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 concerns regarding study compliance and/or subject rights and welfare. For cause visits may also be initiated due to complaints, repeated errors or a lack of responsiveness by the Principal Investigator to IRB/ORSP requests.
Examples of the types of “for cause” reviews are:
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.
Occasionally the IRB/ORSP office will request an in-depth investigation of an Investigator’s studies or study conduct. This may be due to a non-compliance determination and/or significant regulatory problems were found during review.
This investigation may involve significant time on site reviewing study documentation and processes.
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,
- a high number of studies conducted by a PI or managed by a study coordinator
- or randomly from all active studies.
Examples of “routine visits” are:
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.
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 as part of the on-boarding process.
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.
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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 Staff contacts the Investigator via email to request the visit. A mutually acceptable time is agreed upon to conduct the visit. Visits should take place within a week or two of suggested dates.
- In the visit request letter, the QI/QA Staff includes links so the PI can complete the Post Approval Monitoring Study Evaluation Tool (PAM SET), CITI certification, Risk Mitigation Table and the VCU data security classification survey. Links to or attachments of these documents are included in the visit request email. These completed documents are emailed to the Staff a minimum of one week before the visit.
- The PI, Study Coordinator, and QI/QA Staff meet to discuss questions arising from the IRB documentation and PAMSET. This visit 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 Staff may return on another day to observe the consent process, clinical processes, and/or to do an in-depth documentation review, etc.
- Following the visit, the QI/QA Staff will email a final report to the PI & study coordinator noting required actions and recommendations. The “required actions” constitute the Corrective Action Plan. A PI Response form will be attached to the email. 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 stated period of time and/or before the next continuing review.
- The QI/QA Staff 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 Manager 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, comply with the Corrective Action Plan and help the study move through the IRB process more smoothly.
The QI/QA Staff 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.
There may be communication back and forth after the visit to clarify any additional questions that arise while the report is being written.
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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 required pre-visit documentation return it to the QI/QA staff (QI/QA STAFF). This includes:
- Post Approval Monitoring Study Evaluation Tool (PAM SET)
- CITI Certification Table
- Risk Mitigation Table
- VCU Data Security Classification survey
- 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
- Monitoring reports
- Communication from sponsor/funder
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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 contacts the PAMQuIP office by email to request a consult. The PI emails specific questions for review at least a week prior to RAMS IRB submission or a consulting meeting. A meeting is scheduled to discuss the study. The meeting takes place. A consulting report is sent to the PI if needed and uploaded to the RAMS/Office of Research Subject Protections’ secure server if appropriate. 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 advice regarding 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.
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- 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
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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.
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