Reference
Resources for Clinical Research Professionals
Regulatory links, professional organizations, books, and site supplies — organized for quick reference.
Certification Guide — CCRC vs. CCRP requirements, fees, and study materials.
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Physical Tools Guide — What CRCs actually keep on their desks.
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- FDA Clinical Trials Guidance Documents Official FDA guidance on clinical trial conduct, IND requirements, informed consent, and GCP compliance.
- EMA Clinical Trials in Human Medicines European Medicines Agency guidance on clinical trial authorization and GCP in the EU.
- ICH Efficacy Guidelines, including ICH E6(R3) Good Clinical Practice The primary international GCP standard. ICH E6(R3) was adopted January 2025. Download free from the ICH website.
- 45 CFR 46 — The Common Rule (HHS/OHRP) U.S. federal policy governing protection of human subjects in federally funded research.
- 21 CFR Part 312 — IND Regulations (FDA) FDA regulations governing investigational new drug applications and clinical investigations.
- Association of Clinical Research Professionals (ACRP) Offers the CCRC, CCRA, and CPI certifications. Also provides continuing education, job boards, and career resources.
- Society of Clinical Research Associates (SOCRA) Offers the CCRP certification for all clinical research professionals. Year-round testing via Prometric.
- ClinicalTrials.gov U.S. registry of publicly and privately supported clinical studies. Useful for understanding trial landscape and FDAAA registration requirements.
- WHO International Clinical Trials Registry Platform Global registry platform relevant for sites working on international or WHO-registered studies.
The CRC Toolkit participates in the Amazon Associates Program and may earn a small commission from qualifying purchases at no extra cost to you. See disclaimer below.
- ICH E6(R3) Good Clinical Practice — Printed Copy Available free from ich.org. Many CRCs keep an annotated printed copy at their desk for quick reference during monitoring visits. Amazon
- Good Clinical Practice: A Question & Answer Reference Guide A practical GCP reference formatted as Q&A, ideal for quick lookups during daily site work. Amazon
- Fundamentals of Clinical Trials — Friedman, Furberg & DeMets Standard academic textbook on clinical trial design and methodology. Background reading for understanding why trial procedures exist. Amazon
- Pocket Reference for Clinical Lab Values A laminated pocket-sized card used constantly during screening eligibility reviews. Faster than searching online during a visit. Amazon
See our full Certification Guide for fact-checked requirements and a complete study strategy. The CRC Toolkit participates in the Amazon Associates Program.
- CCRC / CCRP Exam Prep Study Guides Look for the most recent edition — exam blueprints update periodically. Confirm the guide reflects ICH E6(R3) before purchasing. Amazon
- Principles of Good Clinical Practice — Rondel, Varley & Webb A thorough GCP reference often recommended by coordinators preparing for certification exams. Amazon
- Acronym Glossary & Interactive Flashcards Free on this site — 80+ acronyms with category filtering and 50+ interactive flashcards organized by topic.
These are general product categories commonly used at clinical research sites. Suitability depends on your specific protocol, sponsor requirements, and institutional policies, always confirm with your site leadership and SOPs before purchasing. See full disclaimer below. The CRC Toolkit participates in the Amazon Associates Program.
- Heavy-Duty D-Ring Binders (3"–4") D-ring binders keep pages flatter than round-ring binders — important during monitoring visits. Label the spine with protocol number and binder number. Amazon
- Insertable Tab Dividers Customizable tabs let you match ISF sections to your sponsor's required template. Amazon
- Self-Inking Date Stamp Date-stamp documents the day they arrive to support received-date records during audits. Amazon
For a comprehensive guide to physical CRC tools, see Physical Tools Every CRC Needs →
⚠️ Disclaimer & Limitations
This page is provided for educational and informational purposes only. The CRC Toolkit makes no representations or warranties, express or implied, about the accuracy, completeness, suitability, or fitness for any particular purpose of any information, product, or resource listed here. Specifically:
- Product recommendations (books, supplies, equipment) are general suggestions based on common clinical research site practice. We have not independently tested, verified, or evaluated any product. Suitability depends entirely on your specific protocol, sponsor requirements, institutional SOPs, and applicable regulations. For example, storage devices (including USB drives or temperature loggers), dispensing equipment, and labeling systems may be subject to 21 CFR Part 11, sponsor validation requirements, or institutional IT policies that are beyond the scope of this page. Always consult your site leadership, sponsor, and applicable SOPs before purchasing or using any product in a clinical research context.
- Regulatory and organizational links point to third-party websites we do not control. Content on those sites may change without notice. Always verify current requirements directly from official sources.
- Book and study material links reflect titles commonly referenced in the clinical research field. We cannot guarantee that any specific edition reflects the most current regulatory guidance (including ICH E6(R3)). Always verify that study materials are current before purchasing for exam preparation.
- Affiliate links: Product links to Amazon are affiliate links — The CRC Toolkit may earn a small commission from qualifying purchases at no extra cost to you. This does not influence which products are listed or recommended.