Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Investigator
From GxPlex
| Document information | |
|---|---|
| Reference | WHO WHO - Guidelines for GCP for trials on
pharmaceutical products* 1995 |
| Validity area | WHO |
| Scope(s) | HM |
| Document name | WHO - Guidelines for GCP for trials on
pharmaceutical products* |
| Version / Revision | 1995 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | World Health Organization
WHO Technical Report Series, No. 850, 1995, Annex 3 Guidelines for good clinical practice (GCP) for trials on pharmaceutical products* |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Scope | HM |
| Document part | 7.2 - Investigator |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Investigator reporting of SAEs to sponsor |
Content
7.2 Reporting [âŚ] The investigator The investigator has to report serious adverse events to the sponsor immediately and to the drug regulatory authority and the ethics committee as specified in the protocol and in accordance with national regulations. Normally, adverse events associated with the use of the product must be reported to the drug regulatory authority within a specified time limit.
Reports on adverse events submitted by the investigator to the drug regulatory authority should contain both subject and trial identification data (i.e. the unique code number assigned to each subject in the trial).
When reporting adverse events to the sponsor, the investigator should protect confidentiality by excluding the names of individual subjects, personal identification numbers (e.g. social security numbers) or addresses. The unique code number assigned to the trial subject should be used in the report and the investigator should retain the code to facilitate data verification by the sponsor or drug regulatory authority and any medical follow-up which may be warranted. The name of the investigator reporting the adverse events should be stated. After the trial has been completed or terminated, all recorded adverse events should be listed, evaluated and discussed in the final report. [...]
