Study Close‑out & Reporting in Clinical Research

This course walks through end‑of‑study activities, including site and sponsor close‑out procedures, essential document reconciliation, Clinical Study Report (CSR) preparation (ICH E3), regulatory reporting requirements, clinical trial registry submissions, electronic record compliance (21 CFR Part 11), and Canadian human research ethics (TCPS 2).

Course Benefits & Career Prospects

• Prepare and conduct site/sponsor close‑out activities and document reconciliation.
• Understand CSR structure and reporting requirements (ICH E3).
• Recognize electronic records/signatures compliance considerations (21 CFR Part 11).
• Navigate clinical trial registration & results reporting expectations (42 CFR Part 11 / ClinicalTrials.gov context).
• Job placement assistance: study close‑out support, CSR documentation, regulatory reporting trainee roles

Modules

• Study Close‑out Procedure & Documentation
• Clinical Study Report (CSR) Preparation – ICH E3
• 21 U.S. Code of Federal Regulations – Part 11 (Electronic Records / Electronic Signatures)
• 42 CFR Part 11 (Clinical Trials Registration & Results Information Submission
• TCPS 2 – Ethical Conduct for Research Involving Humans (Canada)