SOP 900 Quality Assurance (QA)
901 QA/QC Program
1. OBJECTIVE
Quality assurance and control of the daily operations of the IRB ensure effective support of the IRB's mandate. Therefore, the QA/QC program consists of three components:
Training and continuing education of IRB staff
Interactions with the IRB community outside of BRIGHAM YOUNG UNIVERSITY
Regular review and assessment of procedures
Specific Procedures
The AAVP has the authority to implement a QA/QC program and to act on identified deficiencies by implementing corrective action via revisions to the Standard Operating Policies and Procedures.
2. SCOPE
These policies and procedures apply to all IRBs at BRIGHAM YOUNG UNIVERSITY.
3. APPLICABLE REGULATIONS AND GUIDELINES
None
4. REFERENCES TO OTHER APPLICABLE SOPs
This SOP affects all other SOPs.
902 Audits by Regulatory Agencies
1. OBJECTIVE
BRIGHAM YOUNG UNIVERSITY acknowledges that certain regulatory agencies have the authority to audit the operations of IRBs, and supports such audits as part of its continuing effort to maintain high standards for human research protections.
Entities that may audit IRBs include: FDA and OHRP. Sponsors or funding entities of research may also be authorized to audit specific documents and procedures.
Specific Procedures
1.1 Preparing for an Audit
1.1.1 For external audits involving OHRP or FDA, the following must be notified immediately:
Associate Academic Vice President (AAVP)
IRB Chairperson
The IRB staff designated to participate in the audit are required to follow the steps outlined by this institution for preparing the site for an audit.
1.2 Participating in an Audit
1.2.1 IRB staff are expected to know and follow the procedures outlined by this Institution for the conduct of a regulatory audit.
1.2.2 Prior to being granted access to IRB documentation, inspectors or auditors must exhibit proof of their authority or authorization to conduct the audit and to access IRB documents, and no entity other than those listed on the consent forms may have access to any document that includes subject identifiers.
1.2.3 Auditors will be provided with adequate working area to conduct an audit and IRB staff and members must make every reasonable effort to be available and to accommodate and expedite the requests of such auditors.
1.2.4 Documents may be copied and taken off-site only by individuals authorized in writing by the AAVP to do so.
1.3 Follow-up After an Audit
Reports of the audit, either verbal or written, should be addressed by the IRB ADMINISTRATOR/IRB CHAIRPERSON, (with the assistance and support of BRIGHAM YOUNG UNIVERSITY Administration), as soon as possible after the audit.
2. SCOPE
These policies and procedures apply to all IRBs at BRIGHAM YOUNG UNIVERSITY system.
3. APPLICABLE REGULATIONS AND GUIDELINES
45 CFR 46.115
21 CFR 56.115
FDA Compliance Program Guidance Manual 7348.809, Institutional Review Boards
4. REFERENCES TO OTHER APPLICABLE SOPs
This SOP affects all other SOPs.