ICTR Study Monitoring Service (SMS) is available to investigators conducting investigator-initiated clinical trials. Not only is independent study monitoring required by the FDA, the NIH (as applicable) and other national and international best practice models (e.g., Good Clinical Practice), it is also a responsibility of the sponsor-investigator to ensure data integrity and the safety of all subjects involved in clinical investigations.
Sponsors typically perform this activity, but when the sponsor is the investigator (as in investigator-initiated trials), this obligation must be fulfilled the investigator. ICTR Study Monitoring Service can be contracted to help investigators meet their trial monitoring obligations by providing independent oversight of the trial (for the life of the trial) and verifying that the trial is in compliance with the currently approved protocol and applicable regulatory requirements.
Study monitoring activities include:
- Study initiation meetings
- Regular monitoring visits (on-site and remotely) to review study records (regulatory files, consent forms, case report forms, drug/device accountability logs, etc)
- Close-out visits
The Study Monitoring Service is available on a fee-per-study basis (fees based on study characteristics influencing monitor effort commitment).
The ICTR Study Monitoring Service also offers a number of additional services to investigators at no cost:
- Pre-FDA or -NIH audit preparation
- One-time compliance review
- Review of research team’s compliance infrastructure and organization processes
- Assistance answering regulatory or compliance related questions
Finally, the ICTR Study Monitoring Service also conducts random surveillance and for-cause audits at the behest of organizational officials (e.g., UW Health leadership, IRB, Office of Research Policy) in fulfillment of institutional compliance oversight obligations or in response to study-specific concerns.
ICTR Study Monitoring Service is also involved in the management of the Clinical Research Toolkit to help researchers initiate and conduct research in a compliant manner.
To learn more, ask general questions, and/or request study monitoring services, contact Tracy Ohrt via the methods below or complete the consult form to request an in person consultation.