OVERVIEW
This Quickguide provides instructions for completing the Unanticipated Problem and/or the Serious or Continuing Noncompliance (UP/SCN) Submission Application.
INSTRUCTIONS
The UP/SCN Submission Application is required for any study-wide unanticipated problem or noncompliance event. The submitting entity should send an initial notification email to the reviewing CIRB (adultCIRB@emmes.com, EarlyPhaseCIRB@emmes.com, PediatricCIRB@emmes.com, or CPCCIRB@emmes.com) requesting a UP/SCN review. The notification email must include the affected Study ID(s).
Once the notification email is received by the CIRB, a UP/SCN Submission Application will be created. The submitting group will receive an email to requesting that they complete the application.
Information about each question on the Application is listed below. A Word version of the Unanticipated Problem and/or the Serious or Continuing Noncompliance (UP/SCN) Submission Application is also available, if required.
STEPS
Instructions, Study ID, Study Title, Event, and Study Chair
- The first five questions (Application Instructions, Study ID, Study Title, Event, and Study Chair) are prepopulated based on the information in the email provided to the CIRB to start the application.
Checklist of CIRB-Requested Supporting Documents
- Indicate the support documents attached for this application.
- Attach documents to the application.
Protocol Version Date
- The CIRB needs to know the Protocol Version Date associated with the incident occurrence. This may not be the most current version of the study. Enter the Protocol Version Date associated with the study that was in effect at the time of the event.
What is the eligible population for this study?
- Select the eligible population for this study.
Description of Event Being Reported
- Question 1: Enter the date the event occurred. If that is different from the date that the incident was identified, then include both dates.
- Question 2: Describe the event in as much detail as possible in the text box provided. Supporting documents may be attached, but a detailed summary should be included in the text box.
- Include any relevant attachments.
Corrective Actions
- Question 3: Describe any corrective action and preventative plan planned or implemented for the event.
- Include attachments.
Participant Notifications
- Question 4: Specify whether or not participants have been notified about the event.
- Include attachments of any correspondence.
Number of Study Participants
- Question 5:
- Provide the number of participants currently enrolled.
- Provide the number of participants on-treatment.
- Provide the number of participants off-treatment.
- Provide the number of participants in follow-up.
- Provide the number of participants affected by the event.