Quality Improvement and Human Subjects Protection Program

1. Quality Improvementand Human Subjects Protection Program Delia Wolf, MD, MSCI Pat Moran, RN Colleen McFarland, MSCI Julie Kaberry, MHP

2. Quality ImprovementTop Ten List Findings and Corrective Actions Don’t let these happen to you -- Easy to fix and even easier to avoid!!

3. Quality Improvement Top Ten List 10. Record Keeping

4. Record Keeping • Binder for regulatory documents • An industry sponsored study will require more regulatory documents

5. Record Keeping(continued) • Binder for HRC correspondence with labeled sections for -- • Protocol (date versions) • Investigator brochure or device manual • General Correspondence • Logs & Qualifications (signature log & CVs) • Lab Documentation

6. Record Keeping(continued) • A study file should be kept for each subject - • Original signed consent form • Inclusion/exclusion criteria checklist • Adequate source documents to corroborate entries on CRFs • Any correspondence, phone calls, appointment info regarding subject

7. Quality Improvement Top Ten List 9. Protocol deviations, violations & waivers 10. Record Keeping

8. Deviations, Violations& Waivers • Report any deviations, violations & waivers to the IRB • If a deviation, violation or waiver is submitted to a sponsor, it also needs to be submitted to the IRB for approval

9. Quality Improvement Top Ten List 9. Protocol deviations, violations & waivers 10. Record Keeping 8.Consent Form Issues

10. Consent Form Issues • The latest version is not being used • Check approval and expiration dates on consent form Approval Date Expiration Date

11. Consent Form Issues IRB Initial Approval Subject Population: ___Adults IRB Protocol Number: 2000p-000000 Consent Form Approval Date: November 1, 2000 IRB Expiration Date: November 1, 2001

12. Consent Form Issues IRB Approval -- Continuing Review Subject Population: ___Adults IRB Protocol Number: 2000p-000000 Consent Form Approval Date: October 10, 2001 IRB Expiration Date: October 10, 2002

13. Consent Form Issues(continued) • Subject identifier is missing from pages • Subject identifier must appear • on the top of all pages of the • consent form

14. Consent Form Issues(continued) • Did the subject receive a copy of the signed consent form? • Document the fact that • subject received a signed • copy of the consent form Informed Consent

15. Consent Form Issues(continued) • Did the subject date • the signed consent form? • Never backdate a consent form • If subject failed to date the consent form, write a note-to-file

16. Consent Form Issues(continued) Did the subject receive a copy of the signed consent form? If mailed, send 2 copies & document

17. Consent Form Issues(continued) • IRB approval stamp is not on bottom of the consent form IRB Approval

18. Consent Form Issues(continued) Hand written changes can not be made to an approved consent form

19. Quality Improvement Top Ten List 8. Consent Form Issues 9. Protocol deviations, violations & waivers 10. Record Keeping 7. Eligibility Criteria Checklist

20. ELIGIBILITY CHECKLIST • Partners Investigator’s Responsibilities #3 • ICH GCP

21. Quality Improvement Top Ten List 7. Eligibility Criteria Checklist 8. Consent Form Issues 9. Protocol deviations, violations & waivers 10. Record Keeping 6. Study Logs

22. STUDY LOGS • Enrollment Log • Staff Signature Log • Delegation of Responsibility Log • Monitoring Log • Drug Dispensing/Accountability Log

23. Enrollment Log • Subject initials and/or study number • Gender, ethnicity, date of birth • Date of consent • Subject receipt of signed copy of consent form • Date of screening • Reason for exclusion (if applicable)

24. Staff Signature Log • Print name • Signature • Initials • Number 0-9

25. Delegation of Responsibility Log • Trial related duties • PI must sign & date

26. Monitoring Log • Date of review • Name(s) of reviewer • Findings requiring corrective action • Meeting minutes

27. Protocol identifier • Subject identifiers (initials/study number) • Randomization and/or kit number • Date dispensed & amount dispensed • Date returned & amount returned • Initials of person dispensing/receiving Drug Accountability/Dispensing Log

28. Quality Improvement Top Ten List 6. Study Logs 7. Eligibility Criteria Checklist 8. Consent Form Issues 9. Protocol deviations, violations & waivers 10. Record Keeping 5. Curriculum Vitae (CVs)

29. CURRICULUM VITAE (CVs) • Sign & date • Update (~2 years) • ICH GCP Education Training Experience

30. Quality Improvement Top Ten List 5. Curriculum Vitae (CVs) 6. Study Logs 7. Eligibility Criteria Checklist 8. Consent Form Issues 9. Protocol deviations, violations & waivers 10. Record Keeping 4. NIH Progress Report/DSMB

31. NIH Progress Report & DSMB Report Failure to submit a copy of the NIH PROGRESS REPORT and DSMB REPORT to the HRC at continuing review

32. Quality Improvement Top Ten List 4. NIH Progress Report/DSMB 5. Curriculum Vitae (CVs) 6. Study Logs 7. Eligibility Criteria Checklist 8. Consent Form Issues 9. Protocol deviations, violations & waivers 10. Record Keeping 3. Investigator Brochure

33. Investigator Brochure Copy of the INVESTIGATOR BROCHURE (IB) not on file

34. Investigator Brochure Why is the IB not on file? Reason #1: It’s too big to keep in the regulatory binder Solution #1: Write a signed and dated note-to-file indicating where it is located.

35. Investigator Brochure Why is the IB not on file? Reason #2: We’re studying a marketed drug. Solution #2: Obtain a copy of the package insert.

36. Investigator Brochure Why is the IB not on file? Reason #3: There is no investigator brochure and the product is not approved. Solution #3: Obtain a copy of any product information available (e.g. published data)

37. Investigator Brochure Why is the IB not on file? Reason #4: This is a device study. Solution #4: Obtain a copy of the device manual or any product information available

38. Investigator Brochure Why do I need a copy of the IB? To provide safety and efficacy data from pre-clinical and clinical trials to support human exposure by the route, at the dosages, for the duration, and in the population to be studied.

39. Quality Improvement Top Ten List 3. Investigator Brochure 4. NIH Progress Report/DSMB 5. Curriculum Vitae (CVs) 6. Study Logs 7. Eligibility Criteria Checklist 8. Consent Form Issues 9. Protocol deviations, violations & waivers 10. Record Keeping 2. Lab Documentation

40. Laboratory Documentation • Not on file or incomplete • Missing: • Lab Director’s CV • Normal Values • Certification (e.g. CLIA, CAP)

41. Laboratory Documentation Why are lab documents not on file? Reason #1: Using the same lab for multiple studies. Solution #1: Write a signed and dated note-to-file indicating where it is located.

42. Laboratory Documentation Why are lab documents not on file? Reason #2: Using the hospital lab. Solution #2: If not an IND study, N/A If an IND study, obtain a copy of lab documentation.

43. Laboratory Documentation Why are lab documents not on file? Reason #3: The sponsor didn’t provide them. Solution #3: Request a copy of the lab documentation from all labs being used.

44. Laboratory Documentation Why do I need lab documentation? To document the competence of the facility to perform the required tests, and to support the reliability of data.

45. Quality Improvement Top Ten List 2. Lab Documentation 3. Investigator Brochure 4. NIH Progress Report/DSMB 5. Curriculum Vitae (CVs) 6. Study Logs 7. Eligibility Criteria Checklist 8. Consent Form Issues 9. Protocol deviations, violations & waivers 10. Record Keeping 1. Source Documentation

46. Source Documents • Inadequate • Not signed and dated • Pencil used • Cross outs not initialed and dated • Don’t exist

47. Source Documents Q. What are source documents? A. It’s wherever data is first recorded (original records or certified copies)

48. Source Documents Source documents include: 1. hospital records 2. lab notes 3. memos 4. subject diaries 5. evaluation checklists 6. pharmacy dispensing records

49. Source Documents 7. X-rays 8. copies of transcriptions certified after verification as being accurate and complete 9. microfiches 10. photographic negatives 11. microfilm or magnetic media 12. recorded data from automated instruments

50. Source Documents Q. Why are source documents needed? A. To document the existence of the subject and substantiate integrity of trial data collected.