Continuing Review Report Form (CRRF) Work Sheet

The CRRF Work Sheet is a guide to completing the WIRB CRRF for study coordinators and PIs. Click here to download a copy of the Continuing Review Report Form Work Sheet.

Delinquent CRRFs
Signed Consent Form Requirement
Definition of Screen Failures and Withdrawals
Study Renewal

• Delinquent CRRFs:
  
If a completed CRRF is not returned to WIRB, WIRB sends the site a second copy of the missing CRRF marked "Final Notice." The Board may take action to suspend or terminate approval of research if reports are not accurately completed and returned promptly. If WIRB suspends or terminates the study, at a minimum, the investigator, sponsor and FDA and/or OHRP are notified of the Board's action.
When a CRRF is not returned by the due date printed on it, WIRB takes the following action:

• Seven days before the due date, a CRRF labeled “Reminder Notice” is mailed to the site.
  
  
• If no response is received 7 days after the due date, WIRB staff prepare a “past due” letter which explains that if a satisfactory response is not received within 10 days, the delinquency will be reported to the Board and that the Board may take action to suspend the study at the site. The letter is sent to the investigator, sponsor contact, institution contact (if applicable) and other study contacts.
  
  
• If no response is received 17 days after the due date on the CRRF, WIRB staff place courtesy call to sponsor notifying them of the continued delinquency and the likelihood that the Board will take action to suspend the study at the site if a response is not received.
  
  
• If no response is received 24 days after the due date on the CRRF, the delinquency is reported to the Board. If the Board suspends the study, WIRB is required to report the suspension to the appropriate federal agency or agencies (FDA, OHRP, etc.)
  If the suspended investigator is at an institution which has notified WIRB that they will self-report these actions to the appropriate agency or agencies, the institution will receive a notification of the Board’s action and a cover letter reminding them of the reporting requirement. The institution has 30 days to then report to the agency and copy WIRB.
  
  

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• Signed Consent Form Requirement:
  The WIRB CRRF states "If this is the first report submitted after you have begun to enroll subjects, you must enclose a copy of a WIRB-approved consent document, signed by an enrolled subject." Sites are only required to send a signed consent form once; if the study involves multiple consent forms for this study, only a signed copy of the core consent form is required.
  

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• Definition of Screen Failures and Withdrawals:
  Report the number of screen failures and withdrawals on the CRRF according to the following definitions.

  Screen failure: subject removed from the study during the screening process because they do not meet all inclusion and exclusion criteria, or whatever other requirements must be met for research participation. Subjects who leave the study after randomization or assignment to study treatment should be counted as withdrawals rather than screen failures, even if the subject didn't start the study treatment.

  Withdrawal: Regardless of the reason for withdrawal, both subject-initiated decisions to withdraw and investigator- or sponsor- initiated withdrawals should be included in the reported number of withdrawals. Subjects who are withdrawn later in a study because they failed to meet study criteria for continued participation should be counted as withdrawals rather than screen failures. The majority of withdrawals take place after screening is completed.

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• Study Renewal:
  Sites receive a "Study Renewal" version of the WIRB CRRF when the study's expiration date is approaching. The Board may conduct the study renewal review up to 30 days prior to the study expiration date listed on the Certificate of Approval. Review fees apply for the study renewal service and review is carried out unless WIRB receives a study closure notice prior to the Board's renewal review of the study. If a closure notice is received by WIRB before the study expiration date, but after the Board's renewal review, the site is still billed for the renewal review. To avoid unnecessary reviews and fees, do not delay reporting a study closure to WIRB if the expiration date is approaching.
  
  If the Board approves renewal of the study for an additional review period, a Certificate of Approval is forwarded to the investigator and other study contacts as applicable. The Certificate of Approval states "Approval includes: Study and Investigator for an additional continuing review period. This approval expires on the date noted above." Approval of the study encompasses renewal of the protocol, all previously approved amendments or revisions, and the existing consent and study materials as previously approved.
  
  If, at the time of study renewal, the Board determines that a modification to the consent is necessary, the Certificate of Approval will indicate approval of a consent form and will be accompanied by a revised consent form (and a redline illustrating the Board's changes).