312 < Official REVIEW >

Regulations: Good Clinical Practice and Clinical Trials - FDA

Sponsors must submit an IND to the FDA before starting a clinical investigation. Regulations: Good Clinical Practice and Clinical Trials -

Investigators must supervise the administration of the drug and ensure it is only given to authorized subjects. Regulations: Good Clinical Practice and Clinical Trials -

The number refers to several distinct official documents, regulations, and technical materials. Depending on your specific interest, here are the primary "312" guides: 1. Security: Standard Form 312 (SF-312) Regulations: Good Clinical Practice and Clinical Trials -

This FDA regulation governs . It provides the legal framework for clinical trials on human subjects.