2025 Content: Books 1A, 1B and 1C

IMPORTANT NOTICE: As of 2024, we shuffled the content of Books 1A and 1B and added a new book, Book 1C. To help you determine which books you need, the below chart shows the section differences between the 2023 and 2024/25 versions. It also shows the content of our new Book 1C for comparison.

Section Name (truncated)	2023 Book 1A	2024/5 Book 1A	2023 Book 1B	2024/5 Book 1B	2024/5 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
EU Clinical Trials Regulation 536/2014					x
New Informed Consent Guidance (2023)				x
PhRMA Principles on Conduct of Clinical Trials	x	x