Records and source documentation

Master the fundamental requirements for maintaining accurate, complete, and legible trial records, distinguishing source documents from derived data, and applying ALCOA+ principles to all documentation.

25 min

Records and source documentation

"If it wasn't documented, it didn't happen." This phrase echoes through every clinical research training program, and for good reason. But the adage, while memorable, tells only half the story. Documentation is not merely about proving something occurred. It is about creating a reliable record that can be verified, that preserves exactly what happened and when, and that remains accessible for as long as regulators, clinicians, and future researchers need to consult it.

Poor documentation does not simply create gaps in the record. It undermines the entire evidentiary foundation of clinical research. A blood pressure reading scribbled on a paper towel and transcribed hours later is not equivalent to one recorded contemporaneously in the source record. A signature obtained but undated cannot prove when consent was given. Data entered by someone other than the person who collected it cannot be attributed with certainty.

Section 2.12 of ICH E6(R3) Annex 1 establishes the standards that distinguish reliable records from unreliable ones. These are not bureaucratic requirements invented to burden investigators. They are the minimum conditions necessary for trial data to support regulatory decisions about whether a medicine is safe and effective. Every participant who volunteers for research deserves to know their data will be captured with sufficient rigor that their contribution actually matters.

This lesson examines what makes clinical trial documentation trustworthy: the E6(R3) concept of source records (which consolidates the earlier E6(R2) terms "source data" and "source documents"), the data integrity principles, and the retention requirements that ensure records remain accessible for years or decades after the trial concludes.

What you will learn5 objectives

By the end of this lesson, you will be able to:

Maintain accurate, complete, and legible records per ICH E6(R3) Section 2.12
Distinguish between E6(R2) terminology (source data, source documents) and the consolidated E6(R3) term (source records) with practical examples
Apply E6(R3) data integrity principles (often referenced through the industry mnemonic ALCOA+) to all trial documentation
Use unique participant identification codes to protect confidentiality while enabling data linkage
Retain records according to regulatory and sponsor requirements across jurisdictions

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Records and source documentation