Reference:ICH ICH E8 Guideline R1 (2021) 6.1.4: Difference between revisions
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| | | [[Glossary:TAG-00303-Int-lan|Interim analysis]], [[Glossary:TAG-00129-Dat-ali|Data integrity]], [[Glossary:TAG-00123-Bli-ppe|Blinding]], [[Glossary:TAG-00133-Ind-rhe|Data monitoring committee]] | ||
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | ICH ICH E8 Guideline R1 (2021) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E8 Guideline |
| Version / Revision | R1 (2021) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | ICH guideline E8 (R1) on general considerations for clinical studies |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 6 — Unit 6.4.1 |
| Scope | HM |
| Document part | 6.1.4 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Interim analysis, Data integrity, Blinding, Data monitoring committee |
| Comment | Access to interim data: restrictions during study conduct |
Content
6.1.4 Access to Interim Data Inappropriate access to data during the conduct of the study may compromise study integrity (Sections 5.5 and 5.6 and ICH E9). In studies with planned interim analyses, special attention should be given to which individuals have access to the data and results. Even in studies without planned interim analyses, special attention should be paid to any ongoing monitoring of unblinded data to avoid inappropriate access.
