Standard Review

• Purpose: Routine oversight of approved expedited and full board studies
• Basis for Review: Planned (random, risk/complexity informed per PACM selection criteria)
• Engagement Model: Collaborative OHSP & Study Team
• Study Team Involvement: Active engagement based on scope
• Scope: Study activities (consent, recruitment procedures, data management etc); may be focused or comprehensive 

Review Level Alignment

• Purpose: Confirmation of alignment of the IRB review level with the current study activities
• Basis for Review: Planned (random, risk/complexity informed per PACM selection criteria)
• Engagement Model: OHSP-directed structured response
• Study Team Involvement: Clarification; brief response/insight
• Scope: IRB review classification and current study conduct 

For-Cause Review

• Purpose: Investigation of potential or reported non-compliance or harm to participants
• Basis for Review: Triggered (complaints, deviations, external reports, or concerns)
• Engagement Model: Collaborative OHSP & Study Team
• Study Team Involvement: Active engagement
• Scope: Specific issues or areas of concern; may expand in scope depending on findings or emerging information 

Exempt Check-In

• Purpose: Brief touchpoint of exempt studies on progress and ethical practices
• Basis for Review: Planned (random, risk/complexity informed per PACM selection criteria)
• Engagement Model: OHSP-directed structured response
• Study Team Involvement: Brief informational response via checklist
• Scope: Exempt study status and progress updates; may be brief or expanded based on study updates or input by PI 

 Training Check-In 

• Purpose: Verification of training and role compliance
• Basis for Review: Planned (random)
• Engagement Model: OHSP-directed structured response
• Study Team Involvement: Brief informational response via checklist
• Scope: CITI training status and role assignments of study personnel; may included PI-identified training gaps 

Self-Assessment 

• Purpose: PI-led review of study compliance and PACM tools
• Basis for Review: Voluntary (PI-initiated with PACM support requested)
• Engagement Model: Study team-led engagement
• Study Team Involvement: Owned by study team; optional worksheet
• Scope: Study activities as determined by PI using PACM tools; may be submitted for feedback or support 

PACM activities are selected using defined selection criteria applied through two mechanisms: (1) risk/complexity-informed random sampling conducted at defined intervals, and (2) event-driven triggers, such as reported concerns, protocol deviations, external inquiries, or requests from the Principal Investigator.

Together, these approaches support broad and equitable oversight across the research portfolio while allowing for proactive, targeted review based on study complexity, participant risk, and evolving conditions. Selection criteria are designed to minimize burden on Principal Investigators, generally avoiding review of multiple studies under the same Principal Investigator within a 12-month period unless warranted by specific circumstances, such as new information or elevated risk.

PACM activities vary in the level and type of engagement between OHSP and the study team. Some activities are OHSP-directed with study team support, others are collaborative in nature with active participation from both OHSP and study team, and some are PI-led with OHSP involvement available as needed. Across all activities, engagement is designed to be proportionate to the scope and purpose of the review or check-in, and processes are designed to be transparent, clearly communicated, and minimally disruptive to ongoing research.

While specific steps vary by activity type, the general process follows a consistent structure:

• Notification of selection or initiation of a PACM activity, including the type of activity and study or protocol(s) involved
• Clear instructions on what to prepare or provide, including any applicable checklists, documentation requests, or response forms
• Defined timelines for response and review, which vary based on the type of PACM activity
• Ongoing communication throughout the process, including clarification requests or check-ins as needed
• A summary of findings or outcome, which may include confirmation of compliance, recommendations, or required follow-up actions
• When follow-up is required, the PI works with OHSP to address identified findings and complete any required corrective actions, which may include development of a Corrective and Preventive Action (CAPA) plan or other actions as appropriate
• Findings and follow-up actions may be shared with the IRB and other institutional offices as appropriate, particularly when required for reporting, oversight, or review of elevated concerns.

PACM outcomes are intended to support research teams in maintaining compliance, strengthening study practices, and addressing any issues that require follow-up. Outcomes vary based on the type of PACM activity, the scope of the review, and observations identified. Multiple outcomes may apply within a single PACM activity, depending on the circumstances.

Review Outcomes

• No findings
  Study activities and documentation align with the IRB-approved protocol and applicable requirements. No further action is needed.
• Recommendations and best practices
  Minor opportunities for improvement are identified (e.g., documentation updates or process clarifications). Recommendations are shared with the research team; a formal response is not typically required.
• Minor findings
  Limited deficiencies are identified that require correction. The PI provides a response outlining the planned corrective actions and timeline for resolution, as applicable. OHSP may provide guidance as needed and verifies that corrective actions are implemented.
• Reportable findings
  More significant concerns may require formal reporting to the IRB. The PI submits a Reportable New Information (RNI) submission in RAMP IRB. The IRB review process of the RNI determines required corrective actions and next steps.

Follow-Up Actions

• Follow-up or continued monitoring
  In some cases, additional engagement or monitoring may be conducted to support resolution of findings or to confirm sustained compliance.
• Corrective Action Plan Required
• Referral to other offices (if applicable)
  If identified concerns fall outside the scope of PACM oversight (e.g., research integrity, misconduct, or biosafety), OHSP coordinates with the appropriate institutional offices.