Request WCM DSMC Oversight
WCM DSMC oversight can be requested directly by reaching out to DSMC@med.cornell.edu or automatically in the HS system when the WCM DSMC is indicated as the monitoring entity in the Protocol Initiation (Intake) Form or the Initial IRB Application.
More information about requesting WCM DSMC oversight can be found here.
Periodic Reports are submitted using the electronic Periodic Report Form (ePRF) via the REDCap system. The ePRF was designed with simplicity and efficiency in mind for all protocols that utilize the WCM DSMC for data and safety monitoring. To access and complete the ePRF:
- The ePRF can be accessed using the following link: 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.
- When you begin the form, you must enter the “Protocol Number” for the protocol under review prior to saving any information on the survey.
- If you would like to save your completed work to return to later, you may select “Save & Return Later” at the bottom of the survey. Once you select “Save & Return Later”, the survey will provide you with a Return Code. Write down, copy, or email the return code to yourself. You will need the code to continue where you left off. NOTE: Failure to write down, copy, or email the return code to yourself can result in a delay of the submission. Contact email@example.com if you should need assistance with the Return Code.
- Once you complete all required fields and have uploaded all attachments, you may select “Submit” to send the Periodic Report Form to the WCM DSMC. NOTE: You will not be able to return to the form once you submit it. Please review all data field entries for completeness and accuracy prior to submitting for review.
- Once you submit the report, you will be prompted to provide an email address for the confirmation email. If you do not receive a confirmation email, please contact firstname.lastname@example.org to confirm your submission was received. You also have the option of saving the completed form by clicking the download button below the return code. However, the downloading only saves the survey form and does not include the files attached to the form.
The WCM DSMC expects PIs to adhere to the 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 is shared with the IRB. To more information on how to submit an Immediate Report form in WRG-HS, please see the KnowledgeBase article here and send it to email@example.com.