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TASCS User Manual

1. a J Y y d protocol J WAS grid from submit IRB OPTIONAL Submit fully completed final Gage screens GEN Submit initial Researc y DEn TASCS and E nd application 5 PRF and Prepare documents PRF protocol ToB her i obtain PI L Attach signed _ budget approved consent Ke Review protocol and Entry ignat aa billi id contract budget form and signed billing grid y create billing plan Visit Entry signatures LAS KENE ESPA 99 Select A ee A 3 ii Services A No Review contract and initiate negotiation with sponsor Provide PS Chart Ensures contract y gt String number to e SE language aligns astanti Yes investigator ee with consent form SPA AE include TASCS Se a o ba and billing grid Was advance account number Executes contract requested _ Hold for fully Tse yee completed final or agreement Ges PRF submission x No Yes v Send approval Review Match consent letter to PI ens IRB application form Cost Ges peel Yes including reference To ei per IRB language to billing ege rid to approved process grid 9 grid foe consent form SE version
2. Placeholder Medical Record Number This information applies to research where individual subjects will not use Fairview or UMP services If a subject doesn t have a Fairview medical record number enter ten 3s 3333333333 as the medical record number placeholder Use the placeholder medical record numbers with caution Inappropriate use of placeholder medical record numbers places researchers and service providers at risk For questions contact the TASCS Support You are required to enter information into TASCS within 72 hours of a subject signing a consent form For studies utilizing Fairview services As of September 1 2014 it is the researcher s responsibility to enroll and withdraw patients from studies in EPIC directly Please contact Fairview Research Administration research fairview org with questions regarding this process gt E E Provider Responsibilities When the consent date is entered and saved on the Subject Tracking Form an auto email is sent to the Providers UMP will create a patient case number for all subjects enrolled in studies using UMP services UMP will enter case numbers for all subjects entered into the TASCS system on or after August 18 2008 In studies where consent to participate in the study occurs months in advance A of any further screening for eligibility the date of consent must still be entered within 72 hours after consent is signed Subjects found to be ineligible will have to b
3. N A Name Email General Account Information Enter information into the required fields in the General Account Information section of the screen You must complete the information in this section before clicking on the Save Changes button at the top of the screen When you click on the Save Changes button the Providers will receive an email alerting them to establish your research billing accounts After selecting Save Changes a new General Account Information section will appear on the Account Lab Set Up Screen This will allow for additional purchase orders to be added The remaining sections of this screen do not need to be populated in order to Save Changes 33 TASCS Manual Using TASCS Laboratory site needed check all that apply C UMMC East Bank University mi UMMC West Bank Riverside Amplatz Cl Fairview Southdale Hospital _ Fairview Ridges Hospital O Fairview Lakes Hospital C Fairview Northland Hospital O Fairview Range Hospital CJ UMP Owned Clinic Imaging Center Bethesda Broadway Dental Mill City Phalen Reproductive Medicine Smiley s Cl Fairview Clinics includes Maple Grove Ambulatory Care Center Using Fairview Labs to analyze specimens Check Yes No or both below Ifhoth complete the In House and Outside Lab sections Cl Yes complete the In House Lab Analysis section below Ono complete the Outside Laboratory section for collection p
4. Women s Health Recruitment Posting TASCS will send a notice to the Fairview s recruitment website to post your study for recruitment If you do not want your study posted for recruitment check the box to decline Check one or more health categories by which the public should search for your study Click on Save Changes when you have completed this screen Provider Responsibilities As indicated above an email will be automatically generated to Service Providers with a copy to the Protocol Contact and Billing Contact for review and set up of account numbers Fairview Research Administration UMPhysicians Patient Financial Services and Fairview Laboratories will review the Account and Lab Set Up screen UMPhysicians will assign a Flowcast case number to the study and enter it into TASCS Fairview will assign EPIC number and laboratory account numbers U s or B s and enter them into TASCS Providers will communicate with the appropriate contact either Protocol or Billing if more information is needed e Flowcast GEMMS Study Hospital Account IDS Start Up Date mm dd yy EE aa Date Epic Guarantor ClinicalTrials gov 35 TASCS Manual Using TASCS Providers populate the Provider Accounts section on the bottom of the Account and Lab Set Up screen and choose the Account Set Up Complete button The Protocol and Billing Contacts will receive an email stating the account numbers
5. billed to the research account The pricing information is based on the data entered on the Services and Payers screens Complete the Proposal Routing Form PRF process as usual and include the TASCS number where requested on the PRF The TASCS number is auto generated by the system and found at the top of each TASCS screen When the account number EFS chart string is assigned request prepare a purchase order for the research services that will be paid for by the research account When a purchase order number is available it is time to complete the Account Lab Set Up Screen Go to the Edit menu and choose Account Lab Set Up Then search by TASCS number or any search term of your choosing to locate the protocol 32 TASCS Manual Using TASCS Step 6 Account and Lab Set Up Entry Screen Required Information for Step 6 Purchase Order Amount Effective Date End Date Location of Services Save Changes Purchase Order Amount 0 00 Effective Date mm dd yyyy End Date mm dd yyyy Location of Services check all that apply Fairview Facility hospitals UMMC clinics community clinics UMP Owned Clinics Imaging Center Bethesda Broadway Dental Mill City Phalen Reproductive Medicine Smiley s Southdale Cardiology Clinic or Southdale Cardiology Imaging Center Laboratory Contact if different from Protocol Contact Name of research staff with expertise in collection and management of lab specimens
6. have been assigned The account numbers will display on the Protocol screen and on the Account and Lab Set Up screen Fairview Lab will continue to create the laboratory requisitions lab slips and send to the requesters 36 TASCS Manual Using TASCS After Subject Enrollment This section includes data entry and communication processes from the point of subject enrollment through study closure The following TASCS screens are described in this section e Subjects e Subject Tracking Form e Service Discrepancy Step 7 Subject Entry Screen Go to the Edit menu and choose Subjects Then search by TASCS number or any search term of your choosing to locate the protocol Required Information for Step 7 Subject Initials Gender Med Rec Birthdate MO SEH Ps a UEL eo RR ESCH dI ii ci Researcher Responsibilities Subject Create a subject number that is meaningful to you and enter into this field Many users choose to use the subject number assigned by the study sponsor You may change a subject number if needed i e change from screening number to randomization number Initials Enter the subject s initials Gender Indicate the subject s gender by clicking on the M or F button 37 TASCS Manual Using TASCS Medical Rec Enter the subject s Fairview medical record number If the subject is not a Fairview patient use the Placeholder Medical Record number described below
7. 77 Services List Provider Only Field Name Field Type Field Definition Discrepancy Autofill Alerts to new or modified service Fee Schedule Drop down One amp Customary pricing except IDS Lab and Notes entered by the AHC User on the Services Notes Autofill screen Service Location Autofill Directs to appropriate fee schedule Write in Service Description Autofill Free text to ID requested service Service Provider Pricing Entry Provider Only Field Name Field Type Field Definition Manual price to override Calculated Price e g Alternate Price Number special agreements Calculated Price Autofill System generated Gross x Research Rate Effective Date only for alternate prices normals will be from the Month Day Year Service added after original pricing completed annual chargemaster Gross Price Autofill Fee schedule price NIH and other non profit or B amp I except lab IDS Research Rate Autofill and UMP System Service Verify active unique service ID add associated ae Drop down Description services as needed Unique ID Autofill ID specific to fee schedule that locates unique service Total Field Count 7 Account Lab Set up Entry Field Name Field Type Field Definition Enter the purchase order amount for lab medical Amount Number services to be purchased from partner service Provider Fairview Enter the purchase order effective date for Effective Date Month Da
8. Billing Contact Protocol Contact Sponsor Short Protocol Title and Full Protocol Title Entries in these fields can be changed at any time on protocols with an Active status Field Name Dept ID The Dept ID drives security in TASCS and limits access to those associated to a specified Dept ID Once a Dept ID has been selected and saved the number cannot be changed without the assistance of TASCS Support Please contact TASCS Support tascs umn edu for help 50 TASCS Manual Appendices Field name IRB The IRB is an identifier for the study in the IRB s database Once entered into TASCS the number cannot be changed without the assistance of TASCS Support Please contact TASCS Support tascs umn edu for help Field Name IRB Approval Letter Date The IRB Approval Letter Date is the date of the IRB approval letter Once entered this date cannot be changed without the assistance of TASCS Support Please contact TASCS Support tascs umn edu for help Visits Screen Field Name Visit description The visit description indicates the data collection time point for the study Once entered and saved the description cannot be changed except by deleting it and entering a new one To do so check the delete box for the incorrect visit description and save changes Deleting a visit should only be considered during the initial setup of the study Deleting a visit after other data are associated with that visit could be very time consumi
9. Clinical Trial Qualifying Trial Determination Date Yes No ClinicalTrial gov is required of Service Provider when charges are billed Insurance Effective 1 01 2014 Cancer Research All protocols related to cancer must have a CPRC number entered on the Protocol screen in TASCS If you have not yet been assigned a CPRC number enter a placeholder in the CPRC Number field When your number is assigned replace the placeholder number you entered 22 TASCS Manual Using TASCS Question Response How should multiple sponsors be attached to a single protocol Which sponsor should be chosen in TASCS when the study is Investigator initiated but funding is provided by a commercial source business or industry TASCS lets you indicate one sponsor in the system e Ifthe protocol is Investigator initiated choose Investigator initiated with the appropriate funding source in parenthesis e If any of the sponsors is a governmental department or agency list that sponsor in the sponsor field e lf the study sponsor is a non profit entity University foundation etc and there is no governmental sponsor list the non profit entity in the sponsor field e If all the sponsors are commercial a business or industry pick one to list in the sponsor field In all instances you may provide the names of other sponsors in the comment section but they are not required Choose Investigator
10. Enrollment This section includes data entry and communication processes from the point of study concept through study initiation The following TASCS screens are described in this section e Protocol Visits Services Payers Pricing Account Lab Set up Step 1 Protocol Entry Screen Required Information for Step 1 Status Principal Investigator Billing Contact Protocol Contact Sponsor Short Protocol Title Full Protocol Title Dept ID 21 TASCS Manual 1 Go to the New menu and choose Protocol 2 Enter the required information e Fields with red asterisks are required in order to save e Fields with blue asterisks must be updated as the information becomes available e Fields with no asterisks are optional and available as desired 3 Save Changes 4 Write down the TASCS ID for reference Zei The field definitions for the Protocol screen can be found in Appendix E ClinicalTrials gov Using TASCS TASCS Status Eer Inactive Date Billing Contact Protocol Contact Sponsor X Sponsor Protocol ClinicalTrials gov SPA Contact Short Title Full Title CRO E No services needed from Fairview or UMP on this protocol Services refer to tests procedures clinic space clinic visits physician time lab services pharmacy services or hospital services that are required to carry out the protocol 7 Contract with Fairview or UMP Check the box if y
11. Outside Laboratory Name Outside Laboratory Phone Char any text Char 50 Char 15 If an outside or central lab will process specimens and a lab manual is not available enter collection instructions If an outside or central lab will process specimens and a lab manual is not available enter the name of the lab If an outside or central lab will process specimens and a lab manual is not available enter the phone number of the lab 79 Field Name Field Type Field Definition Outside Laboratory Processing Instructions Outside Laboratory Send Out Instructions Char any text Char any text If an outside or central lab will process specimens and a lab manual is not available enter processing instructions If an outside or central lab will process specimens and a lab manual is not available enter send out instructions Purchase Order Recruitment Posting Categories Char 11 Check boxes Enter the purchase order number for lab medical services to be purchased from partner service Provider Fairview If research project will be listed on Fairview s recruitment website check all categories that apply Check box if research project should NOT be Reo Une FORIO CHECHE BGK ener Box posted on Fairview s recruitment website Total Field Count 34 Subject Entry Field Name Field Type Field Definition Birthdates Month Day Year Ente
12. Researcher Phase nroll subjects Consent Add Initial Consent Date In TASCS Associate subject to research study in Epic Research Encounter Link research encounter to research study in Epic Add research visit date into TASCS within 72 hours Withdrawal Add Date W D in TASCS Setup Research Account Epic Lab IDS Flowcast UMP Billing Office Assign patient case number in Flowcast and enter into TASCS Manage service UMP Billing Office Inactivate the patient s case number Verify and manage service charges according to Service Discrepancies entry Initiate Research Accounts Closure in Epic and Flowcast Approved Review and Approve Project Match billing plan to consent language 11 TASCS Manual Section II Using TASCS Using TASCS TASCS Manual Using TASCS GENERAL INFORMATION Access and Security Before access to TASCS is granted each prospective user must complete training and submit a TASCS Access Request form Information regarding TASCS training dates and registration are available on the CTSI website http www ctsi umn edu sites default files TASCS training pdf on the TASCS website via the Links menu or by contacting TASCS Support tascs umn edu The TASCS Access Request Form is found in Appendix B and is also available digitally via the CTSI website http www ctsi umn edu researcher resources forms and templates Researchers and research
13. Services REGISTER Fairview Hospital Adult CV Global v ONLY Active MRI with contrast Fairview Hospital Adult CV Global Y Active EKG lab Fairview Hospital Adult CV Global y Active MRI with contrast UMP Imaging Center Adult CV Global v Select the appropriate fee schedule from the drop down for each service listed based on the service location Click on the Write In service description to advance to the pricing screen Save Changes The Write In service description and desired service location are provided as header information on the pricing screen Use the drop down menu in the Service Description column to locate the requested service The remainder of the row will auto populate If additional services are typically needed e g Colorflow Doppler when Echo is requested or contrast material for Nuclear Medicine tests add the service on the next line Click the Save button to return to the previous screen 31 TASCS Manual Using TASCS Save Changes J ER Y CT mm RR EE TC Tr TC OT TC Tr MO E LETS Continue to price each service requested When finished choose the Completed button This action generates an email notice to the Protocol and Billing Contacts that prices are available Researcher Responsibilities To prepare the protocol budget go to the Report menu and select Research Prices Report This report will list the prices for services to be provided by FairviewUMP and
14. Sponsor assigned protocol unique identifier Protocol Start Date enter date of protocol entry Start Date Month Day Year until firm date is known firm date should match SPA records Startup Payment Number 10 Non refundable start up payment listed in the contract Select from drop down options Active Approved ready to enroll Active In the Approval Process Status Drop down work is in process not ready to enroll Active Future Protocol not working on the protocol yet Inactive completed Inactive rejected declined The number of subjects who have signed a Subjects Consented Autofill consent form for the study pulled from subject tracking entry Subjects Contracted Number 4 Total number of subjects estimated to be enrolled in the protocol from contract if applicable The number of subjects who have signed a Subjects Enrolled Autofill consent form for the study and have completed at least one more study visit pulled from subject tracking form entry Subjects Withdrawn Autofill Total number of subjects withdrawn pulled from subject tracking form entry TASCS Autofill Sequentially assigned 2 digits year 4 digits protocol To Dean Date Month Day Year Date the final Proposal Routing Form and documents go to the Dean for signature Total value of the contract if all subjects Total Value Number 10 completed use number from Notice of Grant Award Total Field Count 94 Visit Entry Field Name Field Type Field D
15. button when you complete a pop up screen TASCS will display the payer information you ve chosen on the Payers screen as text You may 29 TASCS Manual Using TASCS reselect a visit or service link if an error was made and you will re enter the pop up screen Continue to use the links either by service or visit to populate the Payer screen R Research Account Ins Pt Insurance O Other When all services required by the protocol have payers selected click on the Submit to Providers button Service Providers will receive an automatic e mail with a copy to the protocol and Billing Contacts informing them that there is a protocol to review Researchers will receive a prompt to attach their protocol to an e mail to send to Fairview and UMP If you prematurely select Submit to Providers you should contact Fairview 612 672 6737 or 612 672 7678 to let them know your request is not yet complete Service Provider Responsibilities Providers will review the submitted protocol and billing plan that is now available as a TASCS report Billing Grid If the billing plan indicates that the patient insurance will be billed for study related services then further review is required to determine if the study is a qualifying clinical trial under the National Coverage Decision Medicare s Clinical Trial Policy Fairview will alert Investigators early in review if concerns are identified with the billing plan or if the study is
16. encounter forms pdf 87 Appendix G TASCS Manual Changes Changes by Date Date Changes 2015 11 12 Updated TASCS URL to https secure ahc umn edu tascs from http tascs ahc umn edu 2015 07 20 Updated text that references 3 business days to 72 hours for consistency with the Budgeting and Billing Policy 2013 12 31 ClinicalTrial gov requirement information added 2013 03 14 Removed references to IBC Updated the Use of Encounterform to a link to the form 2013 01 14 Recapture and update screenshots Added TASCS Workflow Updated Auto Email list 2012 06 14 Update Auto Email list Updated Appendix A and D 2012 06 08 Updated the screenshot for the Protocol Entry screen Added the specification for the No Services checkbox to the How To section 2012 06 01 Added clarification on the use of Encounter Forms Added a new Appendix G for the Use of Encounter Forms Lab Slips and UMP Case Numbers 2011 09 29 Replacing new PI Sponsor PC and BC forms with new Add Remove Personnel or Sponsor form 2011 09 02 Removed MRN placeholder 9999999999 language Removed CoC autopopulation language Updated the access request form in Appendix B 2011 03 31 Update TASCS Access Request Form Appendix B Changed ORA to RIOP p 5 p 12 and p 13 2010 11 17 Updated SPA role and responsibility p 12 Updated AHC Budgeting and Billing Policy Procedure step 1 to clarify what SPA needs on the PRF p 86 2
17. gt YX No Enter prices for UMPhys UMP services icians Notify FV when pricing complete A Yy Obtain billing grid from TASCS Complete picin Review protocol billing grid and SH See io 9 la EE researcher FLOW CHART ACRONYMS amp TERMS A TASCS Time 8 Study Collection System A IRB Institutional Review Board Research Subjects Protection Programs Fairview FV notifies UMP and SPA Sponsored Projects Administration A d DES SH PRF Proposal Routing Form fe billing grid Perform researcher via PS PeopleSoft 9 SE Yes coverage TASCS when PI Principal Investigator Servicos analysis coverage analysis PO Purchase Order complete CASE number used in UMPhysicians billing system Flowcast IDX FV Fairview Health Services UMP UMPhysicians TASCS Manual The Process PROPOSED RESEARCH BUDGET BILLING PROCESS A5 Schedule appt if needed EH a GE Cr A Does the stud Ready to Identify and using appropriate account Print visit specific invoices B use FV or UMP No gt implement consent potential i gt encounter form s Approve or d Services research subje
18. here httos www umn edu dirtools guestportal Send the new User information to TASCS Support tascs umn edu and request TASCS access TASCS Manual Using TASCS Enter your ID and password in the designated fields and click on the Login button to the right If you forget your password click on the Forgot your password link for help Saving and Timing Out TASCS will prompt the user to save work before exiting screens Some screens allow two options Save and Save Submit Users should choose Save while still working on the entry screen Once a screen is complete choose Save Submit Selecting this option will send e mail notification to service Providers that your request is ready for processing While TASCS allows some amount of time before timing out users are encouraged to save work frequently and whenever data entry in TASCS is interrupted When attempting to close a TASCS entry screen before saving the following message will appear The page at http tascs ahc umn edu says Changes on the previous page were NOT saved To do so now click on the Back button to re display the page then click the Save icon Searching When choosing any options in the Edit menu you ll be presented with a search screen You can search for studies using any one of the criteria Use more than one criterion to further narrow the search Search TASCS ID Protocol Short Name FE Protoc
19. initiated B amp I from the sponsor drop down list You can identify the commercial sponsor s name in the comment field if you like but it is not required How do you enter a single IRB protocol into TASCS when the protocol has multiple funding sources and titles Currently the study has separate account numbers based on title and funding source For projects such as these we ll have to use the EFS account string as the unique identifier rather than the IRB number Each EFS account string will require its own Protocol entry into TASCS Work with your department accountant 23 TASCS Manual Using TASCS Step 2 Visit Entry Screen Required Information for Step 2 Visit Description Are Medical Lab Services Needed 1 To view the Visit screen i either Click the Visits hyperlink near the top of the page or e Gotothe Edit menu and choose Visits Then search by TASCS number or any search term of your choosing for the Visits screen and choose Search H D DD D D RR H D All data collection time points must be defined and entered as uniquely named visits in TASCS Visits should be defined based on the protocol time points at which research data will be collected for each subject Five visit descriptions pricing only startup consent date withdrawn and a reason for the subject withdrawal are auto filled by TASCS The startup visit description is available for b
20. made 67 TASCS Manual Appendices A No action is needed at this time Sponsor Change Trigger when the data in the Sponsor field is changed and saved Email Subject TASCS Sponsor Change TASCS ID Email Message The sponsor has been changed for this study Update the research pricing as needed Subcontract Alert Trigger when Subcontract is checked and Save Changes is clicked Email Subject TASCS Subcontract Alert TASCS ID Email Message The user is requesting a contract with Fairview or UMP Please contact the user for more information Subject Consented Trigger when a new consent date is entered and Save Changes is clicked Email Subject TASCS subject consented TASCS ID Email Message A new subject has been consented for this study The subject s information is as follows list initials MRN Date of Birth and date of consent UMP Please assign a case number and enter into TASCS Fairview Please flag the subject in the appropriate billing system s Subject Consented Date Change Trigger when the consent date on the Subject Tracking Form is changed or deleted Email Subject TASCS Subject Consent Date Change TASCS ID Email Message The date for subject consent was either changed or deleted The subject s information is as follows list initials MRN Date of Birth and date of consent Subject Withdrawn Trigger when a date is entered into the Subject Withdrawn date field and saved Email Subject Su
21. not a qualifying clinical trial When the coverage analysis is completed Providers will click the Coverage Analysis Complete button on the Protocol screen This will initiate a TASCS generated e mail to the Protocol Contact and the Billing Contact to inform them that the billing grid is now ready Researcher Responsibilities After receiving email notification that the billing grid is available go to the Report menu and select Billing Grid Report Print the billing grid and have the PI review sign and date Submit the signed dated billing grid with the IRB application 30 TASCS Manual Using TASCS Step 5 Research Pricing For each service with Research listed as the payer a price must be entered into TASCS by the Provider i Provider Pricing screens are only available to Fairview s Research Administration and UMPhysicians Patient Financial Services employees Service Provider Responsibilities Pricing Complete Status Write in Service Description Service Location Fee schedule Discrepancy Inactive Investigational Drug Services Study Set Up Fairview Hospital Adult CV Global v dl ig i g ices Di p PNS a Inactive Im Es ational Drug Services Dispense Fairview Hospital Adult CV Global v investigational drug i ig i g ices Di D SS P Inactive Investi ational Drug Services Dispense Fairview Hospital Adult CV Global v commercial drug vestigati g vices o Inactive in ational Drug
22. not finished entering visits click the Visits link to return to the page or choose Edit Visits to continue Visit row TASCS will not allow you to delete a visit if there is data stored f To delete visits from the Visit Entry screen check the box at the end of each payers or subject tracking for the visit you wish to delete When all visits have been named choose Save Changes Select Services The Services screen will appear 25 TASCS Manual Using TASCS Step 3 Services Entry Screen Required Information for Step 3 Medical Lab Services Service Location Save Changes Save Changes Choose Payers 3H HE E de JE H lt 5 lt E i E S lt 53 E B Investigational Drug Services Study Setup Fairview Hospital A investigational Drug Services Dispense investigationa Fairview Hospital investigational Drug Services Dispense commercial djl Fairview Hospital n investigational Drug Services REGISTER ONLY MFaiiew Hospital n A a lc A e WE FS E WE Le Le WE WC Lol o X WE WE A lt Researchers are asked to enter medical and laboratory services one line for each service location What this means is that if the protocol will require imaging MRIs for instance at both a Fairview facility and at the UMP Imaging Center MRIs must be listed twice on the Services screen Enter the name of each test or procedure using the clearest and most specific terms poss
23. 010 10 15 Simplified contact list Updated Access form 2010 9 23 Update TASCS training reference p 12 2010 7 13 Updated provider contacts Updated automatic email specifications 2010 5 04 Added Fairview Research Operation Manager contact info 2010 4 30 Added Short Title Change auto email description into Appendix D 2010 04 06 Appendix C Moved Masonic Cancer Clinic from UMP Clinic to UMMC Clinic 2010 03 22 Corrected Fairview contact phone on page 35 labeled 29 from 612 672 7637 to 612 672 6737 88
24. 8 FAIRVIEW UNIVERSITY of MINNESOTA PHYSICIANS Time And Study Collection System TASCS USER GUIDE Clinical Research Budgeting Billing System and Process Version Date November 12 2015 Table of Contents Section E TAPICES isso alia allea 1 APPLICABLE CLINICAL RESEARCH ibra ana lane 3 ROLES IR EE RR 4 ae EE 4 Protocol Contact Research Coordmator 4 Billing Contact Administrator 4 Service ee 4 HEEN 5 Academic Health Center AHC Information Systems E 5 Institutional Review BoarfdXIRB oripildiisile illa loi 5 Sponsored Protocols Administration GPA 5 Assistant Vice President for Research Academic Health Center 5 Research Integrity and Oversight Programs DHIOP 5 RESEARCH PROCESS FLOW i bra lara ae 7 COMPLIANCE tn 9 TASES ene 10 MS A E 13 GENERALINEOR MA TON WE 14 PCCOSS ANG DECI Nana enano 14 Logging In to TAS CS od oars tented op 15 Saving and Timing LE EE 16 e Le e EE 16 Navia OA TDS EE 18 CENA e RE 19 Researcher Responsibilities ENEE 19 Prior to Subject Enrollment sat id 21 Step 1 Protocol Entry Screen i 21 Required Information for Step iii A AAA A 21 Gli icalT ALS COWS E 22 Cancer escarpada 22 Step 2 Vist Entry SCI lic 24 Required Information for Step 2 24 Step 3 Services Entry Science aaa 26 Required Information for Step E DEE 26 ias cn da 27 A abal ipa a i sini i oli iii iia 27 Bee 27 Last Modified cts eee ge eh le sige ate eh e
25. B application was delivered to the Lab Autofill Lab account number pulled from lab account set up entry screen 73 Field Name Field Type Field Definition Other Application to PI Date Month Day Year Lu the application was given to the Investigator or review Other Approval Date Month Day Year Date on the final approval letter Other Scientific Review Drop down Select the scientific review option that applies Other Scientific Review Number Number 10 Number assigned to the protocol Other Stipulation Date Month Day Year Date on the stipulation letter Date the response to stipulations letter is sent to Other Stipulation Response Date Month Day Year the Investigator for review La Date the application was delivered to the Other Submission Date Month Day Year caminit s Indicates no protocol services are needed from Fairview or UMP Prevents auto emails to EE neon ex providers and serves as a filter for various exception reports Used to indicate whether or not the contract with Payment for Screen Fails Yes No the funder includes payment for subjects who are screened but cannot enroll Pl Drop down Principal Investigator for the protocol Check with your department for correct financial Program Char 5 system identification numbers Check with your department for correct financial Project Char 8 system identification numbers Protocol Contact responsible fo
26. D Email Message The user has made changes to the Services or Payers screens The Principal Investigator may need to revise the consent form cost section required visits or tests etc based on these changes and notify the IRB accordingly The changes are as follows list the changes by field Patient Case Number Trigger when a case number is entered and Save Changes is clicked Email Subject TASCS Patient Case Number TASCS ID Email Message A patient case number has been created for your subject Subject ID and initials The patient case number is available on the Subjects screen in TASCS and will also appear on the Encounter forms you print for this subject Pricing Trigger when Pricing Complete is clicked Email Subject TASCS pricing TASCS ID Email Message Your price list for this study is ready to review The Research Pricing report is available under the Report menu in TASCS 66 TASCS Manual Appendices Protocol Status Change Trigger When status is changed to Inactive Email Subject TASCS Protocol Status Change TASCS 1D Email Message Providers The protocol status has been changed from active to inactive Please ensure that all invoicing and collection activity is complete and inactive the billing accounts Protocol Status Correction Trigger When status is changed from Inactive to Active Email Subject TASCS Protocol Status Correction TASCS ID Email Message Providers Protocol has been re act
27. Insurance Effective 01 01 2014 Comments Contract Char any text Char 15 General comments and notes field to store any information useful to the management of the protocol or to communicate about the management of the protocol Financial system number assigned to the contract for the protocol Check with your department for how to find this number Contract Exception Drop down Used to indicate whether a contract remains open until all work is completed or has a firm end date Contract Signature Date Month Day Year Date that indicates contract has been executed by all parties use the latest signature date 71 Field Name Field Type Field Definition Used to indicate to the researcher that Billing Coverage Analysis Complete Check box Grid Report is ready to be printed signed by PI and submitted to IRB Date populated by the system when the a Analysis Complete Autofill Coverage Analysis checkbox is checked for the first time CPRC Application to PI Date Month Day Year Date the completed CPRC application was given to the Investigator for review CPRC Approval Date Month Day Year Date on the CPRC final approval letter Number assigned to the protocol by the Cancer CPRC Number Number 15 Protocol Review Committee CPRC CPRC Stipulation Date Month Day Year Date on the CPRC stipulation letter CPRC Stipulation Response Month Day
28. PUON BE 42 Service Location EE 42 Added Service Payer AEN 42 Service Provider Responsibilities AAA 42 Review the discrepancy and ensure the charges are directed according to the instruction provided on the Service Discrepancy screen 42 Add research modifiers to the charge if the service is research related and billed to Medicare Update maintenance Requirements en 42 Protocol EMY EE 43 Subject Tracking EE ee 43 Section O 45 lgl eier 46 IDS Regist ON Vue ds 46 PRICING Ony EE 47 Subcontracts Professional Services Agreements PSA and Contracts for Professional Services OPS EE 48 Humanitarian Device Exemptions HDEs and Humanitarian Use Devices HUDs NEE 48 Bulk Specimen Processing Services EEN 48 Making Changes to Required Fields by entry screen 50 Protocol ACIS CM E 50 HEES 51 Services Screen lillo lhi EENS SEENEN 51 Table of Contents Payers SCION EE 52 SHEET 52 Subject Tracking Gcreen i 53 Service Discrepancies Screen AEN 53 Appendix A Contacts unt Secchi ee ce Sab Sen e ai 57 TAS CS lee 57 Fairview Research Administration xiii set eee dedo 57 University of Minnesota Physicians snai ire iaia sardi 57 A E 58 TASOS ACCESS di is 59 Add Remove Personnel or Gponsor EE 60 Appendix B Service Locations 61 UNMSCIMES Rasoi EE ANIA 61 E le Un e 61 Fairview elle le 62 Fairview Hospitals EE 62 UMP IMAGING te 62 Ee 62 Appendix C Automatic Emails oooooonoocccccccccccccncnananancncnnncncnnnnnnnnn cnn nnnnncnnnnnn
29. SCS prevents entry of a visit date after a subject has been withdrawn Please use the steps below to update visit tracking for a withdrawn subject 1 Click on the subject that needs to be updated 2 For Date w d change the Additional Service from Yes or No to blank if applicable and delete the date 3 For a visit that needs updating select Yes or No for additional service accordingly and enter the visit date 4 Repeat step 3 until all visits for the subject are updated 5 Update the Date w d visit including Additional Services if any select the Reason and save changes Service Discrepancies Screen Field Name Service Description For Active status protocols the description of the additional service can be changed at any time after the initial entry Field Name Service Location For Active status protocols the location of the additional service can be changed at any time after the initial entry Field Name Payer For Active status protocols the payer of the additional service can be changed at any time after the initial entry 53 TASCS Manual Appendices How to Delete a service discrepancy If by mistake a discrepancy was indicated by selecting Yes for additional service on the Subject Tracking Screen and no discrepancy was entered then change the Yes to No and save changes 54 TASCS Manual Appendices Appendices 55 Appendix A Contacts TASCS Support TASCS Support Madras Mail C
30. Service Discrepancy Entry Screen Required Information Service Description Service Location Added Service Payer Save Changes 3333333333 rr D WE IC In TASCS will auto populate the Subject Medical Record Visit Date and Visit Description fields based on stored data You must complete the remaining three fields Service Description Service Location and Added Service Payer 41 TASCS Manual Using TASCS Researcher Responsibilities Service Description Enter the name of each test or procedure using the clearest and most specific terms possible to indicate the service that was added at the visit Service Location Indicate where the service was provided The Service Location drop down menu includes the same options displayed on the Services screen UMMC Clinic UMP Clinic Fairview Clinic Includes Maple Grove Fairview Hospital UMP Imaging Center Other Added Service Payer Indicate who will pay for the added test procedure at this visit The drop down options for this field are e Research Account e Patient Insurance e Other Service Provider Responsibilities Review the discrepancy and ensure the charges are directed according to the instruction provided on the Service Discrepancy screen Add research modifiers to the charge if the service is research related and billed to Medicare 42 TASCS Manual Using TASCS Update maintenance Requirements Complete information is required in TASCS in order to co
31. Year Pare ihe e stipulation response is sentto the Investigator for review CPRC Submission Date Month Day Year Date the CPRC application was submitted to the committee Contract Research Organization commonly CHO Contract nescarcn Org prop agwi employed by business and industry sponsors CRO Contact Drop down Contact person from contract research organization CTSI Application to PI Date Month Day Year Date The completed CTSI application was given to the Investigator for review CTSI Approval Date Month Day Year Date on the CTSI final approval letter Number assigned to the protocol by the Clinical ro Nae PEMD EE NS and Translational Science Institute CTSI CTSI Stipulation Date Month Day Year Date on the CTSI stipulation letter CTSI Stipulation Response Month Day Year pag me CTS stipulation letter is sent to the Investigator for review ao Date the CTSI application was submitted to the CTSI Submission Date Month Day Year comite Check with your department for correct financial DeptiD Drop town system identification numbers Check with your department for correct financial EFS Fund uhar system identification numbers Projected protocol End Date enter date one End Date Month Day Year year from protocol entry date until firm date is known firm date should match SPA records End of Enrollment Autofill Date that enrollment in the protocol is closed pulled from subject tracking form entry EPIC Autofill Clinic account n
32. Yes or No you enter the visit date When finished click the Save Changes button to exit the pop up screen The Subject Tracking Form is refreshed and displays the data you entered as text H you need to edit the data click on either the Subject or Visit link and repeat the above process 40 TASCS Manual Using TASCS Whenever the answer to the question is yes the Providers will receive an email notification and the Researcher will be prompted to complete another TASCS screen called Service Discrepancies screen This screen looks similar to the original Services screen End of Enrollment Enter a date in this field when no further subjects will be recruited for participation Entry of a date in this field will send a notice to the recruitment website to discontinue your posting This field must be populated before you can enter information into the All Subjects Withdrawn Date field All Subjects Withdrawn Date Enter a date in this field when all subjects have either completed the protocol or withdrawn from the study Once a date is entered into this field the following occur e No further data may be entered on the Subject Tracking Form screen e No encounter forms will be available for the study e Providers will receive an email stating that all subjects have been withdrawn and no further charges will be generated e Providers will remove the research indicator from the subject s billing account s
33. address for fax header In House Lab Routine Protocol Char any text Char 100 Yes No If lab will process enter laboratory processing instructions Enter the name and address to whom faxed lab results should be addressed If centrifuge and separation will be performed by the lab check whether there is a special protocol In House Lab Special Collection Instructions In House Lab Special Protocol Instructions In House Lab Specimen Processed by Investigator Char any text Char any text Yes No Enter any special collection instructions for in house lab specimen collection If there is a special protocol enter instructions here Check whether the specimens will be centrifuged and separated by Investigator staff In House Lab Specimen Storage Check boxes Check specimen storage requirement In House Lab Specimens Collected By In House Laboratory Site s Check boxes Check boxes Check boxes for specimen collection Check all laboratory sites where in house labs will be processed Lab Char any text Lab project account number Location of Services Check boxes Select all service locations at which the research services needed will be provided Outside Laboratory Address Char any text If an outside or central lab will process specimens and a lab manual is not available enter the address of the lab Outside Laboratory Collection Instructions
34. ascs umn edu Fax 612 625 2695 60 Appendix B Service Locations UMMC Clinics 1A Neuro Neuro Surg PMR EEG EMG 2A Transplant Center 3A Primary Care 4A Pediatrics 5A Allergy Asthma Derm PFT Lab 5A Sleep Disorder 6A Medicine 8A ENT 9A Eye 3B Cardiovascular Center 5B BMT 6B Delaware St 1C Women s Health Center 1E Surgery Colon Rectal GE Weight Mgmt 1E Peds Urology Derm Surg and Laser Masonic Cancer Center Masonic Breast Center Masonic Day Hospital Mayo B435 Prostate Cancer and Urology Riverside Ortho Riverside University Specialists Riverside Urology Riverside West Psychiatry UMP Clinics Family Medicine Center for Sexual Health Smiley s Clinic Phalen Village Broadway Family Medicine Bethesda Clinic Riverside Endoscopy Center Imaging Center Reproductive Medicine Center 61 Fairview Clinics Maple Grove Medical Center Columbia Park Medical Group Fairview Cedar Ridge Fairview Oxboro Fairview Ridges Fairview Eagan Fairview EdenCenter Fairview Crosstown Fairview Elk River Fairview Lino Lakes Fairview Bass Lake Fairview Children s Fairview Hiawatha Fairview Northeast Fairview Uptown Fairview Hospitals University of MN Medical Center Fairview Fairview Southdale Hospital Fairview Ridges Hospital Fairview Lakes Medical Center Fairview Northland Medical Center Fairview Red Wing Medical UMP Imaging Center On the UMMC Campus Other Not one of the locations describe
35. bject Withdrawn TASCS ID Email Message A subject has been withdrawn from this study The subject s information is as follows list initials MRN Date of Birth and date of withdrawal UMP Please inactivate the patient case number Fairview Please remove the patient flag from the billing system s 68 TASCS Manual Appendices Subject Withdrawn Date Change Trigger when a date is changed or removed from the Subject Withdrawn date field and saved Email Subject Subject Withdrawn Date Change TASCS ID Email Message The date for subject withdrawal was either changed or deleted The subject s information is as follows list initials MRN Date of Birth and date of withdrawal If the date was deleted the subject continues to participate If the date was changed update the billing accounts accordingly Billing Contact Change Trigger when the name in the Billing Contact field is changed and saved Email Subject Billing Contact Change TASCS ID Email Message The billing contact has been changed Please update the billing files accordingly Short Title Change Trigger when information in the Short Protocol Title field is changed and saved Email Subject Short Title Change TASCS ID Email Message The short titled has been changed Please update the billing files accordingly 69 Appendix D Field Definition by screens Protocol Entry Field Name Field Type Field Definition Date the last subject enro
36. counter forms will only be available in TASCS if the Services and Payers screens have been completed 39 TASCS Manual Using TASCS Step 8 Subject Tracking Form Entry Screen Dates must be entered when a subject is consented a visit is completed and when a subject is withdrawn Each of these dates must be entered within 72 hours of the event Save Changes J Entering Visit Dates The Subject Tracking Form displays the visits you defined and the subjects you have enrolled as a table Both the Subject s and the Visit dates are provided as hyperlinks You may enter visit dates by choosing either the individual subject link or the visit link Selecting a link will open a pop up window The pop up window includes a column titled Additional Services You must answer the question below by selecting yes or no from the drop down menu Were additional services used at the visit e g not planned for this visit and they were not pre printed on the Encounter Form or Research Lab Slip If there were additional services indicate by choosing Yes If there were no additional services indicate by choosing No One time or invoiceable items should be written in the box on the encounter A form and indicated by answering the question Y on the Subject Tracking Form screen for the visit as an additional service not pre printed on the encounter form Once you have answered the above question by choosing
37. cts number or patient case from TASCS m gt dispute 3 number charges Researc Yes A Y SEN her y Use encounter y E y Ge form s and lab i Complete SEI Subject requisition s at closure information i TASCS Tracking Form point of service if into TASCS E Account Set y in TASCS daily charges should Notify IRB and departmental WEE 7 3 a appear on the SPA regardin process 5 Complete Subject Tracking Form in study billing i bs H TASCS for consent Secvunt closure E SPA Close out SN y _ IRB Kee o n V a d bausen Review TASCS Review UMPhys CASE Create patient reports daily Add charges tied Approve icians en CASE and enter or close patient to patient release of p Gare nto TASCS CASES as CASES claim to Review ded daily Move monthly TASCS MEG charges to insurance TASCS gt Generate P COITeECL monthly reports IUI account A study invoices to Flames Y researcher Review TASCS s Assign account reports daily Add or number s and delete patient enter into TASCS research flag in PASS as indicated Afe charges on No the correct Fairview FV Lab creates account Close out study study specific lab A AN requisition and sends to researcher Review flagged y charges daily from SS PASS edit report TASCS Manual The Process COMPLIANCE Institutional policies see Appendix F describe the rationale and procedures for compliant budgeting and billing practices within the AHC UMPhysicians and Fairview Healt
38. d above 62 TASCS Manual Appendix C Automatic Emails Appendices TASCS employs automatic emails as a notification tool The chart below lists emails and to whom they are sent Principal Billing Protocol Emails Investigator Contact Contact Fairview UMPhysicians Lab IRB Account Setup x x Additional PO Entered x x x All Subjects Withdrawn x x x x All Subjects Withdrawn x x x x Correction Billing Accounts x x x x x Billing Contact Change x x x x Budget Info Change x x x x Coverage Analysis x x de Complete IDE HDE Alert x x x Modification Detail x x x x x Patient Case Number x x PI Contact Change x x x x Pricing x x Protocol Contact x x x Change 63 TASCS Manual Appendices Principal Billing Protocol Emails Investigator Contact Contact Fairview UMPhysicians Lab IRB Protocol Status Change x x x x Protocol Status x x x Correction Services Alert x x x Service Discrepancy y y x y Alert Service Discrepancy Alert Correction e s s Services Payers e gt Modification Short Title Change x x x x Sponsor Change A gt S Subcontract Alert x x x Subject Consented x x x x Subject Consented x x S Date Change Subject MRN Change x x x Subject Withdrawn x x x x Subject Withdrawn Date x x x x Change Each email is sent based on a predefined trigger When a certain action is taken it will trigger the auto email which is sent to the contacts l
39. e sent to the lab 10 No further documentation is required in TASCS 49 TASCS Manual Appendices Making Changes to Required Fields by entry screen Protocol Screen Field Name Status The status field indicates whether the study is active or inactive You can further clarify the active status with Approved Future Protocol or In the Approval Process Changing from one active status to another can be done by all users Changing the status from Active to Inactive will require the following conditions 1 All subjects are withdrawn in TASCS 2 All Subjects Withdrawn date is entered entering an All Subjects Withdrawn date also requires the entry of an End of Enrollment date After changing the protocol status to Inactive and saving the change the status becomes grayed out and locks the protocol from any further changes Additional changes to the protocol will require TASCS Support assistance Please contact TASCS Support tascs umn edu to discuss options The Inactive Duplicate status indicates that the protocol is a duplicate of an existing protocol in TASCS Inactivate the duplicate protocol by changing the status to Inactive Duplicate and then saving changes A Choosing the Inactive Duplicate status and saving changes will remove the protocol from the list of viewable protocols For any questions about the Inactive Duplicate status please contact TASCS Support tascs umn edu for help Field Names PI
40. e withdrawn from the study when it is known they are ineligible Using the Encounter Form With the implementation of EPIC most service areas have converted to electronic charge routing and no longer use paper forms tickets There are still some service areas at Fairview and at University of Minnesota Physicians that continue to use paper forms tickets including the research Encounter Forms Please see Appendix G for details 38 TASCS Manual Using TASCS When enrollment for the protocol can begin and a potential subject is identified follow these steps 1 Go to the Reports menu 2 Print visit specific encounter form s from TASCS The visit specific forms will include only those services to be provided by Fairview or UMP and to be billed to the research account Encounter forms and lab slips when required signal Providers to bill services to the research account One time or invoiceable items should be written in the box at the bottom of the encounter form and indicated on the Subject Tracking Form Entry screen as an additional service not pre printed on the encounter form Encounter forms when required can be printed specific to subjects and visits It is also possible to print a visit specific encounter form that does not include information about any specific subject If researchers use these generic forms information about the subject must be handwritten on the encounter form Visit and subject specific en
41. efinition The number of hours budgeted for an employee Administrator Hours Number to complete his her work per subject at this milestone Check box if any Check box if any medical lab services will be needed from any Provider at the visit See note medical lab services SES on Visit Entry screen for definition of medical lab needed services The amount according to the contract the site Contract amount Number will be paid for each subject completing this milestone The number of hours budgeted for an employee Coordinator Hours Number to complete his her work per subject at this milestone 75 Field Name Field Type Field Definition The delete function will only work if there is no Delete Box Check box other saved data related to the visit e g payers or visit dates Label for each research subject encounter ia required by the protocol i e Visit 1 Visit 2 Day Description a 23 Phone Call Visit names must be unique and must be listed in the order they will occur Order is assigned by TASCS but visits can be EES Momper added and the order changed as needed The number of hours budgeted for the PI Hours Number Investigator to complete his her work per subject at this milestone Total Field Count 8 76 Services Entry Field Name Field Type Field Definition Last Modified Autofill Date user last changed information in this row Medical Lab Services Char 65 Enter the requested test
42. en changed or deleted Additional PO Entered Trigger when a subsequent PO is entered and Save Changes is clicked Email Subject TASCS Additional PO Entered TASCS ID Email Message The user has entered a new purchase order for this study Update the billing account with the new information Biling Accounts Trigger when a new PO is entered and Save Changes is clicked Email Subject TASCS Billing Accounts TASCS ID Email Message The user is requesting billing accounts for this study Set up accounts needed based on the information in the Services screen 65 TASCS Manual Appendices Coverage Analysis Complete Trigger when Coverage Analysis Complete is checked and Save Changes is clicked Email Subject TASCS Coverage Analysis Complete TASCS ID Email Message Fairview has completed the coverage analysis A billing grid for this study is now available in the Report menu A A signed billing grid is required with your IRB application IDE HDE Alert Trigger when an IDE HDE number is entered and Save Changes is clicked Email Subject TASCS IDE HDE Alert TASCS ID Email Message Please review the referenced protocol to determine if this is an IDE or HDE use Work with the Protocol Contact to collect the information needed to submit the use to the local Medicare contractor Noridian Modification Detail Trigger when Resubmit to Providers button is clicked Email Subject Modification Detail for TASCS number TASCS I
43. er eb eal cg de eke 28 COMMONS Ha A An AAA LARA RARA 28 Step 4 EMP EE 29 Required Information for Step Asarco doce 29 Service Provider Responsibilities iii 30 Researcher Responsibilities i 30 Step 5 Research Pricing EE 31 Service Provider Responsibilities 31 Researcher Responsibilities eessen 32 Table of Contents Step 6 Account and Lab Set Up Entry Screen 33 Required Information for Step Buin da 33 General Account Information ssssssseeeeeeeseeeenernrrtesserrtrrrnrnrtsserrtnnnnnnnnneeennrnnnnneeeet 33 Lab Afo aO a a a a a A A EA 34 Recruitment Posting sacs sees se eget beige nnd eg cae cesar See nee 35 Provider Responsibilities ee 35 After Subject gea 37 Step 7 SUbjectENty ScreeNi iaia iii ie Agassi 37 Required Information for Step Tasas dis 37 Researcher Responsibilities ENEE 37 later A A E RAA 37 italo 37 GENOA nota Ronan pal An Aa aa Ae rane 37 Medical Rec o iconico ba 38 Provider Responsibilities nnn 38 Using the Encounter Form iii iii 38 Step 8 Subject Tracking Form Entry Screen 40 Entering VISITS Gere ia ei pred inerte a ele a i ai 40 EnQOrenhollMent 22A0c3c 222 bot A She SARS Ae dai SA AL 41 All Subjects Withdrawn Dates sti 41 Service Discrepancy Entry Screen i 41 Regu ired Information EE 41 Researcher Keep neige eer 42 Service DESEN
44. eral money and other sources private commercial etc It also includes research funding passed through other organizations if the original prime funding source specific to the research is a federal entity Common examples in this category are cooperative group studies and NIH multi center trials State Research sponsored OR funded by a MN state organization or entity An example of state funding is research paid for by the Tobacco Settlement Research sponsored or funded by states other than MN should be included in the Other category see below University funds Research sponsored AND funded by aUniversityofMNschool department or organization Examples in this category include seed money from a department or grants awarded from University funds An investigator initiated protocol conducted using internal funds would fall into this category If the research is conducted by University staff or faculty using external funds then it falls into one of the other categories Other Research sponsored OR funded by an organization individual or entity not described in the above four categories Investigator initiated studies fall in this category If a non profit organization received federal money to support a specific research project then the research is consider Federal rather than Other even though the non profit may be the sponsor see comment above in Federal section regarding pass throughs TASCS Support 612 626 4612 t
45. h Services As discussed earlier this is a heavily regulated activity and is viewed as a high risk area Compliance is monitored and reported to Senior Leadership at the AHC UMPhysicians and Fairview Health Services The driving principle used to facilitate compliance is to assist all stakeholders in understanding and adhering to the defined processes Resources are available to assist Users Classroom and individualized training TASCS User Manual TASCS Support Processes have been developed to monitor adherence to the policy Routine reports identifying compliance concerns are reviewed by TASCS Management Users are notified about potential compliance concerns and asked to respond Non response to TASCS Management s notification or issues that can t be addressed by this process are forwarded to the Office of Regulatory Affairs for resolution Pre Award TASCS Manual The Process TASCS Workflow TASCS Workflow Pre Award Researcher Service Provider Provide information to Populate IDE or HDE research regarding Medicare fields if using a approval process Gather device documents and submit to Medicare on behalf of PI IDE or HDE Y N NO Submit to Providers cl A to revise billing plan qualifying trial per SCH Medicare policy eeded OCT Completed Provide research pricing Assign IDS number if applicable 10 TASCS Manual The Process TASCS Workflow Post Award Service Providers
46. hanges Select Services button 4 On the Services screen change the status on all the IDS services to Inactive except for the IDS Register Only service Make sure IDS Register Only is indicated as Active 46 TASCS Manual Appendices Click on the Save Changes Choose Payers button to advance to the Payers screen On the Payers screen choose Research as the payer in the Start Up visit column next to IDS Register Only even though no charges will be generated by Fairview 7 Click on Save Changes and then Submit to Providers 8 9 Complete the IDS Register Only form available at www fairview org research Attach the protocol via the automatic TASCS email under Forms 10 Send completed form via email to IDS IDSPharmacy fairview org If requesting prices from Investigational Drug Services IDS you need to A provide sufficient information for IDS to evaluate and price the requested services Information may be added in the comment box on the Services screen in TASCS or attached in lieu of a protocol Pricing Only You can request research prices from Fairview and UMP in order to help determine study feasibility for grant submissions when no protocol has been developed There may be additional charges associated with these services that are unknown prior to the availability of a full protocol for the study To request prices for services follow these steps 1 2 3 Go to the New menu and choose Protoc
47. heck a list of protocols already entered in TASCS by going to the Edit menu and choosing Protocol Searching by PI will yield the list of protocol short titles sponsors etc that will help users determine whether or not the protocol might already be entered Whenever there is a question the user should check before entering a new protocol It is recommended that the primary Protocol Contact for a protocol be responsible for setting up new protocols in TASCS but researchers and departments can determine how to best assign responsibilities TASCS Support will on a regular basis search for duplicate entries and work with Protocol Contacts to correct any multiple entries of protocols in TASCS Researcher Responsibilities Adding a new Sponsor Principal Investigator Billing Contact or Protocol Contact Every effort will be made to prevent duplicate entries of sponsors and persons including Investigators Billing Contacts Protocol Contacts etc in TASCS When entering a new protocol in TASCS if the Sponsor or Person is not listed as a current drop down option TASCS Support will enter the new Sponsor or Person into TASCS When a sponsor Investigator Billing Contact or Protocol Contact must be added the user should e mail or fax the required new information to Email Fax Phone tascs umn edu 612 625 2695 612 626 4612 Information needed to enter a new Sponsor or new Person in TASCS can be found in Appendix B It is imp
48. ible to indicate the service needed For instance if the MRIs required by the protocol will require the use of a contrast agent enter MRI with contrast Service Providers will communicate with the Protocol Contact entered in TASCS whenever more information is needed to make sure TASCS reflects what the protocol requires 26 TASCS Manual Using TASCS All medical or laboratory services tests procedures clinic space clinic visits physician time lab services pharmacy services or hospital services that are A required to carry out the protocol must be entered on the Services screen whether they will be provided by Fairview University of Minnesota Physicians or not Status The first column on this screen displays a Status dropdown field TASCS will show each service line as active You may change the status to inactive for those services that do not apply Services Four lines related to Investigational Drug Services IDS will be auto filled by TASCS on the Services screen The service location for IDS services will also be auto filled Location After naming the test procedure the next field to enter will be to select the service location from the drop down The Service Location drop down includes e UMMC Clinic UMP Clinic Fairview Clinic Includes Maple Grove Fairview Hospital UMP Imaging Center Other Additional information on categorizing or understanding service locations is available in Appendix C If the O
49. ing Contact assists with purchase order preparation based on the budget Monitors and reviews reports in TASCS as a tool to assist ongoing account management Service Providers Service Providers in this context are employees of University of Minnesota Physicians or Fairview Research Administration Service Providers will assist Investigators in determining whether or not the clinical research protocol meets criteria for a Qualifying Clinical Trial under Medicare s policy They will continue to provide research prices and set up research billing accounts Providers will establish a process to identify research TASCS Manual The Process participants in applicable systems and use TASCS information to help ensure charges are on the correct billing accounts They will also facilitate research coding on claims TASCS Support TASCS Support designs plans and coordinates end user TASCS training and provides assistance to end users including assistance with data entry when necessary This role serves as the TASCS Support and a liaison between Users Providers and TASCS Programmers Academic Health Center AHC Information Systems IS AHC IS writes and maintains code for the web application They resolve technical barriers and end user concerns as appropriate IS participates in the development of reports for various stakeholders including end users and service Providers and in the development of policies procedures and standards for ensuri
50. isit2 Visit3 MRI with contrast Fairview Hospital l MRI with contrast UMP Imaging Center EKG lab Fairview Hospital Your screen may look different Your visits and services appear in a table for you to populate the payer information Payer information is the billing plan indicating who should pay for each service at specified visits In some studies a service might be appropriately billed to patient insurance at some visits but not others TASCS will allow users to indicate how the service should be billed at each visit or whether it will be provided outside of Fairview or UMP If you dont see a visit displayed return to the Visits screen and make sure you A checked the box indicating that medical or lab services are needed at the visit This box must be checked in order for the visit to appear on the Payer screen The visits and services appear as hyperlinks You may choose to populate the payer information by visit or by service If by visit then click on the desired visit link If by service click on the desired service link Either way a pop up window appears in order for you to select a payer The payer drop down options are listed below e Research Account e Patient Insurance e Other Save Changes _ Save Changes Location Fairview Hospital UMP Imaging Center Fairview Hospital Edit Payers by Visit Edit Payers by Service Click on the Save Changes
51. isted in the above chart Each email will provide the TASCS ID number the PI s name and the short study title as the first line of text The last text line will indicate the user who triggered the email The details of each email and the trigger are described below TASCS Manual Appendices Account Setup Trigger when Providers click on the Account Setup Complete button Email Subject Account Setup TASCS ID Email Message Your research billing accounts have been set up by the Providers and the account numbers are available in TASCS on the Protocol screen Encounter forms are now available for your use and are found in the Report menu in TASCS If you requested Lab services the Fairview Lab will create a study specific requisition slip and send to you directly All Subjects Withdrawn Trigger when a date is entered into the All Subjects Withdrawn Date field and saved Email Subject Subject Participation Complete TASCS number TASCS ID Email Message All subjects have been withdrawn from the study and no new patient charges should be generated on the protocol after insert date A IDS charges may continue if the study drug remains in the IDS Pharmacy All Subjects Withdrawn Correction Trigger when a date is changed or removed from the All Subjects Withdrawn Date field and saved Email Subject All Subjects Withdrawn Date Change TASCS ID Email Message The date in the All Subjects Withdrawn Date field has be
52. ivated Please keep billing accounts open If accounts were close and cannot be re opened advise Protocol or Billing Contact regarding necessary action to create new accounts Service Alert Trigger when Submit to Providers is clicked Email Subject TASCS Services Alert TASCS ID Email Message The user has submitted services for review and pricing Service Discrepancy Alert Trigger when a new service discrepancy is entered and Save Changes is clicked Email Subject TASCS Service discrepancy Alert TASCS ID Email Message The user has noted an additional service that occurred during a research visit Please review the additional service to direct charges accordingly list visit date MRN and service description Service Discrepancy Alert Correction Trigger when the Remove checkbox is checked and saved on the Service Discrepancy screen Email Subject TASCS Service Discrepancy Alert Correction TASCS ID Email Message A service discrepancy was entered in error for insert visit date MRN and service description No additional services were used and no action is needed Services Payers Modification Trigger when Unlock amp Modify is clicked on either the Services or Payers screens Email Subject Services Payer Modifications to TASCS TASCS ID Email Message The user has unlocked the Services or Payers screen to make changes See the subsequent email titled Modification Detail for specific information about what changes were
53. ject visit dates e g Subject 101 completed study MRI on 8 13 08 but completed study visit on 8 15 08 Notes Char any text Track by Visit Field Name Field Type Field Definition Before a visit date can be entered as completed the following question must be answered Were additional services used at the visit e g not planned for this visit and they were not pre printed on the Encounter Form or Research Lab Slip If there were additional services indicate by choosing Yes If there were no additional services indicate by choosing No Additional Services Drop down Initials Autofill List the initials from Subject Tracking Form S Autofill List the subject from Subject Tracking Form Enter the date the subject completed the study visit In situations where services for a protocol visit are provided on more than one day for instance an MRI for the protocol is completed in advance of the clinic visit choose and enter the date the protocol visit was completed Visit Month Day Year 81 Track by Subject Field Name Field Type Field Definition Additional Services Subject Initial Visit Drop down Month Day Year Autofill Before a visit date can be entered as completed the following question must be answered Were additional services used at the visit e g not planned for this visit and they were not pre printed on the Encounter Form o
54. lled or to be enrolled All Subjects Withdrawn Date Autofill in the study has ended his her participation pulled from subject tracking form entry AmendmentAmount Number 7 The amount per the contract that can be invoiced for processing the amendment Amendment Date Month Day Year The date of the protocol amendment Amendment Number Number 2 Used to record the number of protocol amendments Amendment Rec d Date Month Day Year The date the protocol amendment was received Protocol business manager the approver of Billing Contact Drop down protocol expenses commonly called administrator or accountant Certificate of Confidentiality Checkbox oo a Certificate of Confidentiality is in Check with your department for correct financial Chartfield1 Char 10 system identification numbers Enter placeholder until known Check with your department for correct financial Chartfield2 Char 10 system identification numbers Enter placeholder until known Check the box if you need to purchase labor from Fairview or UMP Also applies to Professional Check here if you need a new Check box Services Agreements PSA and Contracts for subcontract with Fairview or UMP Professional Services CPS Please note that professional fees do not require a subcontract Contact Fairview or UMP with questions Clinical Trials gov protocol unique identifier ClinicalTrials gov Char 11 ClinicalTrial gov is required of Service Provider when charges are billed
55. mental and critically important component of any Academic Health Center s mission It is also an activity that is highly regulated deeply complex and thus carries an inherent risk Locally as well as nationally there has been a lack of communication intra and inter organizationally regarding clinical research processes Clinical trial budgeting and billing is one of those processes that has become an identified risk area Historically there have been very few or no policies and processes defining or guiding this activity The University s Academic Health Center UMPhysicians and Fairview Health Services have collaborated to create organizational policies in order to address clinical research budgeting and billing The goal in creating policies is to foster compliant clinical research budgeting and billing across our organizations Elements of a successful program include the following e Define payers for protocol services prospectively e Integrate language and practice consent form clinical trial agreement billing practice e Identify research participants within the Providers systems e Identify research related services at point of care assign to correct payers e Correctly code claims A process diagram has been crafted to demonstrate the steps involved in implementing the budgeting and billing policy The process diagram can be found in the Roles and Responsibilities section that follows The AHC Database TASCS i
56. mply with the policy Updates are required as information becomes available The following data fields are marked with blue asterisks indicating they are required Please refer to Appendix E for field definitions by screen The fields are listed by the screen on which they appear Protocol Entry EFS Fund Project Program Start Date End Date CPRC Number IRB Number IRB Approval Letter Date Investigational Device Exemption IDE Humanitarian Device Exemption HDE Subject Tracking Form End of Enrollment All Subjects Withdrawn Date Routine compliance monitoring will identify fields marked with either red or blue asterisks that are missing data or have incomplete data as these are required 43 TASCS Manual Section III How To Appendices 45 TASCS Manual Appendices Protocols without Services A checkbox has been added to the Protocol screen in the middle of the General section The checkbox is designed to add clarity for information added to TASCS that does not involve Fairview or UMP services Examples of TASCS use that may fall into this category include but are not limited to e The research is conducted at another clinical site VA HCMC etc e The research is a registry study or medical record review e The research staff is using TASCS for internal purposes only e g time card tracking The checkbox reads as follows No services needed from Fairview or UMP on this protocol e Services refer
57. mption number assigned by the FDA Investigational drug services account number oe Pulau pulled from lab account set up entry screen Year all work on the protocol was completed or Inactive Date was rejected or declined inactivates the protocol in system Investigational Device The investigational device exemption IDE Char 7 Exemption number assigned by the FDA The investigational new drug IND number re assigned by the Food and Drug Administration EE New Daig SANO FDA If the test article is a biologic enter the BLA number in this field Used to indicate whether or not the contract with Invoice for Amendments Yes No the sponsor will provide payment for processing protocol amendments IRB Application to PI Date Month Day Year Date the application was given to the Investigator for review IRB Approval Letter Date Month Day Year Date on the final IRB approval letter IRB Approval Letter Rec d Date Month Day Year Date final IRB approval letter is received IRB Continuing Review Date Month Day Year IRB end of approval date IRB Meeting Date Month Day Year Date the IRB will consider the application IRB Number Char 10 Code number used by IRB to identify protocol IRB Stipulation Date Month Day Year Date on the initial stipulations letter from the IRB Date the IRB stipulation response letter is IRB Stipulation Response Date Month Day Year delivered to the Investigator for review IRB Submission Date Month Day Year me the IR
58. n the University is the prime award recipient and a subcontract PSA or CPS is needed between the University and Fairview 1 2 Go to the New menu and choose Protocol Complete the required fields and check the box at bottom of the first section General that says Check here if you need a new subcontract with Fairview or UMP Click on Save Changes to save the screen Fairview or UMP will notify the Protocol Contact that the request was received and request a work scope and budget Fairview or UMP will create the Statement of Intent or other necessary documentation obtain Fairview signatures and return to signed document to the Protocol Contact No further documentation is required in TASCS Humanitarian Device Exemptions HDEs and Humanitarian Use Devices HUDs h Goto the New menu and choose Protocol Complete the required fields on the Protocol screen In the IRB section of the Protocol screen indicate the HDE number and save the screen Click on the Visits link to advance to the next screen or go to the Edit menu and choose Visits On the Visits screen add a single visit called HUD Surgery and uncheck the boxes for the remaining pre populated visits Click the Save Changes button NOT the Save Changes Select Services button Fairview will contact you for additional information needed to submit the HUD use to Medicare Once HUD use begins enter patient information on the Subjects sc
59. ng When a Delete box is grayed out it indicates that Payers and or Tracking data are associated to that visit The associated data will have to be removed from TASCS before deleting the visit Please contact TASCS Support tascs umn edu to discuss options Services Screen Field Names Status Medical Lab Services Service Location You can change the Status Medical Lab Services or Service Location before submitting to providers Service description and service location are locked permanently after submitting to providers Please use the steps below to change service description and or service location after submitting to the providers 1 Click on Unlock and Modify and then click OK on the pop up prompt 2 Change the status of the incorrect service to Inactive and save changes 3 On a blank service line enter the correct service description select the correct service location and save changes 51 TASCS Manual Appendices 4 Repeat step 2 until all corrections are completed and click on Save Changes Choose Payers 5 For each new corrected service select the payer for the service for all visits requiring the service 6 Repeat step 5 until payers for all services have been selected and click on Resubmit to Providers Payers Screen How to change payer after submitting to providers Payer data indicates who pays for a service at a particular visit You can change payer data before submitting to providers Afte
60. ng the integrity of the database Institutional Review Board IRB The IRB serves as a checkpoint to help assure congruent language and practice in the research consent process They review language in the consent form regarding cost to the participant and match information to the signed billing grid report The IRB notifies the principal Investigator when discrepancies are identified Final IRB approval is not granted until discrepancies are resolved Sponsored Protocols Administration SPA Facilitates compliance with internal and external requirements Reviews the contract language and proposed budget for conformity with Regents policies Negotiates and executes the clinical trial agreement on behalf of the Regents Provides Notice of Grant Award to principal investigator and designated departmental staff Emails NOGA notification to Fairview Research Administration Office Assistant Vice President for Research Academic Health Center This individual is the policy owner at the AHC and is responsible for compliance Research Integrity and Oversight Programs RIOP This office assists in managing compliance with TASCS policy and procedures TASCS Manual The Process RESEARCH PROCESS FLOW The success of the process is dependent upon a range of stakeholders including the researchers the IRB SPA and the Providers A detailed process map is provided below on the next two pages The shaded steps denote user interaction with TASCS
61. nnnnnnccnnnnnnns 63 Account SOUP EE 65 All Subjects tee Te 65 All Subjects Withdrawn Correction EEN 65 EE 65 Mile Bieren 65 Coverage Analysis Complete uil iii 66 HESE Alea 66 toro liters lire Dl e 66 Patient Gase Numb et ee Eege 66 i dene Rand 66 Protocol Status Change EE 67 delen ER DEE 67 Service Aler A 67 Setvice Discrepanoyv TEE 67 Service Discrepancy Alert Correction EE 67 Services Payers Modification 67 EE 68 Su upcontract Ale dE 68 o AA AZ Mala Aaa Ee 68 Subject Consented Date Change EEN 68 S bject Withdra WM serenidad danes 68 Subject Withdrawn Date Change ANE 69 Billing Contact Change sitial 69 Shor Mile ne ae aaa aiar 69 Appendix D Field Definition by screens un 71 Protocol Eni EE 71 VISIT e EE 75 Table of Contents eler EMY E 77 PG Si iy E 77 Payers Oy EE 77 Payers ENEE ee 77 Services List Provider ONlY i 78 Service Provider Pricing Entry Provider ONlY 78 Account Lab Set up E n 78 EES 80 SUDIOCE Tracking FOI EE 81 TRACK DMI it id 81 MAS nai a Aa aa a ala iia ata la aa otal ali ial stele 82 Selvice Discrepancy EMMY E 82 APppendocE lee 83 A 83 DOM Praia a 84 TL CEE 85 Appendix F Use of Encounter Forms Lab Slip and UMP Case Numbers sannnnneaaa 87 Appendix G TASCS Manual Changes 88 Changes E 88 TASCS Manual The Process Section I The Process TASCS Manual The Process BACKGROUND Clinical research is a funda
62. ode 1932 717 Delaware St SE Minneapolis MN 55455 Email tascs umn edu Fax 612 625 2695 Phone 612 626 5203 Fairview Research Administration Email research fairview org Contacts http www fairview org Research S 034225 University of Minnesota Physicians Email pfs research umphysicians umn edu A Specific provider contacts are also available in TASCS via the Links menu 57 Forms 58 TASCS Access TASCS Access Request Form Name Address 1 Address 2 City request Type Access Type Access Type Descriptions CTO for Masonic Cancer Center Clinical Trial Office employee CTSI for Clinical Transiational Science Institute employee Encounter Form Only provides access to Encounter Form only IRB for Institutional Review Board employee Provider for Fairview or UMP administrative employee Report Only provides access to reports only no training required RIOP for Research Integrity and Oversight Programs employee SPA for Sponsor Project Administration employee Standard for standard access by Dept ID Title Phone Email State MN Zip Code Researcher Role s Check all that apply Principal Investigator Protocol Contact Clinical Research Coordinator Billing Contact Administrator ID To DEPT ID numbers contact the administrator or accountant in your home department LO JL TI JE TI Applicant Signature Supervisor Name Supervisor Signature No super
63. ol Complete the required fields on the Protocol screen and Save Changes Click on the Visits link to advance to the next screen or go to Edit menu and choose Visits Ensure that the Pricing Only visit is checked indicating that Medical Lab Services are needed Click on the Save Changes Select Services button to advance to the next screen Change the status of unused services to Inactive Enter services that need pricing and Save Changes Click on the Save Changes Choose Payers button when all services have been entered Populate the Payers screen using Research as the payer Click on the Save Changes button and then Submit to Providers Disregard the instructions on the notice directing you to attach your protocol to the auto email Feel free to include a proposal or other documents that will help clarify the services you have requested Services and Payers screens to accurately reflect your protocol Prices will Should your study be funded you will need to update the Protocol Visits be sent based on the updated information 47 TASCS Manual Appendices Subcontracts Professional Services Agreements PSA and Contracts for Professional Services CPS Information in this section applies to studies where a prime award or contract has been granted to one institution and an additional contract agreement is needed in order to purchase supplies or labor from a separate organization This process is most commonly used whe
64. ol Contact Sponsor Deptid 16 TASCS Manual Using TASCS e TASCS ID search for the study by its unique identifier in TASCS e Protocol Short Name search for the study using a key word in the Short Protocol Title e PI search for the study using the last name of the PI e Protocol Contact search for the study using the last name of the protocol contact e Sponsor search for the study using the sponsor s name e Deptid search for the study using the Dept ID A The search may result in more than one study Example PI doe Sponsor inter This search will find all studies where the Pl s last name starts with doe AND where the sponsor s name starts with inter The result lists all of John Doe s studies sponsored by Intermune TASCS Manual Navigation Tips The following navigation tips are not necessary but are offered as useful options when Using TASCS entering information in TASCS Keyboard Keys Alt Left Arrow Description Back a page Alt Right Arrow Forward a page ALT D Select the address bar so you can enter a new URL HOME Brings you to the top of the page END Brings you to the bottom of the page TAB Skip to the next field SHIFT TAB Skip to the last field CTRL A Select all CTRL C Copy CTRL V Paste TASCS Manual Using TASCS Getting Started It is important to guard against the duplicate entry of protocols in TASCS Researchers can c
65. ortant to note that every Sponsor entered in TASCS has a funding source associated with that Sponsor The selection of the appropriate funding source has implications for assuring the proper rates for research services are applied If you have questions about the funding source associated with a Sponsor please contact TASCS Support For more information about funding sources please see the Sponsor request form in Appendix B The IRB will review a budgeting billing grid as part of all new protocol applications received after September 1 2008 To prepare a budgeting billing grid follow the steps described in the next sections TASCS Manual Using TASCS You can request research prices from Fairview and UMPhysicians in order to help determine study feasibility for grant submissions See Pricing Only information in the How To section of this manual TASCS requirements are organized into activities that occur before subjects are enrolled and activities that between subject enrollment and study closure The following information describes the data entry and communication process from beginning to end Sections of the process are divided between Researcher Responsibilities most commonly meaning either Investigator or Protocol Contact responsibilities and Service Provider meaning UMP or Fairview responsibilities A complete list of all TASCS entry screen fields can be found in Appendix E 20 TASCS Manual Using TASCS Prior to Subject
66. ou need to purchase Fairview or UMP personnel time to perform work for the research protocol as part of your study staff Social Services Nutrition Nursing etc Example If you need nursing staff to assist with recruitment or perform additional assessments this would require a contract If you need a nurse to perform routine functions that would normally occur outside of a study you do not need a contract Discuss with Fairview Research Administration to determine what type of contract is needed subcontract contract for professional services or a professional services agreement All contracts require a budget and work scope statement Contact Fairview Research Administration at research fairview org or call 612 672 7690 EFS Fund Chartfield1 Deptid Chartfield2 Program Fin Emplid Project Contract Start Date mmiddiyyy pp mmiddiyyy End Date mmiddiyyy To Dean Date mmiddiyyyy Contract First Contact Date mmiddiyyyy Signature Date mmiddiyyy Final Protocol Receipt ate mmiddiyyyy Startup Payment Contract Exception Total Value Estimated S Subject Payment for Screen Balli RENO Research related services billed to patient insurance must meet Medicare s criteria for a Qualifying Clinical Trial For purposes of this form the Qualifying Clinical Trial boxes will also be used to indicate whether or not studies involving investigational devices meet the relevant device rules Qualifying
67. plication form will insure access to the information users need DeptlDs can be added and deleted as needed for each user Exceptions to DeptlD access include e Cancer Center Clinical Trials Office access granted based on populated CPRC Number field Please be aware that all protocols with information in the CPRC A number field will be available to personnel in the Cancer Center Clinical Trials Office e Clinical and Translational Sciences Institute CTSI access granted based on protocols entered by CTSI e Institutional Review Board read only access to the Protocol screens no access to Visits Services Payers or Subject Tracking screens Can view all standard reports except the researcher s version of the Subject Tracking Form Report e Sponsored Projects Administration same access as the IRB e Research Integrity and Oversight Programs RIOP read only access to all e Service Providers access to all Logging into TASCS The web address for TASCS is https secure ahc umn edu tascs The log in screen defaults to the University x500 ID validation screen e University employees University employees will use this screen with their x500 ID and password to log into TASCS e Non university employees or those without an x500 ID You will need to establish a User Account with the University before TASCS can assign a log in for you Contact TASCS Support for assistance University guest accounts can be registered
68. ption Autofill Data pulled from the Subject Tracking Form for each yes answer Total Field Count 8 82 Appendix E Policies AHC AHC s Clinical Research Budgeting and Billing Policy can be found at htto www ctsi umn edu about working us rates and billing tascs policy 83 UMP University of Minnesota Physicians Title Clinical Research Billing Policy University of Minnesota Physicians UMPhysicians billing for clinical services items or tests associated with a clinical research project is accurate and in compliance with federal regulations Compliance 1 UMPhysicians billing practices are consistent with the University of Standards Minnesota and Fairview Health Services policies and procedures The University of Minnesota promotes compliance with the federal regulations through its Clinical Research Budgeting and Billing Policy Fairview Health Services facilitates compliance through its Research Billing Policy 2 UMPhysicians shall not bill clinical services items or tests to the federal government other payers or the research subject when the same clinical services are funded or reimbursed by the clinical research sponsor UMPhysicians may bill for clinical services items or tests when the clinical research sponsor has agreed to pay for clinical services only if payers do not reimburse for such services 3 To facilitate compliance with this requirement UMPhysicians uses the Uni
69. r Research Lab Slip If there were additional services indicate by choosing Yes If there were no additional services indicate by choosing No Enter the date the subject completed the study visit In situations where services for a protocol visit are provided on more than one day for instance an MRI for the protocol is completed in advance of the clinic visit choose and enter the date the protocol visit was completed List the visits from Subject Tracking Form Specific Time Point Description Consent Enter the date the subject signed the initial study consent form This will generate an automatic e mail to Providers to assign a patient case number to each subject if applicable Date w d Enter the date the subject s participation in the study ends no further data should be collected after this date Reason Choose the most appropriate reason from the withdrawal reason drop down Service Discrepancy Entry Field Name Response Field Definition Added Service Payer Drop down Choose the payer for the additional service r SES Enter the added test service free text up to 65 Service Description Char 65 da A Choose the location at which service was Service Location Drop down provided Subject Medical Record Autofill Data pulled from the Subject Tracking Form for each yes answer Visit Date Autofill Data pulled from the Subject Tracking Form for each yes answer Visit Descri
70. r direct to subject Protocol Contact Drop down contact commonly called the research coordinator Data monitor assigned to the protocol person Protocol Monitor Drop down who reviews protocol compliance and data collection Radiation Committee Application Month Day Year Date the completed radiation application was to PI Date given to the investigator for review Radiation Committee Approval Month Day Year Date on the final radiation committee approval Date letter e Number assigned to the protocol by the radiation Radiation Committee Number Char sommittee i e SEKR Month Day Year Date on the radiation committee stipulation letter Radiation Committee Stipulation Month Day Year Date the stipulation response is sent to the Response investigator for review Radiation Committee Submission Date the radiation application was submitted to Date MONDAY rear the committee for review Abbreviated protocol name limited to 70 Short Protocol Title Ghar 72 characters may use acronyms SPA Contact Autofill SPA grant administrator working on the protocol Choose the sponsor the person or group that wrote the protocol Each sponsor has a funding Sponsor Drop down type associated Business Industry Federal State University Other see Appendix B for definitions 74 Field Name Field Type Field Definition Sponsor Contact Drop down Name of sponsor contact Sponsor Protocol Char 11
71. r research subject s date of birth Ethnicity Drop down Choose ethnicity category for research subject Gender Radio Button Choose research subject gender Medical Record Number 10 Enter Fairview medical record number UMP enters the patient case number for each subject This will occur after the AHC user enters pateni Case Number Number 6 the date the subject signed consent on the Subject Tracking Form Entry screen Race Drop down Choose race category for research subject Subiect Char 10 Study or researcher assigned number or other unique identification Subject Initials Char any text Research subject initials Total Field Count 8 80 Subject Tracking Form Field Name Field Type Field Definition Date the last subject enrolled or to be enrolled in the study has ended his her participation Populating this field results in the following e No further data entry permitted on the Ge ects Withdrawn Month Day Year Subject Tracking Form e No encounter forms can be generated for the study e Providers are notified that all subjects are completed withdrawn Date that enrollment in the protocol is closed Field must be populated in order to enter date End of Enrollment Month Day Year into All Subjects Withdrawn Date field Data in this field will notify recruitment website to remove the recruitment posting Use this field to store communicate information about recording sub
72. r submitting to provider the screen is locked to prevent further modification Please use the steps below to change payers after submitting to the providers Click on Unlock and Modify and then click OK on the prompt Click on a visit link to change payers for services happening at that visit or Click on a service link to change payers for the service at study visits Repeat step 2 or 3 until all payers have been selected and click on Resubmit to Providers SOU Subjects Screen Field Name Subject For Active status protocols the subject number can be changed at any time after the initial entry A subject number for each subject must be unique within the subjects enrolled in a protocol Field name Initials For Active status protocols subject initials can be changed at any time after initial entry Field Name Gender For Active status protocols the subject s gender can be changed at any time after initial entry 52 TASCS Manual Appendices Field Name Med Rec The Fairview medical record number is a 10 digit number starting with 00 and can be changed for Active status protocols at any time after initial entry Field Name Birthdate For Active status protocols the subject s date of birth can be changed at any time after initial entry Subject Tracking Screen How to Update a subject visit after a withdrawn date has been entered Because a subject should not complete a visit after they have been withdrawn TA
73. reen and complete the Subject Tracking Form screen by adding the consent and surgery dates within 72 hours of each event Bulk Specimen Processing Services This applies to the following laboratory samples that come from other sites for processing in a Fairview lab 48 TASCS Manual Appendices internal archived stored laboratory specimens including pathology that are pulled for new testing and are analyzed with no patient identifiers 1 2 3 8 9 Go to the New menu and choose Protocol Complete the required fields on the Protocol screen and Save Changes Click the Visits link to advance to the next screen or go to the Edit menu and choose Visits Add a single visit called Specimens and uncheck the boxes for the remaining pre populated visits Click the Save Changes Select Services button On the Services screen add lab services with Fairview Hospital as the Service Location Click on the Save Changes Select Payers button Choose Research as the payer for the services When finished click on the Submit to Providers button When you receive the pop up that says submit the protocol attach any available lab instructions in place of the protocol When funded obtain a purchase order from your departmental accountant and complete the Account Lab Set Up screen Fairview will populate the billing account numbers in TASCS and the lab will send a study specific lab requisition to be used when samples ar
74. rocessing or packaging shipping only Lab Information The lab portion of the Account Lab Set Up screen is required if you are using services from a Fairview lab The In House section must be completed if you want your lab specimens analyzed in a Fairview lab The Outside Lab section is completed when you want Fairview lab to collect or process samples but will send the samples to a non Fairview lab for analysis Any questions about how to complete the fields on this screen should be directed to Fairview at 612 672 7690 34 TASCS Manual Using TASCS Your study will be posted on the AHC and Fairview recruitment websites unless you check the box to decline this option O Check if you do NOT want your study posted on the websites Indicate which search categories should be used for this study check all that apply Addictive Behavior O Aging O Allergies C Arthritis C Asthma C Blood Disorders C Brain Spinal Cord Nervous System C Breathing Lung C Cancer C Children s Health O Complementary Medicine C Critical Care Dental Diabetes O Digestive Systems O Genetics Headaches O Healthy Volunteers Hearing Far _ Heart Cardiovascular Hypertension High Blood Pressure Infection Disease Immune System O Kidney Urinary Tract O Liver Men s Health L Mental Health C Muscle amp Bone CI Nutrition Metabolism Pain Control O Skin O Sleep Disorders Transplant O Vision Eye O Weight Control
75. ry project entered into TASCS has three roles identified Investigator Protocol Contact and Billing Contact Communication about each project includes one or more of the individuals in the identified roles The following are suggested responsibilities related to using TASCS categorized by role Investigator The Investigator enters clinical research information for each clinical research protocol into TASCS or may delegate this function The Investigator prints a copy of the billing grid report signs it and submits it with the initial IRB application TASCS must be updated within 72 hours of the following events e each subject participant who signs an initial consent form e each subject participant visit that occurs and e each subject participant who ends participation in the clinical research Protocol Contact Research Coordinator If delegated to the Protocol Contact Research Coordinator by the Investigator enters clinical research information for each protocol into TASCS The Protocol Contact prints a copy of the billing grid report obtains principal Investigator s signature and submits signed billing plan with the initial IRB application TASCS must be updated within 72 hours of the following events e each subject participant who signs an initial consent form e each subject participant visit that occurs and e each subject participant who ends participation in the clinical research Billing Contact Administrator The Bill
76. s a central tool developed to help support and manage the process TASCS Manual The Process APPLICABLE CLINICAL RESEARCH The AHC policy states that clinical research meeting the following definition must be entered into TASCS Clinical research is defined as a systematic investigation including research development testing and evaluation involving human subjects their data records or tissue and is designed to develop or contribute to generalizable knowledge Clinical research meeting the Institutional Review Board IRB criteria for exemption per 45 CFR 46 101 does not have to be entered into the AHC database NOTE At this time only research involving the use of Fairview or UMPhysicians services must be entered into the AHC database Humanitarian Use Device HUD Humanitarian Device Exemptions HDE According to federal definition 21 CFR 814 HUDs HDEs are not clinical research However the same regulation also requires IRB approval to use these devices and Medicare regulations require that the HDE number appear on any submitted claims Therefore information related to the use of HUDs HDEs must also be entered into the AHC database TASCS Manual The Process ROLES AND RESPONSIBILITIES Managing clinical research is a complex process requiring communication between individuals and across organizations Defining roles and responsibilities will lend clarity and improve efficiencies in the overall research process Eve
77. service free text up to Notes Char any text 65 characters General comments and notes field to store any information about the medical or lab services entered Service Location Status Total Field Count Payers Entry Drop down Dropdown Choose the location at which service will be provided UMMC Clinic UMP Clinic Fairview Clinic Fairview Hospital UMP Imaging Center or Other Services to be provided at multiple locations will have to be added to the Services Screen once for each service location System displays status of each line service as active User may change status to inactive to show that the service is not needed Services may not be deleted rather they should be inactivated Inactive services will sort to the bottom of the screen Field Name Field Type Field Definition Notes Autofill General comments and notes field to store any information about the medical or lab services entered Payers by Visit Field Name Field Type Field Definition Location Autofill Lists the service location from the Payers screen Service Autofill Lists the services from the Payers screen Payer Dropdown Choose the payer at the visit for the listed Payers by Service services Field Name Field Type Field Definition Visit Autofill Lists the visits from the Payers screen Payer Dropdown Choose the payer for the service at the listed visits
78. staff will be asked if they should be assigned to one or more of the following roles Investigator Protocol Contact and or Billing Contact Individuals may select all three if they choose Service Providers IRB SPA and RIOP users should indicate their affiliation on the TASCS Access Application Form The access application options are A Complete scan if printed and e mail the Access form to TASCS Support tascs umn edu Except for Investigators a supervisor s signature is required The supervisor should forward the approved Access form to the TASCS Web Application Specialist B Complete and fax the Access form to 612 625 2695 C You may also choose to complete print and then send the Access form via intercampus mail to TASCS Support Mail Code 1932 717 Delaware Street SE Minneapolis MN 55414 If you have any questions about how to complete the TASCS Access Application Form please call TASCS Support tascs umn edu at 612 624 4612 Applications will be processed as soon as possible usually within one business day of receipt Applicants will receive an e mail notice that access has been granted TASCS Manual Using TASCS TASCS maintains an audit trail and will record the who when and what A regarding data changes made to any field in the system Please be careful when viewing TASCS screens TASCS access will be granted based on DeptID Careful completion of the DeptID section of the TASCS Access Ap
79. to tests procedures clinic space clinic visits physician time lab services pharmacy services or hospital services that are required to carry out the protocol When the box is checked Fairview will not review the protocol for coverage analysis It is also assumed that no pricing information or billing accounts are needed In addition there are no emails generated by TASCS to alert Fairview or UMP regarding the subsequent entries in TASCS Therefore if subjects are entered into TASCS no alert is sent to Fairview or UMP and the subjects will not be flagged as research participants in any of Fairview s or UMP s systems Checking the box excludes the protocol from some of the routine exception reporting functions in TASCS If the research changes and services are needed the user would uncheck the box and all the usual functions in TASCS will be restored IDS Register Only This information applies to those studies that plan on managing the investigational drug agent independently without the assistance of Investigational Drug Services 1 Go to the New menu and choose Protocol 2 Complete the required fields on the Protocol screen and Save Changes 3 Click on the Visits link to advance to the next screen or go to the Edit menu and choose Visits Click the checkbox next to the Start Up visit indicating that Medical Lab Services will be used at this visit Uncheck the boxes for the remaining pre populated visits Click on the Save C
80. umber pulled from lab account set up entry screen Estimated Subject Autofill Calculation Total Value minus Start Up divided by number of subjects Fin Emplid Char 7 Enter the Principal Investigator s employee ID number Final Monitoring Visit Month Day Year Dale ine Sponsor performs the final monitoring visit and close out activities Final Protocol Receipt Date Month Day Year Date final protocol was received 72 Field Name Field Type Field Definition First Contact Date Month Day Year Date site was first approached about the study Date the first subject signed a consent form for First Subject Consent Date Autofill the study pulled from subject tracking form entry e Date the first subject completes one visit after Firs oubjec Enrolled Date EE consent pulled from subject tracking form entry Flowcast Study Autofill Flowcast study number pulled from lab account set up entry screen Full Protocol Title Char any text Full protocol title to match IRB and SPA records Date the funder approves the budget for the Funder Approval Date Month Day Year protocol e Hospital account number pulled from Hospital Account Autofill lab account set up entry screen Additional hospital account number if applicable Hospital Account Autofill pulled from lab account set up entry screen Humanitarian Device Char 7 The humanitarian device exemption HDE Exe
81. usiness use outside of the budgeting billing policy but may be used to store optional information about startup activity All other visits can be named at the user s discretion Common labels include numbering visits such as Visit 1 Visit 2 etc Other possibilities include Day 1 Day 7 Day 14 etc Visits should include a number and be identified in the way that will make information most useful to the researcher Check the box for each visit at which any medical or laboratory services will be needed Medical or lab services refers to e Medical services Lab services Tests or procedures Use of clinic space or hospitalization Physician time 24 TASCS Manual Using TASCS e Pharmacy services The use of the above services must be entered into TASCS whether or not they are provided by Fairview or UMPhysicians When all available lines have been used click on Save Changes and ten more blank lines will be made available If you discover after naming visits that you must add a visit that would occur between visits already named name a new visit on a blank line and use the Order column to indicate in what order the visit should occur When you select Save TASCS will re order the visits Remember to Save whenever your work is interrupted Do not select Save Changes Select Services until all of your visit descriptions have been entered If you accidentally choose Save Changes Select Services button and you are
82. utpatient Laboratory first floor PWB or a hospital laboratory will be used choose Fairview Hospital as the location f If clinic laboratory services will be used choose the appropriate clinic location If for example the protocol will require EKGs to be performed by the Outpatient Laboratory enter EKG Lab and choose Fairview Hospital as the location specific circumstances invoiceable use the Pricing Only procedure This f If the protocol includes services that may be incidental or required only under will allow Providers to provide a price for the services 27 TASCS Manual Using TASCS Last Modified This column is auto populated by TASCS Comments The Comment field is available to all users and is a free text field Use this field as you wish to record details about the protocol provide notes for Providers and other users or store helpful information When you have completed the Services screen click on the Save Changes Choose Payers button and TASCS will bring you to the Payers screen You may also go to the Edit menu and choose Payers Then search by TASCS number or any search term of your choosing and choose Search to open the Payers screen 28 TASCS Manual Using TASCS Step 4 Payers Entry Screen Required Information for Step 4 For each service listed a payer must be identified at one or more visits Submit to Providers Service Location Pricing Only Visit V
83. versity of Minnesota s research database known as the Time and Study Collection System TASCS to appropriateiy identify and track the services which are to be paid by the clinical research sponsor and those which may be billed to a payer or the research subject UMPhysicians is dependent on the research projects Principal Investigator or designee to enter accurate data into TASCS In support of the Principal investigator UMPhysicians maintains service fee schedules in TASCS and determines correci patient code and pricing for service related charges Definitions Clinical Research For the purpose of this policy clinical research is defined as a systematic investigation including research development testing and evaluation invoiving human subjects their data records or tissue and is designed to develop or contribute to generalizable knowledge The policy does not apply to clinical research meeting the Institutional Review Board IRB criteria for exemption per 45 CFR 46 101 Approval Compliance and Risk Management Committee August 19 2008 Contact Ann Peterson Vice President Patient Business Services 84 Fairview Fairview s Policies can be found at http www fairview org Research BusinessOperations Policies index htm Research Billing http Awww fairview org Research S 033232 85 Appendix F Use of Encounter Forms Lab Slip and UMP Case Numbers https secure ahc umn edu tascs use of
84. visor signature required for Principal Investigator Date Remember to attach the e mails stating that HIPAA training courses were successfully completed or attach copy of training record Phone Date TASCS Support 612 626 4612 tascs umn edu Fax 612 625 2695 59 Add Remove Personnel or Sponsor Add Remove Personnel or Sponsor P I Complete this section if you want to add or remove ersonne a Principal Investigator Protocol Contact or Billing Contact to the drop downs Add Principal Investigator Protocol Contact _ Billing Contact Remove Principal Investigator Protocol Contact _ Billing Contact Title First MI Last Phone Fax email Address City State Zip Code Sponsor Complete this section if you want to add or remove a sponsor to the drop down C Add Remove Sponsor Name Funding Type Funding Type Description Business Industry Research sponsored AND funded by a for profit company or entity If an investigator develops a protocol and obtains funding from a business the research is sponsored by the investigator not the business and it would not fall into this category Common examples in this category include research sponsored by pharmaceutical and device companies to investigate products in line with FDA regulations Federal Research sponsored OR funded by a federal entity This category includes protocols with a blend of fed
85. y Year lab medical services to be purchased from partner service Provider Fairview Enter the purchase order expiration date for lab medical services to be purchased from End Date Month Day Year partner service Provider Fairview Estimated end date should be entered if end date is not defined EPIC Char any text EPIC account number Flowcast Study Char any text Flowcast account number Hospital Account 1 Char any text Hospital account number Hospital Account 2 Char any text Hospital account number if obtaining services from more than one hospital more than one is needed 78 Field Name Field Type Field Definition Hospital Account 3 IDS Char any text Char any text Hospital account number if obtaining services from more than two hospitals Investigational Drug Services protocol account number If lab will centrifuge check yes if not check In House Lab Centrifuge Yes No no In House Lab Centrifuge Char 11 If lab will centrifuge enter temperature Temperature requirement In House Lab Choose Result Radio Button Select one option for report method of labs Report Method processed by an in house lab EE Char 15 Enter the fax number if lab results will be faxed Number In House Lab Other Char any text Enter any other in house laboratory instructions In House Lab Processing Instructions In House Lab Results Name

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