Book 1C: 2026 Good Clinical Practice Regulations in the US & the EU <span style="color: #b70202">(With FDA/ICH GCP E6(R3))</span>Description Contents Cover This spiral bound, 5" x 7. 5" book consists of US FDA GCP regulations, including all of 21 CFR Part 314 (NDAs), ICH Guidelines, the new EU Clinical Trials Regulation, as well as the EU GCP Directive and the repealed EU Clinical Trials Directive. Who Uses this Book and How? Clinical Research staff, as job aids Training departments, as training handouts Human Resources, as part of new employee orientation Legal Regulatory QA

Processing

5" book contains the US-adopted versions of the ICH Guidelines on writing clinical study reports and on statistical principles for clinical trials

Investigations (46 FR 8958

The final CLIA '88 regulations were first published in 1992

(48 FR 16658

•  CFR Title 21:  Food and Drugs  (Revised as of April 1

• 21 CFR Part 58:  Good Laboratory Practice

• As a training aid for new and existing staff

•  Index to 21 CFR Parts 11

packing or holding of drugs

• Protection of Human Subjects

• 500-749 copies: $15