Regulatory Framework and Clinical Trial Standards
What you must know
Clinical data management sits inside a web of rules. At the top is ICH-GCP E6, which establishes the investigator's responsibility for accuracy and the sponsor's responsibility for oversight and recordkeeping. ICH E2A covers definitions of adverse events and serious adverse events, while E6 sections 4.9 and 5.5 govern source documentation and data handling. Regional layers add requirements: FDA 21 CFR Part 11 for electronic records and signatures, Part 312 for IND studies, and the EU Clinical Trials Regulation with its CTIS portal. The Common Technical Document (CTD) governs submission structure, not trial conduct. ISO 14155 applies to device studies.
Concepts to master
Know the difference between source data, source documents, and certified copies. Understand ALCOA+ (attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, available). Recognize that the sponsor may transfer duties but never accountability. Know that informed consent must precede any study procedure, and that protocol deviations are classified as major or minor based on participant safety and data integrity impact.
Traps
Questions often swap sponsor and investigator obligations, or present a certified copy as an original. Watch for items that sound regulatory but are guidance only (e.g., FDA data integrity guidance is not a regulation). Another trap: assuming electronic records automatically need Part 11 compliance when the predicate rule may not apply.
Rule of thumb
When unsure who owns a duty, ask: who signs the report to the regulator? The sponsor is always ultimately accountable, even when a CRO performs the work.