Monitoring for Sponsor-Investigator IND/IDE Clinical Trials
The ECS-HSR Division provides local monitoring services to sponsors of clinical investigations that involve an Investigational New Drug (IND) application or Investigational Device Exemptions (IDE) with approval to proceed by the U.S. Food and Drug Administration (FDA).
The monitoring services are completed by trained Education and Compliance Support (ECS) Coordinator(s) to assist with fulfilling the sponsor’s requirement to monitor the progress of the clinical investigation(s).
There are three types of monitoring visits: initial, interim, and close-out visits. A report summarizing each monitoring visit is generated by the ECS-HSR and provided to the appropriate parties. All monitoring visit reports are reviewed by the Compliance Activity Reviews (CARs) Committee and may also be reviewed by the IRB Executive Committee.
Initial Monitoring Visit
An initial monitoring visit usually occurs after IRB approval and, when possible, prior to subject enrollment. This visit is conducted by the assigned ECS Coordinator(s) with the research team and involves an in-depth review of the protocol, source documentation, implementation plan, and identifying the individual(s) responsible for protocol activities.
Interim Monitoring Visit
- Rights and well-being of human subjects are protected,
- Original source documentation is maintained for research subjects,
- Study is conducted in accordance with the protocol and applicable regulatory requirements,
- Adverse events and serious adverse events are accurately and timely reported,
- Protocol deviations/noncompliance are addressed and properly reported,
- Regulatory file is maintained and contains up-to-date essential documents,
- Study product storage is appropriate, as applicable, and
- Study product accountability is accurate, as applicable.
A close-out visit occurs after all subjects have completed their final study visit and all documentation has been completed. The close-out visit is conducted to:
- Formally document the termination of the study,
- Review remaining study documentation,
- Complete final study product accountability, if applicable,
- Complete a final essential documents review, if applicable,
- Confirm resolution of data queries, and
- Verify that the investigator understands his/her post-study obligations.
Monitoring for Other Clinical Trials
The ECS-HSR Division provides fee-based study monitoring services to investigators of other clinical trials at the University of Pittsburgh. We encourage study teams to contact us early in the study development process if monitoring services are needed.