The planning meeting is the initial, high-level discussion about the study requirements. Attendees are the PI and any staff involved in setup (i.e., both customer and Studytrax staff).
Client To-Do's List
- Complete and return the data collection schedule (see Data Collection Schedule.doc)
- Learn what's needed for the Data Definition (see here)
- Send Studytrax staff all available forms (or names of forms if not available)
- Wait to create / further develop forms (e.g., using MS Word) until after the planning meeting!
Agenda
Overview of Setup Components
- Summary of the various components involved in the setup process (see here).
Forms (i.e., CRFs, questionnaires)
- For StudyTRAX staff, learn about...
- What's planned for data collection and have any forms been created
- Customer sends forms for feedback and comparison with forms library
- Layout, look and feel issues
- What is / is not modifiable
- Which forms will be completed by subjects
- What's planned for data collection and have any forms been created
- For clients, learn about...
- How to communicate the data definition (see here)
- What's needed in the data definition
- Form factor (i.e., what size screens are anticipated, mobile → tablets → desktops)
Data Collection Schedule
- Timing of study events
- Visit schedule (e.g., baseline, week 1, week 2, etc.)
- Range around events
- Unplanned events (e.g., adverse events)
- Visit schedule (e.g., baseline, week 1, week 2, etc.)
- Which forms are collected with each study event
- See Data Collection Schedule.doc
- Example