Clinical Trials Resources for Health Professionals

Clinical Trials Office

The Clinical Trials Office (CTO) provides services to assist cancer center investigators in developing, activating and completing scientifically meritorious clinical trials in an efficient, cost-effective and technically sound manner. The CTO provides services to assist investigators with:

• Protocol development
• Regulatory compliance
• Study start-up
• Data management
• Research nursing
• Auditing
• Patient accrual through the V-ISTA program

Learn more in the CTO Site Profile

Budgets and Contracts

The Budgets and Contracts office works in cooperation with principal investigators, industry and non-industry sponsors, and the Office of Contracts Management to develop, negotiate and execute comprehensive and compliant budgets/contracts for all types of clinical trials. The office handles a wide range of responsibilities relating to the budget “pre-award” functions, including:

• Budgets and letters of intent (LOIs) and budget revisions
• Outgoing subcontracts/budgets for multicenter trials
• Contract language review and negotiation of payment and operations terms with sponsor
• Submission of RAC applications for underfunded studies
• Billing Plan/FACTr submissions, and coordination with OCM and Dept of Finance
• Facilitation of contract execution process
• Tracking budget/contract status in OnCore throughout start-up process
• Completing OnCore financial console with budget information to support the “post-award” finance department
• Requesting new center and D&H numbers for all clinical trials
• Serving as subject matter experts on budget and billing questions
• Start-up metrics reporting

Compliance Office

The Compliance Office provides regulatory guidance in the conduct of clinical research at Vanderbilt-Ingram Cancer Center and oversight over the following entities:  

• Scientific Review Committee (SRC)
• Data and Safety Monitoring Committee (DSMC)
• Internal and External Audits
• Clinical Trials.gov registration and results reporting for institutional interventional cancer studies

The Compliance Office holds quarterly Research Compliance Educational presentations on compliance-related topics and communicates monthly compliance tips on Federal guidelines, Good Clinical Practices, institutional policies and departmental standards of operating procedures (SOPs) pertaining to clinical research.

In accordance with the cancer center's Data and Safety Monitoring Plan (DSMP), the audit staff performs internal compliance audits of interventional cancer trials. We also provides guidance and support for investigators and clinical research staff in the preparation and conduct of external audits such as industry-sponsored trials, government sponsored such as NCI/NIH trials and FDA inspections.

 

Clinical Research Implementation Committee

The Clinical Research Implementation Committee (CRIC) provides a forum for clinical trial and clinical research protocol review and problem solving. The committee is responsible and accountable to open clinical trials and implement operational efficiencies in clinical research. The committee provides discipline-specific expertise in clinical research and the conduct of clinical trials in a manner that reduces cost and increases efficiency and effectiveness. The CRIC:

• Provides real-time, ongoing review of protocols across disciplines to ensure operational efficiencies
• Provides early access to pending protocols so that hospital-based services can plan for volumes and needs
• Improves communications to build accountability
• Recognizes and operationalizes process and/or service improvement opportunities that will reduce or eliminate barriers to participating as experienced or perceived by patients

The CRIC holds meetings twice monthly. For schedule and agenda, log in to CRIC Intranet site below.

Download Confidentiality Agreement 

Data and Safety Monitoring Committee

The Data and Safety Monitoring Committee (DSMC) provides centralized review of adverse drug events and safety issues for investigator-initiated trials and NCI-funded trials. The DSMC also audits institutional trials to ensure that the conduct and integrity of the study are of the highest quality and that all trials adhere to the regulatory requirements. All therapeutic and device investigator-initiated and NIH/NCI-funded clinical trials are monitored for scientific progress, accrual, data completeness, and regulatory compliance.

The purpose of the DSMC is to ensure:

• The safety of clinical trial participants
• The validity and integrity of data for all NIH-supported and investigator-initiated clinical trials
• Compliance with NIH policy on data and safety monitoring for NIH-supported clinical trials

For more information on committee membership, meetings and the Data and Safety Monitoring Plan, visit:

Resource Allocation Committee

The Resource Allocation Committee (RAC) provides budget or gap funding to prospective therapeutic studies that materially support the mission and vision of the cancer center.

For general questions, email: vicc-rac@vumc.org

For more information about funding criteria and submitting requests, visit:   

Scientific Review Committee

The Scientific Review Committee (SRC) ensures that all cancer clinical trials conducted under the auspices of the Vanderbilt-Ingram Cancer Center meet peer-reviewed standards of scientific design, including appropriate scientific rationale, specific aims, study endpoints, biostatistical analysis, and adequate ability to accrue patients. These criteria ensure that the study is conducted in accordance with the scientific principles and integrity maintained by the Vanderbilt-Ingram Cancer Center, that the scientific aims of the study can reasonably be met, and that cancer center resources used to support clinical investigation are appropriately and wisely used.

For more information about the scientific review process, submission guidelines, and committee meetings, members, and resources, visit: