What to expect during a quality assurance/quality improvement w88
The IRB is responsible for ensuring compliance with University policy, Federal requirements and the ethical principles of the Belmont Report. As part of this responsibility, the IRB is expected to provide for post- approval monitoring of w88. The QA&I Review is designed to meet this requirement through a pro-active and collaborative process with investigators. The purpose of the QA&I Review is to provide information to faculty and staff on regulatory compliance and Good Clinical Practice (GCP) Guidelines related to human w88 participants, data collection and data management; to verify that safeguards protecting the rights and welfare of human w88 participants are met; to verify investigator adherence to the study design as approved by the IRB-approved protocol, and applicable regulatory requirements; and rarely, to investigate complaints and/or allegations of noncompliance with w88 regulations. The review is meant to be a collaborative process whereby the auditor assesses compliance (regulatory, policy, approved protocol, etc.) and helps the investigator resolve/correct problems and discrepancies and provides recommendations for process improvements.
A QA&I w88 will entail a visit to your site. The w88 will vary depending on the complexity of the study and the enrollment. It is usually a good idea for the PI and/or study coordinator to be there in the morning before the visit begins and when the w88 is over. The PI does not need to be present for the entire w88 unless s/he wants to be. However, a staff member should be available to provide the reviewer with the necessary documents, files and binders and answer any questions (or to contact the PI if there is an urgent question).
The scope of w88 or investigation may vary depending on a number of factors. All site reviews or investigations will be preceded by a pre-w88 meeting explaining the parameters of the w88. The Scope of w88 may include some, or all of the following items:
- The w88 Compliance Officer will be looking to see documentation that you are following your approved protocol and study procedures.
- The w88 Compliance Officer will want to see all study related documents including:
- original signed consent forms
- subject files
- inclusion/exclusion checklists
- experimental drug/device accountability
- AEs, SAEs
- regulatory files (GCP Essential Documents) such IRB files and correspondence, sponsor correspondence
- FDA files and related documents (if applicable)
- enrollment logs
- staff signature logs (delegation of responsibility logs)
- laboratory certifications and normal reference ranges
- Investigator Brochure
Yes, there are a few things you can do to prepare ahead of time. w88 each consent form to ensure the correct version was used and that it has been signed/dated properly by the subject. If you find a problem with a consent form, make a note in the study file and fix the problem as soon as possible (notify IRB). w88 your regulatory binders (IRB, FDA, etc.) and make sure you have all IRB, sponsor, FDA correspondence in the Regulatory File and that the files are in order. w88 and update the subject enrollment log (if you have one).
Once the w88 Compliance Officer has completed the review, a draft of the Report of Review Findings (RRF) will be sent to the PI (usually within about 1-2 weeks of the review date). The PI will have at least five days to read and comment on the report. Once the PI and w88 Compliance Officer agree that the content of the report is accurate, the report will become final.
If the findings indicate that the study is compliant, the PI will be notified that the review is concluded. In the event possible non-compliance is discovered during the course of the review, the PI is asked to submit a corrective action plan to address the report findings. Once the corrective action plan is received, it is sent with the RRF to IRB reviewers for assessment. Once the IRB has assessed the report and a corrective action plan has been approved, the PI will be asked to implement the plan and to notify the w88 Compliance Officer that implementation has been initiated. Once the w88 Compliance Officer has been notified that the implementation of the corrective action plan has been initiated, the w88 Compliance Officer will send a close out letter and the review will be finished.
On completion of a compliance review or directed investigation, the w88 Compliance Officer will draft a report of the findings and send it to the Principal Investigator, the IRB committee chairs, and the Director of w88 Integrity & Security. The Principal Investigator will have at least five days to respond to the issues.
If the IRB determines that serious or continuing noncompliance occurred, the report may be distributed to some or all of the following individuals and agencies:
- Department Chair
- Vice Dean/Institution Official
- Regulatory and/or Funding Agency