2024 Content: Books 1A, 1B and 1C

IMPORTANT NOTICE: As of April 1, 2024, Books 1A and 1B will be amended by adding/deleting sections from previous years. To help you determine which books you need, the below chart shows the section differences between the 2023 and 2024 versions. It also shows the content of our new Book 1C for comparison.

Section Name (truncated)	2023 Book 1A	2024 Book 1A	2023 Book 1B	2024 Book 1B	2024 Book 1C
21 CFR 11: Electronic Records/Signatures	x	x	x	x	x
21 CFR 50: Protection of Human Subjects	x	x	x	x	x
21 CFR 54: Financial Disclosure/Investigators	x	x	x	x	x
21 CFR 56: Institutional Review Boards	x	x	x	x	x
21 CFR 312: Investigational New Drug Application	x	x	x	x	x
21 CFR 314 (Complete): FDA Marketing Application	x	x			x
21 CFR 314 (parts only): Post-Marketing Reporting			x	x
Index to 21 CFR	x	x	x	x	x
FDA Information Sheets (Medical device docs removed)		x	x	x
ICH E2: Clinical Safety Data Management	x	x	x	x	x
ICH E6: Good Clinical Practice	x	x	x	x	x
ICH E8: General Considerations for Clinical Trials	x	x	x	x	x
A Risk-Based Approach to Monitoring	x		x	x
Monitoring Q&A	x			x
FDA CPGM (7348.810): FDA Inspections of Sponsors	x		x	x
AE Reporting to IRBs	x		x	x
Safety Reporting Requirements for INDs and BA/BE Studies	x		x	x
EU Clinical Trials Directive and EU GCP (2005)	x				x
EU Clinical Trials Regulation 536/2014					x
New Informed Consent Guidance (2023)				x
PhRMA Principles on Conduct of Clinical Trials	x	x
Selected Drug Development Websites	x		x