadeteciesadteutants deamiediamatentaanstessdarntansyerntecase 58 Electronic Signatures ce cetestetaianetaasansen tants noamsncien taeda ayinesdcarshentapadeccinnetewiaratecadenentneuniaaus 59 Submitting a Response to a Committee Action Letter CAL ccccccceesseeeeeeeeeaeeeeeeeeaaeees 60 Assigning NCT and Business Officer Information ccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaaaaaas 66 Frequently Asked QUESTIONS ccceccccccceeeeceeecceeesceeeeeaessceeessauseeeeesuaaeceesseaueeeeesseaaeeeeessaaeeeessssaaeeeess 68 SS Sat Or CIS sessrrerre ni aneian e ara EE ENTE E E E EE T O EOE EEA 70 Version Date 04 29 2015 2 Introduction Welcome to the Vanderbilt University Institutional Review Board s new electronic submission system called DISCOVR e the Data Integrated Study Console of Vanderbilt s Research Enterprise Phase allowed researchers to access basic study information as well as their human subjects training continuing education status Phase II allowed researchers to complete an IRB submission online including the ability to use electronic signatures Every type of Submission previously sent in
29. DISCOVR e USER MANUAL Vanderbilt University Human Research Protection Program Johnson Dena M Welcome Dena This is your investigator dashboard From here you can respond to action items manage approved studies and create new study submissions Create a new study Training expires in o ITN Drant N submissions R gt 2061 S Pre review Submissions Submissions requiring a CAL response requests requiring my signature My studies Studies listing me as KSP b Approved Studies Q Study Title IRB PI Study Contact Study Expiration J Test study 3 051201 Johnson Dena M Beadies Jenni 1 32007 Phase Il study test 5 test test test 040302 Berlin Jordan D Johnson Dena M 2 8 2009 Test Study 02062012 Dena 120005 Johnsen Dena M 4 18 2014 j this study for more CAL testing changed for 140018 Boeing Chris Briggs Don 11 29 2015 David Hillers Test Study 150118 Hiller David A Johnson Dena M 4 6 2016 RB test 150036 MEL 1460 Stand Up To Cancer nsortium 150148 Vigil Karen Hutchins Erin 4 8 2016 MEL1451 A Phase 1b 2 Multicenter Open label 150003 Turner Chasiety Dena Radiation Administrative review Approve HSC 120031 Berlin Jordan D Johnson Dena M 9 jg V A Table of Contents mMiroducton and COV GIVI OW esanaren vacansadieneciaunsteaneads Aaa AEE Raia PAA OROAR AA ANE asap PATE NATERA ENE RAKAA AR 3 LOJ INO MNE y SIOM saae e ia ea i Ei 4 imv stigator DAS AN Oh sssini inei ainia aii ideiei
30. Study Title NEW STUDY PENDING DEPT CHAIR SIGNATURE Locate the submission you wish to retract by selecting the study title of that submission discovere vanderbilt edu Version Date 04 29 2015 30 Click the Retract Submission button and then select OK on the confirmation prompt to continue with the submission retraction process a a 5 5 The page at https irbtest mc vanderbilt edu says SH i Dashboard Submissions Studies Are you sure a Home Submissions In Route Submission New Study Title A OK Cancel New Study Title Main KSP Funding Application Document Uploads Signature Reviews Study Details ID Study Title New Study Title Status PENDING DEPT CHAIR SIGNATURE Principal Investigator Study Coordinator Department Chair Division Chief Student PI No cee G Signature History Principal Investigator Signed by on 4 29 2015 at 8 33am Department Chair not yet signed Your submission should now be located in your Drafts Submissions view within your Investigators Dashboard Dashboard Submissions Studies New Study Title has been retracted and sent back to draft status Home Draft Submissions Create a new study submission Draft Submissions Q Study Title IRB Last Updated Type PI Status New Study Title 4 29 2015 NEW STUDY 4 28 2015 NEW STUDY ar 4 23 2015 CONTINUING REVIEW Your submission should now be located free s 4 99
31. Submissions Draft ae ae ear Days requining my requiring a CAL submissions 3 signature response A 2730 Y A Se b Approved Studies Study Title IRB Study Contact Study Expiration Jz ECOGGIEA2131 A Phase and Randomized Double Blinded 150014 1 21 2016 Test Standard 140026 A Phase 1 Study to Evaluate the 150080 4 1 2016 st Repository 140916 IRMH Recruitment Repository 150071 4 1 2016 Grant Review Test 140279 Cardiac structure and function 150068 4 1 2016 Grant Review Test 140067 HDL Function in Human Disease 50058 4 1 2016 Test Expedited 140050 Retrospective Review of Coagulation 4 1 2016 Test Study A randomized study of the effect of chocolate 4 2 2016 New Tools for Assessing Fracture Risk 4 5 2016 IRB 130808The Establishment of the Genotype Phenotype 5 4 5 2016 Investigating immune responses in patients with advanced 150109 4 8 2016 Test A multi center randomized prospective open label 150145 4 8 2016 Test Using patient data to transform care and improve 150133 4 8 2016 Version Date 04 29 2015 45 If you see the study that the adverse event is related to click the study title to go to the study page If you do not see the appropriate study you can use the search field by typing the IRB number sponsor number part of the title or another relevant piece of study information Submissions Welcome This is your investigator dashboard From here you can respond to action items manage
32. TING PRE REVIEW CHANGES By i All of your submissions that are currently in pre review will appear on this page This view can be sorted by study title IRB date type and Principal Investigator Select the study title for the submission you wish to respond to The pre review tab in the study submission will list general issues and comments A summary of changes requested to the IRB application will also appear Version Date 04 29 2015 33 Test Expedited new study Main KSP Funding Application Document Uploads Pre review Reviews D Test Expedited new study Submission Type NEW STUDY Status REQUESTING PRE REVIEW CHANGES ID STRAZNKL03302015124639 This item shows general comments and changes requested to attached Please address the following items documents General issues and comments Last update 3 30 2015 2 57pm A pre review has been conducted on this submission Please respond to the requested changes Please keep in mind these are pre review recommendations and you are free to disagree with any suggested change If you do not wish to make a suggested revision please consider providing a rationale for review by the committee subcommittee Please submit an Assent Form for chidren 7 12 Issues and comments on your application Subject Population s This item gives a summary of changes f individuals under the age of 18 will be enrolled on this study please select Children minors Recruitment e Pleas
33. Version Date 04 29 2015 51 If the Adverse Event form is not complete you will see this error message on the Submit tab Click the Adverse Event tab to complete the missing information click save and then click the Submit tab again Vanderbilt IRB Dashboard Submissions Studies Home Study IRB 150080 Test Standard 140026 A Phase 1 Study to Evaluate the Submission ADVERSE EVENT Test Standard 140026 A Phase 1 Study to Evaluate the IRB 150080 PI Adverse Event Unanticipated Problem 4 3 2015 DRAFT Submission ID Your submission is not yet complete e Adverse Event Adverse Event fom is incomplete Once the required information is complete you will be able to click the Submit button on the Submit tab Dashboard Submissions Studies Home Study RB 150080 Test Standard 140026 A Phase 1 Study to Evaluate the Submission ADVERSE EVENT Test Standard 140026 A Phase 1 Study to Evaluate the IRB 150080 PI Adverse Event Unanticipated Problem 4 3 2015 DRAFT a Submission ID Main Adverse Event Funding Application Document Uploads Submit Reviews Your submission is ready to be submitted Click the submit button to start the signature process Once all required parties have signed off on the submission it will be sent to the IRB for review Debug info After a signature from the PI the submission is automatically routed through the Wizard and ultimately ends its journey at
34. ai 5 SUBMITTING a New StUQY sxcscxccescscxdccsncqnacencedeceeuenenscosdsenscctdneracetdeOyanentsaeedsidndescceinosdentenetaccstceyes 16 Creating a New Study ccccccsesscccccesssseeeeceeeeeceeecseaseceeessaeueceeesseaeeeeesseaseeeseeeaeeeesssaagss 16 Selecting a Principal Investigator eee ccccceeeeceeeeeeeeeeeeeaeeeeeeeeseaeeeeeeeseaeeeeeesaaaeeeeessaaess 17 Selecting a Study Contact Faculty Advisor cccccccccceccsssseceeeeeeeeeeeeeeseeeeeeeesaaeeeeeeeaaaees 17 Selecting Signatory Officials ccccceccccccsseeeceeceeeeeceeecseeseceeeeseaeeeeeeseeeeeeeseaeeeesseaaees 17 Selecting and Managing Key Study Personnel ccccccssssseeceeeeeeeeeeeseeeeeeeeseaeeeeeeeeees 18 Adding a Funding Source ccccccccseeecececeeeeceeeceaeseceeeeseeeeceeseueeeeeesseaeseeeessaaeeeeeessaaeeeess 23 Completing the Wizard Application c cccccccccccsseeeceeeceeeeeeeeecaeeeeeeeesaeaeeeeesaaeeeeesaaaess 26 PAC TIN SINS aeeie EEr E E I E E E A E E E E 27 Electronic Signatures esata cnteniatictiadneecientapassnelaeassioniefasieeisueiientdaskamiavestonttuctsineeiienincesaelas 29 How to Retract a Submission nnnnnnnnnnnnnnrrnennrnrrrrnrrrrrrrrrrrsrrrrrrrrrrrrrrrrrrrrrrrrnn 30 How to Respond to a Pre Review cccccecc cece en ee eee e ence eee eee e ease eae eeae neat enaeenaeenanags 33 Submitting an Amendment to an Approved Study ccccceceeeeeeeeeeeeeeeaeeeeeeeeeeeeeeaaeneeeeee
35. aluate the 150080 41 2016 Test Repository 140916 IRMH Recruitment Repository 150071 4 1 2016 Version Date 04 29 2015 12 Studies listing me as KSP corresponds with the Studies listing me as KSP button BESLUI Submissions Studies My studies Studies listing me as KSP tive studies investigator dashboard From here you can respond to action items meremme NA Create new study submissions Training expires in Submissions Submissions requiring my requiring a CAL signature response View IRB Training My studies Studies listing me as KSP i Approved Studies Study Title IRB Study Contact Study Expiration ECOGGIEA2131 A Phase and Randomized Double Blinded 150014 1 21 2016 Test Standard 140026 A Phase 1 Study to Evaluate the 150080 4 1 2016 Test Repository 140916 IRMH Recruitment Repository 150071 4 1 2016 Clicking Inactive will display a list of your inactive studies BESSI Submissions Studies My studies Studies listing me as KSP Welcor investigator dashboard From here you can respond to action items Create a new study nactive studies manag rr eE aNd Create new study submissions Training expires in 12 397 Pre review Submissions Submissions Draft requiring my requiring a CAL submissions signature response iew IRB Training My studies Studies listing me as KSP b Approved Studies Study Title IRB Study Contact Study Expiration J2 ECOGGIEA2131
36. andard 140026 A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Panitumumab in Children with Solid Tumors Study VICCPED 1395 Amgen 20050252 Prinicipal Investigator Status Approved Committee HS1 Study Coordinator None Listed IRB Number 150080 Study Expiration Date 4 1 2016 345 days until study expires 4 1 2016 Update NCT ID ClinicalTrials gov registry number Click Adverse Event Clicking this button will create the Adverse Event submission Home Approved Studies Study Test Standard 140026 A Phase 1 Study to Evaluate the Test Standard 140026 A Phase 1 Study to Evaluate the IRB 150080 PI Info KSP Approved Documents Submissions Create Submission Create a new submission for this study Amendment Non compliance with Protocol Adverse Event Continuing Review Version Date 04 29 2015 47 Complete the first form and click Save and Continue This will move you to the Adverse Event tab Click Save will save your information but will keep you on the Main tab Dashboard Submissions v Studies Home Draft Submissions Submission Test Standard 140026 A Phase 1 Study to Evaluate the y Test Standard 140026 A Phase 1 Study to Evaluate the IRB 150080 PI Adverse Event Unanticipated Problem 4 13 2015 DRAFT Submission ID Adverse Event Document Uploads Submit Reviews Is this a Cancer Center related AE that has been completed in OnCore No Yes
37. articipant Age Identify Drug Biologic Device Treatment Intervention musi provide value Provide a detailed description of the event problem including the timing of study treatment dosing or intervention Also remember to include start and stop dates of relevant research interventions Indicate the timing of the event problem in relation to the research intervention For example 1 Research drug was started at 10 00 2 Participant began wheezing at 10 15 3 Drug stopped at 10 16 4 Participant continued to have labored breathing and was treated with inhalers 5 Respirations relaxed 6 Breathing sounds clear by 11 00 and participant denied further complaints with breathing 7 The sponsor was notified of the event problem and the participant was withdrawn from further participation in the study List 3 4 keywords describing the event problem g loss of confidentiality nausea vomiting Provide a description of the event problem including the timing of the study treatment dosing or intervention with start and stop dates of relevant research interventions must provide value This study choose one has a Data and Safety Monitoring Committee Board DSMC DSMB or Data Safety Monitor DSM must provide value does not have a Data and Safety Monitoring Committee Board DSMC DSMB or Data Safety Monitor DSM unknown Version Date 04 29 2015 49 Once all required questions are complete click the Save button
38. ation Submit Reviews Attach Study Files Drag and Drop Standard A Protocol IRB Application Continuing Review Application A Consent Assent Document Grant A Investigators Brochure Advertisement Recruitment Study Measures 4 Study Materials Other To upload attach a document the standard way click the Standard button to activate it Click the Choose File button under the Attachment section to search your computer for the item you would like to attach Select the item and then click the Open button The item you selected will be automatically attached to your submission for review Next indicate the type of study document by clicking the one of the choice from the dropdown menu Once the type of study has been selected click Upload to attach the document to your submission Attachments should be uploaded one at a time If you have a group of consent forms you may zip them and attach the zip file as one attachment However we ask that you do not provide a zip file for all of your study documents Version Date 04 29 2015 21 Main KSP Funding Application Document Uploads Submit Reviews Attach Study Files Attachment Choose File No file chosen Type of study document Select Document Type Select Document Type Protocol IRB Application Continuing Review Application Consent Assent Document S Grant Investigators Brochure Advertisement Recruitment Study Measures Study Materials Ot
39. bmissions Submissions for studies listing me as KSP CAL Response Submissions Study Title Type Status Test Repository 140841 Idiopathic Pulmonary Fibrosis NEW STUDY DRAFT lf the title is too long the title will be truncated Hover the cursor over the truncated title to display the entire title Dashboard Submissions Studies Home CAL Response Submissions My submissions Submissions for studies listing me as KSP CAL Response Submissions Study Title Type Status Test Repository 140841 Idiopathic Pulmonary Fibrosis 150061 NEW STUDY DRAFT Test Repository 140841 Idiopathic Pulmonary Fibrosis Prospective Outcomes IPF PRO Registry Version Date 04 29 2015 60 Select the appropriate response item Dashboard Submissions Studies Home CAL Response Submissions My submissions Submissions for studies listing me as KSP CAL Response Submissions Study Title IRB JF Type Status Test Repository 140841 Idiopathic Pulmonary Fibrosis 150061 NEW STUDY DRAFT From the Review Screen there are three options to download the CAL 1 Click the Download CAL button above the letter Dashboard Submissions v Studies v Home Submissions Submission Test Repository 140841 Idiopathic Pulmonary Fibrosis Test Repository 140841 Idiopathic Pulmonary Fibrosis Reviews Main KSP Funding Application Document Uploads Submit lk Test Repository 140841 Idiopathic Pulmonary Fibrosis Prospective O
40. button Amendment 4 15 2015 DRAFT Submission ID STRAZNKL04152015143003 Main Amendment Funding Application Document Uploads Submit Reviews Your submission is ready to be submitted Click the submit button to start the signature process Once all required parties have signed off on the submission it will be sent to the IRB for review Debug info The amendment submission is now ready for the Principal Investigator s signature If you are the Principal Investigator a page will appear listing the responsibilities of the PI Please review these responsibilities At the bottom of the page sign the document by inputting your Vanderbilt password If the submission is being made by key study personnel the amendment will route for the Pl s signature The PI will receive an email notifying him or her that a submission is pending signature The link in this email can be used to access the submission and signatory page This submission can also be accessed for signature under the Submissions Awaiting my Signature item on the dashboard Principal Investigators Assurance Statement certify that the information provided in this application is complete and accurate understand that as Principal Investigator have ultimate responsibility for the conduct of the study the ethical performance of the project the protection of the rights and welfare of human participants and strict adherence to the study protocol and any stipulations imposed
41. by hard copy e g new study continuing review adverse event etc could be submitted with a few clicks of your mouse Another benefit of the DISCOVR e portal allowed researchers to view their approved documents online including Committee Action Letters CALs Final Approval Letters FALs and approved and date stamped consent forms Phase III of this project includes an intuitive investigator dashboard and the implementation of an IRB application wizard that incorporates supplemental form information like vulnerable populations in research repositories radiological procedures for research and waiver into one cohesive document Future phases may include additional features and capabilities as the system grows and users provide the development team with feedback and suggestions The IRB plans to continuously monitor the system to make enhancements and improvements where needed As you work your way around DISCOVR e please feel free to share your thoughts comments and suggestions by sending an email to the address shown below discovere vanderbilt edu Overview The DISCOVR e portal is a web based system You can log in and submit documents or check the status of a previous submission anywhere in the world where you have a connection to the Internet This section of the manual will give you an overview of the system and provide highlights of its capabilities To access the system please visit the Vanderbilt IRB website at hitos
42. col 4 IRB Application Continuing Review Application Consent Assent Document A Grant Investigators Brochure A Advertisement A Recruitment Study Measures Study Materials A Other Submission Documents There are no documents for this study Once all documents are uploaded Click Continue PI Noncompliance with Protocol 4 13 2015 DRAFT Submission ID Main Noncompliance Document Uploads Submit Reviews Attach Study Files Drag and Drop Standard Protocol 4 IRB Application Continuing Review Application Consent Assent Document Grant A Investigators Brochure Advertisement Recruitment Study Measures Study Materials Other Submission Documents There are no documents for this study Version Date 04 29 2015 58 On the Submit tab if the required information is not complete you will get an error message Click on the Non Compliance tab to answer incomplete questions Dashboard Submissions Studies Home Draft Submissions Submission Test Standard 140026 A Phase 1 Study to Evaluate the Test Standard 140026 A Phase 1 Study to Evaluate the IRB 150080 PI Noncompliance with Protocol 4 Submission ID Main Noncompliance Document Uploads Submit Reviews Your submission is not yet complete e Noncompliance Noncompliance form is incomplete Once the form is complete click the Submit button Dashboard Submissions Studies Home Draft Submissi
43. contract Yes No Does the study involve the use of Vanderbilt hospital facilities or assays related to human samples tissue Yes No Does this study have an associated billing plan Yes No Back gt Save and Continue Version Date 04 29 2015 25 Add Funding Source Completing Your Wizard Application You will begin your Wizard application by answering the questions found in each application tab Your response s will prompt additional selections to populate regarding your submission As you work through your submission you will notice a progress bar building across the top of the page You can click any of application headings on the left side of your screen to go back and view or edit your submission New Study Title Main KSP Funding Application Document Uploads Submit Reviews ft Summary Download Application Shii Typs atid Application Submission Summary Application is saved and ono n Performance Site Progress Information 4f complete Study Purpose and Description f complete Research Activities Procedures and Schedule of Events for Study Participants f complete Data and Safety 4 complete Data and Safety Subject Population s 4 compl complete Subject Population s Once all of the tabs appropriate for your research are complete you have finished your Wizard application Incomplete submissions can be saved and returned to later These submissions can be
44. currently approved study documents that are affected by the amendment This will aid the review process In the Document Uploads tab upload any new or revised study documents by dragging and dropping each document into the corresponding category The Other category is available for any documents that do not fit a specific category Alternatively you can change the upload method to a standard selection method in the right corner of this tab Amendment 3 31 2015 DRAFT Submission ID STRAZNKLO3312015133028 Application Document Uploads Submit Reviews Main Amendment Funding Attach Study Files A Protocol IRB Application Drag and Drop m me revised P Consent Assent Document Grant documents into file type Advertisement A Recruitment Study Materials Other Submission Documents File Name Type Revised ICD docx Consent Assent Document Delete selected files Download all Drag and Drop Standard A Continuing Review Application Investigators Brochure The upload method can be Study Measures changed to the standard format Created On Created By File Size 3 31 2015 STRAZNKL 11 KB Select continue after all affected documents have been attached The Submit tab will notify you if any items are incomplete This is a good time to review each section of the submission and ensure that all necessary changes have been made When you are Version Date 04 29 2015 39 ready to move forward select the submit
45. d must provide value Number enrolled since the beginning of the study must provide value Has the adverse event profile experienced by Yes participants differed from that expected since the N most recent IRB continuing review rsat must provide value Adverse event is defined here as any untoward or undesired out f the research includ bot z wW non serious events expected and unexpected events and events related and unrelated to the researc Attach any necessary documents i e Consent forms Progress reports for the continuing review in the Document Uploads tab Submit both a stamped and clean copy of all consent documents for review and approval Version Date 04 29 2015 43 Continuing Review 4 3 2015 DRAFT Submission ID STRAZNKL04032015105547 Main Continuing Review Funding Application Document Uploads Submit Reviews Attach Study Files Drag and Drop Standard Drag and A Protocol IRB Applicati Continuing Review Applicati rotoco ication ontinuing Review Application Drop S p 2 g p documents ex ICD A Consent Assent Document Grant Investigators Brochure publications into the Advertisement Recruitment Study Measures corresponding buckets 4 Study Materials Other Submission Documents There are no documents for this study The Reviews tab allow you to review the currently approved study information To make changes to this information please see the amendment submission section of
46. d Safety DATA COLLECTION STORAGE OF Subject DATA SPECIMEN S AND OR ISSUES OF 2 CONFIDENTIALITY Population s Describe the procedures that will be utilized to protect the privacy of the research participant Recruitment Include who will have access to the researc information for example video audio recordings Attaching new or revised Documents Nephrology lab shares secure server Deception Withholding or Postponing Medications Treatments or Imposing other Restrictions Audio Video Recording Sham Procedure Specimen Collection and or Storage t Data Collection any device e g personal computer d of st dividual WeniMiable health hou Please complete the questions below and describe each research activity and or procedure shown Revise selections and text as necessary for amendment The system will track the changes to the application as you move through the application The de identified data will be stored and saved on a server housed on an approved Vanderbilt Data Center within the Nephrology lab shares secure server in a password protected excel file The server is user and password protected The key to the patient identifying information will be stored in a separate password protected excel fle saved on a server housed in an approved Vanderbilt Data Center within the No patient information wil be stored on a personal computer Dr Kensinger will have access to the information Please track changes to all
47. dvisor will receive an email which contains a link to the letter and study associated documents What if delete the email link that tells me the status of my submission You can always access the status of any submission by logging into DISCOVR E and viewing information in the approved study dashboard Click on the approved study link in the investigator dashboard to locate statuses of submissions What is the difference between the IRB Application within the DISCOVR E system and the other IRB application on the Forms link that find on your website The IRB Applications within the DISCOVR E portal now include all the questions necessary for review of standard expedited exempt non human non research determinations repository and grant reviews Supplemental forms including forms for vulnerable populations investigator held IND s devices radiation et cetera have also been added to this application wizard Other documents required for review can be uploaded into the submissions portal using a convenient drag and drop feature There is a standard browse to file feature available as well These documents will include consent forms protocol investigator s brochure recruitment materials measures etc You will also be able to manage KSP in DISCOVR E without submitting amendment The only key study personnel changes that require an amendment are changes to PI Study Contact and Faculty Advisor As long as an individual has completed
48. e approved studies and create new study submissions Submissions requiring my signature My studies Studies listing me as KSP b Approved Studies Q Study Title IRB PI Study Contact Study Expiration Jz A Phase 1b Open Label Dose Finding Study to Evaluate 150007 Straznicky Kristin 1 21 2016 3 13 2015 CAL testing Preliminary Assessment 150035 Straznicky Kristin 3 11 2016 Expedited Study Test Study of Prophylaxis 150055 Straznicky Kristin 3 30 2016 Do those with generalized neck pain also have undiagnosed 150077 Straznicky Kristin 3 31 2016 On the Create Submission tab select to create a Continuing Review Dashboard Submissions Studies Straznicky Kristin Leigh Home Approved Studies Study Expedited study tes a7 IRB 150100 PI Straznicky Kristin KSP Approved Documents Submissions Create a new submission for this study Amendment Non compliance with Protocol Adverse Event Continuing Review Select the Continuing Review tab to complete the Continuing Review wizard application In the first item select the study type The corresponding continuing review application will begin to build based on this item Version Date 04 29 2015 42 Main Continuing Review Document Uploads Submit Reviews Continuing Review Information Please indicate the status of the research as it is currently Status of the Research Please indicate the type of continuing review Standard or Expedited Study Select th
49. e confirm if flyers will be used for recruitment requested to the IRB electronic application Pre Review History Status Changed By Changed On Emailed On Comments REQUESTING PRE REVIEW CHANGES Straznicky Kristin Leigh 3 30 2015 2 57pm 3 30 2015 2 57pm A pre review has been conducted Re submit to Analyst Select the application tab to respond to pre review suggestions All sections of the application with suggested changes will be highlighted Select each section to view the specific items with change requests Home Submissions in Pre eview Submission Test Expedited new study Test Expedited new study Main KSP Funding Application Document Uploads Pre review Reviews EPEE Pre Review Comments amp Download Application Performance Site Information Subject Population s v complete Check all that apply Complete the appropriate supplemental information as applicable Study Purpose o lf individuals under the age of 18 will be enrolled on this study please select Children minors 2015 03 20 14 53 53 STRAZNKL and Description Recruitment complete e Please identify ALL applicable recruitment methods Research o Please confirm if flyers will be used for recruitment 2015 03 30 14 46 17 STRAZNKL Activities Procedures and Schedule of Events for Study Participants v complete Data and Safety v complete Subject Population s complete comments Recruitment v complete F comments
50. e for obtaining and maintaining current IRB approvais letters of cooperation when applicable Sign Here Please enter your e password in order to electronically sign this submission The system will process this submission upon signing The amendment submission will now be routed for signature to the Faculty Advisor if applicable for your study Each of these individuals will have an alert on his or her dashboard to notify that a submission is pending signature in addition to receiving an email notification This item can be used to access the submission review the amendment and sign at the bottom of the page Version Date 04 29 2015 40 New Tools for Assessing Fracture Risk Submission Type NEW STUDY Status PENDING FAC ADVISOR SIGNATURE ID TURNERC903312015135019 Pi Name Chasiety Tumer Pi VUNetID TURNERCS Review Type Standard Study Type Health Science Faculty Advisor s Assurance Statement By my signature as sponsor on this research application certify that the student or quest investigator is knowledgeable about the regulations and policies governing research with human participants and has sufficient training and experience to conduct this particular study in accordance with the approved protocol In addition agree to meet with the student investigator on a regular basis to monitor study progress Should problems arise during the course of the study agree to be available personally to supervise the student inves
51. e pay type The DaS ENY continuing review Wizard Grant or Umbrela Review application will build questions based on your response Conflict of Interest Disclosure Is there a potential conflict of interest for the Yes Principal Investigator or key personnel N The PI is responsible for assuring that no o arrangement has been entered into where the value of the ownership interests will be affected by the outcome of the research and no arrangement has been entered into where the amount of compensation will be affected by the outcome of the research Assessment should include anyone listed as Principal Investigator or other researc n on page 1 of this application Please note that ownership described below apply to the aggregate ownership of an individual investigator his her spouse domestic partner and depend children Do not consider the combined ownership of all investigators must provide valve Save The continuing review application for standard expedited studies and repositories will ask for the current status of the research Additional questions will appear based on this information Provide an answer to each question and save your answers Incomplete submissions can be saved and returned to later These submissions can be accessed via the drafts submission button on your dashboard The system will not allow an incomplete submission to be submitted or routed for signature Please indicate the status of the research as it i
52. ees 37 Making Changes to the IRB Application cccccccssseecceeceeeeeeeeeeeeeeeeeesseaeeeeeesaaeeeeeeeas 38 Attaching New or Revised Documents cccccseeeceeeeeeeeeceeeeaeeeeeeeeseaeeeeeeseaaeeeesssaaeeees 39 Retracing ah AMGENOMENT ccs irricusiecvaarecacnineuevainanansccneladearievadueiteeieuncmavacinuteladnersannancaiaad 41 Submitting a CONTINUING REVIEW cc ccc cece cece cece eee e eee eee eee eaten ee eee tease eee sane ease etaaes 42 Completing the Continuing Review Wizard ccccccccccceccseeeeeeeecaeeeeeeeeeseeeeeeseeaeeeeeseaaaess 43 Attaching New or Revised Documents cccccssesecececeeeeeceeeeaeeeeeeesssaeeeeeseaaeeeeeessaaeeeess 43 EIECHOMIC DIOM AWTS scrisori E A O ashamed 44 Submitting an Adverse Event cccccccccsssseceeeceeeeeceeecceeeeceeeceeeeeeeeessaeaeeeeesseaeeeeessaaeeeeeseaaaees 45 Creating an Adverse Event Report ccccccccccccecsseeceeeeseeeeeeeeeeeeeeeeeesaeeseeessseaaeeeeesaaaess 47 Completing the Adverse Event FOrmMm cccccccccsseseeeeeeeeeeeeeeeeueeseeeeesaeaeeeessaaseeeesaaaees 48 PR AC MINA SINS ctacd sais imaatneairduns gestern ar veauad qisleeeatodsriind E pumctoad aiveveddin camomaesoeces teats 50 Electronic SiIgNatUl ES tvassnivnvenassesetaeaecuuiscensesudnediaatinswsuianuadaus poesdivacdeubeisevaanaeeeisaniusesiedysncdes 52 Submitting a Non Compliance with the Protocol NCP ssssssssssssssessessssnnnnssenssrnnnrrrressrnnnn 53
53. es A Protocol Attach any documents with requested changes Advertisement Track changes to all documents Study Materials A Consent Assent Document Submission Documents File Name Assent Form doc PRO docx Delete selected files Pre review Reviews Drag and Drop Standard IRB Application Continuing Review Application Grant A Investigators Brochure Recruitment Study Measures Other Type Created On Created By File Size Consent Assent Document 3 30 2015 STRAZNKL 36 KB Protocol 3 30 2015 STRAZNKL 920 KB Download all Once all pre review suggestions have been responded to return to the pre review tab Review the requested changes and ensure that all necessary information has been included Select the green button at the bottom of the tab to submit the pre review response Version Date 04 29 2015 35 Main KSP Funding Application Document Uploads Pre review Reviews Test Expedited new study pe NEW STUDY atus REQUESTING PRE REVIEW CHANGES ID STRAZNKLO3302015124639 ss the following items nd comments Last update 3 30 2015 2 57pm A pre review has been conducted on this submission Please respond to the requested changes Please keep in mind these are pre review recommendations and you are free to disagree with any suggested change If you do not wish to make a suggested revision please consider providing a rationale for review by the committee subcommittee Please subm
54. ffect the integrity of the study must provide value Please provide an explanation of the plan to prevent future Noncompliance with the Protocol events must provide value Has the PI been notified of the Noncompliance with the Protocol and received a copy of this report must provide value Has this Noncompliance with the Protocol been reported to the sponsor must provide value If you have additional documents to upload click the Document Uploads tab If you have no additional documents to upload click the Submit tab Dashboard Submissions v Studies v Home Draft Submissions Submission Test Standard 140026 A Phase 1 Study to Evaluate the l Test Standard 140026 A Phase 1 Study to Evaluate the IRB 150080 PI Noncompliance with Protocol 4 13 2015 DRA Submission ID Main Noncompliance Document Uploads Submit Reviews Noncompliance with Protocol Information Is this a Cancer Center related report of Yes Noncompliance with the Protocol that has been completed in OnCore No must provide value Explain why or how the Noncompliance with the Protocol occurred must provide value Version Date 04 29 2015 57 On the Document Uploads tab upload additional documents using either the Drag and Drop or Standard method PI Noncompliance with Protocol 4 13 2015 DRAFT Submission ID Main Noncompliance Document Uploads Submit Reviews Attach Study Files Proto
55. gov registry number P NCT012345678 Business Officer ce Version Date 04 29 2015 66 a T Home Studies Study ges f _ ay Ge Lae E ed n IRB E PI m Info KSP Approved Documents Submissions Create Submission Rees m memm ee Prinicipal Investigator a 342 days until study expires Status Approved Committee HS1 4 5 2016 Study Coordinator IRB Number Study Expiration Date 4 5 2016 NCT ID ClinicalTrials gov registry number Business Officer _ P Tumer Chasiety TURNERCS ED i T Home Studies Study Sy aa Ey eo poe bomu a oo E m IRB PI a Info KSP Approved Documents Submissions Create Submission Prinicipal Investigator 2 342 days until study expires Aopoa 4 5 2016 Committee HS1 Study Coordinator IRB Number Study Expiration Date 4 5 2016 NCT ID ClinicalTrials gov registry number NCT012345678 Business Officer Turner Chasiety TURNERC9 ce Version Date 04 29 2015 Frequently Asked Questions In this section you will find some questions most commonly asked by people using DISCOVR E As additional questions come in we will update this part of the manual If you have any questions not addressed here please send them to discovere vanderbilt edu How do I know when my submission has been approved When the review of your submission has been finalized the Principal Investigator Study Coordinator and or Faculty A
56. her Th Drag and Drop Standard If you would like to delete an attachment click the box next to item you wish to remove then click the Delete Selected Files button Submission Documents File Name Type O ICD pdf Consent Assent Document mM IND Letter pdf Other PRO _pdf Protocol Survey pdf Study Measures Patient Card pdf d Delete selected files Back Study Materials Download all To continue with submission process click the Continue button Version Date 04 29 2015 Created On Created By 4 16 2015 4 16 2015 4 16 2015 4 16 2015 4 16 2015 File Size 879 KB 879 KB 879 KB 879 KB 879 KB 28 Your submission is now ready to be submitted Click the Submit button to route your submission for the appropriate signatures Home Draft Submissions Submission New Study Title New Study Title Main KSP Funding Application Document Uploads Reviews Your submission is ready to be submitted Click the submit button to start the signature process Once all required parties have signed off on the submission it will be sent to the IRB for review a Debug info As other signatures are obtained the submission is automatically routed through the submission portal and ultimately ends its journey at the IRB Once it arrives at the IRB the submission will be assigned an IRB number and routed to one of the teams for review Version Date 04
57. ing Status and when that training will expire Wizard The computer programming that takes you step by step through DISCOVR E R E Version Date 04 29 2015 70
58. ion 4 1 2016 Grant Review Test 140067 HDL Function in Human Disease 1 4 1 2016 Test Expedited 140050 Retrospective Review of Coagulation 1 4 4 2016 Test Study A randomized study of the effect of chocolate 1 4 2 2076 New Tools for Assessing Fracture Risk 4 5 2016 IRB 130808The Establishment of the Genotype Phenotype 15011 4 5 2016 Investigating immune responses in patients with advanced 150109 4 8 2016 Test A multi center randomized prospective open label 150145 4 8 2016 Version Date 04 29 2015 15 Submitting a New Study Submitting a new study through the DISCOVR E portal does not require any special training The following guide is a basic set of instructions and illustrations to help you in the submission process If you have not logged into the system yet please follow the instructions provided above Click on the Create a New Study button on the right side of the page to start the process Dashboard Submissions Welcome This is your investigator dashboard From here you can respond to action items Create a new study manage approved studies and create new study submissions DEL Loo d Submissions Submissions requiring my requiring a CAL submissions signature response f View IRB Training My studies Studies listing me as KSP b Approved Studies a Study Title IRB PI Study Contact Study Expiration 4 8 2016 After selecting the Create a New Study button you will
59. ipant if applicable Promptly report to the IRB Data Safety and Monitoring Boards sponsors and appropriate federal agencies any adverse experiences and all unanticipated problems involving risks to human subjects or others that occur in the course of the research in accordance with Vanderbilt University IRB Policies and Procedures If unavailable to conduct this research personally as when on sabbatical leave or vacation will arrange for another investigator to assume direct responsibility for the study Either this person is named as another investigator in this application or will notify the IRB of such arrangements Promptly providing the IRB with any information requested relative to the project Promptly and completely complying with an IRB decision to suspend or withdraw approval for the project Obtaining Continuing Review approval prior to the date the approval for the study expires understand if I fail to apply for continuing review approval for the study will automatically expire and all study activity must cease until RB approval is granted Maintain accurate and complete research records including but not limited to all informed consent documents for 3 years from the date of study completion Maintain any authorization documents to use or disclose PHI for 6 years from the date authorization is obtained and Fully informing the VU IRB of all locations in which human participants will be recruited for this project and being responsibl
60. issions ae Days requiring my requiring a CAL G 2732 A X Nee signature response View IRB Training CAL responses corresponds with the red Submissions requiring a CAL response button Dashboard Submissions Studies Drafts Requiring my signature oe kaa ral This is your investigator dashboard From here you can respond to action items re review requests s wed studies and create new study submissions Submissions In route Training expires in Submissions I ve signed Submissions Submissions requiring my requiring a CAL signature response This dropdown also holds views for Submissions in route and Submissions I ve signed Clicking Submissions in route will display a list of submissions pending signature from another person Dashboard Submissions Studies Drafts Requiring my signature os p AN ral This is your investigator dashboard From here you can respond to action items Pre review requests a ived studies and create new study submissions CAL responses Submissions In route Submissions I ve signed o 39 Submissions Submissions Draft requiring my requiring a CAL submissions signature response Training expires in View IRB Training Version Date 04 29 2015 11 Clicking Submissions I ve signed will display a list of all submissions signed by you Dashboard Submissions Studies Drafts Requiring my signature ral This is your investigat
61. it an Assent Form for chidren 7 12 Issues and comments on your application Subject Population s e If individuals under the age of 18 will be enrolled on this study please select Children minors Recruitment e Please confirm if flyers will be used for recruitment Pre Review History Status Changed By Changed On Emailed On Comments REQUESTING PRE REVIEW CHANGES Straznicky Kristin Leigh 3 30 2015 2 57pm 3 30 2015 2 57pm A pre review has been conducted Re submit to Analyst A dialogue box will appear giving you an opportunity to include comments to the analyst Including comments is optional To complete the pre review response select the blue button to re submit to the analyst Pre Review Comments After checking that Enter Comments Below all Comments are optional changes comments ee have been addressed insert any comments you would like to include and then re Cancel E submit to the Analyst The pre review response is now submitted The submission will be processed and moved forward for review by the IRB Version Date 04 29 2015 36 Submitting an Amendment to an Approved Study All amendments will be submitted using the same submission process The administrative amendment and standard amendment forms will no longer be utilized Changes to key study personnel no longer require the submission of an amendment To initiate an amendment submission select from the study in your dashboard and
62. ive open label 50145 4181 21 Version Date 04 29 2015 5 Notice the number in the top right corner of each button This number indicates how many items are requiring that particular action The first button yellow is the pre review requests button The number in the corner indicates how many submissions require a pre review response Clicking this button will allow you to access these studies Welcome This is your investigator dashboard From here you can respond to action items manage approved studies and create new study submissions Training expires in Submissions Submissions Draft requiring my requiring a CAL submissions signature response View IRB Training The next button blue is the Submissions Requiring My Signature button The number in the corner indicates how many submissions require your signature before moving forward Clicking this button will allow you to access these studies Welcome sa This is your investigator dashboard From here you can respond to action items manage approved studies and create new study submissions Training expires in Submissions Submissions Draft requiring my requiring a CAL submissions signature response View IRB Training The next button red is the Submissions Requiring a CAL Response button The number in the corner indicates how many submissions require a response to a CAL Clicking this button will allow you to access these studies Welcome This is y
63. l leave or vacation will arrange for an alternate Faculty Advisor to assume direct responsibility in my absence and will advise the IRB by letter in advance of such arrangements will ensure that the student investigator promptly provides the IRB with any information requested relative to the project will ensure that the student investigator promptly and completely complies with an IRB Decision to suspend or withdraw approval for the project and i will ensure that the student investigator obtains continuing review approval prior to the date approval for the study expires Further understand that if the student investigator fails to apply for continuing review approval for the study will automatically expire and must ensure that all study activity ceases until IRB approval is obtained Sign Here Please enter your e password in order to electronically sign this submission The system will process this submission upon signing Retracting the Amendment Prior to Submission If any signatories PI advisor chair or chief would like to make changes before the submission is sent to the IRB for review the amendment can be placed in draft mode by retracting it on the main page of the amendment After any changes are made the amendment can be submitted by signing at the bottom of the signatory page Home Submissions Pending My Signature Submission Investigating immune responses in patients with advanced Investigating im
64. mune responses in patients with advanced Main KSP Funding Application Document Uploads Signature Reviews ID TURNERC903312015112747 Study Title Investigating immune responses in patients with advanced melanoma treated with immune based therapy Status PENDING DEPT CHAIR SIGNATURE Principal Investigator TURNERCS Study Coordinator VIGILKM Department Chair STRAZNKL Division Chief Student PI Yes Student Type Emphasis Faculty Advisor CYRC O Retirat Submission G Signature History Principal Investigator Signed by Turner Chasiety on 3 31 2015 at 1 43pm Faculty Advisor Signed by Cyr Ciara on 3 31 2015 at 4 06pm Department Chair not yet signed The Amendment is now submitted You can track the progress of the amendment by accessing your submissions on your main Wizard page You will receive a notification if a pre review is necessary Please see the Respond to a Pre Review section of the manual for assistance in making your response Version Date 04 29 2015 41 Submitting a Continuing Review Submit a continuing review for continuing studies or to close a study with the IRB To start a continuing review submission access your approved studies and select the appropriate study Note that any studies with approval expiring in the next 8 weeks will be highlighted red Dashboard Submissions Studies Welcome Kristin This is your investigator dashboard From here you can respond to action items Create a new study manag
65. ns Submissions Draft requests requiring my requiring a CAL submissions signature response My studies stucies listing me as KSP Approved Studies Q Click on the study Study Title IRB PI Study Contact Study Expiration l title to add remove test test test test test test test 050615 Hiller David A Hutchins Erin 10 11 2006 Metabolic and CD4 T Cell Dysregulation in Post Transplant 150013 Hutchins Erin 1 21 2016 IRB test 150036 MEL 1460 Stand Up To Cancer Consortium 150148 Vigil Karen Hutchins Erin 4 8 2016 Test IRB 130393 A Phase 2 Randomized Double Blind 150151 Hutchins Erin Johnson Tiara B 4 9 2016 Highlighted studies are expiring in the next 8 weeks Version Date 04 29 2015 18 Click on the KSP tab Dashboard Submissions v Home Approved Studies Studies Study IRB test 150036 MEL 1460 Stand Up To Cancer Consortium IRB test 150036 MEL 1460 Stand Up To Cancer Consortium IRB 150148 PI Vigil Karen Info Approved Documents Submissions Create Submission lk IRB test 150036 MEL 1460 Stand Up To Cancer Consortium Genomics Enabled Medicine for Melanoma G E M M Using Molecularly Guided Therapy for Patients with BRAF Wild Type BRAFwt Metastatic Melanoma Prinicipal Investigator Status Click on the KSP Committee tab Study Coordinator IRB Number Study Expiration Date PR ER 345 days until study expires 4 8 2016 HS3 Erin Hutchins a 150
66. ons Submission Test Standard 140026 A Phase 1 Study to Evaluate the Test Standard 140026 A Phase 1 Study to Evaluate the IRB 150080 PI Noncompliance with Protocol 4 13 2015 DRAFT Submission ID Main Noncompliance Document Uploads Submit Reviews Your submission is ready to be submitted Click the submit button to start the signature process Once all required parties have signed off on the submission it will be sent to the IRB for review Debug info After a signature from the PI the submission is automatically routed through the Wizard and ultimately ends its journey at the IRB where it will be sent to a team to start the review process Version Date 04 29 2015 59 Submitting a Response to a Committee Action Letter CAL On the dashboard the Submissions Requiring a CAL Response button will display a number indicating the number of outstanding items awaiting a response from you Dashboard Submissions Studies Welcome i This is your investigator dashboard From here you can respond to action items manage approved studies and create new study submissions Training expires in oO Submissions f Days y T A N a requiring a CAL signature response Es ate J My studies Studies listing me as KSP i Approved Studies Clicking this button will show you a list of these outstanding items Dashboard Submissions Studies Home CAL Response Submissions My su
67. ontact the IRB Each team has a Regulatory Compliance Analyst that has been involved with the development of the Wizard system These analysts are there to help you with any issues or difficulties you may encounter Version Date 04 29 2015 65 Assign an NCT number and or Business Officer The Info tab for your approved study has been designed to allow you to enter information regarding your National Clinical Trial registry number if you are required to register your study or assign a Business Officer for your study The Business Officer is responsible for the financial aspects of the study with regard to payment of IRB invoices If you need to add update either item just follow the step by step instructions below Home Approved Studies Study a T fy Bl fq a IRB Pl Info KSP Approved Documents Submissions Create Submission b E m Prinicipal Investigator Status Approved Committee HS1 Study Coordinator IRB Number Study Expiration Date 4 5 2016 342 days until study expires 4 5 2016 NCT ID ClinicalTrials gov registry number Business Officer Study updated successfully Home Studies Study ms IRB PI Info KSP Approved Documents Submissions Create Submission h gt g Prinicipal Investigator 342 days until study expires Status Approved 4 5 2016 Committee HS1 i Study Coordinator gt le N IRB Number i Study Expiration Date 4 5 2016 Days A NCT ID ClinicalTrials
68. or currently approved documents as well as a tab for Documents History for a historical view of all previously approved study documents If you need to see a document s associated with one particular submission click on the link beside the study item that you wish to review to download the document Where can I find my list of key study personnel since it is no longer included in the IRB application When you log in to DISCOVR E simply click the link for the study you wish to review in the Approved Studies dashboard Click on the KSP tab to review the KSP currently listed on the study You can manage KSP as well as Business Officer on this tab You will not that there are new required fields prior to saving the information These include the credentials of your KSP their role in the project and whether they will be accessing PHI while working on the study Credential information will help the IRB Committees assess the appropriateness of study staff The role in project has been limited to three selections Research Non clinical Research Clinical and Sub Investigator When you click on the KSP tab you will see current KSP To add new KSP start by searching for their name email or VUnetID in the Add another field Select the appropriate individual and enter the required information Our system has been programmed to automatically enter an individual s phone number and pager You may make edit
69. or dashboard From here you can respond to action items ived studies and create new study submissions Pre review requests CAL responses Submissions In route a ek Training expires in Submissions I ve signed 39 Submissions Submissions Draft requiring my requiring a CAL submissions signature response View IRB Training Clicking Studies will display another drop down menu This menu holds items corresponding with the studies lists on the Dashboard as well as Inactive studies Dashboard Submissions Studies My studies Studies listing me as KSP Welcor ee investigator dashboard From here you can respond to action items nactive studies mana goppreeea nnna NA Create new study submissions Training expires in o 39 Submissions Submissions Draft ay Days f View IRB Training requiring my requiring a CAL submissions signature response Dashboard Submissions Studies investigator dashboard From here you can respond to action items Create a new study studies vewnans NA create new study submissions Training expires in Submissions Submissions Draft requiring my requiring a CAL submissions signature response few IRB Training My studies Studies listing me as KSP b Approved Studies Study Title IRB Study Contact Study Expiration Jz ECOGGIEA2131 A Phase and Randomized Double Blinded 150014 1 21 2016 Test Standard 140026 A Phase 1 Study to Ev
70. our investigator dashboard From here you can respond to action items manage approved studies and create new study submissions Training expires in Submissions Submissions Draft requiring my requiring a CAL submissions signature response View IRB Training Version Date 04 29 2015 6 The final button purple is the Draft Submissions button The number in the corner indicates how many submissions have been started but have not been completed or sent to the IRB Clicking this button will allow you to access these studies Welcome This is your investigator dashboard From here you can respond to action items manage approved studies and create new study submissions Training expires in Submissions Submissions Draft requiring my requiring a CAL submissions signature response View IRB Training Lists of approved studies are located below the buttons for quick access My studies is the default view on the dashboard This view shows studies in which you are listed as PI Study Contact or Faculty Advisor Studies listing me as KSP b Approved Studies Study Title IRB Study Contact Study Expiration j ECOGGIEA2131 A Phase and Randomized Double Blinded 150014 1 21 2016 Test Standard 140026 A Phase 1 Study to Evaluate the 150080 4 1 2016 Test Repository 140916 IRMH Recruitment Repository 150071 4 1 2016 Grant Review Test 140279 Cardiac structure and function 150068 4 1 2016 Grant Review Test 140
71. ploads Submit Protocol IRB Application Continuing Review Application Consent Assent Document Grant A Investigators Brochure Advertisement Recruitment A Study Measures Study Materials Other Submission Documents There are no documents for this study Previously Submitted Documents When all documents have been uploaded click the Continue button at the bottom of the page This button will bring you to the Submit tab Attach Study Files Drag and Drop Standard Protocol IRB Application Continuing Review Application Consent Assent Document Grant A Investigators Brochure A Advertisement A Recruitment A Study Measures Study Materials Other Submission Documents There are no documents for this study Previously Submitted Ma Version Date 04 29 2015 64 When you are sure every concern listed in the CAL has been addressed click the Submit button Home Submissions Submission Test Repository 140841 Idiopathic Pulmonary Fibrosis Test Repository 140841 Idiopathic Pulmonary Fibrosis Reviews Main KSP Funding Application Document Uploads Submit Please check to make sure you have addressed all changes requested in the Committee Action Letter When this is complete you can submit your updated submission for signature and review Debug info Once the CAL has been submitted it will be routed for signature by the PI If you need assistance please do not hesitate to c
72. ption Dashboard Submissions Studies Home Study IRB 150080 Test Standard 140026 A Phase 1 Study to Evaluate the Submission ADVERSE EVENT Test Standard 140026 A Phase 1 Study to Evaluate the IRB 150080 PI Adverse Event Unanticipated Problem 4 3 2015 DRAFT Submission ID Main Adverse Event Funding Application Document Uploads Submit Reviews N Attach Study Files Protocol A IRB Application A Continuing Review Application Consent Assent Document Grant Investigators Brochure Advertisement Recruitment Study Measures A Study Materials Other Submission Documents There are no documents for this study When all documents have been uploaded click the Continue button at the bottom of the page This button will bring you to the Submit tab Dashboard Submissions Home Study IRB 150080 Test Standard 140026 A Phase 1 Study to Evaluate the Submission ADVERSE EVENT Test Standard 140026 A Phase 1 Study to Evaluate the IRB 150080 Pl Adverse Event Unanticipated Problem 4 3 2015 DRAFT Submission ID Main Adverse Event Funding Application Document Uploads Submit Reviews Attach Study Files Drag and Drop Standard Protocol IRB Application Continuing Review Application A Consent Assent Document Grant A Investigators Brochure A Advertisement Recruitment Study Measures A Study Materials Other Submission Documents There are no documents for this study
73. r Role in Project HIPAA Expire VIGILKM Karen Vigil Human Research Protection MD 615 875 9905 Principal Investigator YES Rot 2022 HUTCHIEL Erin Hutchins Human Research Protection MD 615 322 2918 Study Coordinator YES 06 Oct 2022 JOHNSTB7 Tiara Johnson Human Research Protection MD 615 322 2918 Research Clffiical v YES 7 03Feb 2026 HUBBARTM Tyler Hubbard Human Research Protection MD 615 875 8716 Research C nical v YES EENE 2022 aRRINGJG James Arrington Human Research Protection BA 615 875 8961 Research Non Clinical YES Y 31 Mar x CYRC Ciara cyr Human Research Protection 615 875 9704 Select a Role v Select 21 Oct 2022 Add another Hit the Save KSPs button to save your changes Sergi C Hit the Save KSP s button to save your changes Version Date 04 29 2015 20 To remove a person from the list of KSP click the trash icon next to the VUNetID of that person s name The individual will be removed from your KSP listing Z IRB test 150036 MEL 1460 Stand Up To Cancer Consortium IRB 150148 PI Vigil Karen Click on the trash icon of the KSP member you Info KSP Approved Documents Submissions Create Submission wish to remove from the CurrentKSP History study Add another amp Print Accessing PHI Training VUNetID First Name Department Credentials Phone Pager Role in
74. s currently Status of the Research Please indicate the type of continuing review Standard or Expedited Study Data or Specimen Repository Grant or Umbrella Review Please indicate the status of the study No participants have been enrolled to date Recruitment and or enrollment of new participants or review of records specimens continue Study is no longer enrolling but participants still receive research related interventions e g still receiving treatment obtaining blood draws etc Answers to subsequent questions will pre longer enrolling and participant have completed research related interventions The study remains active only for long term j j j S ollment i closed participant h leted all ch related int tions and long term follow up h build the application so that only the ep ra empl a ha fora mgmt T a healers necessary questions for your study specimens Close the study Enrollment and follow up are complete and no further contact with participants records or specimens is anticipated Data queries are complete type and enrollment status will appear reset faximum number of particip complete the study must provide value Please provide ALL information requested below NOTE These numbers should reflect participants enrolled by the VU Principal Investigator and or additional personnel involved in the study Number enrolled means enrolled beyond screening Number enrolled within the last IRB approval perio
75. s the event been reported to the Sponsor musi provide value Please add any additional comments After saving if you need to submit additional documents click the Document Uploads tab at the top of the page If no other documents need to be submitted click the Submit tab Home Study IRB 150080 Test Standard 140026 A Phase 1 Study to Evaluate the Submission ADVERSE EVENT Test Standard 140026 A Phase 1 Study to Evaluate the IRB 150080 PI Adverse Event Unanticipated Problem 4 3 2015 DRAFT Submission ID Main Adverse Event Funding Application Document Uploads Submit Reviews Adverse Event Unanticipated Problem Information does not require the signature of the Principal Investigator Is there a MedWatch Report to attach Yes must provide value No Date of Event must provide value Participant Identifier NOTE DO NOT include a name or ANY personal identifiers Participant Age Identify Drug Biologic Device Treatment Intervention must provide value List 3 4 keywords describing the event problem e g loss of confidentiality nausea vomiting Provide a description of the event problem including the timing of the study treatment dosing or intervention with start and stop dates of relevant research interventions must provide value Version Date 04 29 2015 50 On the Document Uploads tab documents can be submitted with either the Drag and Drop option or the Standard o
76. s to phone number if the number automatically pulled from People Finder is not the best contact number Make sure to click Save KSPs before navigating away from the page The History tab shows everyone who has been listed as KSP on the study the date they were added or removed if applicable and the information on who added or deleted the individual Both views are easily printable in your browser Version Date 04 29 2015 69 Glossary of Terms Committee Action Letter CAL A letter from the IRB that needs a response from the Principal Investigator DISCOVR E Data Integrated Study Console of Vanderbilt s Research Enterprise E Submission An electronic study submission sent to the IRB for review Final Approval Letter FAL A letter from the IRB stating that a submission has received approval KSP Key Study Personnel People responsible for helping with the conduct of a study Log In Use your VUnetID and password to enter the DISCOVR E system My Studies The view within DISCOVR E where you can view studies where you are listed as the PI Faculty Advisor or Study Contact Principal Investigator The individual responsible for the conduct of a study Portal Another name for the DISCOVR E system Studies listing me as KSP The tab within DISCOVR E where you can view studies in which you are listed as KSP View IRB Training The dashboard in DISCOVR E where you can view your current IRB Train
77. te 2015 v Apr v 15 M To select a new Principal Investigator Study Coordinator or Faculty Advisor the person must already be listed as a KSP on this study Edit KSP for this study Before changing the PI study coordinator or faculty advisor use the link to add the individual as key study personnel Change Principal Investigator from Straznicky Kristin to Select from current key study personnel Y Change Study Coordinator from to Select from current key study personnel v Change Faculty Advisor Select from current key study personnel Y This tab is also used to change the Principal Investigator Study Coordinator or Faculty Advisor This change must be made as an amendment after the individuals are added as Key Study Personnel Completing the Amendment Tab Check the boxes for each document being revised or change being made as a part of this amendment Additional questions will appear based on these selections Please answer each item and save to continue the submission Appl cation ocument ploads Submit Amendment Information Please indicate what is being changed with this Indicate what items are amendment being changed as a part nest provide wale Study Title Grant Title Increase in total subject numbers accrual Investigators Brochure IB with NO change in safety data or the currently approved consent documentis of this amendment Additional questions will appear based on
78. te 150103 4 2 2016 New Tools for Assessing Fracture Risk 150110 4 5 2016 IRB 130808The Establishment of the Genotype Phenotype 3 4 5 2016 Investigating immune responses in patients with advanced 0 4 8 2016 Test A multi center randomized prospective open label 5 4 8 2016 Test Using patient data to transform care and improve 5013 4 8 2016 Version Date 04 29 2015 54 From the study page click Create Submission Home Approved Studies Study Test Standard 140026 A Phase 1 Study to Evaluate the est Standard 140026 A Phase 1 Study to Evaluate the IRB 150080 PI Info KSP Approved Documents Submissions Create Submission i Test Standard 140026 A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Panitumumab in Children with Solid Tumors Study VICCPED 1395 Amgen 20050252 Prinicipal Investigator Status Approved Committee HS1 Study Coordinator None Listed IRB Number 150080 Study Expiration Date 4 1 2016 345 days until study expires 4 1 2016 Update NCT ID ClinicalTrials gov registry number Click Non compliance with Protocol This will create the non compliance with the protocol submission Home Approved Studies Study Test Standard 140026 A Phase 1 Study to Evaluate the est Standard 140026 A Phase 1 Study to Evaluate the IRB 150080 PI Info KSP Approved Documents Submissions Create Submission Create a new submission for this study
79. the IRB where it will be sent to a team to start the review process Version Date 04 29 2015 52 Submitting a Non Compliance with the Protocol On the Dashboard Approved Studies can be found in the list at the bottom of the screen Approved studies for which you are the PI Study Coordinator or Faculty Advisor are found on the My Studies tab This is the default view for the dashboard Studies for which you are listed as KSP are found on the Studies listing me as KSP tab Submissions Studies Welcome This is your investigator dashboard From here you can respond to action items manage approved studies and create new study submissions Training expires in Submissions Submissions Draft requiring my requiring a CAL submissions signature response b Approved Studies Study Title IRB Study Contact Study Expiration Jz ECOGGIEA2131 A Phase and Randomized Double Blinded 150014 1 21 2016 Test Standard 140026 A Phase 1 Study to Evaluate the 150080 4 1 2016 Test Repository 140916 IRMH Recruitment Repository 150071 4 1 2016 Grant Review Test 140279 Cardiac structure and function 150068 4 1 2016 Grant Review Test 140067 HDL Function in Human Disease 150058 4 1 2016 Test Expedited 140050 Retrospective Review of Coagulation 150087 4 1 2016 Test Study A randomized study of the effect of chocolate 150103 4 2 2016 New Tools for Assessing Fracture Risk 150110 4 5 2016 IRB 130808The Establishment of the Genotype Phenotype 15011
80. tigator in solving them e will ensure that all investigators and key study personnel have completed the VU human subjects training program will ensure that the project is performed only by qualified personnel according to the approved IRB application e will ensure that the student investigator does not implement any changes to the approved IRB application or informed consent document without prior IRB approval in accordance with VU IRB policy except in an emergency if necessary to safeguard the well being of human participants and will report to the IRB within 5 days of such change will ensure that the student investigator only obtains legally effective informed consent from human participants or their legally responsible representative only the currently approved date stamped informed consent documents for human participants are used and a copy of the Informed consent is provided to the participant will ensure that the study investigator promptly reports any unanticipated problems involving risks to participants or others or any serious adverse events whether anticipated or not to the IRB in accordance with Vanderbilt University IRB Policies and Procedures will assume the responsibility for the accurate documentation investigation and follow up of all possible study related adverse events and unanticipated problems involving risks to participants if will be unavailable to supervise this research personally as when on sabbatica
81. ts with advanced 150109 4 8 2016 Test A multi center randomized prospective open label 150145 4 8 2016 These lists are automatically sorted by Study Expiration If a study is within 8 weeks of expiration it will appear highlighted in red Lists can be sorted by Study Title IRB Number PI and Study Contact by clicking on the heading My studies Studies listing me as KSP b Approved Studies Study Title IRB Study Contact Study Expiration Jz ECOGGIEA2131 A Phase and Randomized Double Blinded 150014 1 21 2016 Test Standard 140026 A Phase 1 Study to Evaluate the 150080 4 1 2016 Test Repository 140916 IRMH Recruitment Repository 150071 4 1 2016 Grant Review Test 140279 Cardiac structure and function 150068 4 1 2016 Grant Review Test 140067 HDL Function in Human Disease 150058 4 1 2016 Test Expedited 140050 Retrospective Review of Coagulation 150087 4 1 2016 Test Study A randomized study of the effect of chocolate 150103 4 2 2016 New Tools for Assessing Fracture Risk 150110 4 5 2016 IRB 130808The Establishment of the Genotype Phenotype 150113 4 5 2016 Investigating immune responses in patients with advanced 150109 4 8 2016 Test A multi center randomized prospective open label 150145 4 8 2016 Version Date 04 29 2015 8 You can also search for studies in these lists by entering study identifiers such as PI or Study Contact name parts of the study title or IRB number into the
82. ure response View IRB Training Drafts corresponds with the purple Drafts button Dashboard Submissions Studies Requiring my signature s aires ral This estigator dashboard From here you can respond to action items Pre review requests O wed studies and create dy submissions CAL responses Submissions In route Training expires in Submissions I ve signed 42 Submissions Submissions requiring my requiring a CAL signature response View IRB Training Requiring my signature corresponds with the blue Submissions requiring my signature button Dashboard Submissions Studies Requiring my signature his is your investigator dashboard From here you can respond to action items Pre review requests dies and create new study submissions CAL responses Submissions In route T RE I Training expires in ubmissions I ve sign g 0 fim i Submissions Submissions Draft requiring my requiring a CAL submissions signature response View IRB Training Version Date 04 29 2015 10 Pre review requests corresponds with the yellow Pre review requests button Dashboard Submissions Studies Drafts Requiring my signature ral This is your investigator dashboard From here you can respond to action items ived studies and create new study submissions CAL responses Submissions In route Training expires in Submissions I ve signed 9 fin y Submissions Subm
83. ustry O VICTR funding support or use of VICTR facilities Vanderbilt O Internal funds LJ No funds Please specify this study s funding sources Is there a grant application or proposal required for the external support Yes No Will the external support require the signing of a written letter MOU agreementi contract Yes O No Does the study involve the use of Vanderbilt hospital facilities or assays related to human samps tissue O Yes No Does this study have an associated billing plan Yes O No Funding Sources Add Funding Source DEPARTMENT FUNDS Vanderbilt Version Date 04 29 2015 24 Once all funding related questions have been completed and you are ready to proceed with the creation of your new study submission click the Save and Continue button at the bottom of the form Main KSP Application Document Uploads Submit Reviews Funding Questions Funding Sources Indicate whether the study involves check all that apply DEPARTMENT FUNDS External Support of any kind funding drug supplies equipment or personnel from Government Foundation or Industry VICTR funding support or use of VICTR facilities Vanderbilt Internal funds No funds Please specify this study s funding sources EO L ur pst Is there a grant application or proposal required for the external support Yes No Will the external support require the signing of a written letter MOU agreement
84. utcomes IPF PRO Registry Latest IRB Review Info Committee concerns regarding this submission can be found in the Committee Action Letter below Please review the letter and select the corresponding tabs at the top of this page to begin addressing these concerns X Download CAL g Vanderbilt University 504 Oxford House Nashville Tennessee 37232 4315 615 322 2918 Fax 615 343 2648 www mc vanderbilt edu irb Institutional Review Board April 2 2015 Version Date 04 29 2015 61 2 Save the save button in the PDF viewer Test Repository 140841 Idiopathic Pulmonary Fibrosis Prospective Outcomes IPF PRO Registry Latest IRB Review Info Committee concerns regarding this submission can be found in the Committee Action Letter below Please review the letter and select the corresponding tabs at the top of this page to begin addressing these concerns XX Download CAL a Vanderbilt Universi Institutional Review Board 504 Oxford House Nashville Tennessee 37232 4315 615 322 2918 Fax 615 343 2648 vwww mc vanderbiltedu rb April 2 2015 Human Research Protection Prog mn mna A m RE IRB 150061 Test Repository 140841 Idiopathic Pulmonary Fibrosis Pre Kol Q Q CN m IPF PRO Registry 3 Click the Download CAL link at the bottom of the page under Submission Reviews Vanderbilt Universi Institutional Review Board 504 Oxford House Nashville Tennessee 37232 4315 615 322 2918 Fax 615 34
85. wizard once it is implememed You can also access the system by typing the following internet address into your browser https irb mc vanderbilt edu You may want to save this address in your list of favorites bookmarks This will bring you to the Login page To enter DISCOVR e enter your VUnetID and e password vUnetiD ePassword Version Date 04 29 2015 Investigator Dashboard Overview This is your Investigator Dashboard When you log in this is the first screen you will see From here you can access all of your studies and view submissions that require action from you Dashboard Submissio Welcome This is your investigator dashboard From here you can respond to action items manage approved studies and create new study submissions Training expires in Submissions Submissions requiring my requiring a CAL signature response re 2732 Sy q Days ta View IRB Training My studies Studies listing me as KSP b Approved Studies Study Title Study Contact Study Expiration J2 OGGIEA2131 A Phase and Randomized Double Blinded 1 1 21 2016 est Standard 140026 A Phase 1 Study to Evaluate the 1500 4 1 2016 t Repository 140916 IRMH Recruitment Repository 15 4 1 2016 Grant Review Test 140279 Cardiac structure and function 15 4 1 2016 Grant Review Test 140067 HDL Function in Human Disease 15005 4 1 2016 Test Expedited 140050 Retrospective Review of Coagulation 15 4 1 2016 Test Stud
86. www4 vanderbilt edu irb and click on the DISCOVR e link on the right hand section of the page When prompted enter your VUnetID and e password That s all it takes After logging in you will see your Investigator Dashboard This is your home page which shows all of your outstanding action items and approved studies The following pages will provide step by step screenshots for creating and responding to outstanding submissions as well as navigation tips for the site We plan to provide video tutorials following the rollout as a secondary training tool for the research community so check back often Version Date 04 29 2015 3 Log into the System You can access the system by going to the IRB website https www4 vanderbilt edu irb and clicking on the DISCOVR E link VANDERBILT HUMAN RESEARCH PROTECTION PROGRAM tA About Announcements On May 4 VHRPP will roll out an enhanced version of DISCOVR E that will streamline the sutenission process for the research community The new system includes many exciting new features not the least of which is an application wizard thet wil build your IRB application as you enter information in light of this we advise researchers who are planning to submit a new standard or expedited study that is not time sensitive to consider waiting unti after the rollout to submit This will save you time n the bong rum as all currently approved IRB applications will peed to be entered into the
87. y A randomized study of the effect of chocolate 151 4 2 2016 New Tools for Assessing Fracture Risk 151 4 5 2016 IRB 130808The Establishment of the Genotype Phenotype 151 4 5 2016 Investigating immune responses in patients with advanced 15 4 8 2016 Test A multi center randomized prospective open label 15 4 8 2016 Welcome This is your investigator dashboard From here you can respond to action items manage approved studies and create new study submissions Training expires in 1 Submissions Submissions LOO requiring my requiring a CAL signature se 9 gr ah 2732 M Days View IRB Training My studies Studies listing me as KSP b Approved Studies Study Title Study Contact Study Expiration J2 ECOGGIEA2131 A Phase and Randomized Double Blinded 5 1 21 2016 Test Standard 140026 A Phase 1 Study to Evaluate the 5 4 1 2016 Test Repository 140916 IRMH Recruitment Repository 5 4 1 2016 Grant Review Test 140279 Cardiac structure and function 5 4 1 2016 Grant Review Test 140067 HDL Function in Human Disease 5 8 41 2016 Test Expedited 140050 Retrospective Review of Coagulation 1 8 4 1 2016 Test Study A randomized study of the effect of chocolate 15011 4 2 2016 New Tools for Assessing Fracture Risk 0110 4 5 2016 IRB 130808The Establishment of the Genotype Phenotype 0113 4 5 2016 Investigating immune responses in patients with advanced 0109 4 8 2016 Test A multi center randomized prospect
88. y specific changes within the Wizard simply click the Document Uploads tab which is the tab where you can upload your cover letter to address each change requested by the Committee and any revised documents Vanderbilt IRB Dashboard Submissions Studies Home Submissions Submission Test Repository 140841 Idiopathic Pulmonary Fibrosis Test Repository 140841 Idiopathic Pulmonary Fibrosis Reviews Main KSP Funding Application Document Uploads Submit li Test Repository 1 241 Idiopathic Pulmonary Fibrosis Prospective Outcomes IPF PRO Registry Latest IRB Review Info Committee concerns regarding this submission can be found in the Committee Action Letter below Please review the letter and select the corresponding tabs at the top of this page to begin addressing these concerns X Download CAL Vanderbilt Universi Institutional Review Board 504 Oxford House Nashville Tennessee 37232 4315 615 322 2918 Fax 615 343 2648 vwwwmce vanderbilt edu irb April 2 2015 Version Date 04 29 2015 63 Please be sure to update the revision date and track all changes on any revised documents Documents can be submitted with either the Drag and Drop option or the Standard option Dashboard Submissions Studies Home Submissions Submission Test Repository 140841 Idiopathic Pulmonary Fibrosis Test Repository 140841 Idiopathic Pulmonary Fibrosis Reviews Main KSP Funding Application Document U

DISCOVR-e USER MANUAL Vanderbilt University Human

Contents

Download Pdf Manuals

Related Search

Related Contents