Guidelines for Data Safety Monitoring Plan in Protocols
- Review will include the evaluation and progress of the research study, including assessment of data quality and timeliness of participant recruitment and accrual retention.
- Identify who (PI or internal/external data safety monitoring committee) will review the data, and provide the frequency of review.
- Identify what information will be reported to the IRB and UPCI DSMC and provide the frequency of reporting. For example, frequency should reflect the complexity of the study and should be designated as monthly, quarterly, or yearly.
- Describe how serious adverse events (SAE) information will be reported and how the risk/benefit ratio will be reassessed against current medical literature to determine if the study should continue.
- Describe how breeches in confidentiality of the data will be handled.
- Describe how new information regarding the trial will be addressed. For example, information note in abstracts or articles showing that the investigational agent(s) or device(s) are no longer beneficial in relation to the toxicities will cause the trial to close.