Monitoring is an essential element of study conduct designed to ensure ethical conduct, proper collection and documentation of study results, appropriate records of study procedures and subject interactions, and compliance with the approved protocol. Monitoring ensures the protection of subjects' rights and safety, as well as the integrity and quality of the resulting data.
The process of study monitoring begins in the early stages of study development, often with the development of a monitoring plan, and continues through site selection and study conduct to study closure. A description of the full spectrum of monitoring activities can be found in here.
The Office of Clinical Research (OCR) offers assistance to Penn faculty in obtaining monitoring services from Penn vendors.
Using the protocol and clinical trial monitoring plan, a monitor assists Sponsors in ensuring compliance. Specifically, monitors conduct periodic, ongoing review of subject records and regulatory documents including:
- Confirmation of subject eligibility
- Documentation of informed consent
- Protocol adherence
- Data collection and quality
- Source documentation review
- Study drug/device management and accountability
- Adverse event review and compliance with reporting obligations
- Compliance with sponsor-investigator obligations
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