How to create study specifications in Vault CDMS?
Study documentation can be generated at any point in the design process.
- Navigate to Studio --> Studies --> Study Instance.
- Click on the gear icon at the top right corner and select Create Specifications.
- Select one or more checkboxes to indicate the type of documentation to generate.
There are three types of study specifications:
- All CRFs: Forms are ordered by their appearance in the study schedule and repeat for each Event they occur in within the schedule.
- Unique CRFs: Forms are ordered alphabetically and do not repeat even if they are used more than once in the study schedule.
- Study Design Specification(SDS): Contains worksheets for key study design components.
- Click Save.
- Vault begins a job to generate the study specifications. When finished, Vault sends a notification with a link to download the file.
Vault Help Documentation: Creating Study Specifications