For Studies Not Yet Initiated
The WCM DSMB recommends that you first view the Investigator Initiated Trial (IIT) Template, which is available in the “Regulatory Tools and Templates” section of the Researcher’s Toolbox. Number 14 of the document, labeled, “Data and Safety Monitoring Plan,” guides you through what information needs to be included in your data and safety monitoring plan (DSMP).
Once you’ve drafted the protocol and DSMP section, the WCM DSMB is available to assist you in further refining the DSMP, including whether to incorporate the WCM DSMB into your monitoring plan. Contact the Board during the early, Clinical Study Evaluation Committee (CSEC) phase of your protocol’s regulatory review process to maximize the efficiency with which your DSMP is evaluated by CSEC, the WCM DSMB, if used, and the Institutional Review Board (IRB); however, assistance with the DSMP is not restricted to this stage.
The WCM DSMB can also be requested during the IRB review stage by selecting “Yes” in answer to the question, “Will you be using the WCM DSMB?” in the Data and Safety Monitoring Plan (DSMP) section of the eIRB application. The DSMB will be automatically notified of your request and 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, then before submitting an amendment to the IRB, please contact the DSMB directly at firstname.lastname@example.org. Provide a copy of the research protocol so the DSMB can evaluate whether the Board is an appropriate means of monitoring the trial. This will avoid initiating an unnecessary amendment with the IRB. If the IRB is requesting that you use the DSMB, please take the same course of action so that the DSMB is notified and can begin the process of reviewing the data and safety monitoring plan.