Resources

Regulatory Links

21 CFR Part 11 Regulations
21 CFR 50 Protection of Human Subjects
21 CFR 56 Institutional Review Boards
45 CFR 46 Protection of Human Subjects
ICH Website
ICH Efficacy Guidelines

EMA

EMA Guideline for content, management and archiving of the clinical TMF

FDA

FDA Clinical Trials Guidance Documents

ALCOA

ALCOA Guidelines
ICH E6 R2

DIA Reference Model

FAQs

We have accumulated a document backlog. What can you do to help?
Can you assist with CRO managed TMFs?
How can you help us transition from paper to electronic TMF?
We are choosing an eTMF vendor, can you help?
Does your team work remotely?  What if we need someone onsite?

DIA Reference Model 3.1