Data Management, Source Documentation, and Recordkeeping
This domain tests whether the data can survive a monitor's review and an inspector's questions years later. Items focus on what counts as source, how corrections are made, how eCRF data are controlled, and how long records must be kept and made available.
Source documents and ALCOA-C
- Source data are the original records and certified copies: notes, laboratory reports, ECGs, diaries, dispensing logs.
- The quality attributes: Attributable, Legible, Contemporaneous, Original, Accurate - plus complete, consistent, enduring and available.
- Direct-entry eSource is acceptable when controlled systems capture an audit trail, user identity and timestamps.
- The CRF is source only where the protocol or a documented site procedure prospectively designates it.
Corrections
Single line through the error, correct value alongside, initial and date, plus a reason when the change is not self-evident. Never obliterate, never backdate, never "tidy" later. In electronic systems the original value and reason for change stay visible in the audit trail.
Queries and eCRF control (21 CFR Part 11)
- Respond to queries with the corrected or confirmed value, not a bare "done"; ensure the source supports the answer.
- Unique logins, access controls, validated systems, and e-signatures that are attributable and dated.
Retention
- 21 CFR 312.62(c): 2 years after a marketing application is approved, or 2 years after the investigation is discontinued and FDA is notified.
- ICH E6 §4.9.5: at least 2 years after the last approval of a marketing application in an ICH region and until no pending applications exist, or 2 years after formal discontinuation of development.
- HIPAA documentation: 6 years. Local law, contracts or the sponsor may require longer - apply the longest. Records must be available for FDA inspection (21 CFR 312.68).
Worked example
A blood pressure is transcribed into the source as 128/82 when the device printed 182/82. Reasoning: correct with a single line, write 182/82, initial and date, and note "transcription error." Then assess the consequence: a diastolic/systolic value of this magnitude may be an adverse event and may affect eligibility or dosing, so it must be evaluated, not merely corrected.
Traps that cost marks
- White-out, overwriting, or recreating source after the fact.
- Late entries without explanation of when and why they were made.
- Destroying records at close-out, or storing them where they cannot be retrieved for an inspection.
- Shared eCRF accounts, so entries cannot be attributed.
- Eligibility or endpoint data existing only in the CRF with no underlying source.