For Studies Not Yet Initiated
The WCM DSMB recommends that you first view the Therapeutic Studies (Drug, Device) Template while the protocol is being drafted. The template is available in the “Regulatory Tools and Templates” section of the Researcher’s Toolbox. Section 15 of the template, “Data and Safety Monitoring Plan,” outlines what information needs to be included in the study’s data and safety monitoring plan (DSMP).
Requests to the DSMB can be submitted either before or during the IRB’s review of the Human Subjects Initial IRB application.
Submitting Requests Before the HS Initial IRB Application
The WCM DSMB is available to assist investigators in further refining the DSMP, including whether to incorporate the WCM DSMB into your monitoring plan. These requests are submitted to the DSMB directly through DSMB@med.cornell.edu. It is recommended that you contact the Board during the early, ideally at the time the protocol is undergoing review by the Protocol Review and Monitoring Committee (PRMC) to make the protocol review process more efficient. However, submission to the DSMB at this stage is not required.
DSMB Submissions with the HS Initial IRB Application
Requests to the DSMB are submitted automatically through the Human Subjects system either in the Protocol Initiation (Intake) Form or the Initial IRB Application, when the following responses are indicated:
Protocol Initiation (Intake) Form
Initial IRB Application
Risks and Risks Minimization Section
Once the DSMB receives an automatic requests, DSMB administrators will reach out to you to schedule a presentation of your protocol to the Board. The Board will then evaluate the DSMP as the requested safety monitoring entity.
For Currently Active Studies
If your protocol is already underway and you wish to utilize the WCM DSMB, please contact the DSMB directly at firstname.lastname@example.org. It is strongly recommended you contact the DSMB prior to submitting an amendment to the IRB so that: a) the DSMB can evaluate whether DSMB oversight is appropriate and b) the DSMB is notified that its oversight is required, in cases where the request is initiated by the IRB.
In the request email to the DSMB, please attach the following documents:
1) The current protocol
2) Data and Safety Monitoring Plan (if not incorporated in the protocol)
3) Safety information regarding the study intervention(s)
4) informed consent form(s) and/or assent forms