OnCore: DFD - DSMC Review Frequency
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| DSMC Review Frequency | DSMC Review Frequency indicates how often the protocol is reviewed by its Data Safety Monitoring Committee. | Required in the situations described If the DSMC field is N/A, enter a frequency of 0 to avoid discrepancies. Oncology: Enter the frequency (in months) that a Protocol Summary Report is submitted to the DSMC for review, as indicated in the protocol's PRMC Approval letter. Non-oncology: For investigator-initiated protocols with an appropriately selected DSMC, enter the frequency (in months) of that data safety monitoring committee review. |
PC Console edit / Protocol Coordinator | Yes |