Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2

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 — 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 site’s 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.