The following study types no longer require SRC Renewal:
- Pediatric studies
- Rare disease studies
- 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.
