Resources

Finding Clinical Trials

Search the official registry and results database of publicly and privately supported clinical studies of human participants conducted around the world

https://clinicaltrials.gov/

Clinical Trials and Human Subject Protection

There are numerous references related to good clinical practice (GCP) and human subject protection (HSP), available on FDA’s website, including:

• FDA’s GCP and HSP regulations found in Title 21 of the Code of Federal Regulations, Parts 50, 54, 56, 312, and 812
• the preambles related to these regulations
• INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2) Current Step 4 version dated 9 November 2016
• FDA Information Sheets for IRBs and Clinical Investigators
• Compliance Program Guidance Manuals
• FDA guidance for industry: Finalized documents and draft guidance documents (and proposed regulations).

For the European Medicines Agency (EMA), the best place to start is:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/landing/human_medicines_regulatory.jsp&mid=

Attributes of Exemplary Clinical Trial Sites

ASCO Statement on Minimum Standards & Attributes of Exemplary Clinical Trial Sites