Proactive Audits for Continued Training (PACTs)

Quality Assurance Program Contact

101 Technology Center, University Park, PA 16802
Phone: 814-865-1775 • Fax: 814-863-8699
Email: ORP-QM@psu.edu

The Office for Research Protections Quality Assurance Program conducts post-IRB approval reviews and supports investigators conducting FDA-regulated studies, conducting other clinical trials, and registering and reporting on ClinicalTrials.gov.

Office Directory

Proactive Audits for Continued Training (PACTs) are an opportunity for the study team and investigators to meet with the Quality Assurance team to successfully implement the study procedures as approved by the IRB before participant enrollment. The Quality Assurance team tries to provide constructive, helpful feedback on study procedures to facilitate a smooth transition from study approval to study implementation, as well as to address common pitfalls the QA team finds during routine audits. PACTs are a preemptive post-approval audit. Penn State Policy RP05 establishes that the Quality Assurance (QA) program conducts audits and offers training to enhance the protection of human subjects and verify that IRB-approved procedures are being followed.

During a PACT, the QA team will give guidance on best practices for:

Recruitment
Consent
Data management
Modifications
How to handle unexpected events/reportable information
Study closure

How are studies selected?

Any study approved by the IRB may be selected for a PACT. However, the QA team will select studies with input from IRB Analysts and will focus on researchers newer to Penn State or the IRB process.

After the PACT, the QA team may follow-up to see how study implementation and participant enrollment is proceeding. Participation in a PACT may allow the QA team to conduct an abbreviated post-IRB approval audit as opposed to a full routine review in the future.

If you would like to request a PACT, please email ORP-QM@psu.edu.