perception of clinical research amongst clinical investigators in saudi arabia
A Primer on FDA Resources for Clinical Investigators · BIMO Shared Documents BIMO Compliance...
Transcript of A Primer on FDA Resources for Clinical Investigators · BIMO Shared Documents BIMO Compliance...
![Page 1: A Primer on FDA Resources for Clinical Investigators · BIMO Shared Documents BIMO Compliance Policy . Page Clinical Trials and Human... Commissioned Corps Ma... Inside.FDA Home Search](https://reader034.fdocuments.net/reader034/viewer/2022052520/6090bd9485ef47130d2dc8a7/html5/thumbnails/1.jpg)
A Primer on FDA Resourcesfor Clinical Investigators
Bridget Foltz, M.S., MT(ASCP)
Policy Analyst
Office of Good Clinical Practice
![Page 2: A Primer on FDA Resources for Clinical Investigators · BIMO Shared Documents BIMO Compliance Policy . Page Clinical Trials and Human... Commissioned Corps Ma... Inside.FDA Home Search](https://reader034.fdocuments.net/reader034/viewer/2022052520/6090bd9485ef47130d2dc8a7/html5/thumbnails/2.jpg)
![Page 3: A Primer on FDA Resources for Clinical Investigators · BIMO Shared Documents BIMO Compliance Policy . Page Clinical Trials and Human... Commissioned Corps Ma... Inside.FDA Home Search](https://reader034.fdocuments.net/reader034/viewer/2022052520/6090bd9485ef47130d2dc8a7/html5/thumbnails/3.jpg)
![Page 4: A Primer on FDA Resources for Clinical Investigators · BIMO Shared Documents BIMO Compliance Policy . Page Clinical Trials and Human... Commissioned Corps Ma... Inside.FDA Home Search](https://reader034.fdocuments.net/reader034/viewer/2022052520/6090bd9485ef47130d2dc8a7/html5/thumbnails/4.jpg)
4
Links to electronic Code of Federal Regulations
Preambles contain useful background information
including public comments and FDA’s analysis pertaining to the
final rule
![Page 5: A Primer on FDA Resources for Clinical Investigators · BIMO Shared Documents BIMO Compliance Policy . Page Clinical Trials and Human... Commissioned Corps Ma... Inside.FDA Home Search](https://reader034.fdocuments.net/reader034/viewer/2022052520/6090bd9485ef47130d2dc8a7/html5/thumbnails/5.jpg)
![Page 6: A Primer on FDA Resources for Clinical Investigators · BIMO Shared Documents BIMO Compliance Policy . Page Clinical Trials and Human... Commissioned Corps Ma... Inside.FDA Home Search](https://reader034.fdocuments.net/reader034/viewer/2022052520/6090bd9485ef47130d2dc8a7/html5/thumbnails/6.jpg)
6
Final Guidances
Information Sheets
ICH Guidance Documents
![Page 7: A Primer on FDA Resources for Clinical Investigators · BIMO Shared Documents BIMO Compliance Policy . Page Clinical Trials and Human... Commissioned Corps Ma... Inside.FDA Home Search](https://reader034.fdocuments.net/reader034/viewer/2022052520/6090bd9485ef47130d2dc8a7/html5/thumbnails/7.jpg)
Most Frequently Referenced Guidances for CIs
• Investigator Responsibilities– https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulato
ryInformation/Guidances/UCM187772.pdf
• FAQ Statement of Investigator (Form FDA-1572)– https://www.fda.gov/downloads/RegulatoryInformation/Guidances/U
CM214282.pdf
• Financial Disclosure by Clinical Investigators– https://www.fda.gov/downloads/RegulatoryInformation/Guidances/U
CM341008.pdf
• ICH E6 – Good Clinical Practice Consolidated Guidance– https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulato
ryInformation/Guidances/UCM073122.pdf
7
![Page 8: A Primer on FDA Resources for Clinical Investigators · BIMO Shared Documents BIMO Compliance Policy . Page Clinical Trials and Human... Commissioned Corps Ma... Inside.FDA Home Search](https://reader034.fdocuments.net/reader034/viewer/2022052520/6090bd9485ef47130d2dc8a7/html5/thumbnails/8.jpg)
![Page 9: A Primer on FDA Resources for Clinical Investigators · BIMO Shared Documents BIMO Compliance Policy . Page Clinical Trials and Human... Commissioned Corps Ma... Inside.FDA Home Search](https://reader034.fdocuments.net/reader034/viewer/2022052520/6090bd9485ef47130d2dc8a7/html5/thumbnails/9.jpg)
OGCP’s Listserv for notifications of new guidance documents,
regulations, etc. as well as FDA webinars
![Page 10: A Primer on FDA Resources for Clinical Investigators · BIMO Shared Documents BIMO Compliance Policy . Page Clinical Trials and Human... Commissioned Corps Ma... Inside.FDA Home Search](https://reader034.fdocuments.net/reader034/viewer/2022052520/6090bd9485ef47130d2dc8a7/html5/thumbnails/10.jpg)
OGCP’s Mailbox
Redacted Email Inquiries
![Page 11: A Primer on FDA Resources for Clinical Investigators · BIMO Shared Documents BIMO Compliance Policy . Page Clinical Trials and Human... Commissioned Corps Ma... Inside.FDA Home Search](https://reader034.fdocuments.net/reader034/viewer/2022052520/6090bd9485ef47130d2dc8a7/html5/thumbnails/11.jpg)
![Page 12: A Primer on FDA Resources for Clinical Investigators · BIMO Shared Documents BIMO Compliance Policy . Page Clinical Trials and Human... Commissioned Corps Ma... Inside.FDA Home Search](https://reader034.fdocuments.net/reader034/viewer/2022052520/6090bd9485ef47130d2dc8a7/html5/thumbnails/12.jpg)
![Page 13: A Primer on FDA Resources for Clinical Investigators · BIMO Shared Documents BIMO Compliance Policy . Page Clinical Trials and Human... Commissioned Corps Ma... Inside.FDA Home Search](https://reader034.fdocuments.net/reader034/viewer/2022052520/6090bd9485ef47130d2dc8a7/html5/thumbnails/13.jpg)
![Page 14: A Primer on FDA Resources for Clinical Investigators · BIMO Shared Documents BIMO Compliance Policy . Page Clinical Trials and Human... Commissioned Corps Ma... Inside.FDA Home Search](https://reader034.fdocuments.net/reader034/viewer/2022052520/6090bd9485ef47130d2dc8a7/html5/thumbnails/14.jpg)
Compliance/Enforcement
Implementation of CT.gov Databank