Clinical Research

We strive to deepen clinical insight and support the continuous learning of our physician community through active engagement in research. Each year, we participate in a wide range of clinical trials designed to explore new approaches to prevention, diagnosis, and treatment across many conditions. These efforts not only contribute to scientific discovery but also offer patients the opportunity to consider research participation as part of their care journey.

Clinical trials are research studies involving human participants that help scientists and clinicians evaluate new treatments, procedures, or approaches to care. These studies are essential for determining whether new interventions are safe and effective.

Types of trials may include:

  • Testing new medications or medical devices
  • Comparing standard treatments
  • Studying disease prevention or early detection
  • Improving quality of life for those with chronic illness

By joining a clinical trial, you play a direct role in advancing science and potentially gaining access to promising new therapies.

Potential benefits:

  • Access to leading-edge treatments not widely available
  • Close monitoring by a team of medical experts
  • Contributing to discoveries that benefit future patients

Please note: Participation is always voluntary, and you can withdraw at any time.

Each study is unique, but participants generally go through these steps:

  • Pre-screening – Learn more and determine eligibility
  • Informed Consent – Review and sign documents with full transparency
  • Participation – Attend study visits, follow the protocol, ask questions
  • Follow-up – Some studies include check-ins after treatment ends

Questions are always welcome. Your safety and comfort are our top priorities.

All clinical trials at [Institution] follow strict ethical standards. Studies are reviewed by an Institutional Review Board (IRB) to protect participant rights and welfare.

We are committed to:

  • Clear and honest communication
  • Respecting your privacy and data
  • Ensuring that participation is fully voluntary

  • Will it cost me anything?
    Most trials cover study-related procedures. Any potential costs or reimbursements will be discussed upfront.
     
  • Can I leave a trial early?
    Yes. You can withdraw from any study at any time, for any reason.
     
  • What if I don’t qualify?
    Even if you’re not eligible for one study, we may help connect you with others that are a better fit.

At Â鶹´«Ã½, decisions to participate in industry-sponsored clinical trials are made within the clinical units based on alignment with departmental priorities, faculty interest, and available resources. Once a study is identified, we work closely with sponsors and CROs to facilitate a timely and compliant contracting process.

Sponsors and CROs are encouraged to connect directly with the appropriate physician-investigator or study team with expertise relevant to the trial. During this stage, it is critical that sponsors provide:

  • Full study protocol

  • Draft budget and contract (CTA)

  • Investigator brochure or product information

  • Any required sponsor/CRO questionnaires or feasibility forms

Once the clinical team has reviewed the study and it has completed all required internal and scientific feasibility reviews, the assigned Â鶹´«Ã½ study coordinator or VHS regulatory liaison will submit the trial for institutional risk assessment, negotiation, and approval via the internal Clinical Trial Request Form. This submission formally initiates:

  • Budget negotiation

  • Clinical Trial Agreement (CTA) review

  • IRB or other regulatory pathways as applicable

As part of this process, the sponsor/CRO will be introduced to the designated points of contact for:

  • Budget negotiation

  • Contract review and execution

To ensure proper institutional oversight and audit readiness, all Clinical Trial Agreements must be routed and negotiated through the Sponsored Programs Administration Clinical Trials Team via the approved internal workflow. Contracts submitted outside of this process—such as directly to investigators or via unsolicited email—will not be reviewed or accepted.

To help streamline the review process, sponsors should be aware of:

  • Â鶹´«Ã½ participates in any national contracting programs (e.g., ACTA, Accelerated CTA review initiatives)

  • Use of pre-negotiated templates, if available

  • CTA negotiations must follow the institutional routing process. Submissions outside of formal workflows delay review and may compromise compliance.

  • Budget and contract negotiations occur in parallel and are handled by the Sponsored Programs Administration Clinical Trial Team.  

  • Timelines vary depending on sponsor responsiveness, use of standard terms, and regulatory readiness.

°¿¶Ù±«â€™s Sponsored Programs Administration Clinical Trial Team operates through the Research Foundation.

  • Standard CTAs are executed by the University, which serves as the contracting party.

  • Only when CTAs include non‑conforming terms (i.e. language the University cannot accept) are they executed through the Research Foundation.

This structural arrangement is similar to other institutions with foundations, where the foundation supports contracting for exceptions while typical CTAs remain under university authority.

To facilitate faster review and execution, we strongly encourage sponsors and CROs to use one of the following standard agreement templates:

  • ACTA (Accelerated Clinical Trial Agreement)

  • ACDA (Accelerated Confidential Disclosure Agreement)

  • ¹ó¶Ù±Ê‑C°Õ³§´¡ (Federal Demonstration Partnership Clinical Trial Subaward Agreement)

  • °ä°Õ³§´¡â€‘D°Õ±«´¡ (Data Transfer and Use Agreement for CTSA-supported trials)

These templates have been widely adopted across U.S. academic medical centers and government-funded institutions.  Studies have shown that using ACTA reduced contract negotiation timelines by an average of 40–55 days, and use of ¹ó¶Ù±Ê‑C°Õ³§´¡ often saved even more time—up to 57 days.

How does using these templates benefit the process?

  • Significant time savings: ACTA and ¹ó¶Ù±Ê‑C°Õ³§´¡ negotiations complete more rapidly than non-standard contracts 

  • High acceptance rate: Over 350 sites have adopted these agreements and accept them without modification.

  • Reduced negotiation scope: Where modifications occur (e.g., MACTA), efforts are focused on a few key terms rather than the whole agreement, further accelerating the process. 

 

  • If a CTA contains non-conforming terms that the University cannot accept (e.g., governing law provisions, indemnification beyond state limits, non-standard intellectual property clauses), the agreement will be processed through the Research Foundation.

  • This exception process ensures compliance with institutional policies while still allowing flexibility when required.

For information on submitting a clinical trial for contract review, or to confirm the correct process, contact the Â鶹´«Ã½ Clinical Trials Team at:  rfhsc-clinical@odu.edu

We offer sponsors and CROs the opportunity to use the Accelerated Clinical Trial Agreement (ACTA) template as part of the University’s commitment to expedite the contracting process and facilitate clinical trials opening faster. Projects that utilize the unmodified ACTA will be fast-tracked for contract negotiation.  We can do this because the unmodified ACTA requires no negotiation.

Only use of the unmodified ACTA qualifies a study for expedited contract review. 

There are three ACTA templates available: 

There are three ACTA templates available:

  • Standard ACTA: contracting parties are sponsor and institution;
  • CRO-ACTA: contracting parties to the CTA are CRO and institution, separate letter of indemnification between sponsor and institution included as exhibit;
  • Coming Soon: International ACTA: parties are sponsor and institution; used when the sponsor is a foreign entity.

Each template has been pre-filled with certain Â鶹´«Ã½ information.  For your convenience, the areas that require sponsor or study specific information have been highlighted in yellow.  Complete those fields ONLY – make no other changes –  and return the template to the Â鶹´«Ã½ VHS clinical study team contact who provided it to you.  If you receive this template early in Â鶹´«Ã½'s internal process, your contact likely is the assigned clinical study team's research coordinator.  

PLEASE NOTE:  ANY REVISIONS WHATSOEVER to the ACTA template will disqualify the study for expedited contract review, and the agreement will be reviewed according to its position in the queue. 

*PLEASE NOTE:  The contract, budget, and regulatory processes are three separate processes that are undertaken in parallel.  Contract execution requires that both contract language and study budget are finalized but does not necessarily require that the IRB process is complete although the language in the informed consent form (ICF) must be reviewed and aligned with the contract terms.  However, the study cannot open until the contract is fully executed and the study has IRB approval. 

The Accelerated Clinical Trial Agreement (ACTA) is a nationally recognized, pre-negotiated template designed to streamline the contracting process for industry-sponsored clinical trials. Developed collaboratively by academic research institutions, contract research organizations (CROs), and industry sponsors, the ACTA reflects balanced, neutral language that does not favor either party.

This standardized agreement is widely accepted across the clinical research community and helps reduce negotiation time by addressing common legal and administrative terms up front.

More information about the ACTA is available from the following organizations:

 

At Â鶹´«Ã½ and the Â鶹´«Ã½ Research Foundation, we are committed to building efficient, collaborative partnerships that accelerate clinical research and advance innovation. To support this mission, we’ve outlined our institutional expectations and preferred practices for negotiating Clinical Trial Agreements (CTAs) in an open letter to sponsors and CROs.

This letter outlines our institutional terms and expectations for sponsors or CROs who propose using their own Clinical Trial Agreement (CTA) templates. While we are prepared to review sponsor-provided agreements, we strongly encourage the use of nationally accepted templates—such as the Accelerated Clinical Trial Agreement (ACTA) and other standard agreements—which help expedite contract negotiations and reduce administrative delays.

For access to these recommended templates, please visit: Â鶹´«Ã½ Research Foundation Clinical Research Agreement Templates

👉 Access the Open Letter to Sponsors and CROs (PDF)

For additional information or assistance, please contact our Sponsored Programs Administration Clinical Contracts Team at rfhsc-clinical@odu.edu.

Please see the F&A Rate Guidance for Clinical Contract Agreements F&A rate. 

We strive to deepen clinical insight and support the continuous learning of our physician community through active engagement in research. Each year, we participate in a wide range of clinical trials designed to explore new approaches to prevention, diagnosis, and treatment across many conditions. These efforts not only contribute to scientific discovery but also offer patients the opportunity to consider research participation as part of their care journey.

Clinical trials are research studies involving human participants that help scientists and clinicians evaluate new treatments, procedures, or approaches to care. These studies are essential for determining whether new interventions are safe and effective.

Types of trials may include:

  • Testing new medications or medical devices
  • Comparing standard treatments
  • Studying disease prevention or early detection
  • Improving quality of life for those with chronic illness

By joining a clinical trial, you play a direct role in advancing science and potentially gaining access to promising new therapies.

Potential benefits:

  • Access to leading-edge treatments not widely available
  • Close monitoring by a team of medical experts
  • Contributing to discoveries that benefit future patients

Please note: Participation is always voluntary, and you can withdraw at any time.

Each study is unique, but participants generally go through these steps:

  • Pre-screening – Learn more and determine eligibility
  • Informed Consent – Review and sign documents with full transparency
  • Participation – Attend study visits, follow the protocol, ask questions
  • Follow-up – Some studies include check-ins after treatment ends

Questions are always welcome. Your safety and comfort are our top priorities.

All clinical trials at [Institution] follow strict ethical standards. Studies are reviewed by an Institutional Review Board (IRB) to protect participant rights and welfare.

We are committed to:

  • Clear and honest communication
  • Respecting your privacy and data
  • Ensuring that participation is fully voluntary

  • Will it cost me anything?
    Most trials cover study-related procedures. Any potential costs or reimbursements will be discussed upfront.
     
  • Can I leave a trial early?
    Yes. You can withdraw from any study at any time, for any reason.
     
  • What if I don’t qualify?
    Even if you’re not eligible for one study, we may help connect you with others that are a better fit.

At Â鶹´«Ã½, decisions to participate in industry-sponsored clinical trials are made within the clinical units based on alignment with departmental priorities, faculty interest, and available resources. Once a study is identified, we work closely with sponsors and CROs to facilitate a timely and compliant contracting process.

Sponsors and CROs are encouraged to connect directly with the appropriate physician-investigator or study team with expertise relevant to the trial. During this stage, it is critical that sponsors provide:

  • Full study protocol

  • Draft budget and contract (CTA)

  • Investigator brochure or product information

  • Any required sponsor/CRO questionnaires or feasibility forms

Once the clinical team has reviewed the study and it has completed all required internal and scientific feasibility reviews, the assigned Â鶹´«Ã½ study coordinator or VHS regulatory liaison will submit the trial for institutional risk assessment, negotiation, and approval via the internal Clinical Trial Request Form. This submission formally initiates:

  • Budget negotiation

  • Clinical Trial Agreement (CTA) review

  • IRB or other regulatory pathways as applicable

As part of this process, the sponsor/CRO will be introduced to the designated points of contact for:

  • Budget negotiation

  • Contract review and execution

To ensure proper institutional oversight and audit readiness, all Clinical Trial Agreements must be routed and negotiated through the Sponsored Programs Administration Clinical Trials Team via the approved internal workflow. Contracts submitted outside of this process—such as directly to investigators or via unsolicited email—will not be reviewed or accepted.

To help streamline the review process, sponsors should be aware of:

  • Â鶹´«Ã½ participates in any national contracting programs (e.g., ACTA, Accelerated CTA review initiatives)

  • Use of pre-negotiated templates, if available

  • CTA negotiations must follow the institutional routing process. Submissions outside of formal workflows delay review and may compromise compliance.

  • Budget and contract negotiations occur in parallel and are handled by the Sponsored Programs Administration Clinical Trial Team.  

  • Timelines vary depending on sponsor responsiveness, use of standard terms, and regulatory readiness.

°¿¶Ù±«â€™s Sponsored Programs Administration Clinical Trial Team operates through the Research Foundation.

  • Standard CTAs are executed by the University, which serves as the contracting party.

  • Only when CTAs include non‑conforming terms (i.e. language the University cannot accept) are they executed through the Research Foundation.

This structural arrangement is similar to other institutions with foundations, where the foundation supports contracting for exceptions while typical CTAs remain under university authority.

To facilitate faster review and execution, we strongly encourage sponsors and CROs to use one of the following standard agreement templates:

  • ACTA (Accelerated Clinical Trial Agreement)

  • ACDA (Accelerated Confidential Disclosure Agreement)

  • ¹ó¶Ù±Ê‑C°Õ³§´¡ (Federal Demonstration Partnership Clinical Trial Subaward Agreement)

  • °ä°Õ³§´¡â€‘D°Õ±«´¡ (Data Transfer and Use Agreement for CTSA-supported trials)

These templates have been widely adopted across U.S. academic medical centers and government-funded institutions.  Studies have shown that using ACTA reduced contract negotiation timelines by an average of 40–55 days, and use of ¹ó¶Ù±Ê‑C°Õ³§´¡ often saved even more time—up to 57 days.

How does using these templates benefit the process?

  • Significant time savings: ACTA and ¹ó¶Ù±Ê‑C°Õ³§´¡ negotiations complete more rapidly than non-standard contracts 

  • High acceptance rate: Over 350 sites have adopted these agreements and accept them without modification.

  • Reduced negotiation scope: Where modifications occur (e.g., MACTA), efforts are focused on a few key terms rather than the whole agreement, further accelerating the process. 

 

  • If a CTA contains non-conforming terms that the University cannot accept (e.g., governing law provisions, indemnification beyond state limits, non-standard intellectual property clauses), the agreement will be processed through the Research Foundation.

  • This exception process ensures compliance with institutional policies while still allowing flexibility when required.

For information on submitting a clinical trial for contract review, or to confirm the correct process, contact the Â鶹´«Ã½ Clinical Trials Team at:  rfhsc-clinical@odu.edu

We offer sponsors and CROs the opportunity to use the Accelerated Clinical Trial Agreement (ACTA) template as part of the University’s commitment to expedite the contracting process and facilitate clinical trials opening faster. Projects that utilize the unmodified ACTA will be fast-tracked for contract negotiation.  We can do this because the unmodified ACTA requires no negotiation.

Only use of the unmodified ACTA qualifies a study for expedited contract review. 

There are three ACTA templates available: 

There are three ACTA templates available:

  • Standard ACTA: contracting parties are sponsor and institution;
  • CRO-ACTA: contracting parties to the CTA are CRO and institution, separate letter of indemnification between sponsor and institution included as exhibit;
  • Coming Soon: International ACTA: parties are sponsor and institution; used when the sponsor is a foreign entity.

Each template has been pre-filled with certain Â鶹´«Ã½ information.  For your convenience, the areas that require sponsor or study specific information have been highlighted in yellow.  Complete those fields ONLY – make no other changes –  and return the template to the Â鶹´«Ã½ VHS clinical study team contact who provided it to you.  If you receive this template early in Â鶹´«Ã½'s internal process, your contact likely is the assigned clinical study team's research coordinator.  

PLEASE NOTE:  ANY REVISIONS WHATSOEVER to the ACTA template will disqualify the study for expedited contract review, and the agreement will be reviewed according to its position in the queue. 

*PLEASE NOTE:  The contract, budget, and regulatory processes are three separate processes that are undertaken in parallel.  Contract execution requires that both contract language and study budget are finalized but does not necessarily require that the IRB process is complete although the language in the informed consent form (ICF) must be reviewed and aligned with the contract terms.  However, the study cannot open until the contract is fully executed and the study has IRB approval. 

The Accelerated Clinical Trial Agreement (ACTA) is a nationally recognized, pre-negotiated template designed to streamline the contracting process for industry-sponsored clinical trials. Developed collaboratively by academic research institutions, contract research organizations (CROs), and industry sponsors, the ACTA reflects balanced, neutral language that does not favor either party.

This standardized agreement is widely accepted across the clinical research community and helps reduce negotiation time by addressing common legal and administrative terms up front.

More information about the ACTA is available from the following organizations:

 

At Â鶹´«Ã½ and the Â鶹´«Ã½ Research Foundation, we are committed to building efficient, collaborative partnerships that accelerate clinical research and advance innovation. To support this mission, we’ve outlined our institutional expectations and preferred practices for negotiating Clinical Trial Agreements (CTAs) in an open letter to sponsors and CROs.

This letter outlines our institutional terms and expectations for sponsors or CROs who propose using their own Clinical Trial Agreement (CTA) templates. While we are prepared to review sponsor-provided agreements, we strongly encourage the use of nationally accepted templates—such as the Accelerated Clinical Trial Agreement (ACTA) and other standard agreements—which help expedite contract negotiations and reduce administrative delays.

For access to these recommended templates, please visit: Â鶹´«Ã½ Research Foundation Clinical Research Agreement Templates

👉 Access the Open Letter to Sponsors and CROs (PDF)

For additional information or assistance, please contact our Sponsored Programs Administration Clinical Contracts Team at rfhsc-clinical@odu.edu.

Please see the F&A Rate Guidance for Clinical Contract Agreements F&A rate. 

Â鶹´«Ã½ Research Foundation