Data Safety and Monitoring Committee (DSMC)

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:

• WCM investigator‐initiated trials phase II or higher
• Large, multi‐site, randomized, blinded, and Phase III trials
• Phase I and II studies for which risk to the subjects appears unusually high
• Phase I studies for which the principal investigator is the IND/IDE sponsor or manufacturer and independent monitoring is required to maintain the integrity of the trial
• Gene transfer studies
• Studies with vulnerable populations or risky interventions/procedures or any other factors that might indicate high morbidity/mortality end‐points
• Multi‐center clinical trials in which WCM is the coordinating center or the PI of the study is a WCM faculty member

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: 

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.

The SAE Narrative attachment should provide a written narrative for individual serious adverse events (SAEs) experienced and should include all SAEs that occurred on study (cumulative). A combined file of all SAE Report coversheets/documents containing narratives may be provided instead. The details that should be included in the narrative are:

1. The subject’s study ID.
2. SAE description and grade.
3. The start and end dates of the SAE.
4. When the subject consented to the study.
5. The first and last dates of when the study intervention was administered.
6. Where the subject presented with the SAE and symptoms that were experienced.
7. Any procedures performed aimed at either diagnosing or treating the SAE.
8. Sequela or outcomes, including whether the SAE is still ongoing or was resolved. 

Below is a template that may be modified and customized to best suit your study’s report. 

Template Narrative: 

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.].

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.