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SRC Updates – August 2017

August 24, 2017 - SCI Communications

The following study types no longer require SRC Renewal:

  • Pediatric studies,
  • Rare disease studies, and
  • Non-interventional studies.

Coordinators do not need to submit Renewal Protocol Statements of Support (PSOS) for these studies.

You will no longer receive a signed hard copy of SRC approval/renewal letters. The email notification from SRC-office will be the only communication moving forward.

For information on how to verify whether your study is a rare disease or non-interventional, keep on reading.

Non-interventional Studies

To verify whether your study is non-interventional, go to PC Console > Main Page > Details Tab.

If the Data Table 4 Report Type field says Observational or Ancillary/Correlative, it is considered non-interventional.

Rare Disease Studies

To verify whether your study is classified as rare disease, go to PC Console > Main Page > Management Tab.

If the study is a rare disease, it will show up in the Management Group table.

 

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