Oncology Clinical Trials Support Unit (O-CTSU)

Specimens

Clinical Research Specimen Processing (CRSP) is committed to providing quality services in support of UM oncology research. CRSP provides research sample processing, aliquoting, storage and shipping, including chain of custody documentation of sample receipt through distribution, processing per protocol specific guidelines, freezer storage, as required and same day and/or batch shipments. Samples may be blood, urine, bone marrow aspirate, hair, saliva, stool, complex PK profiles, paraffin embedded tissue blocks or slide recuts.

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Data Management

The CTSU 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 CTSU 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

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Regulatory

The CTSU 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 CTSU 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-Site

The multi-site project management team provides data management and clinical monitoring support for multi-site trials coordinated by the CTSU 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

Finance

The CTSU 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.

• Clinical Trial Pre-award Support (LOIs, research billing calendar, budget development, budget negotiations, etc.)
• Clinical Trial Post-award Support (patient & study account reconciliation, patient reimbursement, etc.)
• Financial liaison (sponsor/CRAO/ORSP/study teams)
• Administer Cancer Center Trial Support (CCTS) Awards
• Finance management of O-CTSU service accounts
• O-CTSU department budget reconciliation for UMCCC

Informatics

Information 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, CTSU, 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.

CCTS

The Cancer Center Trial Support (CCTS) invests in investigator’s underfunded trials by subsidizing services of the Oncology Clinical Trials Support Unit (O-CTSU) and other specified institutional cores. The Oncology CTSU pre-award team will assess funding shortfalls. No separate application is required. This model is designed to draw a clear connection between the trial’s scientific merit determined by the Protocol Review Committee (PRC) and the funding award.

The CCTS website provides the requirements for supplemental support for IITs.

PRC

The University of Michigan Rogel Cancer Center Protocol Review Committee (PRC) is a multidisciplinary committee charged with providing peer review of the scientific merit, prioritization, and progress of all cancer clinical research conducted at the Medical Center. The goal is to improve the overall quality of clinical research throughout the University of Michigan Rogel 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.

DSMC

The University of Michigan Rogel Cancer Center Data and Safety Monitoring Committee (DSMC) is a multidisciplinary committee responsible for monitoring the safety and data integrity of all active cancer clinical trials that are not reviewed by another external, independent data and safety monitoring body.

The DSMC website was created to publish the data and safety monitoring requirements for all clinical trial research conducted in the Cancer Center and to provide guidance and support for Cancer Center investigators and study team members.

QARC

The Quality Assurance Review Committee (QARC) provides assurance that trials are conducted and data are collected, documented, and reported in compliance with the protocol and Good Clinical Practice (GCP) Guidelines by performing yearly quality assurance audits on all therapeutic trials that do not have an established external audit mechanism. The QARC reports all audit findings to the UMCCC DSMB and the DSMB performs any follow-up based on those findings. Additionally, the DSMB can request a ‘for cause’ QARC audit of a specific trial if the Board identifies a need for a more rigorous evaluation of an issue.