For Studies Not Yet Initiated

The WCM DSMC 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 WCM DSMC 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 DSMC is available to assist investigators in further refining the DSMP, including whether to incorporate the WCM DSMC into your monitoring plan.  These requests are submitted to the WCM DSMC directly through DSMC@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 WCM DSMC at this stage is not required.

Requests Through the HS Initial IRB Application

Requests to the WCM DSMC 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

Intake Section

Initial IRB Application

Risks and Risks Minimization Section

Once the WCM DSMC receives an automatic requests, WCM DSMC 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 DSMC, please contact the WCM DSMC directly at dsmc@med.cornell.edu.  It is strongly recommended you contact the WCM DSMC prior to submitting an amendment to the IRB so that: a) the WCM DSMC can evaluate whether WCM DSMC oversight is appropriate and b) the WCM DSMC is notified that its oversight is required, in cases where the request is initiated by the IRB.

In the request email to the WCM DSMC, 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