1. Research and Development Protocol Submission and Continuing Review Processes Kimberly Summers, PharmD Assistant Chief for Clinical Research South Texas Veterans Health Care System Research & Development Service

2. When is R&D Committee Approval Needed? R&D Committee approval is required to conduct any and all VA research What constitutes VA research?

3. Definition of VA Research Research sponsored by the VA Research conducted using any property or facility of STVHCS Research conducted by or under the direction of any salaried or without compensation (WOC) employee of the STVHCS during and in connection with her/his STVHCS responsibilities Funds for the research activities are managed by the STVHCS or Biomedical Research Foundation of South Texas Research which recruits subjects at the STVHCS or uses the STVHCS's nonpublic information to identify or contact human research subjects for research purposes

4. R&D Approval – –Must have R&D approval letter prior to any of the following being conducted at the VA Recruitment Obtaining informed consent – –Having an IRB approved VA consent form does NOT constitute R&D approval Enrollment Providing patient follow up – –An IRB approval letter does NOT constitute R&D approval

5. CPRS can be accessed for information on any Veteran enrolled in a research protocol? YES – –For VA approved research – –Following signed informed consent by the veteran – –As per approved research protocol NO – –For Veterans enrolled in non-VA approved research Must obtain a signed release of information from the subject and receive copies thru Medical Records

6. Research and Development Protocol Submission Process

7. Requirements for R&D Submission

8. What Does It Mean To Have Research Privileges at the STVHCS?

9. Research Privileges Research credentialing and privileges are required prior to work on any VA protocol Requirements are different for the following groups – –VA Employees Investigators and study personnel – –Fellows, Residents, and Students – –Non-VA investigators or study personnel – –Exempt study staff

10. VA Research Privileges for VA Employees Copies of training certificates – –Documentation of Human Subjects Training and VA Data Security Training Conflict of Interest Form – –NEW REQUIREMENT – –Required for all investigators and study personnel Scope of practice – –Required for all investigators and study personnel EXCEPT credentialed medical staff providers – –Signed by principal investigator(s) and/or supervising physician

11. VA Research Privileges for Fellows, Residents, and Students Copies of training certificates – –Documentation of Human Subjects Training and VA Data Security Training Conflict of Interest Form – –NEW REQUIREMENT Scope of practice – –Signed by supervising physician(s) and principal investigator Signed Intellectual Property Agreement (IPA) Copy of appointment memo – –Obtained from the VA Education Office – –Education Office (210)617-5300 ext 15109

12. VA Research Privileges for Non-VA Employees – –Without Compensation (WOC) appointment for Research Privileges Submit through the appropriate service Must request Research privileges for correct routing – –Copies of training certificates Documentation of Human Subjects Training and VA Data Security Training – –Conflict of Interest Form NEW REQUIREMENT Required for all investigators and study personnel – –Scope of practice Signed by principal investigator(s) – –Signed Intellectual Property Agreement (IPA) – –Signed Written Release of Information

13. VA Research Privileges for Contract Credentialed Medical Care Providers – –Without Compensation (WOC) appointment for Research Privileges Submit through the appropriate service Must request Research privileges for correct routing Attach Medical Staff Member Appointment Request signed by appropriate Service Chief – –Form available from Medical Staff Office – –Copies of training certificates Documentation of Human Subjects Training and VA Data Security Training – –Conflict of Interest Form NEW REQUIREMENT – –Signed Intellectual Property Agreement (IPA)

14. Exempt Personnel Study personnel who are not physically conducting research on VA property, only have access to de-identified data and/or not directly working with research subjects – –Examples: lab personnel, data or administrative personnel Requirements – –Copies of training certificates Documentation of Human Subjects Training and VA Data Security Training – –Memorandum from PI denoting what their role in the study will be – –Conflict of Interest Form

15. Changes in Personnel Changes to personnel list submitted to IRB – –IRB Form B-2 For personnel engaged in research conducted at the VA – –IRB will verify with the R&D office that all study personnel have submitted the required documentation and been assigned research privileges at the VA prior to approval of the amendment

16. New Conflict of Interest (COI) Form and Procedures

17. Conflict of Interest Form No longer protocol specific Required for all investigators and collaborators – –Collaborators = all research personnel New form will be collected as part of – –New personnel application – –New protocol submission if old version of form is on file Must be verified as accurate or updated annually – –Continuing review – –New protocol submission if investigator or personnel have not been engaged in research for greater than one year

18. New Protocol Submission and COI COI forms no longer required for protocol submission – –Must verify on “Green Sheet” if a COI form is on file for each member of the research team Transition from old form to new form – –Must have form Version 1 dated May 2008 on file

19. NEW COI Form

20. Most Commonly Missed Information for R&D Submissions

21. Requirements for R&D Submission

22. VA Form 10-5368 Investigator Data Sheet Required for all NEW principal investigators – –Must have one on file for every principal investigator Information entered into VA research tracking database

23. Requirements for R&D Submission

24. Research Protocol Safety Survey Required for ALL submissions If all answers are NO – –Documented review by the Research Safety Subcommittee is still required prior to R&D approval – –Assurance of study personnel safety Protocol required blood draws require answering YES to item 1.b.

25. Requirements for R&D Submission

26. VA Research Data Security Checklist Required for ALL submissions If the research does NOT involve human subjects OR their identifiable information – –Only PI signature on front page is required for completion

27. Most Common Discrepancies Noted for R&D Submissions

28. VA Form 10-9012 Investigational Drug Information Form Must be submitted for all drugs used in research – –Provides information to all healthcare providers regarding potential drug-drug interactions, side effects, antidotes if available, information on blind breaking if applicable Form O in the UTHSCSA IRB application Must be signed by IRB Director AND R&D Chairman prior to approval and initiation of protocol VA Research Pharmacist will verify it has been scanned prior to dispensing of investigational medication

29. Authorized Prescribers for Investigational Medications All prescribers for investigational medications must be listed on VA form 10-9012 – –Should be consistent with FDA 1572 Prescribers must be credentialed at the VA to write medication orders – –Should be consistent with Scope of Practice if applicable VA form 10-9012 must be amended if – –Prescribing investigators are added to a protocol – –Principal investigator changes Research Pharmacist verifies orders are received by an investigator listed on the 10-9012

30. Data Security Checklist Disclosure of PHI to third parties is listed in informed consent/authorization but not on Data Security Checklist – –Verify PHI must be released versus de- identified information

31. Data Security Checklist Documentation for retention of PHI is inconsistent – –Protocol data management section states subject identification codes (PHI) need to be retained by the investigator for 15 years – –Data security checklist states data will be stored for 5 years as per VA requirements – –Informed consent document states there is no expiration date for how long your PHI will be used All sections should state the same information

32. Statement of Clinical Impact Form Procedures must be consistent with protocol Collaborating service will not sign off on statement of clinical impact if information provided is incomplete Time to identify items which can not be done by the VA without additional associated costs

33. Statement of Clinical Impact Form Statement of Clinical Impact Form to Pathology and Laboratory Service stated routine labs only Fibrinogen and albumin are also to be completed locally CRP-HS, Ceruloplasmin, Fetuin-A, IGF-1are to be sent to a central laboratory

34. Continuing Review Process

35. New form VA specific information in addition to IRB continuing review form – –Submission of the IRB continuing review form and/or approval letter to the R&D office is NOT required Exempt research – –VA continuing review form required at least annually – –Updated protocol abstract required anually

36. Continuing Review Form Page 1 First page required for all research protocols If this is a final report – –All data have been collected and analyzed – –Only page 5 of form is completed

37. Continuing Review Form Page 1 PI must verify project personnel on file in R&D is accurate PI must verify if duties or procedures have changed for any study personnel PI must verify updated conflict of interest forms are on file for all active study personnel PI must verify if data is being collected, stored, or used in a new or different way

38. Continuing Review Form Human Subjects Research Section Page 2 Updates to VA form 10-9012 (Investigational Drug Information) Verify Research Pharmacy has current protocol, consent form, and 10-9012 Exempt protocols complete page 5

39. Continuing Review Form Research Safety Section Page 3 Continuing review by the Research Safety Subcommittee is required at least annually PI must verify if any changes to the Research Protocol Safety Survey are required PI must verify all research personnel are familiar with the current Research Protocol Safety Survey Remember blood draws require Research Safety Subcommittee review initially and annually

40. Continuing Review Form Project Update / Summary Section Page 5 Required for all human EXEMPT projects with each continuing review – –Must be at least annually Required for all human projects if final continuing review is being submitted – –All research projects are completed and all data have been analyzed – –Project will be inactivated in R&D office

41. Continuing Review Process Protocol approval will expire if – –Continuing review is not completed Must be approved by IRB AND R&D Committee prior to the expiration date – –Training requirements for the PI are not up-to-date at the time of continuing review Co-investigators and other study personnel will be removed from active protocols if training requirements are not up-to-date ALL activities related to the research protocol must immediately cease if approval expires – –Except those activities required to ensure the safety of enrolled subjects Expiration of approval will be corrected upon receipt and satisfactory review and approval of the required documentation

42. All Training Session Slides Are Now Available On-line

43. http://www.south-texas.med.va.gov/research

45. Questions? Kimberly Summers, PharmD Office: (210) 617-5300 ext 15969 Email: kimberlyk.Summers@va.gov