Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3
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| Document information | |
|---|---|
| Reference | ICH ICH E6 Guideline R3 (2025) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E6 Guideline |
| Version / Revision | R3 (2025) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | GUIDELINE FOR GOOD CLINICAL PRACTICE |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 â Unit 4.2.3 |
| Scope | G |
| Document part | III. Annex 1
4.3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Systems validation, Responsibilities, Sponsor, Investigator responsibilities, Documentation |
Content
4.3 Computerised Systems
As described in sections 2 and 3, the responsibilities of the sponsor, investigator and the activities of other parties with respect to a computerised system used in clinical trials should be clear and documented. The responsible party should ensure that those developing computerised systems for clinical trials on their behalf are aware of the intended purpose and the regulatory requirements that apply to them. It is recommended that representatives of intended participant populations and healthcare professionals are involved in the design of the system, where relevant, to ensure that computerised systems are suitable for use by the intended user population.
4.3.1 Procedures for the Use of Computerised Systems Documented procedures should be in place to ensure the appropriate use of computerised systems in clinical trials for essential activities related to data collection, handling and management.
4.3.2 Training The responsible party should ensure that those using computerised systems are appropriately trained in their use. [...]
