Our vision is to be the partner of choice in research that changes cancer therapy.The Clinical Trials Office (CTO) serves as the centralized core facility of all clinical research trials conducted by investigators at the University of Michigan Comprehensive Cancer Center (UMCCC). This includes investigator-initiated (II), peer reviewed clinical trials, NCI-CTEP approved protocols, pilot transitional institutional studies, cooperative group trials and industry sponsored trials. The CTO offers a broad range of expert services to investigators to help them facilitate the conduct of their studies according to federal regulations and GCPs.
Data ManagementThe CTO Data Management (DM) Teams provide all aspects of data management and research support services beginning with pre-trial review and planning through study close-out. The data management teams work closely with the investigators and study teams on individual projects to understand their support requirements and ensure those requirements are delivered according to GCP’s and the relevant CTO Standard Practice Guidelines.
- Study startup liaison
- Pre-site visit coordination
- Eligibility determination
- CRF development
- Source document development
- Monitor visit coordination
- SAEs- monitor and report
- Data queries
- Protocol deviation reporting
- CRF completion
- Patient enrollments, registrations, screening
- Data liaison between study team/sponsor
- Facilitate audit preparation
- MCRU Liaison (facilitate study start-up and data collection)
- Specimen/sample coordination
- Coordinate IDS monitor visits, patient registration
- Data Safety Monitoring Reports
- Non-TRL lab kit inventory management
- Liaise with MICHR- IND support
- Ad Hoc reports
RegulatoryThe CTO Regulatory team ensures regulatory compliance during the conduct of clinical research studies via appropriate management of clinical study documentation as well as actively supporting the all regulatory aspects of clinical trials start-up, conduct and close out. The regulatory team works closely with the projects to understand their support requirements and ensure those requirements are delivered according to GCP’s and the relevant CTO Standard Practice Guidelines.
- IRB submissions (Initial Approval, Amendments, Renewals, SAEs, DSMR’s ORIOs)
- Compliance with Sponsor Forms
- Trial Master File
- FDA mandated forms
- Consent Documents
- CRBU compliance
- IRB compliance
- Management of outside drug safety letters, reports
- Ancillary committee compliance
- Liaison with internal and external audits, including FDA
- Regulatory liaison between study team/sponsor/IRB
Multi-SiteThe multi-site project management team provides data management and clinical monitoring support for multi-site trials coordinated by the CTO from trial start-up through trial closeout.
- II trials coordination with peer investigators and institutions
- Assist in the coordination of site budget and sub contract development
- Develop and maintain study operations manual
- CRF and Database development
- Maintain master trial file
- Coordinates and track regulatory, data management, DSMB, SAE submissions
- Review Informed Consent Documents
- Prepare sites for study start-up by reviewing and tracking regulatory documents, ordering study start-up supplies and conducting site initiation visits
- Manage central enrollment of all study subjects
- Coordinates distribution of protocol amendments and SAEs to sites, study supporter and FDA.
- Coordinate and facilitates conference calls
- Oversite of Sample management
- Oversite of drug distribution process (multi-site)
- Conduct site monitor visits and follow-up
- Work with protocol statisticians during interim and final analysis
- Liaison between coordinating center and external sites to resolve any issues that arise during the conduct of the trial
OutcomesThe Standard of Care teams provide support for the collection of data and ongoing communication with external supporting agencies to assure complete and accurate documentation of retrospective patient care outcomes.
- SOC- BMT long-term follow-up CIBMTR database
- NCCN- data collection
FinanceThe CTO Finance team provides financial analysis and resource management services to support Cancer Center Investigators. This team works collaboratively with sponsors, doctors, patients, faculty and staff to offer centralized, integrated and flexible financial management of clinical trials.
- Ravitz Phase I pre and post award, billing calendar
- Financial liaison between sponsor/CRBU/DRDA/study team
- Administer CTRAC pre and post award
- Oversight of billing for CTO services
- CTO budget/account reconciliation for UMCCC
InformaticsInformation Technology team provides database infrastructure supporting research operations such as data collection and reporting for data management, regulatory, administration, and auditing. The infrastructure is centralized around Velos eResearch, a commercial web-based application, along with in-house developed applications to meet the various needs.
- Database technical support and training
- Electronic case report form development with DM staff
- Customized reporting for Cancer Center, CTO, Programs, Studies, PIs
- Data migrations to Velos eResearch from Excel, Access, etc
- Support for both clinical trials and outcomes research
- Coordinators innovation and advancements with other IT groups: MICHR, MSIS, MCIT, etc.
AdminThe CTO administration provides infrastructure support for CTO operations.
- Feasibility meetings
- Day to day operational issues
PRCThe University of Michigan Comprehensive Cancer Center maintains a multidisciplinary committee known as the Protocol Review Committee (PRC). The PRC is charged with providing peer review of the scientific merit of all cancer clinical research in the Medical Center and defining priorities for the use of Cancer Center resources. The goal is to improve the overall quality of clinical research throughout the Comprehensive Cancer Center.
The PRC website was created to provide tools and support for Cancer Center investigators and study team members to assist with the development and the submission of clinical research protocols for PRC review and approval.
DSMBThe University of Michigan Comprehensive Cancer Center Data and Safety Monitoring Board (DSMB) is responsible for monitoring all on-going clinical trials initially reviewed by the Comprehensive Cancer Center Protocol Review Committee. The purpose of the DSMB review is to monitor the scientific progress, accrual, continued scientific merit, data integrity and safety of appropriate research protocols.
The DSMB review is focused on investigator-initiated trials, including phase I trials and other high-risk studies, which are not reviewed by another external data and safety monitoring body. Protocols that have established data and safety monitoring boards or oversight committees, such as multi-institutional, national cooperative group trials or industry-initiated trials, are monitored for local accrual performance.
The DSMB website was created to publish the investigator responsibilities and data and safety monitoring requirements for all clinical trial research conducted in the Cancer Center. The site also provides supporting documents and guidance for Cancer Center investigators and study team members.