Study Record
The Study Record consists of five sections:
- Section 1 - Basic Information: Title, exemptions, and Clinical Trial information
- Section 2 - Study Population Characteristics: Focus, Demographics, IERs, etc.
- Section 3 - Protection and Monitoring Plans: Information regarding PHS issues, data and safety monitoring, and team structure.
- Section 4 - Protocol Synopsis: Study design, purpose, interventions, metric parameters, etc.
- Section 5 - Other Clinical Trial-related Attachments: Area used for any additional attachments that do not fit the other sections.
- Section 6 - Clinical Milestone Plan: Used to record milestone dates and whether study is an applicable clinical trial under FDAAA.
The bottom of the Study Record includes five buttons:
- Save and Keep Lock. Save your changes and keep the form locked from further changes
- Save and Release Lock. Save your changes and release the form to be edited by others
- Save and Add.
- Cancel and Release Lock.Cancel any changes made and release the form to be edited by others.
- Remove Study. Removes the current study and saves the deletion.
