Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6: 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=4.6 | |||
|language=EN | |||
|entry_by=Florian Adragna | |||
|contributors= | |||
|tags=TAG-00127-Com-meC ++ TAG-00176-Ris-erh ++ TAG-00246-Inv-hte ++ TAG-00165-Sys-omb | |||
|tags_display=[[Glossary:TAG-00127-Com-meC|Systems validation]], [[Glossary:TAG-00176-Ris-erh|Risk]], [[Glossary:TAG-00246-Inv-hte|Investigator responsibilities]], [[Glossary:TAG-00165-Sys-omb|Device system]] | |||
|comment=Criticality and risk assessment for investigator/institution systems | |||
|content=4.6. Criticality and risks | |||
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4.6. Criticality and risks | |||
For systems deployed by the investigator/institution specifically for the purposes of clinical trials, the investigator should ensure that the requirements for computerised systems as described in this guideline are addressed and proportionately implemented. For systems deployed by the investigator/institution, the sponsor should determine during site selection whether such systems (e.g. electronic medical records and other record keeping systems for source data collection and the investigator site file) are fit for purpose. | For systems deployed by the investigator/institution specifically for the purposes of clinical trials, the investigator should ensure that the requirements for computerised systems as described in this guideline are addressed and proportionately implemented. For systems deployed by the investigator/institution, the sponsor should determine during site selection whether such systems (e.g. electronic medical records and other record keeping systems for source data collection and the investigator site file) are fit for purpose. | ||
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Latest revision as of 13:50, 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 | 4.6 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Systems validation, Risk, Investigator responsibilities, Device system |
Content
4.6. Criticality and risks
For systems deployed by the investigator/institution specifically for the purposes of clinical trials, the investigator should ensure that the requirements for computerised systems as described in this guideline are addressed and proportionately implemented. For systems deployed by the investigator/institution, the sponsor should determine during site selection whether such systems (e.g. electronic medical records and other record keeping systems for source data collection and the investigator site file) are fit for purpose.
