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OnCore: DFD - DSMC Review Frequency

Data Field definition table including the field name, definition, entry instructions and requirements
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

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, enter the frequency (in months) that data safety monitoring committee review.

PC Console edit / Protocol Coordinator Yes


Keywords:
DSMC Review Frequency 
Doc ID:
24234
Owned by:
Molly H. in SMPH Research Informatics
Created:
2012-05-09
Updated:
2024-08-29
Sites:
SMPH Research Informatics