Book M2: 2025 Mini Pocket-Sized (3" x 5") Code of Federal Regulations on Good Clinical Practice, 21 CFR Parts 11, 50, 54, 56, 312Description Contents Cover This spiral bound, 3" x 5" book contains the key US regulations governing the conduct of clinical studies for FDA approval. It also includes a detailed subject index for quick and convenient access to information. NOTE: It does not contain 21 CFR Part 314 or any ICH guidelines or FDA guidance documents. Users requiring ICH guidelines and FDA guidance documents should browse through the other books listed under the heading,

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Subpart D: Additional Protections for

• Quality Systems for GMP

Please see the "Contents" link above for a detailed listing of the documents in this book

• Part 11: Electronic Records and Signatures

811 - Clinical Investigators

210 and 211

Explanatory Notes on Site Master File

Review Procedure Set Forth in FDA Regulations (46 FR 8980

to its final form

• Electronic Records/Signatures (62 FR 13429

o All NCI CTEP/DCP data reporting (CDUS