The Weill Cornell Medicine Data and Safety Monitoring Committee (WCM DSMC) is an independent committee within the institution that is available to the research community to act as a monitoring entity for clinical trials. It performs a regular review of cumulative data to evaluate research subject safety, rates of accrual, and efficacy of experimental intervention. Based on its review, the WCM DSMC provides investigators with recommendations for protocol modification, continuation or termination. The intensity ad frequency at which the WCM DSMC monitors a study is commensurate with the study's risks and needs.
If you are unsure of whether your study needs WCM DSMC oversight, contact firstname.lastname@example.org for assistance.
Meeting dates and their associated deadlines for the WCM DSMC are provided below.
Starting September 16, 2020, the WCM DSMC will split into the General and Cancer subcommittees. These will meet at 2:00 PM, every third Wednesday on alternating months, starting with the Cancer subcommittee.
|COMMITTEE||MEETING DATE||SUBMISSION DEADLINE|
|Cancer||Wednesday, September 15, 2021||Wednesday, August 25, 2021|
|General||Wednesday, October 20, 2021||Wednesday, September 29, 2021|
|Cancer||Wednesday, November 17, 2021||Wednesday, October 27, 2021|
|General||Wednesday, December 15, 2021||Wednesday, November 24, 2021|
|Cancer||Wednesday, January 19, 2022||Wednesday, December 29, 2021|
|General||Wednesday, February 16, 2022||Wednesday, January 26, 2022|
|Cancer||Wednesday, March 16, 2022||Wednesday, February 23, 2022|
|General||Wednesday, April 20, 2022||Wednesday, March 30, 2022|
|Cancer||Wednesday, May 18, 2022||Wednesday, April 27, 2022|
|General||Wednesday, June 15, 2022||Wednesday, May 25, 2022|
|Cancer||Wednesday, July 20, 2022||Wednesday, June 29, 2022|
|General||Wednesday, August 17, 2022||Wednesday, July 27, 2022|
More FAQs can be found on our FAQs page
WCM DSMC oversight can be requested via the following:
For more details, please refer to the following information page: Make a Submission
The AE Narratives should paint a picture of the experiences that are important medical events that may not result in death, be life-threatening or require hospitalization, but based on appropriate medical judgment require medical or surgical intervention to manage them.
The PI, research nurse or Co-I with appropriate qualifications should draft these narratives. Individual incidents of AEs do not have to be described. They may be written in such a way that would summarize the experiences of the study subjects to aid the DSMC in identifying trends that could inform the DSMC whether the risks of the study have changed.
Example 1, By study arm
The # most common AEs for this group include pain/tenderness/soreness at the injection site (##%), fever (#%), headache (##%), nausea (#%), and chills (#%). Serious adverse event (SAE) occurred with # subjects, and included one occurrence of Grade # fever and two occurrences of Grade # sepsis.
The only AEs experienced by subjects in this arm is pain/tenderness/soreness at the injection site (##%).
Example 2, By subject
No remarkable AEs were experienced by subjects except the following:
Subject 1 experienced several incidents of increased LFTs ranging from Grade 2-3 throughout participation in the study (MM/DD/YY – MM/DD/YY). Subject 1 had a baseline diagnosis of diabetes. As of MM/DDYY all AEs have resolved.
The SAE Narrative attachment should provide a written narrative for individual serious adverse events (SAEs) experienced since the last periodic report. The details that should be included in the narrative are:
Information fields and instructions are enclosed in brackets in bold.
[Subject ID] experienced Grade [#] [SAE] from [SAE Start date] to [SAE end date]. Subject consented to the study on [consent date] date and began receiving [study intervention] on [date of first administration of study intervention]. The last administration of study intervention occurred on [date of last intervention]. Subject presented to [hospital] with the following symptoms: [list symptoms]. The following procedures were performed: [list procedures that were conducted and for what purpose the procedure was performed]. The event is [ongoing/resolved]. [Include any additional details if available, such as any sequela, next anticipated follow-up, etc.]
Starting 1/01/2021 for all new studies requesting oversight by the WCM DSMC, both General and Cancer, a DSMC Charter will be requested. Studies using the Cancer DSMC will also be required to generate a Monitoring Plan document using the most current version of the WCM DSMC template. All other studies could describe the monitoring plan in the protocol document.
The most current template versions of the WCM Charter and WCM DSMP can be found in the Forms Section of the DSMC website.