This meeting is scheduled AFTER all the forms, study design and methods have been finalized. The implementation meeting involves the covers cover the details of the setup Project Setup document (see example image below) so as to gather all the study requirements including:
- 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)
Project Setup Document example
