This meeting is scheduled AFTER all the forms, study design and methods have been finalized. StudyTRAX staff organize the requirements of the study in detail into a setup plan using the Project Setup Document (see example image below). Items covered include:
- Data collection schedule
- Forms (a.k.a., CRFs, questionnaires)
- Data entry
- Subjects
- Staff
- Data import
- Study design and methods (e.g., randomization)
- Administrative issues such as:
- Sites
- Users and roles
- Training materials
- Reporting
- Datasets and planned analyses (here)
Example Page from Project Setup Document
