This meeting is scheduled AFTER all the forms, study design and methods have been finalized. The implementation meeting involves cover the details of the Project Setup document StudyTRAX staff organize the requirements of the study in detail into a setup plan using the Project Setup Document (see example image below) so as to gather all the study requirements including. 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 Part of Page from Project Setup Document