Audience Question

1
Audience Question
Replace content of Slide 25

• Study Coordinators and research assistants
  change over time, so if you have an IND and
  ongoing study, are you supposed to inform the FDA
  that your study coordinator is a different
  person or if you have a new research assistant?

2
Review Warning Letter (WL) Cases
Place between slides 37 and 38

• Instructions
• Click Stop Button under video window
• Read all 3 Warning Letters (Click each name)
• Mitchell Creinin
• Michael Gruber
• Alkis Togias
• Match statements in WLs with SMALL PRINT issues
• e.g. failed to retainrecords R (Retain
  records)
• Restart video by clicking under video
  window

3
Speaker Dr Mitchell Creinin, what were the
SMALL PRINT issues for him?

• Audience Discussion
• Maintain Records (M)
• Adhere to Protocol (A)
• Inform Subjects (I)
• Notify IRB (N)
• Report Adverse Events (P)

Replace content of slide 38
4
Speaker Dr. Michael Gruber, what were the
problems with his study?

• Audience Discussion
• Maintain Records (M)
• Lack of source data
• Supervise (S)
• Investigator as team leader in charge of study
• Adhere to Protocol (A)
• Retain Records (R)

Replace content of slide 40
5
Speaker Dr. Togias, what were the 2 most
significant issues?

• Audience Discussion
• He did not file an IND.
• Drug crossed state lines and was administered
  without FDA approval of IND.
• A normal healthy volunteer died.

Replace content of slide 42
6
Speaker Other findings with Dr. Togias?

• Audience Discussion
• Adhere to Protocol (A)
• Inadequate protocol
• Change protocol on a whim
• Notify IRB (N)
• Report Adverse Events (P)
• Learn IB (L)
• No animal data
• Maintain and Retain Records (M) (R)

Replace content of slide 44
7
Read OHRP Determination Letters
Place between slides 48 and 49

• Instructions
• Click Stop Button under video window
• Click each date for letter
• Jul 19, 2001 (MPA Suspension)
• Jul 23, 2001 (MPA Reinstatement)
• Oct 03, 2001 (1st Monthly Report)
• Aug 23, 2002 (Followup inspection)
• Restart video by clicking under video
  window

8
Speaker Who can tell me what OHRP stands for?

• Audience Answer
• Office of Human Research Protection

Replace content of slide 51
9
Review Determination LetterCase 1 John Hopkins
University
Place between slides 58 and 59

• Instructions
• Click Stop Button under video window
• Click Date for letter
• Dec 14, 2001 (Dr. Rolley E. Johnson)
• Restart video by clicking under video
  window

10
Speaker introduces Case 1
Replace Slides 60 and 61

• Audience discusses

11
Review Determination LetterCase 2 Thomas
Jefferson University
Place between slides 61 and 62

• Instructions
• Click Stop Button under video window
• Click Date for letter
• Dec 11, 2001 (Dr. David W. Andrews)
• Restart video by clicking under video
  window

12
Speaker introduces Case 2
Replace Slides 63 and 64

• Audience discusses

13
Review Determination Letter Case 3
Massachusetts General Hospital
Place between slides 65 and 66

• Instructions
• Click Stop Button under video window
• Click Date for letter
• Apr 03, 2002 (Dr. John Growden)
• Restart video by clicking under video
  window

14
Speaker introduces Case 3
Replace Slides 67 and 68

• Audience discusses

15
Review Determination LetterCase 4 John Hopkins
University
Place between slides 68 and 69

• Instructions
• Click Stop Button under video window
• Click Date for letter
• Aug 19, 2002 (Dr. Mark Farfel)
• Restart video by clicking under video
  window

16
Speaker introduces Case 4
Replace Slide 70

• Audience discusses

17
Summary Determination Letters
Include as Slide 73

• Not always determinations of non-compliance.
• Of interest in terms of current OHRP
  interpretations -- recognizing that you are
  getting only one side of the story
• Actions/corrective actions taken by the
  institutions although the institution may
  require actions by the investigator.

18
Summary Warning Letter (WL) versus Determination
Letter (DL)
Include as Slide 74

• Source
• WL FDA
• DL OHRP
• Target Audience
• WL e.g., Investigators, IRBs, not Institution
  level
• DL Institution, not Investigator, IRB levels
• Cause
• WL FDA Inspection noting serious compliance
  problems
• DL Various reports including institution self
  reports
• Issuance and Inspections
• WL Always issued post FDA site inspection
• DL Usually issued pre OHRP site inspection, if
  any