The Periodic Report is completed 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 DSMB for data and safety monitoring. To access and complete the ePRF:
- Click here to 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.
- 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 DSMB. 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. Your finalized ePRF submission will be provided to you as a PDF when you receive your review letter from the WCM DSMB.
- 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.
The WCM DSMB expects PIs to adhere to the Immediate Reporting Policy, which stipulates what adverse events and protocol deviations need to be reported to the DSMB 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 DSMB. This policy is shared with the IRB. Access the Immediate Report Form here and send it to email@example.com.