Post-Approval Monitoring FAQ

Question Overview

(1) What is post-approval monitoring?
(2) What are some of the benefits that an investigator may gain?
(3) What should I expect?
(4) What are the possible outcomes?
(5) When will I know of the outcome of the PAM review?

(1) What is post-approval monitoring?

Post-approval monitoring is an examination of the research facility and study-related documents to ensure that human and vertebrate animal subjects’ rights and welfare are protected, and that researchers are in compliance with applicable University and federal regulations. Post-approval monitoring helps ensure the safety of these research subjects, provides education to researchers, and identifies strengths and areas for improvement in research practice at UAlbany.

(2) What are some of the benefits that an investigator may gain?

Some possible benefits that may be gained from a review include:

  • increased understanding of the regulations that guide research at UAlbany;
  • increased communication regarding updates to federal and university regulations;
  • access to resources and individuals to clarify the federal and university regulations.

(3) What should I expect?

Generally, the PAM review is involves the following:

  • You will be asked to complete a protocol self-assessment questionnaire which asks for information about how the research study is being conducted and if there were any complaints or untoward events;
  • You may be asked to pull research records/files;
  • The PAM Administrator may request to observe ongoing research activities; e.g., procedures performed in the laboratory, the consent process or study procedures, as appropriate, and with the permission of study participants.

The scope of what is reviewed varies depends upon the type of research, but items that are reviewed may include any of the following:

  • retention and security of research documents;
  • appropriate use of committee-approved documents;
  • for research involving human subjects, re-evaluation of the risk/benefit assessment based on current study information and/or observation of the consent process;
  • that study procedures are conducted according to what is approved in the protocol.

(4) What are the possible outcomes?

A PAM review will result in one of several determinations:

  • the research activities are found to be compliant with the protocol: no further information is needed;
  • minor deficiencies are noted: the investigator provides a written plan to address the issues found within a designated timeframe, and e-mails the document back to the PAM Administrator;
  • significant deficiencies are noted: The Research Compliance Officer and the related review committee are notified of significant deficiencies. The investigator provides a written plan to address the issues found within a designated timeframe, and e-mails the document back to the PAM Administrator; the protocol may be subject to a more in-depth review and monitoring to ensure all issues regarding compliance are met.

(5) When will I know of the outcome of the PAM review?

If there are no findings or once the investigator satisfactorily responds to requests for clarification or revisions, a written report will be provided to the investigator within approximately five business days from the response.