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Reference:ICH ICH E8 Guideline R1 (2021) 6.1.4: Difference between revisions

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{{#set:
{{ReferenceData
|HasDocument=Document:ICH ICH E8 Guideline R1 (2021)
|has_document=Document:ICH ICH E8 Guideline R1 (2021)
|RefScope=HM
|module=6
|RefDocPart=6.1.4
|unit=6.4.1
|RefLanguage=EN
|scope=HM
|RefTagsEN=
|doc_part=6.1.4
|RefTagsOriginal=
|language=EN
|RefTagsFR=
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00303-Int-lan ++ TAG-00129-Dat-ali ++ TAG-00123-Bli-ppe ++ TAG-00133-Ind-rhe
|tags_display=[[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]]
|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.
}}
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{{:Document:ICH ICH E8 Guideline R1 (2021)}}
{| class="gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| HM
|-
! Document part
| 6.1.4
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags (EN)
|
|-
! Tags (original language)
|
|-
! Tags (FR)
|
|-
! 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.

Latest revision as of 13:50, 16 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

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.

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