A clinical trial using an investigational drug in humans must follow the requirements laid out in the Code of Federal Regulations (CFR) Title 21.
Requirements:
(1) all drugs must meet the approval of the Food and Drug Administration for investigational drugs
(2) the study is registered on Clinicaltrials.gov
(3) sponsors and investigators adhere to the principles of good clinical practice and fulfill all of their responsibilities (CFR21321.50 and CFR21312.60).
(4) the study has a clinical trial monitoring program under the oversight of the Institutional Review Board (IRB, 21CFR312.66)
(5) a data and safety monitoring program is in place prior to the initiation of the study
(6) clinical trials data is stored in compliance with 21CFR312.
(7) the rights, safety and welfare of human subjects are protected, with use of informed consent
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