By Food and Drug Administration
Read or Download Compact Regs Parts 50, 54, 56, and 312: CFR 21 Parts 50, 56, and 312 Good Clinical Practices (10 Pack) PDF
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Additional info for Compact Regs Parts 50, 54, 56, and 312: CFR 21 Parts 50, 56, and 312 Good Clinical Practices (10 Pack)
As drug development proceeds, the sponsor is required to submit informational amendments, as appropriate, with additional information pertinent to safety. (i) Pharmacology and drug disposition. A section describing the pharmacological effects and mechanism(s) of action of the drug in animals, and information on the absorption, distribution, metabolism, and excretion of the drug, if known. (ii) Toxicology. (a) An integrated summary of the toxicological effects of the drug in animals and in vitro.
B) The records required by this regulation shall be retained for at least 3 years after completion of the research, and the records shall be accessible for inspection and copying by authorized representatives of the Food and Drug Administration at reasonable times and in a reasonable manner. (c) The Food and Drug Administration may refuse to consider a clinical investigation in support of an application for a research or marketing permit if the institution or the IRB that reviewed the investigation refuses to allow an inspection under this section.
Modifications of the experimental design of Phase 1 studies that do not affect critical safety assessments are required to be reported to FDA only in the annual report. (ii) In Phases 2 and 3, detailed protocols describing all aspects of the study should be submitted. A protocol for a Phase 2 or 3 investigation should be designed in such a way that, if the sponsor anticipates that some deviation from the study design may become necessary as the investigation progresses, alternatives or contingencies to provide for such deviation are built into the protocols at the outset.
Compact Regs Parts 50, 54, 56, and 312: CFR 21 Parts 50, 56, and 312 Good Clinical Practices (10 Pack) by Food and Drug Administration