Hands-on Training for Velos Study-Setup Procedures
Contents
1. patient Only once Editable Blank This is a blank form to p Submit lt _ lt e Signature Click once only D Under the Study Setup tab under Associated Forms notice the existence of the form you just pulled into your study Note the status is work in progress and that the form is linked to the patient level Summary I ve rabt ns Admin Schedule EOE AT Motitications IETT Ei atus Reports Il Study Team Broadcast Form ssn ialbed Forms ams curmenthy asseciated wath this Sudy are Save to Status Library This is a blank form ta pull inte studies Patient Work In Progress H T Click on the blank form link to begin developing the form in your study E Start by renaming your form optional you may also designate if an e Signature is required for data entry eet the Form Add Fields Form Settings Form Name Blank Preview Blank lt This is a blank form to pull into studies Form Name Form Description Work In Progress gt Iv e Signature is Mandatory for this form s responses e Signature Form Status Submit Click once only Back to the Study Setup page Version 5 0 Check mark Date of Completion Comments Notes Check mark Date of Completion Comments Notes Check mark Date of Completion Comments Notes Released August 2010 Page 4 of 23 E Then navigate to the Add Fields tab2. icon and navigate to the Study Team tab Notice that Velos has automatically added you to the study team as Data Manager Click on the Access Rights link to discover the full range of privileges to the study data afforded the Data Manager Role To maintain your full rights to your study do not change your role on the study team OPTIONAL Practice adding study team members and assigning roles to your study team by clicking on the Add Edit Study Team Members link Adding study team members allows other users to see your study from their Velos homepage and access your study data To learn more about adding study team members assigning roles and access rights to study data please consult the Velos User Manual and query on Study Team Tab To learn more about Study Access Rights refer to HH10 Study Access Rights Table in the Velos User Manual x Summary Admin Schedule Study Setup Notifications Study Status Reports Study Number kwilsoni View S U ith to this Stud e ear haematite All 7 h iew Super Users with access to this Study Team ADD NEW ORGANIZATION ADD EDIT STUDY TEAM MEMBER L Organization User Name Role Access Rights Status University of Michigan Local Sample Size Track Study Status x Kay Wilson Data Manager Atcess Rights ights Active C H Remove from Team Check mark Date of Completion Comments Notes Check mark Date of Completion Comments No
3. Lo ewes Y Training 005 Enrolled kwilson1 University 001 Sigmond Freud 03 10 2010 Edit c PO a nE a LO i net a eh Dh Check mark Date of Completion B To link an enrolled patient to the study Calendar click on the Comments Notes Edit Calendar Date link to select the protocol calendar in your study and designate a patient start date Manage Patients gt gt Schedule Demographics Patient Profile itor Reports Pat ID 45 Pat Study ID 45 Age 29 years Gender Org University P Screening Enrollment Schedule Advers Study 276NO 07KW View Te Calendar No Associated Calendar Edit Calendar Date his patient has not been assigned to any Protocol Calendar Then generate a patient schedule by completing saving the following data entry screen Treatment Details The following fields must be filled in order to generate a schedule for the patient and track events Protocol Calendar My Study Calendar Qe Select the specific protocol calendar that the patient is assigned to for this study Patient Start Date Select Date from Calendar peee Patient s schedule will be generated based on this start date Calculate Schedule from the First Visit of the Calendar Template Calculate Schedule from a Visit other than the First Visit of the Calendar Template Select a Visit Selected Visit Read Only e Signature Sune Click once only Be sure to select a Date from the Calendar to designate this patient
4. Non Tabular section Repeat Fields 0 Fortial Mon Tabular line as previous field Image5 Form Preview of a Multiple Choice Field after adding a space break Has the patient or authorized representative signed informed consent Cyes FO No Date of Birth fiii Source Velos Form Manual page 77 J Once you are satisfied with your form finalize the form by updating the form status to Active To do this go to the Study Setup tab click on Work in Progress link in the Form Status column Summary f versions f Admin Schedule Ei p Notifications Study Status Study Number 26Novo7KW P Associated Forms Forms currently associated with this study are COPY AN EXISTING DISPLAY AND SEQUENCING OPTIONS Name Description Linked Tu Form Status Additional Demographics Additional Demographics Work In Progress H For each form change Form Status to Active and submit Manage Protocols gt gt Associated Forms gt gt Form Status Form Name Blank Please enter status details Form Status Active gt Form Start Date 03 03 2010 Select Date from Calendar Changed By Kay Wilson Select User Notes e Signature Back Submit Check mark Date of Completion Comments Notes Version 5 0 Released August 2010 Page 8 of 23 4 Copy a Basic Patient Study Calendar from the Calendar Library into your Study and modify appropriately A Inthe Study Setup tab scroll DOWN to Associated Cale
5. Select Enrolled from the Comments Notes Status drop down list and enter a Status Date Patient Study Status Patient ID 005001 Study Number kwilsoni Please enter Status details Status _ Enrolled Reason Select an Option Status Date Select Date W This is patient s current status in this study Notes l Enrollment Details Randomization Number Enrolled By Kay Wilson Select Uses Additional Information Patient Study ID 005 001 Training University Enrolling Site Fe In ee E Repeat the patient search Velos registration and enrollment process until at least 3 patients have been enrolled in your study Version 5 0 Released August 2010 Page 17 of 23 Q Link Your Enrolled Patients to the Study Calendar This links all forms in your study calendar to your patient Therefore the Patient ID will automatically be associated with each form A From My Homepage click on the P icon and then click on the a aa Completion patient study ID link of one of the patients whom you ve enrolled in your study Patient Search Search By Patients on Study kwilson1 Organization All Patient ID Enrolled On ALL gt Patient Study ID Patient Status All Enter Screening Enrollment details SELECT AN EXISTING PATIENT ADD A NEW PATIENT iy a Pagel of 1 pil Rows per page Showing 1 Study Enrolling a Pt F Name L Enrolled Last Pt Number Site Study Name Visit Visit status ID Status
6. 23 B Complete all mandatory fields in the Study Status screen enter your Check mark Date of Completion e Signature and click on the Submit button Comments Notes su mma ry Versi o ns Study Setu p Notificatio ns Ban VRS Study Number kwilsoni Study Start Date Study End Date Please enter status details Note that Organization is tree TEE a automatically filled Organization University of Michigan with your primary Status Type General organization name Study Status Active Enrolling Documented By Kay Wilson Select User Assigned To Select User Status Valid From 3 10 2010 ae Status Valid Until iii Meeting Date FA Review Board Select an Option Outcome Select an Option a El Notes IM This is Study s Current Status Signature Submit Click once only P Check mark Date of Completion Comments Notes icon when the current study status is C Notice the presence of the Active Enrolling The P icon provides a navigation link to enroll and manage patients on your study Summary f Versions f Admin Schedule Study Setup Notifications Study Status Reports Study Team Broadcast Study Number kwilsoni Po i i Current Status Study Start Date Study End Date izati gt Search repentance torr meta maaan owen gt Search by Organization All ajeni 03 10 2010 eae Study Status History ADD NEW STATUS Organization Study Status Sta
7. LIBRARY H Save to Description Linked To Status Preview Delete Info Library Check mark Date of Completion B Enter Blank into Form Name field click on the Search button Comments Notes select the blank form and click on the downward arrow Search a Form Form Name Form T Stud Search blank Select an Option x Select an Option z The following are the Forms currently listed in your Library Select the Form that you wish to associate with your Study or go to the Form Library to create a new Form CREATE A NEW FORM Form Type O Blank Form for Traini TRAINING Work In Progress Vv _ Blank Work In TRAINING This is a blank form to pull into studies Progress J e J j Deselect a Description Display Form Link Characteristic e Signature _Submit_ Click once only Version 5 0 Released August 2010 Page 3 of 23 C Scroll to the bottom of the screen and select the appropriate radio buttons for Display Form Link and Characteristics a Choose the patient level option b Choose the once only editable option Enter your e Signature and click on the Submit button to copy this blank form into your study from the library Work In Progress L VELOS SOC Acute GVHD PRM lal E Deselect Name Description ____ Display Form Link _Characteristic Organization Cc v a Nie Multiple entry
8. VELOS HOMEWORK in the subject line Generate Patient Management Tracking Reports p A In your study click on the P icon and click on a patient Check mark Date of Completion study ID link of the patient in your study for whom you have COmments Notes linked to a calendar and entered data B Click on the Reports tab Check mark Date of Completion Comments Notes Manage Patients gt gt Reports Demographics Patient Profile Protocols Reports C Under All Patient Reports Select Patient Form Tracking Check mark Date of Completion enter appropriate filters click the Display Report button and Comments Notes export report to excel Name the excel file STUDYNAME Patient Form Tracking and save it toa folder on your computer Under Patient Specific Reports Select Patient Timeline Check mark Date of Completion enter appropriate filters select a patient who was linked to Comments Notes your study calendar click the Display Report button and export report to excel Name the excel file STUDYNAME Patient Timeline and save it to a folder on your computer Check mark Date of Completion Under Patient Specific Reports Select Patient Visit Comments Not s Calendar enter appropriate filters select a patient who was linked to your study calendar click the Display Report button and export report to excel Name the excel file STUDYNAME Patient Visit Calendar and save it toa folder on your computer Versio
9. a variable for data entry helpful for look and feel organization of form layout New Section you can divide your form into sections for organizational purposes Datamap IMPORTANT Before your form is made active and thus ready for data entry you may create your metadata table with this link Metadata is exportable to excel for easy review Space Break used to control the vertical spacing in the form layout its usage is well defined on page 77 of the Velos Form Manual Accessible via the Velos Customer Corner Version 5 0 Released August 2010 Page 7 of 23 The Space Break is a powerful tool used to refine the layout of the form See the image below for details of how this tool can be utilized Image1 Form Preview of a Multiple Choice Field before adding a space break to move the yes no responses closer together Has the patient or authorized representative signed intarmed consent C Yes E ho Date of Bith al Image Form Table with no space break in the No Repeat Non Tabular section No Repeat Nore Tabular Repeat Flelds 0 Format Noa Tabular 2 Cate of Birth dob_ mimo pry IImage3 Adding a Space break FIELD TYPE SPACE BREAK Note the difference between Section No Repeat Non Tabular Image1 vs Image5 This is Sequence E the result of putting a Space Break at 25 on the Same Space Percentage 25 af M Same line as previous field Image4 Form Table with a space break in the No Repeat
10. programs velos training html Please FAX these signed dated documents to MICHR Support FAX 734 998 7546 or scan and e mail them to michr support umich edu Thank you Version 5 0 Released August 2010 Page 23 of 23
11. where you will see various form Check mark Date of Completion development tools across the top of the screen and the form elements Comments Notes listed below in table format C n ERIE Form Settings Form Name Blank Preview Edit Box MultiChoice Copy Field Comments Lookup Line Break New Edit Datamap Sar wares Section Section E g Eres E Field Name Field ID Field Type Section 1 Repeat Fields 0 Format Non Tabular J 2 Data Entry Date lt er_def_date_01 Edit Back to the Study Setu Note that the blank form comes with a single date field required in all Velos forms to capture the data entry date This field can be and is in this case set to default to the current date In addition to this Velos required date field we recommend creating a second date field to capture the date of visit Version 5 0 Released August 2010 Page 5 of 23 G Add a Visit Date Field to your from 1 Click on the Edit Box tool Edit Box 2 In the subsequent screen that pops up select Date for Edit Box Type Then fill out the details of your new date field as shown below Note you can add and rename sections to your form as well as change the sequence of each field All mandatory fields designated with must be completed Other details such as field validations and help text can be completed at your discretion FIELD TYPE EDIT BOX Section Section Sequence B o l Field Nam
12. 6 Attention MICHR CRIC Operational Support o 1 Create a study in the UM Velos training database Use your Unique Name as study number A Logon to Velos training database click Manage Protocols gt New Check mark Date of Completion Comments Notes Manage Protocols B Enter data for all mandatory fields depicted by in the Study Check mark Date of Completion Summary tab Enter your e signature and click on the Submit button at Comments Notes the bottom of the Study Summary data entry screen to save your data Avoid Selecting yourself as the Principal Investigator for this study Note Principal Investigator is NOT a mandatory field CUFT AN ER STUUT Study Entered By Principal Investigator Principal Investigator was a major swhonir iator of this stud IF OTHER E nwesngetor Meld INDVIDE INLWIDE Study Contact Study Definition Study Humber aN Mer DETALE He ee Agenti Device Division Peerageutic Area oa kii oe j e Mr ha ae tt ee en ee baal i g Version 5 0 Released August 2010 Page 1 of 23 C On the left menu bar navigate to the Velos homepage and notice the presence of your study record Use the S icon to access Study Administration area of your study Ho ee Search a Study Search _ Personalize Account Last Modified Studies D VIEW ALL STUDIES Study Number Study Title Study Status S oo kwilsoni kwilson study Manage Protocols D Click on the S
13. Done You can also ADD UNSCH close this box click on the C in the Event status column to update the event status manuallv Version 5 0 Released August 2010 Page 20 of 23 E Perform data entry on at least several visits worth of forms for at least Check mark Date of Completion 2 of your patients to get a feel for how data entry is managed using a Comments Notes study calendar Please note that it is not mandatory to use a calendar in your study To enter patient data without using a calendar access the patient forms via the Forms link as shown r 7o as i A sa Demographics Patient Profile Buigu clas Reports Appendix Pat ID 005001 Pat Study ID 005 001i Age 54 years Gender Male Pat Name Sigmond Freud Org Training P SCREENING ENROLLMENT SCHEDULE ADVERSE EVENTS gt FORMS HOWEVER if you DO use a patient calendar in your study it is important to ALWAYS enter data via the form link within the patient schedule Do NOT mix data entry methods by sometimes entering data via the form link and sometimes entering data via the form link in the patient calendar This practice will result in unwanted and confusing multiple records 11 Explore a few patient management reports For each report that you explore export report results to excel and save the files to your computer When you have completed this step email the data reports to michr support umich edu with your UNIQUE NAME
14. Reference guide for New Users Hands on Training for Velos Study Setup Procedures Name Unique Name Phone Prerequisite Velos 100 Introduction to Velos eResearch for UM New Users Learning Objective Take advantage of the UM Velos TRAINING instance to learn Velos using a self guided hands on approach At the end of this exercise you will have completed all of the minimum process steps necessary to manage a Clinical trial using Velos including e Create a study Copy a Clinical Report Forms CRF into the study from the Forms Library and modify it Copy a patient study calendar into the study from the Calendar Library and modify it Enroll registered patients into your study Enter data for enrolled patients Explore some reporting functions to report on the data for patient management and tracking This checklist is a high level reference guide to help you sequentially work through the process steps to achieve these learning objectives This exercise should be supplemented with additional parallel training from the Velos Customer Corner web site and reference to the Velos Corporation User Manuals The successful completion of this exercise is a prerequisite for acquiring access to the UM Velos production database instance To create a report of the patient form data contact MICHR support umich edu to enroll in Velos 500 Introduction to Ad Hoc Queries an e learnina corse Please fax the last page of this document to 734 998 754
15. ault Organization Specific On submission of study centric enrollment page user is taken to Select an Option e Signature Submit Develop Patient Case Report Forms for data entry in your study For this exercise copy a blank form from the library into your study then add fields to it Copy a form from the Form Library and edit the form C NECA mark Mate Ol Completion l i l Comments Notes A Start by copying a blank form into your study from the library From the Study Setup Tab click on SELECT A FORM FROM YOUR LIBRARY link Summary Versions f Admin Schedule Notifications Study Status Reports Study Team Broadcast Forms Study Number kwilsoni Study Dictionaries Settings If no modifications have been specified the default settings will be applied VIEW EDIT DICTIONARIES AND SETTINGS Adverse Event Dictionary Free Text Entry Patient Study ID Generation manual Study Treatment Arm Treatment Arms currently associated with this study are ADD NEW Description Associated Calendars Calendars currently associated with this study are UPDATE MULTIPLE SCHEDULES COPY AN EXISTING CALENDAR SELECT A CALENDAR FROM YOUR LIBRARY Refresh Slt Notifications Description Status Status Details Reports Delete j Associated Forms PE Forms currently associated with this study are DISPLAY AND SEQUENCING OPTIONS SELECT A FORM FROM YOUR
16. e Date of Visit H Field ID VISIT_DT Edit Box Type C Text C RA 5 Field Characteristics _ Visible Hide I Disable l Reed Only Label Display Width aa 3 Expand Label Hide Label Bold I ttalics Field Description Search Keyword s T Field Help On Mouse Over Please note you can specify that the new field appears on the same line as the previous field or object Align Field Display Name let Right Center Top Same line as previous field FIELD VALIDATIONS Mandatory Override Mandatory Validation NUMBER and DATE fields can also For Text Box Number Field Field Length be defined using the Edit Box Number of Lines field type Maximum Characters Numbers are NUMBER FIELDS In order to Default Response specify a range of values that can For Date Field 1_ Date cannot ba a future data be allowed for example 0 0 M Override Date validation 999 9 you would use the I Default date to current date Response Should Be option and ir eee ae fill in the min gt 0 0 and max For Number Field Override Number Format Validation D lt 999 9 values as needed Specify the format and maximum numbers that can be entered 9 or 32 S etc signifies a number and signifies a decimal point To specify a format mask for the number use the For Number Field option For example if you specify as the format mask you must enter the number e S
17. ignature C Submit as Click once only 1 2 as 001 2 Response Should Be Override Number Range Validation M 3 When you have completed designating the new field attributes enter your e signature and click submit Version 5 0 Released August 2010 Page 6 of 23 H Now you will notice the addition of your new date field Please note the Field Name is what is displayed in your data entry form whereas Field ID is the corresponding name of the variable in the database Form Name Blank Preview Field Multi Choice Copy Field Comments Lookup Line Break New Edit Datamap Library p e_ FZ _ d o mss io Section Section Delete Space Form ie E Multiple Break Link oy E Field ID Field Type Modify Delete Section 1 Repeat Fields 0 Format Non Tabular gt y 1 Data Entry Date er_def_date_01 Edit Modify A 2 Date of Vist p _ VISIT_DT Eon j be Use Preview link to view the results as you add fields and work on the form layout Additional tools to complete your form creation are as follows Check mark Date of Completion Comments Notes Field Library Edit Box Multi Choice rr Comment Edit Box choose text number or date field Multiple Choice choose Drop down list single response possible Check Box multiple responses allowed or Radio Button single response Comment not a variable for data entry this is a text box that can be used for labeling purposes in your form Line Break not
18. ival status Finally select your study to enter screening enrollment details for this patient enter your e Signature and click the Submit button to save this data Homepage Personalize Account Patient ID oot 001 lt e Always use CPI number for Patient ID Manage Account First Name Jake _ Manage Protocols Last Name suey soil Date of Birth josyioyiess H lt Manage Patients Cender Mae H pane a a oats Ethnicity Non Hispanic gt Additional SELECT Manage Inventory oe White zl Additional SELECT Budget Registration Details Milestones E f TFP Report Central oe University of Michigan _ Patient Facility ID Dashboards a Select User If Other Ad Hoc Queries Survival Status Alive Date of Death A sare Help Cause of Death Select an Option Specify Cause BLANK Logout Specify groups departments with access to edit patient s demographics If blank all groups have access SELECT SPECIALITY Select a study to enter screening enrollment details for this patient kwilson1 eo urrent User ay Wilson System Timezone e Signature Submit J GMT 05 00 Eastern ime US and Click once only Note If there are additional demographic fields required for capture these would have to be captured on a form that you develop for your study In the Patient Study Status window which pops up enter all mandatory Check mark Date of Completion data as designated by the red asterisks
19. izard for calendar creation Define the Calendar Select Events Ea LE IT iti Betis cir Study Number Multi Site Trial DEMO Calendar My Study Calendar Protocol Calendar Preview h Display Select an Option gt Event Search Scheduled Events currently associated to this Calendar ADD VISIT S ADD EVENTS TO VISITS DELETE SELECTED Le EE isit 1 Month 1 Week 1 Day1 Copy visit oe a a Z Oo S E l ofe pee o y e Month Week 1 Day1 oovwst O a training fammicewons O ee ee a z O E a m O e z Training Lab Event Ce es NOTE There can be multiple events for each visit To modify the visits or events in the calendar click on the respective links under Visit Name and Event Refer to the Velos eResearch 8 0 Calendar Manual for details A Under the Schedule and Customize tab click on the event name to access the event details screens Define the Calendar Select Events Bete it IT Corti Bettts tyr Study Number kwilsoni Calendar My Study Calendar Search By isit Select an Option gt Event Scheduled Events currently associated to this Calendar ADD VISIT S Visit Name Interval Category Vi Baseline Month 1 Week 1 Day1 Copy visit Check mark Date of Completion Comments Notes Check mark Date of Completion Comments Notes Version 5 0 Released August 2010 Page 10
20. ked forms links and perform data entry You can also Click on the Event status links to change the status of the events as appropriate D From the previous screen click on the P icon and repeat these Check mark Date of Completion steps for all of the enrolled patients in your study Select different start Comments Notes dates for each patient 10 Enter CRF data for your enrolled patients in your study Check mark Date of Completion P l A Click on the icon for your study to access the patient enrollment Comments Notes roster then click on the patient ID link Patie nt Search Gage if Search By t Patients on Study kwilsont 4 Patient ID F Patient Study ID 4 Enter Screening Enrollment details liq al panel 1 of 1 Study Enrolling a Pt F Name Number Site Study ID Training W4 University 001 Sigmond Freud el Pe ee ee E kwilsonl gt y P Version 5 0 Released August 2010 Page 19 of 23 B Begin data entry by accessing the forms from the Form Links within the patient calendar Demographics Patient Profile Bago creas amp Reports Appendix Pat ID 005 001 Pat Study ID 005001 Age 54 years Gender Male Pat Name Sigmond Freud Org Training University P SCREENING ENRODS SCHEDULE ADVERSE EVENTS FORMS Study kwilsoni View Title Calendar My Study Calendar Pat Start Date 03 10 2010 Schedule Current Edit Calendar Date View Previous Delete Schedule Select Patien
21. mber kwilsoni AERA AP OES a PSS TE o a o o Pa Associated Calendars gt Calendars currently associated with this study are UPDATE MUL HEDULES COPY AN EXISTING CALENDAR Refresh m Name Notifications Description Status Statu S Calendar Velos HOMEWORK Assignment Work in Progress Status Di K Foa gt we et eee ee j a an ao et es et a gate oe eee 7 Update Study Status to Active e A From the Study Setup tab navigate to the Study Status tab Click on the ADD NEw STATUS link su mma ry ve rsio ns ad min Schedu le Study Setu p Notificatio ns E a Repo rts Study Tea m B roadcast Fo rms Study Number kwilsoni saith by naa All Current Status Study Start Date Study End Date NotActive Change Dates Study Status History ADD NEW STATUS Organization Study Status Status Valid From Status Valid Until Meeting Date University of Michigan ee B Select Active from the dropdown box complete the mandatory fields Check mark Date of Completion enter your e Signature and click on the Submit button Comments Notes Summary Versions Admin Schedule Ban Setup Notification Study Number kwilsonl Please change the Status Protocol Calendar Name My study Calendal Status _ _ _ Active T What does this mean a 03 10 2010 Select Date Status Changed By gt Kay Wilson aa Notes e Signature Version 5 0 Released August 2010 Page 13 of
22. n 5 0 Released August 2010 Page 21 of 23 F Under Study Specific Reports Study Visit Calendar enter Check mark Date of Completion appropriate date filters Display Report and export report to Comments Notes excel Name the excel file STUDYNAME_ Study Visit Calendar and save it to a folder on your computer Email your excel output files of the 4 reports to michr Check mark Date of Completion support umich edu with your UNIQUE NAME VELOS Comments Notes Training in the subject line Version 5 0 Released August 2010 Page 22 of 23 Please fax this page with your signature to 734 998 7546 Attention MICHR SUPPORT Record of COMPLETION Hands on Training for New Users Velos Study Setup Procedures PLEASE PRINT have successfully completed the Velos Study Setup Procedures outlined in this reference guide using the UM Velos Training instance understand that it is my responsibility to keep up to date copies of my Velos training record and pursue additional Velos training UNIQUE NAME opportunities in the future FIRST NAME LAST NAME YOUR SIGNATURE The procedures outlined in this reference guide were to be conducted in conjunction with additional Velos training available on the Velos Customer Corner web site Please include your Velos Record of Training Completion with your application for an account in the UM Velos Production instance These forms are available on the MICHR Velos web site http Awww michr umich edu
23. ndars click on SELECT A CALENDAR FROM YOUR LIBRARY link edule Bintan Notifications Study Status Broadcast SELECT 4 CALENDAR FROM TOUR s study are COPY AN EXISTING CALENDAR LIBRARY B Search for and select My Study Calendar in the Training category type This provides a basic calendar template with 3 Visits which you can use for this particular study and evaluation Search By Calendar Name Type TRAINING gt Search Library Calendars Select the Calendar that you wish to use in your Protocol CREATE A NEW CALENDAR Sacr for Simple calendar with 6 visits Work in Progress All Account Preview Schedule Select TRAINING Associated Calendars Calendars currently associated with this study are UPDATE MULTIPLE SCHEDULES COPY AN EXISTING CALENDAR SELECT A CALENDAR FROM YOUR LIBRARY Refresh a r Save to Notifications Description Status Status Details Reports Delete Library Velos HOMEWORK Assignment Work in Progress Status Details To view the details of the calendar click on the calendar name as shown above Check mark Date of Completion Comments Notes Check mark Date of Completion Comments Notes Check mark Date of Completion Comments Notes Version 5 0 Released August 2010 Page 9 of 23 D The details of the calendar are viewable and editable through three tabs Define the Calendar Select Events Schedule and Customize which comprises the 3 step w
24. of 23 Event Detail Mess cetcode os Durston Days il Visit Window 0 Days Before fo Days E After Changes to Event Name and Description will not be applied to other events when you select Apply to all Events in this Visit I Apply to all Events in this Visit I Apply to all Clinic Event Events in this Calendar e Signatire hnisanie Click once only Version 5 0 Released August 2010 Page 11 of 23 C Click on the Link Forms and then select your active forms to be linked Check mark Date of Completion to the specific event Comments Notes Protocol Calendar My Study Calendar gt gt Event Crf event Detail Message f Cost Appendix Resource CRF Details Event Name Inclusion Exclusion amp Consent No Records Present Add CRF Link Forms gt https velostraining med umich edu eventId 04137 amp protocolid 104124 amp studyvie Associated Forms ns i Study Number kwilson1 Forms Linked to Patie Protocol Calendar My Study Calendar Event Inclusion Exclusion amp Consent Forms Linked to Patie 5 Active Lockdown Forms Forms Linked to Patients of this Study Forms Linked to Patie Blank CHILDHOOD TRAUMATIC Events Scale Patient Links CURRENT HEALTH ASSESSMENT FAMILY HISTORY FORMAL CARE amp SERVICES QUESTIONNAIRE INCLUSION CRITERIA INFORMED CONSENT VERIFICATION al os Uap SS _ a Scroll down to the bo
25. que number designated by the patient CPI number Velos is a patient centric database This means that a unique patient and demographics data only needs to be entered once into Velos It is extremely important not to add a patient into Velos that actually already exists Duplicate patients will result in the need for a time consuming technical intervention to correct and always results in the need to re enter data for that patient C IF the patient you are looking for already exists and you have verified the CPI number click on Patient ID link and select your study number from the drop down list 4 1 Patient Search I EN rolled Search By Fatient ID Patient Name T Survival Status ii a Patient IOD To screen enroll an existing Velos patient into a new study select the study and Patient organization from the drop down box o screen enroll this patient in a new study select Study and Patient kwilson Training i aa rganization kwilson Training Submit Version 5 0 Released August 2010 Page 15 of 23 In the Patient Study Status window which pops up enter all mandatory data as designated by the red asterisks Select Enrolled from the Status drop down list and enter a Status Date Patient Study Status Patient ID 005001 Study Number kwilsoni Please enter Status details Status _ Enrolled r Reason Select an Option Select Date M This is patient s current
26. s DAY1 date which is the date from which the entire schedule for this patient will be generated Version 5 0 Released August 2010 Page 18 of 23 C Upon submission of the form Velos links the patient to the calendar and generates the patient schedule as represented in the following screen Demograph ics Patie nt Profile aru g Repo rts Appe nd ix Pat ID 005 001 Pat Study ID 005001 Age 54 years Gender Male Pat Name Sigmond Freud Org Training University P SCREENING ENROCEMENT SCHEDULE ADVERSE EVENTS FORMS Study kwilsoni View Title Calendar My Study Calendar Pat Start Date 03 10 2010 Schedule Current Edit Calendar Date View Previous Delete Schedule Select Patient Schedule My Study Calendar 34Q 2010 _Search_ Wisit All Month Year All All Ewent AN Status AN EDIT MULTIPLE EVENTS Suggested Date Scheduled Date Visit Window Events Event Status Linked Forms March 2010 V1 Baseline eo A UNSCHEDULED EVENT O INCLUSION CRITERIA 03 10 2010 03 10 2010 c Inclusion Exclusion amp Consent h No Response Entered INFORMED CONSENT VERIFICATION No Response Entered CHILDHOOD TRAUMATIC Events Scale 03 10 2010 03 10 2010 c Eligibility and Screening No Response Entered CURRENT HEALTH ASSESSMENT No Response Entered FAMILY HISTORY ww LIBRO popwoypse oly y pditignsl pmonranhics _ Net poose H No RapooqssEntgesd p pai From here you can click on the Lin
27. status in this study Status Date Notes Enrollment Details Kay Wilson Select Use 005 001 Training University Randomization Number Enrolled By Additional Information Patient Study ID Enrolling Site ame tei Pa a D IF patient CPI number DOES NOT exist Manage Patients gt gt All Patients Patient Search Enrolled PATIENT ID 3609863490 No patient found for your search criteria Please modify the criteria and click on Search create a new patient and REGISTER that patient to the Training University organization Version 5 0 Check mark Date of Completion Comments Notes Note that Patient Study ID is pre populated with the CPI number This number can be changed manually after the patient is enrolled However if you had selected AUTO Generated Velos would have populated this field with the format you specified Check mark Date of Completion Comments Notes Released August 2010 Page 16 of 23 Click on Manage Patients gt New on the menu bar and enter data for the Patient Demographics form This includes the Patient ID field which at Michigan is always defined as the CPI number Complete the data of birth field by clicking on the Calendar ICON and selecting a year month and date Select Gender Then register the patient to the Training University organization note in the Production database it would be the University of Michigan and designate surv
28. t Schedule My Study Calendar 034Q 2010 7 Search Visit All Month Year All x Al Event fan a stas fa EDIT MULTIPLE EVENTS Suggested Date Scheduled Date Visit Window Events Event Status Linked Forms March 2010 V1 Baseline INCLUSION CRITERIA 03 10 2010 03 10 2010 c Inclusion Exclusion amp Consent Not Done No Response Eni No Response Entered NN No Response Entered CONSENT VERIFICATION No Response Entered ws TRAUMATIC Events Scale 03 10 2010 03 10 2010 c Eligibility and Screening No Response Entered CURRENT HEALTH ASSESSMENT No Response Entered FAMILY HISTORY wen ge LORY gS 1010 6 pe man Additional Demographics Not Doos H fro Regnogsa Entesed on gre Check mark Date of Completion C Enter data on the form update the form status to Completed and Comments Notes save the data by submitting your e Signature D Upon completing the last form within an event Velos provides an opportunity to enter your e Signature to mark the event as Done Study kwilsoni View Title Calendar My Study Calendar Pat Start Date 03 10 2010 Schedule Current Edit Calendar Date View Previous Delete Schedule https velostraining med umich edu eres jsp promptMarkEventDone Enter your e All CRF forms associated with this event have one or more responses added Would Status Al Sig nature to change you like to mark this event as Done S the event status to e Signature 7
29. tes 2 Define basic study setup infrastructure by establishing the adverse event dictionary if needed method of patient study ID generation and patient enrollment process for your study A Navigate to the Study Setup tab and then click on VIEW EDIT DICTIONARIES AND SETTINGS link Manage Protocols gt gt Study Setup Summary ersions Admin Schedule Big k A Notifications Study Number 26Novorkw P Study Dictionaries Settings If no modifications have been specified the default settings will be applied FIEW EDIT DICTIONARIES AND SETTINGS Type Use Adverse Event Dictionary Patient Study ID Generation manual Check mark Date of Completion Comments Notes Version 5 0 Released August 2010 Page 2 of 23 In the Dictionaries and Settings window choose the AE dictionary Check mark Date of Completion method of Patient Study ID generation select manual and the Comments Notes study enrollment process as shown Submit the data by entering your valid e Signature to save your data Associate Adverse Event Dictionary Adverse Event Dictionary Use Free Text Entry 6 NCI v2 0 O NCI v3 0 amp 4 Patient Study ID Generation o Type O Use Allow Manual Entry q System Generated sequential C Select an Option gt Select an Option 7 E Study Enrollment Process Enable Study centric enrollment C yes No 4 Flag to Allow Patient Accrual Def
30. ttom of the screen where you can optionally link forms to all events in this visit or link forms to all events in the calendar to save time Apply to all Events in this Visit Apply to all Clinic Event Events in this Calenda e Signature sal Submit Click once only Enter your e Signature and click on the Submit button to save your work Velos verifies the inclusion of the forms linked to the event Protocol Calendar My Study Calendar gt gt Event Crf Event Detail Message Cost Appendix Resource CRF Details Event Name Inclusion Exclusion amp Consent No Records Present Add CRE Link Forms Associated Forms Form Name Forms Linked to Patients of this Study INCLUSION CRITERIA INFORMED CONSENT VERIFICATION F j k gae are FT ee eee ee Repeat these steps 5 A through 5 C for linking the appropriate forms to the appropriate events in the calendar 6 Finalize the Calendar and change status to Active Please note that you can still link additional forms to your Calendar after the status is changed to Active Version 5 0 Released August 2010 Page 12 of 23 A Navigate to the Associated Calendars section with the Study Setup Check mark Date of Completion Tab and click on the Work In Progress link under the status column Comments Notes Summary Versions Admin Schedule Bj ct Vaso oye Notifications Study Status Reports Study Team Broadcast Form Study Nu
31. tus Valid From Status Valid Until Meeting Date Notes University of Michigan Active Emolling 03 10 2010 Not Active 03 03 2010 8 Enroll Patients in your Study Search for existing patients register new patients enroll registered patients Check mark Date of Completion A Click on the P icon and then the Patient Search tab Comments Notes Manage Patients gt gt All Patients Patient Search Enrolled A large patient pool has already been registered into the Training Organization in UM Velos training database Version 5 0 Released August 2010 Page 14 of 23 B Search for an existing patient by entering criteria such as first amp last name birth date or CPI number in the Patient ID field The CPI number is the UM Hospital unique patient identifier In this example training data is used Enter CPI number as search criteria in the Patient ID field Search By Patient ID 5 Age AN Training University Patient Name Gender Select an Option Specialty Selec i Survival Status Select an Option Study fan Provider i a Pagel ofi H Hl Rows per eel Showing 1 1 of 1 id save view g SAVE D SEARCH Patient ID amp First Name Last Name Age Gender Patient Status Other ID s On a Study w Pawl Sigmond Freud 54 Years Male Alive View Yes 1 AE SCH FORM NOTE In the UM Velos Production database for patients affiliated with the UM organization PATIENT ID is a uni
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