Office of Sponsored Programs FAP/SiteMinder User Group Meeting

1. Office of Sponsored ProgramsFAP/SiteMinder User Group Meeting Sponsored by: UAB Office of Sponsored Programs Clinical Billing Review http://www.uab.edu/osp/clinical-billing-review May 14, 2013 Kaul Human Genetics Building Finley Conference Center

2. AgendaMay 14 FAP/ SiteMinder User Group Meeting • Overview of clinicaltrials.gov-Penny Jester • OIRB questions-Nancy Stansfield • SiteMinder updates – Ashley Specht

3. ClinicalTrials.gov: Registration and Results Reporting 14 May 2013 Penelope Jester, BSN, MPH Program Director, Department of Pediatrics and Center for Clinical and Translational Research University of Alabama at Birmingham pjester@peds.uab.edu

4. Avoid common mistakes in registering clinical trials and reporting results

5. Avoid common mistakes in registering clinical trials and reporting results Tackle the situation from different perspectives Academic Medical Center policy/ process The (very busy) user

6. What are the common mistakes?? • Studies are not registered • Incorrect Responsible Party is listed • Records are not ‘approved’ or ‘released’ • Records are not ‘updated’ • Study is overdue for results reporting • CT.gov QA comments are not addressed • Clinical trials…what?!?!

7. Strategies to Consider for Registration

8. Strategies for Registration Full Service Self Service • Automated System: • eIRB system identifies applicable trials • Mapping to ClinicalTrials.gov fields • System notifies Investigators of applicable trials • System emails ClinicalTrials.gov to obtain user account • Sends reminders via automatic compliance monitoring 8

9. Strategies for Registration Self Service Full Service • Department Administrators fulfills registration role • or • PRS Administrator fulfills registration role • Identifies applicable trials • Registers (sends to RP for release) • Update as needed 9

10. Strategies for Registration Full Service Self Service • Add on to existing system: • eIRB application includes CT.gov module - identifies applicable trials - identifies the RP - directs PIs to appropriate resources if questions • Continuing review eIRB application - Update reminders - Tracks primary endpoint completion • Compliance also monitored via PRS administrators 10

11. Strategies for Registration Full Service Self Service Investigators are ‘on their own’! 11

12. Background: Responsible Party (FDAAA) The Responsible Party (RP) defined as… IND / IDE holder If no IND/IDE: The industry, cooperative group, consortium or other external sponsor that initiated the study If initiated by a Principal Investigator The grantee institution If no external funding, the PI 12

13. Background: Responsible Party (FDAAA) RP can be designated to another party that: Is responsible for conducting the study Has access to and control over the data Has the right to publish the trial results, AND Has the ability to meet the requirements Example of RP designation PI initiated study at Institution X funded by NHLBI Institution X is the grant recipient (X = RP) Institution X can designate the PI as the RP 13

14. Strategies to Consider: Managing the RP Who is designated the RP at your institution? Institution vs. the Principal Investigator Ensure your institutional policy addresses this If the RP is designated to PI, how do you acknowledge this? Rely on policy Require PI to acknowledge responsibilities per protocol Letter outlining responsibilities Embed in eIRB CT.gov section of application Require this prior to IRB approval 14

15. Strategies to Consider: Managing the RP - 2 The Responsible Party has to release the record! Draft template language and use in every communication with Responsible Parties Check the CT.gov ‘Problems List’ for ‘Never Released’ Interesting in publishing? Remind Investigators that registration must be complete before 1st subject is enrolled to be compliant with ICMJE! 15

16. Strategies to Consider for Results Reporting • Integrate a ‘smart form’ into your system that tracks primary endpoint completion • Ask if this is still realistic • If overdue for results reporting, initiate a consistent means of communication • Check the CT.gov ‘Problems List’ for ‘Late Results – per FDAAA’ • Communicate to Investigators via a heavy hitter if you need to (e.g. Institutional Official) • ClinicalTrials.gov Results Database Train-the-Trainers workshops 16

17. Strategies to Consider for Registration and Results Reporting: the BASICS

18. Questions that cause ‘?’s What is FDAAA? • Food and Drug Administration Amendments Act (FDAAA) (Sept 27, 2007) • Scope: Expanded current clinical trial registration requirements with new results reporting provision • Added enforcement provisions and penalties • Impacts all Applicable Clinical Trials (ACTs) initiated on or after 9/27/2007 or ongoing as of 12/26/2007

19. FDAAA (con’t) • Two main categories • Trial Registration no later than 21 days after enrollment of the first subject • Results Reporting within 12 months of the primary completion date • Includes AE reporting • Extensions sometimes permitted

20. FDAAA (con’t) • What is an Applicable Clinical Trial (ACT) • Intervention (drug, biologic, device) • FDA-approved drug, biologic, and/or device • IND/IDE

21. FDAAA (con’t) • What is not an ACT? • Not conducted and manufactured within US FDA jurisdiction • Phase I • Pilot • Observational • Behavioral • Registries

22. Exceptions to FDAAA? If this is not an applicable clinical trial, registration and results reporting may still be done based on PIs preference, industry’s request, NIH request, or journal’s requirement ** Once registered, CT.gov states record cannot be removed

23. Objective: Starting from scratch! • Obtain access • Complete registration • Update every 6 months • May update as needed • Report results within 12 months after last subject meets primary endpoint • May request extension

24. Obtain access • Contact local PRS Administrator • Obtain temp password and login ID • Have protocol available • Complete a worksheet prior to entering data* • Select ‘Create’ • Complete required data fields

25. Complete registration • Answer each question. • If “WARNING“ followed by a statement appears, this means you cannot approve and release the record until the issue is resolved. • If “Note” appears followed by a statement, this is guidance that something doesn’t look quite right, but may be fine. You are not prevented from registering. • After clicking on the “Edit”, clicking on the blue field name, provides a link to additional information or descriptions about the data required for the fields.

26. Complete registration (con’t.) Pay attention to: • Spelling • When describing intervention, be sure to include dose, frequency and route of administration (if applicable) • Outcome Title: are they measurable? • Outcome Time Frame: give clear time points • Outcome Description: explain exactly how the Outcome is being measured; add scoring scheme, if applicable

27. Questions that cause ‘?’s (con’t) • Difference between Intervention and Arm • Intervention: describe each intervention one time, providing sufficient details to explain dose, route, frequency • Arm: An arm may include 1 or more combinations of interventions

28. Update registration • Every 6 months: REVIEW • Change date defined as Record Verification Date: (current month and year) • Review entire record, paying close attention to Primary Completion Date and Study Completion Date • If a new version of the protocol has been generated during the prior 6 months, be sure that the CT.gov record reflects the changes.

29. Update registration (Con’t) • As required changes or at the 6 month update: • Update when enrollment met: Update under Study Design Enrollment: ## – from Anticipated to Actual.

30. Results reporting • Start early!! • Expect requests for clarification from ClinicalTrials.gov after first attempt • Report results for all applicable clinical trials within 12 months after the last subject meets the study required primary outcome (s).

31. Critical to remember: • These results are being posted for the public to view: • Keep the results reporting as simple as possible: report in a way that they are clearly understood by the layman (when possible) • Must match the truth: consistent with manuscript • Only report the required analysis (matching the outcome of the study)

32. Results reporting: key problem areas • Make sure numbers match! • Use correct Units • Describe measures clearly (do not include results in description) • Complicated study analysis • Consult with statistician

33. Requesting an extension • If reporting the primary outcome now compromises the secondary outcome • If there are extenuating circumstances • If there are unique issues related to the analysis of reporting an outcome

34. Support • Email questions: register@clinicaltrials.gov • http://clinicaltrials.gov/ct2/manage-recs/ • Http://prsinfo.clinicaltrials.gov • Penny Jester (pjester@peds.uab.edu) 996-7800 • Linda Austin (laustin@uabmc.edu) • Consult with statistician

35. What gives you headaches?

36. The future • Require more protocols to be registered and results reported • Training of UAB staff • Education of faculty

37. Thank you & Questions

38. SiteMinder Reminders Ashley Specht Program Manager II knightae@uab.edu 205-996-9754

39. SiteMinder Reminders • Clinical billables • Protocol-driven clinical billable services are protocol required clinical activities performed during the conduct of a clinical trial that are billed through HSF/MSO or UAB Hospital (PFS) billing offices. • Protocol-driven clinical billable services can be activities billed to the sponsor AND/OR to insurance (clinically indicated/standard of care). • Please note that studies that are all SOC still need to go through FAP review and may have to be managed in Siteminder.

40. SiteMinder Reminders • Research Visit Outline • After populating your 1’s in the Siteminder budget build, and before finalizing your study, it is important for your research team to review the way the visits are labeled in Siteminder and what activities have been assigned to each of those visits • In order to thoroughly review the Siteminder study budget, you can print out a Research Visit Outline (RVO) to review with the team.

41. SiteMinder Reminders • Research Visit Outline • From the desktop, click on Research Visit Outline under the UABHS Reports • Enter your Siteminder study number • You can choose “All Visits” to see all the visits or you can choose the specific visit you’d like to review. • Study Budget • We would like to ask that study staff please not add any visits or activities to the Siteminder study budget build. If something needs to be revised, please let us know so that we may do that for you (there is a specific way that information must be populated in these fields).

42. SiteMinder Reminders • Finalization: • When you are ready to finalize your study in Siteminder, please send an email with the following: • A statement that study is ready to be finalized • IRB number • OSP Assigned # (formerly Link#/Proposal#), if applicable • At that time, we will review your study build and budget for completeness . We will then change the budget status to finalized.

43. SiteMinder Reminders • Siteminder Access: • SiteMinder can be accessed from any computer behind the UAB Health System firewall. • Siteminder only functions in Internet Explorer 7 or below. It will not function properly in Firefox, Camino, Safari, or Google Chrome.

44. SiteMinder Reminders • Scheduling Appointments in Siteminder • Please remember to schedule your appointments in Siteminder by 5pm before the date of service • Screening Visits • The scheduling by 5pm before the date of service requirement is waived when study association and scheduling of a study visit for a patient occur on the same day • Keeping Visits in Siteminder • Visits are to be kept in Siteminder within 2 business days after the date of service.

45. SiteMinder Reminders • CTBN Reports • After a study visit with clinical billables is Kept with Variations in Siteminder, a CTBN is electronically sent to the billing office(s) • Coordinators are able to view their CTBN Reports by going into Siteminder and: • From the desktop, click CTBN Report from the UABHS Reports section • Enter the IRB number • Delete the “Create Date or Range:” and “Thru (if range):” fields • Enter the visit date (or a range of dates) in the “Visit Date or Range:” and “Thru (if range)” fields • Click Continue • CTBN reports should show in a table. The “R” in the column on the far right indicates “Revised,” and this will be the most recent CTBN.

46. CTBN Performance Reports04/22/2013 – 05/10/2013

47. CTBN Overall Performance04/22/2013 – 05/10/2013

48. CTBN YTD PerformanceUnits 80% and Above Through May 2013

49. SiteMinder 100% Club PI and Study Coordinators100% Scheduling and Keeping Appointments04/22/2013 – 05/10/2013 • 008 - Nephrology Transplant • 012 – Microbicide • 014 – Clinical Nutrition • 025 – Cardiology MRI • 060 – OB/GYN – MFM • 066 – OTOL • 078 – Hypertension • 096 – Ophthalmology

50. SiteMinder Training 2013 • Siteminder Initial Coordinator Training • Next Class , Friday, June 7th • Location: Cudworth Hall (CEC) Room 305 • Time: 9:00am to 12:30pm • To Register: • Complete CBR Siteminder registration form located at http://www.uab.edu/osp/forms • and request username at Centernet support at http://centernetsupport.hs.uab.edu