ICH E6 GCP - AtlaSent

ICH E6 is the international Good Clinical Practice guideline for clinical trials. It applies to AI agents handling protocol data, subject records, adverse events, and trial master files.

Requirement-to-primitive mapping

Section numbers below follow ICH E6(R3) (Step 4, adopted 6 January 2025), which replaced E6(R2). R3 puts the operational requirements in Annex 1: section 1 covers the IRB/IEC, section 2 the investigator, section 3 the sponsor, and section 4 data governance. Essential records are in Appendix C.

E6(R3) location	Requirement	AtlaSent primitive
Annex 1 §2.12.2	Source records are attributable, legible, contemporaneous, original, accurate and complete; changes are traceable through an audit trail	Permit tokens attribute each AI action to a specific agent and timestamp; ALCOA+ mapping.
Annex 1 §4.2.2	Relevant metadata, including audit trails	Immutable audit chain on every evaluation.
Annex 1 §4.2.4	Data corrections are attributed to the person or system making them, and justified	Locked-data changes are denied or held for a named approver, with the reason captured in the signed record.
Annex 1 §4.3.8	Access controls limit system access to authorised users and keep actions attributable to an individual	RACI rules restrict which agents can collect or modify which data classes.
Annex 1 §2.11, §4.1	Unblinding only in accordance with the protocol; defined roles for access to unblinded information	Unblinding is held for the authorized human roles; randomisation-code access is denied to agents.
Appendix C	Essential records	Permit IDs are the evidence, stored with the record in your eCRF.

Starter policy

[
  { "action_type": "subject:read",           "decision": "allow" },
  { "action_type": "source:enter",           "decision": "allow" },
  { "action_type": "query:discrepancy",      "decision": "allow" },
  { "action_type": "ae:report",              "decision": "allow" },
  { "action_type": "data:modify-locked",     "decision": "deny",  "reason": "E6(R3) Annex 1 §4.2.4: corrections must be attributed and justified" },
  { "action_type": "subject:delete",         "decision": "deny",  "reason": "E6(R3) Annex 1 §4.2.7: trial data must be retained for the retention period" },
  { "action_type": "trial:unblind",          "decision": "hold",  "reason": "E6(R3) Annex 1 §2.11: unblind only in accordance with the protocol" },
  { "action_type": "randomization:access",   "decision": "deny",  "reason": "E6(R3) Annex 1 §4.1.2: access to unblinded information is limited to defined roles" }
]

Implementation checklist

Import the ICH E6 GCP starter policy from gxp-starter (not yet publicly available).
Set actor.id to the AI system’s validated identifier in the Trial Master File.
Store permit_id with every source data entry created by an AI agent.
Reference permit IDs in eCRF audit trails.
Export AtlaSent audit bundles as part of TMF archiving.
Cite AtlaSent policy version in the Data Management Plan.