Resources

We value our client's education. Browse our comprehensive list of regulatory links and glossary of clinical trials terms.

Education Center

FDA and EMA COVID Guidance

EMA’s governance during COVID-19 pandemic

https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/emas-governance-during-covid-19-pandemic

COVID-19: Latest Updates

https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/covid-19-whats-new

Guidance Documents Related to Coronovirus Disease 2019 (COVID-19)

https://www.federalregister.gov/documents/2020/05/12/2020-10146/guidance-documents-related-to-coronavirus-disease-2019-covid-19-availability

www.federalregister.gov

Regulatory Links

21 CFR, Part 11 Electronic Records; Electronic Signatures

21 CFR Part 50 Protection of Human Subjects

Integrated Addendum to ICH E6(R2): Guideline for Good Clinical Practice

21 CFR, Part 312: Subpart D Investigator and Sponsor Responsibilities.

21 CFR, Part 812: Investigational Device Exemptions

EMA Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)

21 CFR, Part 56: Institutional Review Boards

45 CFR, Part 46: Protection of Human Subjects

FDA BIMO Sponsor, CRO, and Monitor Inspections 7348.10

FDA BIMO Clinical Investigators 7348.811