Wrk Instructin Patient Visits THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO Wrk Instructin Patient Visits Vels - eresearch Versin 9.2 Versin: 2.0, 04/30/2015
Wrk Instructin Patient Visits Revisin Histry Versin/Amendment #: Versin Date: Descriptin: Cmpleted By: Versin 0.1 10/01/2014 Initial Draft Dcument Jasn R. Bates, MBA Versin 0.2 10/22/2014 Peer Review Lissa Perssn Versin 1.0 3/10/2015 CTRC Review Kim Marksfeld/Melissa Nashawati Versin 2.0 4/30/2015 Final Dcument Pamela Sabrsula Dcumentatin f Change Histry: Versin 0.1; 10/01/2014: Initial Draft f Patient Visits Wrk Instructin Versin 0.2; 10/22/2014: Peer review t incrprate new frmatting and RACI chart Versin 1.0; 3/10/2015: CTRC Review Versin 2.0; 4/30/2015: Revise Adding Unscheduled Event/Visit sectin; Finalize Dcument Versin 2.0, 04/30/2015 Page 1 f 12 University f Texas Health Science Center at San Antni
Wrk Instructin Patient Visits PURPOSE The purpse f this wrk instructin is t walk thrugh the prcesses fr managing Patient Visits fr patients that have been screened and/r enrlled nt a Research Study within Vels eresearch fr the benefit f regulatry cmpliance, as well as patient and financial tracking. RESPONSIBILITY It is the respnsibility f the Principal Investigatr and designated t cmplete the tasks assciated with Patient Visit Management. The CTO Offices and s will be respnsible fr tasks assciated with adding unscheduled visits r events as these may have a financial affect. These respnsibilities are further defined in Appendix: A Rles and Respnsibilities. ENTRY/PREREQUISITE CRITERIA Prir t perfrming the tasks described in this wrk instructin, the fllwing must be cmpleted: The Study has been submitted t the Office f the Institutinal Review Bard (OIRB) The Study Summary Page within eresearch has been fully cmpleted. The Study Start-up als knwn as Study Set-up prcess shuld be cmplete within eresearch Cverage Analysis has been cmpleted Calendar, Budget and Milestne builds have been fully cmpleted and have been set t active The Study has reached all requirements t ascertain IRB Apprval and Institutinal Apprvals The Study has been set t Open t Enrllment/UT Patient has been registered t the system Patient has been enrlled n the study Patient has been assigned t a study calendar REFERENCE DOCUMENTS Users must have access t the fllwing dcuments which shall be used as reference pints thrughut these wrk instructins: Access t all Study Dcuments, as needed Cmplete Patient Study Recrd (Patient Surce Chart), as needed Patient Medical Recrd, as needed Versin 2.0, 04/30/2015 Page 2 f 12 University f Texas Health Science Center at San Antni
Wrk Instructin Patient Visits WORK INSTRUCTIONS Rle/Functin All Rles Navigate t Study Patient Descriptin f Actin 1. Lg int eresearch 2. CLICK the MANAGE buttn frm the tlbar and select ENROLLED under the PATIENTS ptin 3. Using the Search by field, SELECT the desired Study and CLICK the SEARCH buttn. 4. Frm the list f patients that appear, CLICK the Pt. Study ID link fr the desired patient frm the Enrlled tab 5. User is navigated t Manage Patients >> Schedule page. NOTE: An alternative way t search fr a patient is t CLICK n the Patient Search tab and ENTER the patient number r the first r last name in the apprpriate field and CLICK the SEARCH buttn t quickly lcate the desired Patient. Refer t the fllwing screenshts when updating a Patient Schedule When the Visit windw is expanded Versin 2.0, 04/30/2015 Page 3 f 12 University f Texas Health Science Center at San Antni
Wrk Instructin Patient Visits Navigate t Patient Study Visit Visits: Editing a Visit Date 1. Frm the Manage Patients >> Schedule page 2. SELECT the apprpriate study schedule frm the Select Schedule drpdwn field. NOTE: The user can use the VISIT field t select the current visit and navigate directly t it. 3. EXPAND the VISIT WINDOW by CLICKING the ARROW t the LEFT f the Visit Name t mdify. 1. Frm the expanded VISIT WINDOW, tw types f visit dates are visible: Suggested Date and Scheduled Date a. Suggested Date The date calculated based n the Visit Intervals and Start Date prvide fr the patient. b. Schedule Date The date that the Visit r Event actually ccurs n. This date defaults t the Suggested Date NOTE: If the Calendar des nt have visit intervals defined, Nt Defined will be displayed in the Suggested Date and Scheduled Date clumns 2. SELECT the EDIT icn in the Scheduled Date clumn 3. Frm the CHANGE ACTUAL DATE windw ENTER the crrect date fr the Visit r event. 4. SELECT the mst apprpriate ptin: a. Mve this event nly This will nly mdify the current event yu are wrking n. NOTE: Mve this event nly wuld be the cmmn selectin fr singular events that may nt be able t be cmpleted n the same day as ther prcedures (i.e. x-rays, CT scans, MRI r ther prcedures) b. Mve all events f this visit This will mve all events under the current visit nly t the same date. c. Mve all dependent subsequent events accrdingly This will mve all events under this visit AND will mve subsequent events and the scheduled date f visits accrding t their dependent time pints. d. Mve All subsequent events accrdingly This will mve all events under the current visit AND all ther visits regardless f the dependent time pints. NOTE: Mve All subsequent events accrdingly wuld be the cmmn selectin fr a patient that had t reschedule their visit. Versin 2.0, 04/30/2015 Page 4 f 12 University f Texas Health Science Center at San Antni
Wrk Instructin Patient Visits Visits: Editing a Visit Date (cnt.) 5. MARK the checkbx Mve suggested Date t be in sync with Actual Date, if it is applicable. a. This ptin mves the actual date t be in sync with the Scheduled date. b. This ptin wuld nly be used when it is necessary t mve the schedule accrding t the new date, such as a visit which has dependencies. (Visit 3 must ccur 1 mnth after Visit 2, if Visit 2 is rescheduled, yu wuld select this bx t mve the suggested date in sync with the actual date. This wuld crrect the suggested date fr Visit 3 t be in sync with Visit 2 s actual date.) NOTE: Actual Date refers t the Scheduled Date. 6. A Reasn fr Change (FDA Audit) cmment is nly required fr FDA regulated studies as indicated by a red asterisk. Ntes may be entered if desired fr all ther studies. 7. ENTER yur e-signature and click the SUBMIT buttn t save yur selectins. The fllwing is an example f the screen when updating the suggested r scheduled date Visits: Editing Visit Status fr a Single Event 1. Frm the Manage Patient >> Schedule page 2. SELECT the apprpriate study schedule frm the Select Schedule drpdwn field. 3. EXPAND the VISIT WINDOW by CLICKING the ARROW t the LEFT f the Visit Name t mdify. 4. NAVIGATE t the Specific Event t update. NOTE: CLICK the Advanced Search Event name and status. icn t search by a specific Versin 2.0, 04/30/2015 Page 5 f 12 University f Texas Health Science Center at San Antni
Wrk Instructin Patient Visits Visits: Editing Visit Status fr a Single Event (cnt.) 5. SELECT the EDIT icn in the EVENT STATUS clumn, f the specific Event rw that requires the update. 6. FROM the EVENT STATUS windw, SELECT the apprpriate EVENT STATUS frm the drpdwn field. a. Dne Event/Prcedure/Lab has been cmpleted accrdingly. b. Nt Required Subject did nt meet the requirements fr this event t ccur, such as an ptinal sample cllectin r event, therefre it will nt ccur. c. Nt Dne The event did nt ccur, and will nt ccur. d. Suspended This event has been pstpned till a later date. e. T be rescheduled This event was nt cmpleted, but will be scheduled t be cmpleted at a later date. 7. SELECT the apprpriate status date in the STATUS VALID FROM field. 8. USE the NOTES field t make any cmments related t the status change. 9. ENTER e-signature and click the SUBMIT buttn t save selectins. 10. VERIFY the event status has been updated under the EVENT STATUS clumn. NOTE: REPEAT the steps in this sectin t update an Event Status shuld the event require an update at a later pint in time. CLICK the HISTORY icn fr an Event Status Histry. Refer t the fllwing screensht when updating a Visit frm the EVENT STATUS windw fr a Single Event. Versin 2.0, 04/30/2015 Page 6 f 12 University f Texas Health Science Center at San Antni
Wrk Instructin Patient Visits Visits: Editing Visit Status fr Multiple Events 1. Frm the Manage Patient >> Schedule page 2. SELECT the apprpriate study schedule frm the Select Schedule drpdwn field. 3. EXPAND the VISIT WINDOW by CLICKING the ARROW t the LEFT f the Visit Name t mdify. 4. FROM within the expanded VISIT WINDOW, CLICK n the Edit Visit link. 5. The EDIT VISIT windw will appear which lists all events/prcedures that are assciated with the selected visit. REFER t the EDIT VISIT screensht abve this sectin. 6. SELECT the apprpriate event STATUS frm the drpdwn field. a. Dne Event has been cmpleted accrdingly. b. Nt Required Subject did nt meet the requirements fr this event t ccur such as an ptinal sample cllectin r event, therefre it will nt ccur. c. Nt Dne The event did nt ccur, and will nt ccur. d. Suspended This event has been pstpned till a later date. e. T be rescheduled This event was nt cmpleted, but will be scheduled t be cmpleted at a later date. 7. SELECT the apprpriate STATUS DATE. CAUTION: DO NOT edit the Cverage Type field frm within the EDIT VISIT windw. Refer t the Visits: Request Change in Cverage Type r Site f Service sectin belw. 8. SELECT all events that meet the current STATUS and STATUS DATE by MARKING the checkbx that appears next t the event name. 9. CLICK the SELECTED buttn at the tp f the windw t APPLY the updates t the events selected. CAUTION: T PREVENT the update f an event that has nt ccurred, will nt ccur r will be scheduled at a later date, DO NOT use the APPLY TO ALL functin. Ding s is nt nly a Regulatry/Cmpliance issue, but may als trigger events t be billed that may nt have been dne. Please verify the crrect status fr all events, including any designated as Invice-R. These may include csts, such as parking, that may nt be dcumented in the medical recrd. ENTER e-signature and click the SUBMIT buttn t save selectins. Versin 2.0, 04/30/2015 Page 7 f 12 University f Texas Health Science Center at San Antni
Wrk Instructin Patient Visits Refer t the fllwing screensht when updating a Visit frm the EDIT VISIT windw fr Multiple Events Visits: Request Change in Cverage Type r Site f Service CAUTION: While users have the ability t mdify the COVERAGE TYPE and/r the SITE OF SERVICE, these MUST NOT be changed withut cntacting the respective CTO listed belw. The COVERAGE TYPE and SITE OF SERVICE have been designated during the initial Cverage Analysis fr the study. Altering these sectins may result in billing errrs leading t fines charged t the University. If an errr in the COVERAGE TYPE r SITE OF SERVICE is suspected r needs t be updated, CONTACT the respective fr supprt: EMAIL: UTHSCSA (Nn-Cancer): CTRC (Cancer): VPRCTO@uthscsa.edu CTOFinance@uthscsa.edu TO REQUEST CHANGE IN COVERAGE TYPE: Prvide the fllwing infrmatin t the respective via EMAIL: Principal Investigatr Name Versin 2.0, 04/30/2015 Page 8 f 12 University f Texas Health Science Center at San Antni
Wrk Instructin Patient Visits Visits: Request Change in Cverage Type r Site f Service (cnt.) CTMS Study Number r the HSC-IRB Number Patient ID Number Patient Initials Visit Number and Name Event Name and Brief Descriptin Date event was cmpleted Revised Cverage Type Reasn fr change in Cverage Type TO REQUEST CHANGE IN SITE OF SERVICE: Prvide the fllwing infrmatin t the respective via EMAIL: Principal Investigatr Name CTMS Study Number r the HSC-IRB Number Patient ID Number Patient Initials Visit Number and Name Event Name and Brief Descriptin. Date event was cmpleted. Site f Service t be changed (primary lcatin where prcedure ccurred) Reasn fr change in Site f Service CTO Visits: Editing Event Cverage Type r Site f Service NOTE: The CTO will prvide NOTIFICATION t the f the mdificatins made fllwing the CTO s review f the request. The will be cntacted/cnsulted if the CTO review determines that the changes cannt be made as requested. 1. Frm the Manage >> Patient >> Schedule page 2. SELECT the apprpriate study schedule frm the Select Schedule drpdwn field. 3. EXPAND the VISIT WINDOW by CLICKING the ARROW t the LEFT f the Visit Name t mdify. 4. NAVIGATE t the Specific Event t update. NOTE: CLICK the Advanced Search Event name and status. icn t search by a specific 5. SELECT the EDIT icn in the EVENT STATUS clumn f the specific Event rw that requires the update. 6. Frm this sectin UPDATE the fllwing items fr a singular Event within a Visit: a. Event Status b. Status Valid Date Versin 2.0, 04/30/2015 Page 9 f 12 University f Texas Health Science Center at San Antni
Wrk Instructin Patient Visits Visits: Editing Event Cverage Type r Site f Service (cnt.) c. Site f Service d. Cverage Type e. COMMENT SECTION: Reasn fr Change in Cverage Type f. COMMENT SECTION: Ntes g. COMMENT SECTION: Reasn fr Change (FDA Audit) Visits: Adding an Unscheduled Event r Visit NOTE: Unscheduled events and/r visits may ccur at any time during the curse f a study. Sme Spnsred cntracts make prvisins fr such events. In such cases, the CTO will build this infrmatin int the Study Calendar t be used as needed per patient. If such prvisins are NOT made in the cntract, the CTO will create a blank Unscheduled Visit in the Calendar withut any events listed. A request must be sent t the CTO t add the required events as needed t ensure prper billing. 1. If Schedule cntains a Pre-Ppulated Unscheduled Visit a. Verify that the Events listed were perfrmed fr the Patient b. Cmplete dates and Event Statuses accrding t Editing Visit Status fr Single (Multiple) Events abve 2. If Unscheduled Event r Unscheduled Visit are nt listed, submit the fllwing t the respective CTO listed belw: a. Principal Investigatr Name b. CTMS Study Number r the HSC IRB Number c. Patient ID Number d. Patient Initials e. Unscheduled Event Cmpleted - prvide Cmmn Name and Brief Descriptin. f. Date event was cmpleted g. Reasn fr the Unscheduled Event/Visit CONTACT the respective t request an Unscheduled Event r Visit t be added: EMAIL: UTHSCSA (Nn-Cancer): CTRC (Cancer): VPRCTO@uthscsa.edu CTOFinance@uthscsa.edu Versin 2.0, 04/30/2015 Page 10 f 12 University f Texas Health Science Center at San Antni
Wrk Instructin Patient Visits CTO Visits: Cmpleting Requests t Add an Unscheduled Event r Visit 1. Frm the Manage >> Patient >> Schedule page 2. SELECT the apprpriate study schedule frm the Select Schedule drpdwn field. 3. EXPAND the VISIT WINDOW by CLICKING the ARROW t the LEFT f the Visit Name t add the Unscheduled Event. (Select Unscheduled Visit if new visit is requested) 4. CLICK Add Unscheduled Event link in right upper crner f Visit 5. SELECT the crrect Event Library and Event(s) based n infrmatin received frm 6. ENTER e-signature and click the SUBMIT buttn t save selectins 7. LOCATE the Added Events in the Visit 8. SELECT the EDIT icn in the EVENT STATUS clumn next t the Added Event t update. 9. FROM the EVENT STATUS windw, SELECT the apprpriate EVENT STATUS frm the drpdwn field. a. Dne Event/Prcedure/Lab has been cmpleted accrdingly. 10. SELECT the apprpriate status date in the STATUS VALID FROM field. 11. SELECT the apprpriate Site f Service. 12. SELECT the apprpriate Cverage Type based n financial dcumentatin 13. USE the NOTES field t make any cmments related t the status change. 14. ENTER e-signature and click the SUBMIT buttn t save selectins. 15. VERIFY the event status has been updated under the EVENT STATUS clumn. 16. NOTIFY that Unscheduled Event(s) has(have) been added as requested and is ready fr verificatin. EXIT CRITERIA: Upn cmpletin f this wrk instructin, Event Statuses fr Visits that have been cmpleted will be marked apprpriately and Visit schedules will reflect actual visit dates. Any Unscheduled Events r Visits are added apprpriately fr a study patient, as needed. Cverage types are accurate fr all cmpleted events fr prper billing and/r invicing. Versin 2.0, 04/30/2015 Page 11 f 12 University f Texas Health Science Center at San Antni
Wrk Instructin Patient Visits Appendix A: ROLES & RESPONSIBILITIES RACI Chart PATIENT MANAGEMENT -Manage Patient Visits Clinical Trials Office Principal Investigatr Research Team -Edit Visit Date C R,A R -Edit Visit Status Single Event C R,A R -Edit Visit Status Multiple Events C R,A R -Request Change in Cverage Type r Site f Service C,I R,A R -Edit Event Cverage Type r Site f Service R R,A,C,I R,C,I -Adding an Unscheduled Event r Visit C,I R,A,C,I R,C,I -Cmpleting Requests t Add Unscheduled Event r Visit R,C,I R,A,C,I C,I R = Respnsible party A = Accuntable party C = cnsulting party I = party t be kept infrmed Appendix B: DEFINITIONS N/A END OF DOCUMENT Versin 2.0, 04/30/2015 Page 12 f 12 University f Texas Health Science Center at San Antni