The UW Office of Clinical Trials, established in 1988, today offers comprehensive support services to investigators conducting clinical trials (all areas of investigation except oncology) through the UW Institute for Clinical and Translational Research.
The OCT provides services on a fee-for-service basis. In general, regulatory services are provided for a fixed fee, while financial and clinical coordination services are provided at hourly rates.
OCT offers services to investigators regardless of funding source. While the majority of current studies are industry-sponsored, many federal grants, subcontracts, investigator-initiated studies, or foundation-sponsored trials are also supported.
Contracted OCT regulatory services include development of the initial submission to HS-IRB, Minimal Risk IRB, Western IRB, VA, or deferral requests. Regulatory specialists steer the protocol applications through IRB pre-review and assist in all aspects until IRB or other approvals are received.
OCT Regulatory Services concentrate exclusively on regulatory submissions and maintenance for HS-IRBs, WIRB, Meriter, VA, and other regulatory bodies related to human clinical trials. OCT regulatory specialists work together on applications for hundreds of individual protocols, from industry to investigator-initiated protocols, and from single site to multi-center oversight projects. They work closely with OCT coordinators, financial specialists, and IRB personnel to assure an accurate, complete, and comprehensive IRB submission.
Regulatory Services information can be found at the ICTR OnCore Help and Documentation Knowledge Base
Regulatory services can be contracted separately from other OCT services – individually by any SMPH investigator for a specific activity or for the life of the study.
For assistance with regulatory services for your clinical trial please request a consultation.
The Office of Clinical Trials provides budgetary services in a variety of ways, from those that help investigators meet billing compliance requirements to others that help investigators negotiate and manage contracts.
OCT provides without charge certain budgetary services to all School of Medicine and Public Health investigators to assure billing compliance, but also contracts with investigators or departments to deliver a list of more comprehensive, intensive financial management services. In addition, OCT offers budget development services for new grant applications.
Annual Purchase Agreements
Purchase Agreements (with discounted hourly rates) are up-front bulk purchases that can result in up to 45% discount from usual OCT hourly service rates. These volume purchases are through an ICTR-OCT agreement. For more information, contact OCT Interim Director, Jennifer Parnell at (608) 265-0631 or at firstname.lastname@example.org.
OCT Coordination Services has qualified research specialists specifically trained to provide comprehensive protocol implementation from the initial study feasibility analysis through end of study. OCT coordinates studies at UWHC. Coordination services may also be available at other locations, including the VA Hospital, Meriter Hospital, and UW Health Clinics.
Many OCT coordinators are CCRC (Certified Clinical Research Coordinator) certified – a higher professional recognition of research competence. OCT coordinators function under the HIPAA covered entity and have access to Healthlink and Oncore records for review and ongoing documentation of research subjects.
OCT coordinators work closely with the PI, industry sponsor (if applicable), the Pharmaceutical Research Center, and OCT Regulatory and Budgetary services to ensure an efficient study start up and smooth implementation throughout the study.
Study Administration Services
- Initial study feasibility analysis
- Oncore entry and assisting OCT Budgetary with study budget development
- Development of source documentation and recruitment materials
- Ongoing liaison with external sponsor and PI/Study Team
- Working with and training ancillary departments to arrange for study-related activities
- Receiving and inventorying study supplies
- Maintaining all study-related regulatory documents and materials
- Collaborating with OCT Regulatory to ensure timely IRB submission of continuing reviews, protocol amendments, and other IRB required reporting
- Scheduling and implementing monitoring visits
- Completing archival storage of study-related documents
- Subject prescreening/eligibility
- Obtaining Informed consent
- Completing study visits and performing/assisting with required procedures
- Completing required visit documentation and billing
- AE and SAE reporting
- Ongoing liaison for all subject–related communications with PI/Study Team
OCT coordination services can be contracted separately by any SMPH investigator. To request coordination services for your clinical trial, please complete the OCT Consult form.
External Sponsor Liaison
OCT provides the connecting link between external sponsors seeking a potential investigator and/or site for a sponsored trial and accomplished UW clinical investigators. Sponsors interested in identifying a UW investigator should complete the OCT Consult form.
Main office (Administration, Finance, Regulatory): Suite 210, 800 University Bay Drive, Madison, WI 53705-2881; mail code 9445
Main clinical office: H6/174 CSC, 600 Highland Ave, Madison, WI 53792; mail code 1615