Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-002
From GxPlex
| 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 5 — Unit 5.4.1 |
| Scope | G |
| Document part | III. Annex 1
2.7.1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Medical care, Sub-investigator, Healthcare professional, Investigator responsibilities, Trial participant |
Content
2.7.1 Medical Care of Trial Participants (a) A qualified physician or, where appropriate, a qualified dentist (or other qualified healthcare professionals in accordance with local regulatory requirements) who is an investigator or a sub-investigator for the trial should have the responsibility for trial-related medical care and decisions.
(b) Other appropriately qualified healthcare professionals may be involved in the medical care of trial participants, in line with their normal activities and in accordance with local regulatory requirements.
(c) During and following participation in a trial, the investigator/institution should ensure that adequate medical care is provided to a participant for any adverse events, including clinically significant laboratory values, related to the trial. The investigator/institution should inform a participant when medical care is needed for intercurrent illness(es) of which the investigator becomes aware.
(d) The investigator should inform the participant’s primary physician about the participant’s involvement in the trial if the participant has a primary physician and agrees to the primary physician being informed.
