Document:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023: Difference between revisions
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Latest revision as of 14:15, 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 | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2 | G | 4.2 | EN | 4.2. Responsibilities Roles and responsibilities in clinical trials should be clearly defined. The responsibility for the conduct of clinical trials β¦ |
| EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4 | G | 4.4 | EN | 4.4. Source data The term source data refers to the original reported observation in a source document. Source documents could be e.g. hospital record⦠|
| EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 ALCOA | G | 4.5 ALCOA | EN | 4.5. ALCOA++ principles
A number of attributes are considered of universal importance to data. These include that the data are: Attributable Data sho⦠|
| EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 CCEAT | G | 4.5 CCEAT | EN | 4.5. ALCOA++ principles
[...] Complete To reconstruct and fully understand an event, data should be a complete representation of the observation made.β¦ |
| EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6 | G | 4.6 | EN | 4.6. Criticality and risks For systems deployed by the investigator/institution specifically for the purposes of clinical trials, the investigator sh⦠|
| EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8 | G | 4.8 | EN | 4.8. Electronic signatures Whenever ICH E6 requires a document to be signed and an electronic signature is used for that purpose, the electronic signa⦠|
| EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13 | G | A4.13 | EN | The level of security should be proportionate to the sensitivity and confidentiality of the data (e.g. nominative data in electronic medical records a⦠|
| EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2 | G | Annex 5 A5.2 | EN | Annex 5 Additional consideration to specific systems
[...] A5.2 Interactive response technology system [...] A5.2.1.2 Stratified randomisation Where t⦠|
| EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3 | G | Annex A A5.3 | EN | A5.3 Electronic informed consent Ethics committees will review all material related to the informed consent process. Before the implementation of an e⦠|
