SOCRA 2024 Annual Conference Program Book - Flipbook - Page 51
FY23 Inspections
Basic Tips
Follow the protocol
1200
1100
Inspections Classified
1056
Maintain accurate records
2%
959
1000
18%
900
Obtain informed consent
800
700
600
Monitor adequately
500
400
300
200
Submit an IND
80%
100
0
Conducted
Classified
OAI
VAI
NAI
Respond to the 483
19
www.fda.gov
www.fda.gov
20
Contact Information
Chrissy J. Cochran, PhD
Director
Office of Bioresearch Monitoring Operations
Office of Regulatory Affairs
U.S. Food and Drug Administration
Tel: +1-301-796-5633
Chrissy.Cochran@fda.hhs.gov
21
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