Quality Improvement & Quality Assessment Program
Post Approval Monitoring (PAMQuIP)
The purpose of the program is to assist the university and investigators in conducting human research that is of the highest ethical quality and is compliant with federal, state, and local requirements. The PAMQuIP staff works towards this goal by improving investigator/IRB performance through monitoring, education and measurement of the overall quality, effectiveness, and efficiency. In addition, the PAMQuIP staff acts as a resource for the VCU/HS research community by offering help through problem-solving tips, templates, focused educational services, external/internal audit preparation and referrals.
- Types of Visits
- Overview of the Visit Process
- Preparing for a Visit
- Quality Improvement Education, Consultation & Assistance
- Study Conduct Toolkit
Types of Visits
Visits requested by the IRB, ORSP staff, institutional official, and department chairs, etc. generally due to a potential concern regarding study compliance and/or subject rights and welfare.
Visits to studies that are not initiated by any cause for concern. Studies may be selected based on any number of criteria including risk level of the study, studies enrolling vulnerable populations, studies involving investigational new drugs (INDs) or devices (IDEs), studies involving an investigator held IND-IDE, studies involving complex procedures, or randomly from all active studies.
More narrow reviews of research activities that concentrate on direct research subject impact. The informed consent process (including documentation, observation), recruitment, or treatment outcomes could each be object of a focused review. This type of review is not prompted by a specific concern or issue and is similar to routine review.
Visits requested by the PI, study staff, IRB, ORSP staff, and department chairs, etc. to address a perceived educational need related to study conduct. This is often requested when there are new study staff/PIs.
Visits or document reviews targeted toward a particular type of study such as studies reviewed by an external IRB, expedited research, or IRB review of studies involving a vulnerable population.
This type of visit is often requested by the PI or research staff to assist with preparation for an external audit or in anticipation of the start of recruitment.
[ Top of Page ]
Overview of the QA Review Process
Most visits follow the process outlined below. Educational visits or those otherwise requested by the study staff may have a slightly different process.
- The QI/QA Administrator contacts the Investigator via email to request the visit. A mutually acceptable time is agreed upon to conduct the visit. Visits should take place with a week or two of suggested dates.
- In the visit request letter, the QI/QA Administrator includes links so the PI can complete the Post Approval Monitoring Study Evaluation Tool (PAM SET) and the VCU data security classification survey.
- The PI, Study Coordinator, and QI/QA Administrator meet to discuss questions from the IRB documentation and PAMSET. This usually takes 90-120 minutes depending on questions/issues that PI and Study Coordinator want to discuss or the complexity of the questions that arose from the pre-visit document review.
- The QI/QA Administrator may return on another day to observe the consent process, clinical processes, etc.
- Following the visit, the QI/QA Administrator will send a final report to the PI & study coordinator noting visit outcomes, recommendations, and outstanding issues that must be addressed. A PI Response form will also be attached. The PI Response form should be completed and returned within a week of receipt. This does not mean that the required changed need to be completed within a week, but the PI response form denotes the PI’s intentions and commitment to fulfilling those intentions within a short period of time.
- The QI/QA Administrator will upload the final report, questions, and completed PI response form to the secure server in the Office of the Vice President of Research & Innovation and to RAMS IRB for IRB review.
- If there is a possibility of the PI being cited for non-compliance (general, serious, and/or continuing), the QI/QA Administrator will discuss the report & PI response with Executive Director of the Office of Research Subjects Protection. The findings and response will be referred to the full IRB Panel if the Executive Director believes there may be Continuing and/or Serious non-compliance.
- If applicable, the QI/QA staff may offer up to six hours of consulting time to help the PI and Staff resolve issues and help the study move through the IRB process more smoothly.
The QI/QA administrator will make an effort to give an overview of recommendations and required changes that will be included in the final report before leaving the final meeting with the PI and staff.
Overview of the Focused Review Process
Most visits, other than educational visits or those otherwise requested by the study staff, follow the process outlined below.
- The QI/QA staff contacts the Investigator via email to request the visit. A mutually acceptable time to conduct the visit is agreed upon.
- The QI/QA STAFF member requests the PI complete the Post Approval Monitoring Study Evaluation Tool (PAM SET), which includes questions about current study conduct and progress.
- An initial, brief meeting (~30 minutes for discussion) will be scheduled with the PI and pertinent study staff to discuss the monitoring process. Preparatory questions will be posed regarding the study, IRB approvals, and the PAM SET. Following the discussion, the QI/QA STAFF will review research records including regulatory documentation and informed consent forms. The PI and study staff do not need to attend this portion of the review. If there is too much documentation to review in one sitting, the QI/QA STAFF may need to return to complete the record review.
- The QI/QA STAFF may return to observe the consent process.
- A second meeting will be scheduled where the RLS will more fully discuss the study with the PI and pertinent study staff. Discussion of any potential issues/findings will occur during this meeting.
- Following the visit, the QI/QA STAFF will send a letter to the PI noting required findings that must be addressed and recommendations to improve various aspects of the study and make the IRB process proceed more smoothly.
- The PI will receive a PI Response form with the Findings Report. The completed PI Response form is due one week after receiving the Findings Report. The PI can request more time if needed.
- The Findings Report and the PI Response are uploaded into RAMS IRB and the IRB panel members may review it if they wish.
- If applicable, the QI/QA staff may offer up to 6 hours of consulting time to help the PI and staff resolve issues and enhance the study.
[ Top of Page ]
Preparing for a Visit
Visits will be completed in a timely fashion and flow more smoothly if the following preparation is done prior to the scheduled visit:
- Complete the Post Approval Monitoring Study Evaluation Tool (PAM SET) and return it to the QI/QA staff (QI/QA STAFF).
- Reserve a conference room with a table for the visit/record review to occur.
- Have applicable research records ready for review, including:
- IRB submissions
- Recruitment materials
- Subject screening and enrollment logs
- Signed consent forms
- DSMB reports
- FDA visit reports
[ Top of Page ]
Education, Consulting & Assistance
The Quality Improvement and Quality Assessment office is available for education and consulting sessions as well as assistance.
The QI/QA office staff has unique skills in understanding how to adjust study procedures/processes to comply with federal, state, and institutional policies. The staff will offer recommendations for increasing compliance while maintaining or increasing good research design.
The office staff is available for research design and compliance consulting. The process usually takes this form:
The PI’s send specific questions for review prior to RAMS IRB submission. A meeting is scheduled to discuss the study. The PI sends the materials and initial questions, at least, a week before the meeting. The meeting takes place. A consulting report is sent to the PI and uploaded to the Office of Research Subject Protections’ secure server. The report includes questions and recommendations.
The staff can offer up to six hours of assistance after a visit/consultation. This usually takes the form of reviewing upcoming submissions/amendments, researching PI questions, and conversations with the PI about research design enhancements for current or upcoming research.
To schedule a visit, contact Dr. Enid Virago at firstname.lastname@example.org.
[ Top of Page ]
- Post Approval Monitoring Study Evaluation Tool (PAM SET) for Biomedical Research
- Post Approval Monitoring Study Evaluation Tool (PAM SET) for Social-Behavioral Research
- WPP X-3: Post Approval Monitoring of IRB-Approved Protocols
[ Top of Page ]
Study Conduct Toolkit
Click here to view the study conduct toolkit, which contains a wide variety of templates to assist investigators and study coordinators with study organization and conduct.
[ Top of Page ]