Post Approval Monitoring
Monitoring enhances human subject protections by promoting regulatory compliance and supporting institute-wide standards for the ethical conduct of research. At NYSPI, monitoring of IRB approved research activities includes a conventional compliance auditing function, but also enriches the process of ongoing review of approved research by providing data on the experience of subjects participating in the research and interim data on risks and benefits. Finally, the monitoring process contributes to investigator education and training. Click on each of the following monitoring activities to view a description.
Monitoring activities include monitoring IND or IDE Regulatory binders. All FDA-regulated studies must maintain a Regulatory Binder with essential documents. These documents individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced and serve to demonstrate the investigators compliance with Good Clinical Practice Standards and all applicable regulatory requirements. When monitoring studies that are FDA-regulated, the IRB Research Monitor will review the Regulatory Binders to ensure that they contain all required documents.
- Record Review
Record review is aimed at determining compliance with IRB approved recruitment, consent, procedural, exclusion, drop-out and adverse event reporting requirements. For this type of review, the IRB research monitor, or others independent of the research team, examine research files and charts.
Self-Assessment (Record Review)
Record review, as above, is conducted by a member of the research team. Training, oversight, and periodic re-audit are conducted by the IRB research monitor.
The research monitor observes the subject’s participation in a study procedure or component. Procedural observation assesses the subject’s experience during the research procedure, ensures compliance with research procedures as specified in the research protocol, and observes the environment of care and the research team’s interactions with the subject with regard to privacy, safety, and respect.
The research monitor observes the consent process to assure that required information is conveyed to the subject, the subject’s understanding of the study is facilitated and the choice to participate is carefully considered and discussed. The monitor may focus the assessment on one component of the consent process, at the request of the IRB, when special emphasis is required.
Interim Progress Reports
The IRB regularly requires investigators to “report back” as a condition of initial approval. The IRB will require that the investigator provide information on the experience of the first subjects to take part in the study—on either a case basis or after a defined number of subjects have been enrolled or complete study procedures. The Board regularly requires this information when novel or high- risk procedures are involved.
Special monitoring refers to any other form of monitoring conducted at the request of the Board or the chair. For example, special monitoring may be requested following the report of an adverse event to document that study inclusion and exclusion criteria or study drop-out criteria were met as per the approved protocol. In the event of a report of a protocol violation, special monitoring may require a systematic audit of study compliance with consent documentation requirements.
Subject Feedback Surveys
Periodically, the IRB Monitor may request a study to query their participants regarding their experience in the study.
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