Transcript Completing WL Cases “On

Replace content of Slide 25
Audience Question
“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?
Place between slides 37 and 38
Review Warning Letter (WL) Cases
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Instructions
1. Click “Stop Button:
“ under video window
2. Read all 3 Warning Letters (Click each name)
– Mitchell Creinin
– Michael Gruber
– Alkis Togias
3. Match statements in WLs with “SMALL PRINT” issues
– e.g. “failed to retain…records” = R (Retain records)
4. Restart video by clicking “
“ under video window
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
Speaker: Dr. Michael Gruber, what
were the problems with his study?
Audience Discussion:
 Maintain Records (M)
–

Supervise (S)
–
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
Lack of source data
Investigator as “team leader” in charge of study
Adhere to Protocol (A)
Retain Records (R)
Replace content of slide 40
Speaker: Dr. Togias, what were the
2 most significant issues?
Audience Discussion:
1. He did not file an IND.
– Drug crossed state lines and was administered
without [FDA] approval of IND.
2. A normal healthy volunteer died.
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Speaker: “Other findings with Dr.
Togias?”
Audience Discussion:
1. Adhere to Protocol (A)
Replace content of slide 44
– Inadequate protocol
– Change protocol “on a whim”
2. Notify IRB (N)
3. Report Adverse Events (P)
4. Learn IB (L)
– No animal data
5. Maintain and Retain Records (M) (R)
Place between slides 48 and 49
Read OHRP Determination Letters
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Instructions
1. Click “Stop Button:
“ under video window
2. Click each date for letter
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Jul 19, 2001 (MPA Suspension)
Jul 23, 2001 (MPA Reinstatement)
Oct 03, 2001 (1st Monthly Report)
Aug 23, 2002 (Follow–up inspection)
3. Restart video by clicking “
“ under video window
Speaker: Who can tell me what
OHRP stands for?
Audience Answer:
“Office of Human Research Protection”
Replace content of slide 51
Place between slides 58 and 59
Review Determination Letter:
Case 1: John Hopkins University
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Instructions
1. Click “Stop Button:
“ under video window
2. Click “Date” for letter

Dec 14, 2001 (Dr. Rolley E. Johnson)
3. Restart video by clicking “
“ under video window
Replace Slides 60 and 61
Speaker introduces Case 1
Audience discusses
Place between slides 61 and 62
Review Determination Letter:
Case 2: Thomas Jefferson University
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Instructions
1. Click “Stop Button:
“ under video window
2. Click “Date” for letter

Dec 11, 2001 (Dr. David W. Andrews)
3. Restart video by clicking “
“ under video window
Replace Slides 63 and 64
Speaker introduces Case 2
Audience discusses
Place between slides 65 and 66
Review Determination Letter: Case 3:
Massachusetts General Hospital
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Instructions
1. Click “Stop Button:
“ under video window
2. Click “Date” for letter

Apr 03, 2002 (Dr. John Growden)
3. Restart video by clicking “
“ under video window
Replace Slides 67 and 68
Speaker introduces Case 3
Audience discusses
Place between slides 68 and 69
Review Determination Letter:
Case 4: John Hopkins University

Instructions
1. Click “Stop Button:
“ under video window
2. Click “Date” for letter

Aug 19, 2002 (Dr. Mark Farfel)
3. Restart video by clicking “
“ under video window
Replace Slide 70
Speaker introduces Case 4
Audience discusses
Include as Slide 73
Summary: Determination Letters
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.
Include as Slide 74
Summary: Warning Letter (WL)
versus Determination Letter (DL)
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Source
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–
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Target Audience
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–
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WL: e.g., Investigators, IRBs, not Institution level
DL: Institution, not Investigator, IRB levels
Cause
–
–
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WL: FDA
DL: OHRP
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