Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8: 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=4.2.4 | ||
| | |scope=G | ||
| | |doc_part=4.8 | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
|tags=TAG-00286-Ele-sch ++ TAG-00149-Sig-nds ++ TAG-00340-Req-nfo ++ TAG-00165-Sys-omb | |||
|tags_display=[[Glossary:TAG-00286-Ele-sch|Electronic signature]], [[Glossary:TAG-00149-Sig-nds|Signature]], [[Glossary:TAG-00340-Req-nfo|Requirements]], [[Glossary:TAG-00165-Sys-omb|Device system]] | |||
|comment=Electronic signature requirements under ICH E6 | |||
|content=4.8. Electronic signatures | |||
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4.8. Electronic signatures | |||
Whenever ICH E6 requires a document to be signed and an electronic signature is used for that purpose, the electronic signature functionality should meet the expectations stated below regarding authentication, non-repudiation, unbreakable link, and timestamp of the signature. | Whenever ICH E6 requires a document to be signed and an electronic signature is used for that purpose, the electronic signature functionality should meet the expectations stated below regarding authentication, non-repudiation, unbreakable link, and timestamp of the signature. | ||
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For 'open' systems, the signatories (and users) are not known in advance. For sites located in the EU, electronic signatures should meet the requirements defined in the 'eIDAS' regulation. Sites located in third countries should use electronic or digital signature solutions compliant with local regulations and proven to meet the expectations mentioned above. | For 'open' systems, the signatories (and users) are not known in advance. For sites located in the EU, electronic signatures should meet the requirements defined in the 'eIDAS' regulation. Sites located in third countries should use electronic or digital signature solutions compliant with local regulations and proven to meet the expectations mentioned above. | ||
}} | |||
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 4.2.4 |
| Scope | G |
| Document part | 4.8 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Electronic signature, Signature, Requirements, Device system |
Content
4.8. Electronic signatures Whenever ICH E6 requires a document to be signed and an electronic signature is used for that purpose, the electronic signature functionality should meet the expectations stated below regarding authentication, non-repudiation, unbreakable link, and timestamp of the signature.
The system should thus include functionality to: • authenticate the signatory, i.e. establish a high degree of certainty that a record was signed by the claimed signatory; • ensure non-repudiation, i.e. that the signatory cannot later deny having signed the record; • ensure an unbreakable link between the electronic record and its signature, i.e. that the contents of a signed (approved) version of a record cannot later be changed by anyone without the signature being rendered visibly invalid; • provide a timestamp, i.e. that the date, time, and time zone when the signature was applied is recorded.
Electronic signatures can further be divided into two groups depending on whether the identity of the signatory is known in advance, i.e. signatures executed in 'closed' and in 'open' systems.
For 'closed' systems, which constitute the majority of systems used in clinical trials and which are typically provided by the responsible party or by their respective service provider, the system owner knows the identity of all users and signatories and grants and controls their access rights to the system. Regulation (EU) No 910/2014 ('eIDAS') on electronic identification and trust services for electronic transactions is not applicable for 'closed' systems ('eIDAS' article 2.2). The electronic signature functionality in these systems should be proven during system validation to meet the expectations mentioned above.
For 'open' systems, the signatories (and users) are not known in advance. For sites located in the EU, electronic signatures should meet the requirements defined in the 'eIDAS' regulation. Sites located in third countries should use electronic or digital signature solutions compliant with local regulations and proven to meet the expectations mentioned above.
