Add "seed" to randomisation #66
aleksandraduda2
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Link: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf
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.
Question: Whether and how this can be implemented to be both random but also deterministic?
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