1. Purpose

To define the standards for creating, correcting and maintaining source documentation so that study data are attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available.

2. Scope

Applies to all source records created at the site, including paper worksheets, medical records, electronic source systems, diaries, questionnaires, laboratory reports and imaging reports.

3. Responsibilities

• Data Management Lead: Defines the source documentation plan for each study and identifies the source for every protocol data point.
• All Personnel recording data: Record data at the time of the activity, accurately and legibly, and correct errors only by the approved method.
• Supervisors: Review a sample of source records for quality and completeness at defined intervals.
• Quality Assurance: Audits source records against ALCOA+ criteria and reports findings.

4. Definitions

ALCOA+

Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring and Available.

Source data

All information in original records and certified copies of original records of clinical findings, observations and other activities necessary for reconstruction and evaluation of the trial.

Certified copy

A copy verified by a dated signature or a validated process as having the same content and meaning as the original.

Source documentation plan

The study-specific document that identifies, for every data point, where the source record resides.

5. Procedure

1. Create a source documentation plan at study start-up that names the source location for every protocol-required data point, and update it with each amendment.
2. Record data at the time the observation or activity occurs; never record in advance and never reconstruct entries from memory at a later date.
3. Make entries attributable: use permanent black or blue ink on paper and a unique user account in electronic systems, with initials and date on every paper entry.
4. Write legibly and completely; leave no required field blank, entering 'ND' for not done, 'NA' for not applicable, or 'UNK' for unknown, with an explanatory note where needed.
5. Correct paper errors with a single line through the incorrect entry, the correct value written adjacent, and the corrector's initials and date; add a brief reason where the change is substantive.
6. Never obliterate, erase, overwrite or use correction fluid on any record, and never remove a page from a bound worksheet.
7. Record the actual date and time for time-sensitive assessments such as vital signs, specimen collection, dosing and consent, using a synchronised clock.
8. Record only the minimum necessary protected health information in research source records and identify subjects by study identifier wherever the protocol permits, per HIP-001.
9. Produce certified copies when an original record must be retained elsewhere, documenting the verification method and the person certifying the copy.
10. Ensure electronic source systems meet the requirements of DAT-002, including unique user accounts, audit trails and validated date and time stamps.
11. Perform documented quality control review of source records for each subject visit, by a second trained person, within five business days of the visit.
12. Reconcile source records against the case report form before each monitoring visit and resolve discrepancies through documented correction, never by changing the source to match the case report form.
13. Store paper source records in locked, fire-resistant cabinets in access-controlled rooms, and back up electronic source data as required by HIP-002.
14. Retain source records for the period defined in DAT-003 and ensure they remain legible and retrievable throughout.

6. References

• ICH E6(R3) Good Clinical Practice, data handling
• 21 CFR Part 11 — Electronic Records; Electronic Signatures
• 21 CFR Part 312.62 — Investigator recordkeeping
• FDA Guidance: Electronic Source Data in Clinical Investigations
• DAT-002 Electronic Records & Electronic Signatures

7. Revision History

• v2.0 · Jan 16, 2023 — Added source documentation plan requirement.
• v3.0 · Oct 20, 2025 — Added second-person quality control review of visit records.