Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2: 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=3 | ||
| | |unit=3.3.2 | ||
|scope=G | |||
|doc_part=Annex 5 | |||
A5.2 | A5.2 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
|tags=TAG-00307-Int-gsu ++ TAG-00145-Ran-ute ++ TAG-00123-Bli-ppe ++ TAG-00127-Com-meC | |||
|tags_display=[[Glossary:TAG-00307-Int-gsu|Interactive response technology]], [[Glossary:TAG-00145-Ran-ute|Randomisation]], [[Glossary:TAG-00123-Bli-ppe|Blinding]], [[Glossary:TAG-00127-Com-meC|Systems validation]] | |||
Β | |comment=Interactive response technology (IRT) systems: blinding | ||
|content=Annex 5 Additional consideration to specific systems | |||
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Annex 5 Additional consideration to specific systems | |||
[...] | [...] | ||
A5.2 Interactive response technology system | A5.2 Interactive response technology system | ||
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Ad hoc randomization via a web-service is not recommended as randomization distribution is unknown, the sponsor is not in control of the process e.g. the seed may vary. | Ad hoc randomization via a web-service is not recommended as randomization distribution is unknown, the sponsor is not in control of the process e.g. the seed may vary. | ||
The sponsor should ensure that the process of randomisation can be reconstructed via retained documentation and data and that a final randomisation schedule is retained. | The sponsor should ensure that the process of randomisation can be reconstructed via retained documentation and data and that a final randomisation schedule is retained. | ||
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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 3 β Unit 3.3.2 |
| Scope | G |
| Document part | Annex 5
A5.2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Interactive response technology, Randomisation, Blinding, Systems validation |
Content
Annex 5 Additional consideration to specific systems [...] A5.2 Interactive response technology system [...] A5.2.1.2 Stratified randomisation Where the randomisation is stratified by factors inputted by the user, all the combinations of the strata should be tested to confirm that the allocation is occurring from the correct randomisation table.
A5.2.1.3 Blinding and unblinding Unblinded information should only be provided and accessible to pre-identified user roles.
A5.2.2 Emergency unblinding The process for emergency unblinding should be tested. A backup process should also be in place in case the online-technology emergency unblinding is unavailable. It should be verified that a siteβs ability for emergency unblinding is effectively available before administering IMP to a trial participant. [...] A5.2.4 Web-based randomisation Where justified, sponsor or investigator/sponsor may also use a web-based application to create randomisation lists for clinical trials. When using a web-service, the process to evaluate the suitability of the system and GCP compliance as well as the fitness for purpose of the created randomization list should be documented. The version of the service used, and where applicable, the seed should be maintained. Ad hoc randomization via a web-service is not recommended as randomization distribution is unknown, the sponsor is not in control of the process e.g. the seed may vary. The sponsor should ensure that the process of randomisation can be reconstructed via retained documentation and data and that a final randomisation schedule is retained.
