| Task: A4a - Analyze activities of the study protocol |
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Purpose
The activities of the Study Protocol must be reviewed, as well as how these activities will be performed |
Relationships
| Roles | Primary Performer: | Additional Performers: |
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| Inputs | Mandatory:
| Optional:
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| Process Usage | ||
Main Description
This task will be performed when the Process Executor needs to review the developed study protocol. |
Steps
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1. Conduct protocol analysis by domain experts.
2. Select a small population to perform the Pilot test
3. Performing the same protocol (Pilot Test) will be performed in the main study
4. Review what was not in accordance with the desired and correct in the final protocol
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Key Considerations
At first the Process executor must verify possible problems in the evaluation protocol. In a second moment must perform a pilot test to verify the study protocol efficiency, if there are no missing documents, if the participants have understood what should be done, if the time is adequate to finish the task that should be accomplished, among other things that it considers important. |