Reference:ICH ICH E8 Guideline R1 (2021) 6.2.2: Difference between revisions
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{{:Document:ICH ICH E8 Guideline R1 (2021)}} | {{:Document:ICH ICH E8 Guideline R1 (2021)}} | ||
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! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
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! Scope | |||
| HM | | HM | ||
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! | ! Document part | ||
| 6.2.2 | | 6.2.2 | ||
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! | ! Language | ||
| EN | | EN | ||
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! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
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! | ! Contributors | ||
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! | ! Tags (EN) | ||
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! | ! Tags (original language) | ||
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! | ! Tags (FR) | ||
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! | ! Comment | ||
| Withdrawal criteria for individual subjects | | Withdrawal criteria for individual subjects | ||
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== | == Content == | ||
6.2.2 Withdrawal Criteria | 6.2.2 Withdrawal Criteria | ||
Clear criteria for stopping treatment or study procedures for a study participant while remaining in the study are necessary to ensure the protection of the participants but should also minimise loss of critical data. | Clear criteria for stopping treatment or study procedures for a study participant while remaining in the study are necessary to ensure the protection of the participants but should also minimise loss of critical data. | ||
Revision as of 14:27, 29 June 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 | |
|---|---|
| Scope | HM |
| Document part | 6.2.2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Withdrawal criteria for individual subjects |
Content
6.2.2 Withdrawal Criteria Clear criteria for stopping treatment or study procedures for a study participant while remaining in the study are necessary to ensure the protection of the participants but should also minimise loss of critical data.
