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 and frequency at which the WCM DSMC monitors a study is commensurate with the study's risks and needs.
DSMC oversight can be requested in the WRG-HS Intake form or the Initial IRB application, or by emailing us directly.
If you are unsure of whether your study needs WCM DSMC oversight, contact dsmc@med.cornell.edu for assistance.
The Weill Cornell Medicine (WCM) DSMC is available to aid WCM principal investigators and the Institutional Review Board (IRB) in providing an independent means of data and safety monitoring for clinical trials that involve significant risk to research subjects. Use of the WCM DSMC is required for all interventional cancer trials, regardless of sponsor, submitted to the MCC Protocol Review Monitoring Committee (Cancer PRMC) where WCM serves as the data coordinating center. Studies for which the WCM DSMC is appropriate as an independent method of monitoring include:
For further questions on whether WCM DSMC oversight is required for your study, contact dsmc@med.cornell.edu for assistance.
WCM DSMC oversight can be requested via either of the following:
For more details, please refer to the submission checklist guidance.
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 are on this page, above.
Periodic reports will become due starting from the date of first subject enrollment. The frequency will be followed for the life of the study, until end of DSMC oversight request has been acknowledged. If your protocol’s DSMC review schedule is calendar based (e.g., semiannually), the WCM DSMC recommends a periodic report be submitted for a meeting that falls within the review period to prevent a deviation from the protocol approved frequency. DSMC meeting dates and submission deadlines can be found on the DSMC website.
If your protocol’s DSMC review schedule is accrual based (e.g., after every 3 subjects are enrolled), then the PI is responsible for submitting to the DSMC for the next scheduled DSMC meeting once the accrual threshold has been met. This requires careful enrollment tracking on the part of the research team.
If your protocol’s DSMC review schedule is a combination of calendar-based and accrual based (e.g., every 6 months or after every 3 subjects are enrolled, whichever occurs first), then the PI is responsible for submitting to the DSMC once the lesser of the two criteria is met. Careful enrollment tracking on the part of the research team is required, as is an awareness of the DSMC’s meeting dates and submission deadlines, so that a submission is made to the DSMC as soon as required.
The Periodic Report is completed using the electronic Periodic Report Form (ePRF) via the REDCap system. To access and complete the ePRF, navigate to the ePRF. You can also copy and paste the following link into your browser: https://redcap.ctsc.med.cornell.edu/redcap_protocols/surveys/?s=K38L4ARET7. We recommend that you utilize Mozilla Firefox or Internet Explorer as the web browser for completing the form.
For more details, please refer to the submission checklist guidance.
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 narratives are provided below:
Example 1, By study arm
Arm 1
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.
Arm 2
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
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.
All individual Serious Adverse Events (SAEs) experienced must be reported for DSMC review either at the time of Periodic Report submission or in the event an Immediate Report was submitted to the WCM IRB, IRB of record, Sponsor(s), or FDA via MedWatch Report.
Serious Adverse Event (SAE) Narratives are accepted in many forms (i.e., WCM SAE Cover Sheet, MCC SAE Cover Sheet, JCTO SAE Cover Sheet). Additionally, the SAE Narrative- formatted as a cumulated PI signed and dated memo must be submitted with corresponding SAE Narrative entry for each SAE Grade 3, 4 or 5 listed on the AE/IND Table, in lieu or in addition to SAE Cover Sheets.
SAE Narrative Guidance: Submit a formal, PI-signed, and dated memo to the WCM DSMC (include the IRB # and Protocol Title)
Required details that should be included in the narrative are:
For each protocol intervention (i.e., study drug, device, chemo, radiation, surgery, etc.) provide the following PI Attributions as related to each respective intervention:
1. The harm is “unexpected” when its specificity and severity are not accurately reflected in the WCM consent document, Investigator’s Brochure (if applicable), or package insert (if applicable)
2. The harm is “related” or “possibly related”, where there is a reasonable possibility that the harm may have been caused by the research procedure(s), or intervention(s)
3. The harm suggests that the research places WCM subjects at greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized
Note* PI may include additional attributions identified (as related to patients underlying diagnosis, standard of care treatment, disease progression, etc.), please specify in detail, as applicable.
IMPORTANT!
If the SAE qualifies as a Dose Limiting Toxicity (DLT), Suspected Unexpected Serious Adverse Reaction (SUSAR), Adverse Event of Special Interest (AESI) please ensure to note this clearly and ensure all required reporting is complete.
If the SAE triggers (or was evaluated for) a Stopping Rule or Interim Analysis, please indicate within the SAE Narrative.
Submit additional documents, as applicable, including:
The WCM DSMC expects PIs to adhere to the institutional Immediate Reporting Policy, which stipulates what adverse events and protocol deviations need to be reported to the DSMC right away, as well as what adverse events need to be listed in the Adverse Event & IND Safety Reporting Cumulative Table when submitting a Periodic Report to the WCM DSMC. This policy can be found on the Institutional Policies & Procedures page on the IRB Website. For more information on how to submit an Immediate Report form in WRG-HS, please see the WRG-HS KnowledgeBase article.
PIs can expect to receive a recommendation letter from the DSMC within approximately one week of the meeting. Letters will alert the PI as to the DSMC’s recommendation and/or whether the committee requires follow-up before a determination can be made. The DSMC may recommend that the trial continue without modification, continue with modifications, be placed on an enrollment hold, or be terminated (e.g., for slow accrual; immediate safety concerns; trial clearly identifies the more efficacious treatment). Placing the trial on enrollment hold or terminating a trial is extremely rare.
If the DSMC recommends that the trial continue with modifications, the PI is asked to respond to confirm that the modification to the protocol will be made. Most often, the modification is one that alters the DSMC reporting schedule (e.g. semiannually to annually). To comply with the DSMC’s recommendation, the PI will need to submit an amendment to the IRB. The amendment needs to modify both the WRG-HS IRB application and the research protocol.
If the PI disagrees with the DSMC, they are invited to respond with the rationale for the disagreement. If desired, the PI can attend an upcoming DSMC meeting to discuss the issue in-person.
Any Protocol having WCM DSMC Approval is required to submit all Immediate Reports for WCM DSMC Review.
Upon submission to the IRB, all Immediate Reports (Reportable Events) must also be submitted for WCM DSMC Review.
Avoid delay when sending Immediate Report submissions to the WCM DSMC, as a delay in Immediate Report submission is considered a Protocol Deviation.
Immediate Reports submitted for IRB Review via WRG Reportable Event Submission must be downloaded and emailed to the WCM DSMC via DSMC@med.cornell.edu.
To prevent delays in review, routing, and DSMC determination, take care to include “Immediate Report,” “Reportable Event,” PI’s Last Name and the IRB # in the subject line.
