Study design migration
In eClinical, study development and design occur in multiple consecutive lifecycles to ensure that all the aspects are properly configured and tested before initiating the actual trial with real data. The lifecycles that are supported in eClinical are:
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DEV: the development lifecycle where all the configurations and preparations are made.
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UAT: the testing lifecycle where all the configurations are tested and validated.
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PROD: the production lifecycle where the clinical trial is conducted with real study data.
The current lifecycle flow at eClinical is depicted with the following schema.
When a new lifecycle is first initialized and not yet configured in IWRS, the system offers you to select between the following:
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Configure the study design from scratch.
The study design configurations in IWRS are done for the study in terms of subject (registration, randomization, and cohorts), item (supply and dispensing), and data management (blind setting and study information).
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Migrate your configurations from the previous lifecycle.
The migration of study design facilitates the transfer and eliminates the number of configurations that need to be made manually. This ensures that the same configurations that are tested and proved to be suitable for your study in the previous lifecycle are applied to the next one.
Important
Study design migration is a one-time action per lifecycle. You can only migrate the design once upon new lifecycle initiation. Once migrated, you cannot reverse your action but do the follow-up configurations or amendments manually in the designated modules of IWRS.