> ## Documentation Index
> Fetch the complete documentation index at: https://docs.atlasent.io/llms.txt
> Use this file to discover all available pages before exploring further.

# ICH E6 GCP

> International GCP for clinical trials — which section maps to which AtlaSent primitive.

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](/concepts/permit) attribute each AI action to a specific agent and timestamp; [ALCOA+ mapping](/compliance/alcoa-plus). |
| Annex 1 §4.2.2 | Relevant metadata, including audit trails | Immutable [audit chain](/concepts/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

```json theme={null}
[
  { "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.


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