Monitoring and Oversight Review

Monitoring and Oversight Review

Principal Investigator
Department
Protocol Number & Title
Date of Review
Sponsor
Reason for MO Review
Regulatory Documentation / Y / N / NA / Comments
1. / Is there a Regulatory Binder? /  /  / 
2. / Are all versions of the protocol on file? /  /  / 
3. / Are all versions of the IRB approved consent on file? /  /  / 
4. / Is initial IRB approval letter on file? /  /  / 
5. / Are all continuing reviews/IRB approval memos on file? /  /  / 
6. / Are all amendments/IRB approval memos on file? /  /  / 
7. / Are all IRB approved advertising materials on file? /  /  / 
8. / Are all IRB approved questionnaires, diaries, and surveys on file? /  /  / 
9. / Is investigational product information on file? /  /  / 
10. / If NIH funded, is a copy of the grant and progress report(s) on file? /  /  / 
11. / If the study is funded by a pharmaceutical co., is a 1572 on file? /  /  / 
12. / If PI holds IND, is there a 1571 on file? /  /  / 
13. / If there is a DSMB, are DSMB reports on file? /  /  / 
14. / Are IND safety reports on file? /  /  / 
15. / Are medical licenses of PI/Co-Inv. On file? /  /  / 
16. / Are CVs of PI/Co-Inv. On file? /  /  / 
17. / Is there an enrollment log? /  /  / 
18. / Is there a site responsibility log? /  /  / 
19. / Is there a protocol deviation log? /  /  / 
20. / Is there an IP accountability log? /  /  / 
21. / Is there a blood/tissue storage log? /  /  / 
22. / Are there any other issues related to Regulatory documentation? /  /  / 
Consent Documentation / Y / N / NA / Comments
23. / Did all enrolled subjects sign a consent form? /  /  / 
24. / Was the correct, IRB stamped version of the consent form used? /  /  / 
25. / Is the number of subjects enrolled consistent with the number of subjects approved by the IRB for enrollment? /  /  / 
26. / Was the consent signed by the study subject? /  /  / 
27. / Was the consent dated by the study subject? /  /  / 
28. / Was the consent signed by the appropriately designated staff member? /  /  / 
29. / Was the consent dated by the appropriately designated staff member? /  /  / 
30. / If applicable, were all pages of the consent initialed? /  /  / 
31. / If applicable, were all optional procedures initialed and checked off by the subject? /  /  / 
32. / Was consent obtained prior to any study related procedures being done? /  /  / 
33. / Was HIPAA authorization obtained? /  /  / 
34. / Are all contact numbers and contact names correct on the consent? /  /  / 
35. / If applicable, was assent obtained? /  /  / 
36. / Are all pages of the consent/assent form present? /  /  / 
37. / Are there any unexplained discrepancies or other issues related to consent? /  /  / 
Protocol Adherence/Source Documentation / Y / N / NA / Comments
38. / Is there documentation of subject eligibility? /  /  / 
39. / Did all enrolled subjects meet inclusion/exclusion criteria? /  /  / 
40. / Is there adequate and complete source documentation to corroborate data entries and protocol adherence /  /  / 
41. / Were all protocol required labs obtained? /  /  / 
42. / Were all protocol required procedures completed? /  /  / 
43. / Were all protocol required visits conducted? /  /  / 
44. / Were protocol deviations reported to the IRB per WFUHS policy? /  /  / 
45. / Were UAPs reported to the IRB per WFUHS policy? /  /  / 
46. / If IRB approval lapsed, did any research activity occur during this interval? /  /  / 
47. / Are changes/crossouts in subject files routinely initialed and dated? /  /  / 
48. / Are there any other issues related to protocol adherence/source documentation? /  /  / 
Facilities / Personnel / Y / N / NA / Comments
49. / Are personnel knowledgeable about the protocol? /  /  / 
50. / Have tasks been delegated appropriately? /  /  / 
51. / Are facilities adequate to conduct the study? /  /  / 
52. / Are supplies kept in a secure, locked location? /  /  / 
53. / If using an IP, is it kept in a locked cabinet? /  /  / 
54. / Are study specimens coded and stored per protocol? /  /  / 
55. / Are there any other issues related to Facilities/Personnel? /  /  / 
IRB / Y / N / NA / Comments
56. / Was quorum maintained for all IRB votes on this study? /  /  / 
57. / Was a non-scientist present for all IRB votes on this study /  /  / 
58. / Are the changes approved by the IRB reflected in the study documents? /  /  / 
59. / Were consent forms watermarked appropriately? /  /  / 
60. / If an IRB member had a conflict, did he/she recuse? /  /  / 
61. / Was the study without IRB lapse in approval? /  /  / 
62. / Are there any other issues related to the IRB? /  /  / 
Summary of Review

Monitoring and Oversight Specialist: ______

Mary L. Ragusky, RN

Office of Research

Cc: IRB Director

IRB Executive Chair

Assistant Dean for Research

8.10.11