Question:

How to create study specifications in Vault CDMS?

Answer:

Study documentation can be generated at any point in the design process.

1. Navigate to Studio --> Studies --> Study Instance.
   
   
   
   
2. Click on the gear icon at the top right corner and select Create Specifications.
   
   
   
   
3. 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.
   
   
4. Click Save.
   
   
5. Vault begins a job to generate the study specifications. When finished, Vault sends a notification with a link to download the file.

Related Documentation:

Vault Help Documentation: Creating Study Specifications