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- Information about the randomization configuration: Randomization
- Be sure there will be enough subjects to reasonably ensure the distribution across strata blocks are filled when using Stratification Factors
- In pilot studies the limited sample size typically limits the number of strata that can feasibly be used, maybe 1 or 2 variables at most.
Info The number of strata are multiplicative across variables (e.g., 2 variables with 2 categories each = 4 strata groups)
- In pilot studies the limited sample size typically limits the number of strata that can feasibly be used, maybe 1 or 2 variables at most.
- Review if there are known confounding factors that need to be controlled
- The variables should be controlled in the randomization scheme (e.g., smoking status for a study on lung cancer)
- Consider the main dependent measure and whether any of the proposed stratification varaibles are 1) markedly related or 2) would differentially interact with the intervention
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Randomization cannot be removed from a project once subjects are randomized, Likewise, once subjects are enrolled in a project, randomization cannot be added as a feature. |
Screening
- Screening is used to determine if a subject meets the criteria to be included in the study
- There can be multiple screening encounters
- Screening encounters can also be used for visits that occur before Baseline/Time 0 but do not affect screening status
- The encounter that is set for Baseline determines the projected date of the follow-up encounters
- Baseline would be set for the visit that starts the timeline and prior visits would be set up as screening visits
- All screening encounters must occur before Baseline/Time 0
- Subjects who have not passed screening (they are still in-process or failed screening) cannot move to their Baseline or Follow-up encounters
Subject Login
Versioning
Electronic Signatures
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