Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2: Difference between revisions
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| | |has_document=Document:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 | ||
| | |module=4 | ||
| | |unit=4.2.3 | ||
| | |scope=G | ||
| | |doc_part=4.2 | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
|tags=TAG-00341-Res-ben ++ TAG-00127-Com-meC ++ TAG-00017-Spo-die ++ TAG-00246-Inv-hte ++ TAG-00306-Dat-nDa | |||
|tags_display=[[Glossary:TAG-00341-Res-ben|Responsibilities]], [[Glossary:TAG-00127-Com-meC|Systems validation]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00246-Inv-hte|Investigator responsibilities]], [[Glossary:TAG-00306-Dat-nDa|Data management plan]] | |||
|comment=Roles and responsibilities in clinical trial data management | |||
|content=4.2. Responsibilities | |||
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4.2. Responsibilities | |||
Roles and responsibilities in clinical trials should be clearly defined. The responsibility for the conduct of clinical trials is assigned via legislation to two parties, which may each have implemented computerised systems for holding/managing data: | Roles and responsibilities in clinical trials should be clearly defined. The responsibility for the conduct of clinical trials is assigned via legislation to two parties, which may each have implemented computerised systems for holding/managing data: | ||
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Please refer to Annex 1 regarding the transfer/delegation to service providers of tasks related to the use of computerised systems and services. | Please refer to Annex 1 regarding the transfer/delegation to service providers of tasks related to the use of computerised systems and services. | ||
}} | |||
Revision as of 12:55, 16 July 2026
| Document information | |
|---|---|
| Reference | EU EMA/INS/GCP/112288/2023
- Guideline on computerised systems and electronic data in clinical trials 2023 |
| Validity area | EU |
| Scope(s) | G |
| Document name | EMA/INS/GCP/112288/2023
- Guideline on computerised systems and electronic data in clinical trials |
| Version / Revision | 2023 |
| Status | Current |
| Document type | Official guideline |
| Language(s) | EN |
| Description | EMA/INS/GCP/112288/2023
Good Clinical Practice Inspectors Working Group (GCP IWG) Guideline on computerised systems and electronic data in clinical trials |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 — Unit 4.2.3 |
| Scope | G |
| Document part | 4.2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Responsibilities, Systems validation, Sponsor, Investigator responsibilities, Data management plan |
Content
4.2. Responsibilities
Roles and responsibilities in clinical trials should be clearly defined. The responsibility for the conduct of clinical trials is assigned via legislation to two parties, which may each have implemented computerised systems for holding/managing data:
• Investigators and their institutions, laboratories and other technical departments or clinics, generate and store the data, construct the record, and may use their own software and hardware (purchased, part of national or institutional health information systems, or locally developed).
• Sponsors that supply, store and/or, manage and operate computerised systems (including software and hardware) and the records generated by them. Sponsors may do this directly, or via service providers, including organisations providing e.g. eCOA, eCRF, or IRT that collect and store data on behalf of sponsors.
Please refer to Annex 1 regarding the transfer/delegation to service providers of tasks related to the use of computerised systems and services.
