•  WCM DSMC SOP Version 17AUG2020

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.  

•  WCM DSMC_Charter Main Document_Template_v2.0_21DEC2020
  DSMC Charter Template
  
  
•  WCM DSMC Data and Safety Monitoring Plan template v1.0 21dec2020.docx
  
  Template of the Data and Safety Monitoring Plan that outlines the level of monitoring that will be performed for the study.
  
  
•  enrollment_summary_table_v.10.04.2019.docx

WCM DSMC oversight can be requested via the following: 

1. The Human Subjects System by indicating the appropriate responses in the Intake Form or Initial IRB application.   
2. Via a direct email request submitted to DSMC@med.cornell.edu.  

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 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 since the last periodic report.  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.]

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.