Faculty of Medicine CHS

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Home Forms and Instructions Forms Ceded Review Deadlines and Timelines Committee Meeting Dates Consent Requirements Consent Templates Required Consent Elements Conditions for a Waiver of Consent Investigator Manual Policy and Procedures IRB Policy and Procedures HMS and Harvard University HIPAA at HMS Department Assignments ESTR Information ESTR Assistance Human Research Required Training CITI Human Subjects Training HETHR and Other Trainings Training Requirements Study Management Tools Definitions Reference Federal and State Guidelines Countway Library Records Review Harvard University Links Research with Student Participants Information for Multi-Site Studies Information for International Studies Information for Students Information for IRB Members Reviewer Sheets Educational Materials Quality Improvement Program (QIP) Information Contact Information	Post-Study Approval Monitoring Program (P-StAMP) The Office for Research Subject Protection and the Office for Research Compliance is proud to announce the formation of the Post-Study Approval Monitoring Program (P-StAMP) under the direction of our Quality Assurance Coordinator, Lisa Gabel. The mission of the program is to help carry out the Faculty of Medicine's commitment through its Human Research Protection Program (HRPP) to comply with Federal and State regulations governing research with human research participants and to help the investigator meet this commitment and ensure that research is conducted within accepted ethical standards. Through post-approval reviews P-StAMP aims to monitor investigator compliance with the approved research protocol and all Federal, State, and Institutional policies thus ensuring that research activities involving human participants, are carried out according to the highest standards. P-StAMP will conduct “Not for Cause” and occasionally “For Cause” study reviews if warranted. Studies chosen for "Not for Cause" review are selected equitably based on computer generated random prioritization that incorporates weighted risk factors. Research studies will be assessed in two separate stages: 1) Review of the Committee on Human Studies (CHS) files; and 2) Review of the research site and study files maintained by the Principal Investigator (PI). The review of the CHS files hopefully will capture any areas of the CHS record keeping or review process that may require corrective action to fully comply with federal, non-federal or institutional regulations or policies. The PI and Study Site Review component will provide an individual evaluation of the study’s strengths and areas that may require corrective action to fully comply with federal, non-federal or institutional regulations or policies. By evaluating both the CHS files and the way in which the PI is conducting the study, the monitoring program aims to provide “full circle” protection of human research participants. A separate component of the P-StAMP Program includes an annual review of Faculty of Medicine’s overall HRPP Program, in conjunction with the Office of Research Compliance (ORC). If you have any questions regarding P-StAMP or would like to request a P-StAMP review of your protocol please contact: Lisa Gabel Quality Assurance Coordinator 617.432.5842 lisa_gabel@hms.harvard.edu Updated: 22-Oct-2009
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