Post-Approval Monitoring Program

Post-approval monitoring review is being planned and executed by the KSU Post-Approval Monitoring (PAM) Program.

The purpose of these reviews are to facilitate collaborative educational opportunities that support the administration and execution of protocols by KSU faculty, staff, and students conducting research involving human subjects.

During the visit, the KSU PAM team will engage in a discussion regarding your protocol while inquiring about the progress of enrollment, any challenges or concerns that have arisen, and so forth.

quality assurance

In addition, the team will evaluate your study records and provide necessary assistance, feedback, and direction regarding data security/record keeping and the conduct of your research activities in order to assist you in ensuring that your protocol complies with all regulatory requirements. Investigators whose schedules do fill up rapidly are encouraged to respond to the notification regarding a PAM assessment visit in a timely manner.

We await the opportunity to be of assistance to you and are readily available to do so.

PAM

The Institutional Review Board (IRB) of ÁñÁ«»ÆÊÓƵ established the PAM program to enhance safeguards for human research at KSU and to showcase the institution's dedication to ongoing compliance improvement. Maintaining a quality program requires the identification of the strengths and weaknesses of protection efforts; doing so allows the IRB to uphold KSU's history of excellence.

The purpose of PAM implementation at KSU is to assess the adequacy of protections for human research at different levels, raise awareness regarding current processes, operating procedures, and educational programs, and obtain the information required to strengthen protections. By utilizing the PAM program, KSU can evaluate its adherence to Good Clinical Practice (GCP) guidelines and federal, state, and institutional regulations. This adherence is critical in ensuring that the institution meets the utmost standards for the protection of human subjects.

  • The IRB or the Executive Vice President for Research conducts this category of review in response to the following: exceptional circumstances, substantial risks to subjects, investigators' routine non-compliance with federal and/or institutional regulations, allegations or concerns regarding the study's execution that are brought to the IRB's attention, or any other case that the IRB deems suitable for additional scrutiny.

    In order to ascertain the investigator's research records' consistency and accuracy, as well as to validate that no significant modifications were implemented to the protocol before IRB approval, a comparison may be drawn between the records maintained by the IRB and those of the investigator. In order to determine whether additional action is required, the IRB is notified of the findings of the directed review, which are subsequently shared with the Principal Investigator (PI) and his/her research personnel.

    IRB develops a plan for follow up, which may include, but is not limited to, another PAM review or monitoring of the informed consent process, if it determines during a review of the results of a directed review that the exposed deficiencies warrant suspension or termination of the research.

  • The PI or a member of his or her research personnel may conduct this type of review voluntarily. Nonetheless, a PI may be prompted to conduct a self-assessment evaluation upon direct invitation and at the discretion of the Executive Vice President for Research or of the IRB. For completion by the PI and/or research personnel, the IRB provides a web-based self-assessment form (also available electronically or on paper). The outcomes of a PI self-assessment evaluation may be uploaded to a secure database, following which the IRB may provide the PI with recommended remedial measures for deficiencies.
  • An IRB or Executive Vice President for Research may initiate this form of review at their discretion. To evaluate the procedures implemented and/or concerns addressed by the IRB regarding the protection of human subjects in research, or to enhance management, a comprehensive examination of the IRB records may be performed. Periodic performance evaluations of IRB members are carried out in order to validate their qualifications. The vice president of research is informed of the outcomes of an administrative evaluation. The findings might have an effect on current procedures and necessitate supplementary educational endeavors for investigators/study personnel, IRB staff, or IRB members.

 

PAM Findings – Reporting Requirement

One of the objectives of the PAM Program is to provide researchers with information on the safeguards that are in place to protect studies involving human beings. The outcomes of routine PAM evaluations and PI Self-Assessment evaluations are documented with the IRB in order to ensure that this intention is met.

Review Outcomes Documented With the IRB

Significant or serious deficiencies in human research protections (including, but not limited to):

Review Outcomes Not Documented With the IRB

Minor deficiencies in human research protections (might include, but is not limited to):

  • Administrative/management errors which do not impact subject safety, do not substantially alter risks to subjects, or do not affect data integrity