The Trauma Survivors Outcomes and Support (TSOS) study team had a proactive site visit and regulatory review with their sponsor liaison to the DSMB from the National Institutes of Mental Health. The site visit was treated as a knowledge exchange and was helpful to both the TSOS study team and the sponsor. The visit helped the TSOS team work out issues such as how to obtain consent from patients remotely, the process for review of serious adverse events, and reporting to and interactions with the trial’s central IRB.
The TSOS principal investigator was concerned about having some level of oversight for adverse events that did not meet criteria for expedited submission to the IRB. The NIH Collaboratory Regulatory/Ethics Core suggested that the DSMB might be able to provide an appropriate safety check in these instances, either with DSMB review of these events in aggregate or by a subset of the DSMB (e.g., chair) of individual adverse events when necessary.
The site visit required a lot of preparation and differed from traditional site visits in that there was more focus on information technology (IT) aspects of the study. The sponsor representative had experience with electronic data capture systems and was able to provide some helpful input. After the discussions, the TSOS team was tasked with finalizing tables for data sorting and cleaning for the DSMB. The principal investigator expressed a need to be careful with the level of data cleaning, because the PCT is not resourced for staff to spend too much time on these tasks.
Conducting a site visit and follow-up discussions showed how a proactive dialog on data monitoring between the sponsor and investigator can benefit both entities and help to reach a mutually acceptable monitoring plan.
- Which PCTs Should Have a DMC?
- Monitoring Protocol Adherence
- Data Issues With Monitoring PCTs
- Monitoring for Serious Adverse Events
- Futility Assessment
- Case Study: Planning for Monitoring PCTs
- Including Stakeholder Perspectives
- Special Training and Resources for DMCs of Pragmatic Trials
- Additional Resources
- Futility Assessment – ARCHIVED