Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:ICH ICH E6 Guideline R3 (2025) | ||
| | |module=4 | ||
| | |unit=4.2.3 | ||
|scope=G | |||
|doc_part=III. Annex 1 | |||
3.16.1 | 3.16.1 | ||
For systems used or deployed by the investigator/institution | For systems used or deployed by the investigator/institution | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
|tags=TAG-00129-Dat-ali ++ TAG-00127-Com-meC ++ TAG-00309-Rea-eal ++ TAG-00122-Aud-Aud ++ TAG-00246-Inv-hte | |||
|tags_display=[[Glossary:TAG-00129-Dat-ali|Data integrity]], [[Glossary:TAG-00127-Com-meC|Systems validation]], [[Glossary:TAG-00309-Rea-eal|Real-world evidence]], [[Glossary:TAG-00122-Aud-Aud|Audit trail]], [[Glossary:TAG-00246-Inv-hte|Investigator responsibilities]] | |||
|comment=Data handling procedures in clinical trials | |||
|content=3.16 Data and Records | |||
| | |||
| | |||
= | |||
3.16 Data and Records | |||
3.16.1 Data Handling | 3.16.1 Data Handling | ||
[...] | [...] | ||
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(viii) The assessment should be performed before being used in the trial and should be proportionate to the importance of the data managed in the system. Factors such as data security (including measures for backup), user management and audit trails, which help ensure the protection of confidentiality and integrity of the trial data, should be considered as appropriate; | (viii) The assessment should be performed before being used in the trial and should be proportionate to the importance of the data managed in the system. Factors such as data security (including measures for backup), user management and audit trails, which help ensure the protection of confidentiality and integrity of the trial data, should be considered as appropriate; | ||
}} | |||
Latest revision as of 13:50, 16 July 2026
| Document information | |
|---|---|
| Reference | ICH ICH E6 Guideline R3 (2025) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E6 Guideline |
| Version / Revision | R3 (2025) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | GUIDELINE FOR GOOD CLINICAL PRACTICE |
| 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 | III. Annex 1
3.16.1 For systems used or deployed by the investigator/institution |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Data integrity, Systems validation, Real-world evidence, Audit trail, Investigator responsibilities |
Content
3.16 Data and Records 3.16.1 Data Handling [...] For systems used or deployed by the investigator/institution: [...] (vii) In situations where clinical practice computerised systems are being considered for use in clinical trials (e.g., electronic health records or imaging systems used or deployed by the investigator/institution), these systems should be assessed for their fitness for purpose in the context of the trial;
(viii) The assessment should be performed before being used in the trial and should be proportionate to the importance of the data managed in the system. Factors such as data security (including measures for backup), user management and audit trails, which help ensure the protection of confidentiality and integrity of the trial data, should be considered as appropriate;
