Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Randomisation
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Document Information
| Document information | |
|---|---|
| Reference | EU EMA/INS/GCP/126568/2023
- Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 |
| Validity area | EU |
| Scope(s) | G |
| Document name | EMA/INS/GCP/126568/2023
- Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 |
| Version / Revision | 2023 |
| Status | Current |
| Document type | Official guideline |
| Language(s) | EN |
| Description | EMA/INS/GCP/164938/2024
Inspections Office Quality and Safety of Medicines Department Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2023 Adopted by the GCP IWG on 26 November 2024 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
Reference Details
| Scope | G |
|---|---|
| Document part | 3.1.2 - Randomisation |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Examples of critical and major findings (randomisation) |
Text
Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" are listed below. [...] Randomisation/Blinding/Codes IMP: ⢠Accidental Suspected Unexpected Serious Adverse Reaction (SUSAR) unmasking: there were three cases where unblinding information was included in SUSAR queries / acknowledgement reports that were sent to blinded sponsor personnel and in two cases the unblinding information was subsequently forwarded to investigator sites. ⢠Deficiencies in maintaining the integrity of the blind. ⢠An issue in the Interactive Response Technology (IRT) system was not solved during the study. No possibility of changes in the IRT system were planned at least in the agreement with the vendor in case of issues. Only a simple communication to investigators was undertaken. [...]
