Research Services and Resources

Please note that only designated Carilion Clinic employees may negotiate and execute contracts on behalf of the organization. Research and Development is designated to provide this service on behalf of the institution and its employees. The Institutional Research Official is the authorized signatory for all research-related contracts.

Research and Development will work directly with legal services, outside collaborators, clinical trial industry sponsors and vendors on behalf of Carilion Clinic investigators to negotiate and execute the following agreements:

Confidentiality and Nondisclosure Agreements

A confidentiality agreement, which is also known as nondisclosure agreement (NDA), is a contract between two or more parties in which the subject of the agreement is a promise that information conveyed will be maintained in secrecy.

Clinical Trial Agreements

Clinical trial agreements (CTAs) are legally binding agreements between a sponsor and an institution (site) as to how certain business and property rights will be dealt with between the parties. CTAs are important because they allocate risk, responsibility, financial support and obligations of the parties, while protecting the rights of the parties. CTAs may also be referred to as clinical research agreements or clinical study agreements.

For CDAs and CTAs, please contact:

Andrea Mohr, MHA, CCRP
Director of Clinical Trials
abmohr@carilionclinic.org

Primary and Subaward Agreements

Subaward agreements are between an institution that has a sponsored agreement (primary awardee) and another institution (subrecipient) that will perform a portion of the work. The subaward agreement includes elements of the primary agreement between the sponsor and the primary awardee by incorporating many of the terms and conditions that have been agreed to by the external sponsor and the primary awardee. This agreement covers the entirety of the relationship between the primary awardee and the subrecipient and contains provisions covering payments, financial reporting, intellectual property, publication rights, data retention, etc.

Grant agreements are legally binding agreements of financial assistance between an awarding agency or pass-through entity and an institution (site).

For grant agreements and subaward agreements, please contact:

Vera Hollen, MA
Grants Management Director
vlhollen@carilionclinic.org

For all other agreements listed below, excluding business associate agreements (BAAs), please contact:

Melissa Z. Mercure, PhD
Contract Analyst
mzmercure@carilionclinic.org

Research Service Agreements

A research service agreement is a contract between the institution and an outside contractor for performance of outside services for sponsored research funds.

Research Collaboration Agreements

Research collaboration agreements (RCAs) are contracts between Carilion Clinic and one or more organizations that are cooperating in the conduct of a research program.

RCAs encompass any additional agreement required for grants or clinical trials not listed above, with the exception of business associate agreements (BAAs). Carilion Clinic’s Office of Integrity and Compliance manages all BAAs on behalf of the organization.

Material Transfer Agreements

A material transfer agreement (MTA) is a contract governing the transfer of tangible research materials between two organizations, when the recipient intends to use it for their own research purposes. The MTA defines the rights of both the healthcare professional and recipient with respect to the materials and derivatives.

Data Use Agreement

Data use agreements (DUAs) are contractual documents used for the transfer of data that has been developed by nonprofit, government or private industry, where the data is nonpublic or is otherwise subject to some restrictions of use.

• Coverage analysis
• Clinical trial budget preparation
• Grant budget preparation
• Budget negotiation with external partners

For industry-sponsored clinical trial budgeting services, budget negotiations and coverage analysis, please contact:

Andrea Mohr, MHA, CCRP
Director of Clinical Trials
abmohr@carilionclinic.org

For grant budgeting services, please contact:

Vera Hollen, MA
Grants Management Director
vlhollen@carilionclinic.org

Clinical Research Coordinator and Regulatory Specialist Pool (CRC/RS Pool):

Clinical research is a highly regulated, fast-paced field requiring skilled and flexible resources to provide efficient study startup, compliant study conduct, and support for busy research investigators. The CRC/RS Pool is a team of trained professionals able to manage a wide range of customizable responsibilities to best fit the needs of your research team.

About:

Due to the complexities of clinical research, study teams utilizing experienced staff can manage study processes efficiently and respond quickly to the ever-evolving clinical research landscape. Hiring CRCs and regulatory staff requires significant time and investment. The CRC/RS pool provides on-demand, reliable support. All CRC/RS staff have received full onboarding and training prior to receiving assignments. Continuing education is provided to remain current with regulations, policies, SOPs, and best practices.

In addition to CRC and Regulatory Specialist competency verification, staff have completed the following training: Human Subject Research Protections, Good Clinical Practices (GCP), Biomedical Researcher, eReg, Clinical Conductor CTMS, Epic, IATA, and clinical skills (i.e., vital signs, ECG, and phlebotomy, as needed). Our team is proficient with REDCap and multiple EDC systems.  The CRC/RS pool has diverse experience working with multiple sponsors and systems across Carilion Clinic.

Services:

The CRC/RS pool can provide the following support services, customized to fit specific project needs:

• End-to-end project support (study startup, implementation, coordination and closeout, including regulatory and IRB process support)
• Temporary CRC coverage for employees on leave or during periods of turnover
• Supplemental support during busy study periods (enrollment push, etc.)
• CRC/RS support for PIs who do not have funding for a full-time CRC or Regulatory Specialist

Support requests can be full-service or a la carte, including:

Clinical Coordination:

• Subject prescreening and subject recruitment
• Obtaining informed consent
• Data collection
• CRF completion/query resolution
• Specimen collection/processing
• Receipt and inventory of study supplies
• Central imaging uploads
• Study visit completion in accordance with study protocol
• AE and SAE reporting
• Ongoing liaison for all subject-related communications with PI/study team
• Ongoing liaison with external sponsor and PI/study team
• Monitoring/audit visit preparation and management

IRB and Regulatory:

• Preparation and submission of IRB applications in PRIS3M, including stipulation responses
• Customization of consent form templates with site-specific requirements
• Preparation of subject recruitment materials
• Preparation and submission of regulatory documents (e.g. 1572, Financial Disclosure Forms, CVs, etc.)
• Preparation and submission of amendments to the IRB including revisions to the ICF
• Regulatory document preparation (Investigator Site File)
• Preparation of study documents (e.g. source documents, participant visit packets, dosing cards, etc.)
• Monitoring/audit visit preparation and management
• Study archival

Payment and Fees:

CRC/RS Pool staff are available as a fee-for-service program. This service can be requested by any Carilion Clinic investigator.

• CRC/RS support is charged at an hourly rate, inclusive of benefits
• CRC/RS time is tracked via effort reporting and charged to the project activity code and/or designated cost center on a monthly basis
• For studies in start-up, time will be captured via effort report under ‘non-sponsored’ effort until the creation of a project activity code. At the time of activity code creation, the charges will be transferred to the project activity code or designated cost center.
• Based on the requested services, R&D can provide estimated budgets to investigators for planning purposes
• Services are provided during normal business hours (M-F, 8am-5pm)
• Time allowed per investigator or per study will be monitored and adjusted based on need and overall demand for service
• Requests will be managed on a first-come, first-served basis, contingent upon resource availability

Request Process:

Complete the form linked below to request central CRC/RS support services:

CRC/RS Request Form

Prior to beginning a work assignment, the assigned staff will need to complete all study-specific protocol training. Additionally, a study kickoff meeting may be scheduled with the study team in order to ensure there is a clear understanding of expectations and scope of work.

If central support is no longer needed, the assigned CRC/RS Pool team member will assist with the transition process and will continue providing support until the transition is complete.

Research and Development employs a clinical research financial specialist to manage clinical trial invoicing, billing compliance and financial reporting.

For clinical research financial requests, please contact:

Robin Dair, MA, PMP
Financial Servies Manager - Clinical Trials 
radair@carilionclinic.org