CFR Flashcards
(20 cards)
Financial disclosure from CI to sponsor
21 CFR Part 54
Electronic signatures and records
22 CFR Part 11
Protect human subject. Clear explanation using unapproved test article, participation voluntary, informed consent unless IRB waiver
21 CFR Part 50
IRBs initially review and approve clinical trials, periodic oversight on test articles regulated by FDA, must comply with FDA regulations
22 CFR Part 56
Investigational New Drug Applications (INDs) and CI responsibilities
22 CFR Part 12
CI conducted per plan
21 CFR Part 312.60
CI only administer under their supervision
21 CFR Part 312.61
CI maintain records for drug disposition and subject case history
21 CFR Part 312.62
CI furnish reports in drug or serious AEs and financial disclosure reports.
21 CFR Part 312.64
CI must involve IRB to review, approved and continual review of study
21 CFR Part 312.66
CI must allow FDA to review and copy any records and reports from study
21 CFR Part 312.68
CI must ensure adequate control of controlled substances.
21 CFR Part 312.69
Investigational Device Exemptions IDE
21 CFR Part 812
CI ensure investigation conducted per signed agreement, plan, regulations
21 CFR Part 812.100
CI must wait for IRB and FDA approval prior to obtaining informed consent
21 CFR Part 812.110
Maintain investigator records and submit reports
21 CFR Part 812.140(a)
Overall responsibility of clinical trial is sponsor’s and to ensure CI qualified to evaluate safety
21 CFR Part 511 (CVM)
Deviations from the investigation plan
investigator to notify sponsor and IRB of deviation from plan to project life or physical well-being within 5 working days after emergency
21 CFR Part 812.15
Investigational New Drug Application INDA
21 CFR Part 312
CPGM
Compliance Program Guidance Manual
