New online DSRB Supplementary Report Forms Chicken Soup for the Busy Coordinator (January 2010)

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Presentation transcript:

New online DSRB Supplementary Report Forms Chicken Soup for the Busy Coordinator (January 2010)

New Report Forms There are 6 new online DSRB Supplementary Forms. Study Amendment Form Study Amendment Form Study Status Report Study Status Report Study Non-Compliance / Deviation Report Study Non-Compliance / Deviation Report UPIRTSO Reports UPIRTSO Reports Other Study Notifications Other Study Notifications HSA Clinical Trial Certificate Records HSA Clinical Trial Certificate Records

Supplementary Report Forms can be found under “My Studies” Click ‘View’ to see the documents you have attached, or ‘Create’ to generate reports for DSRB submission.

Once a report form is submitted, the form is locked unless modifications or changes are required by the DSRB. The Form is LOCKED against changes. The Form is UNLOCKED. The PI/Study Team can make changes. Supplementary Report Form Workflow

Important Note on Study Amendment Form Workflow For study amendments that include changes in the original objectives innovation and scientific methodology alignment of the study to the institutions’ research objectives image and standards of the research study  These will be directed to the Department and Institutional Representatives for approval prior to submission to DSRB.

For Feedback, Suggestions or Questions on B2B Online : Clinical Research Coordinator Society c/o Research & Development Office 6 Commonwealth Lane #04-01/02 GMTI Building Singapore Clinical Research Coordinator Society c/o Research & Development Office 6 Commonwealth Lane #04-01/02 GMTI Building Singapore For Feedback or Suggestions for CRCS :