The planning meeting (10-15 min.) 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)
- Communicate the Data Definition (see below)
- 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!
Communicating the Data Definition
Ensuring the data definition is accurately communicated to setup staff is a key issue.
Use A Spreadsheet
Document your data definition using the spreadsheet here.
Mark It UP
Forms list out the data definition, not just the layout.
Example Marked Up Form
Keep It Simple
Forms should use the cleanest, simplest layout possible. Standard practice is to use one-row-per-variable (examples here).
Leverage Visual Validation
A form's spatial and visual layout can be it's most important validation (see examples 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...
- 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