The Clinical Trial Process

In order to evaluate the feasibility of a principal investigator’s (PI's) participation in a research project, sponsors may want to provide GW protocols, scopes of work, or other confidential information so the PI may evaluate the appropriateness of their involvement in the project. In these instances, the sponsor may require a confidentiality disclosure, or non-disclosure, agreement (CDA or NDA) in order to protect their confidential information. BOU is responsible for the review, negotiation, acceptance, and execution of all CDAs and NDAs.

In order to initiate review of a CDA, the study coordinator must create a study shell in OnCore and initiate a Task List by uploading the CDA and sponsor contact information. The Sr. Contracting Officer will work directly with the sponsor to negotiate the terms of the CDA. Once the agreement is fully-executed, the Sr. Contracting Officer will forward the completed agreement to the PI and their designated departmental staff.

Once a CDA is in place, a sponsor will typically disclose the study protocol, investigator brochure, draft Informed Consent Form (ICF), Lab and/or Pharmacy Manual (if applicable), draft Clinical Trial Agreement (CTA) and draft budget to the PI for review.

After reviewing the study protocol, if the PI is interested in participating in the study, the PI or the study coordinator would forward the following to researchcontracts@mfa.gwu.edu:

1. Completed Intake Form
2. Study Protocol
3. Draft ICF
4. Lab and Pharmacy Manual (if applicable)
5. Draft CTA
6. Draft Budget

The Intake Form allows the BOU team to gather information about the study to expedite the budget and contract negotiation process.

Before budget negotiations can begin, a Medicare Coverage Analysis (MCA) must be prepared to determine whether procedures in the protocol are considered standard of care (SOC or “routine”) or if they are research activities.  This exercise allows BOU to ensure all research-related costs are included in the budget and is crucial to ensure appropriate billing of clinical trial procedures.

Once the MCA is complete, the BOU Clinical Research Financial Analyst will incorporate the information into the budget grid, and will ask the PI and study coordinator to review and confirm the MCA and budget is acceptable.

Upon confirmation from the PI, the BOU Clinical Research Financial Analyst will begin budget negotiations with the sponsor on behalf of GW. Budget negotiations typically take 60 days to complete, but this timeline may vary depending on the complexity of the study protocol.

In parallel with budget negotiations, the Sr. Contracting Officer will negotiate the contact terms in a Clinical Trial Agreement (CTA) with the sponsor.

CTAs govern the terms of research between GW and its clinical partners, Medical Faculty Associates, Inc., and The George Washington University Hospital (as applicable), and an industry sponsor, and are executed for trials following a sponsor- or investigator-initiated protocol.

Clinical trials, generally funded by pharmaceutical and medical device companies, are an important part of the Food and Drug Administration (FDA) approval process to ensure the safety and efficacy of the drug or device being brought to market. Other sponsored research for investigator-initiated clinical studies are often funded by pharmaceutical and medical device companies, sometimes providing drug or devices at no cost, and are typically initiated after a PI has submitted a proposal to the sponsor.

The BOU team is responsible for the review negotiation, and execution of CTAs and sponsored research agreements. PIs and study teams should forward all agreement drafts - and company contact information - to researchcontracts@mfa.gwu.edu as part of the Intake Form for review and negotiation. The Sr. Contracting Officer will work directly with the research sponsor to finalize these agreements.

Typical components of a CTA are as follows:

1. Agreement Parties
   All CTAs are agreements between GW/MFA, and GW Hospital, as applicable, and the sponsor. The PI may be named as a faculty member of GW, but will not be a named party to the Agreement.
    
2. Publication
   Timely publication and dissemination of the results of research performed by faculty are important principles behind GW’s mission as an academic medical institution. Research sponsors are afforded a period of time to review and comment upon on the content of such publications, to protect intellectual property, and to ensure their confidential information is not improperly published, but GW does not accept terms that restrict faculty from freely publishing the results of their research.
    
3. Indemnification
   Indemnification is addressed in all clinical trial agreements, and the terms may differ depending on the entity developing the protocol or providing the funding.  
   1. For Sponsor-Initiated Protocols: GW faculty members conducting a sponsor-designed clinical trial protocol are following the sponsor’s instructions. Therefore, GW cannot be held responsible for any injury or damages resulting from work performed during a clinical trial, or from a sponsor’s use of results of the study.
   2. For Investigator-Initiated Protocols: When the protocol is developed by the investigator, the sponsor is generally not required to provide indemnification, except coverage for the sponsor’s negligence and use or exploitation of study results . However, if the industry-sponsor is providing funding source as well as drugs or materials, the sponsor is required to provide limited indemnification. The industry sponsor generally expects indemnification from GW.
       
4. Intellectual Property
   GW encourages the development of intellectual property to enhance research, scholarship, teaching, and discovery for the best interest of the public, the creator, and the research sponsor.
   1. For Sponsor-Initiated Protocols: Patent rights for inventions made in the direct performance of a sponsor-developed clinical trial protocol, involving little or no PI involvement in the conception or development of the protocol, are generally granted to the sponsor. However, GW reviews patent terms on a case-by-case basis.
   2. For Investigator-Initiated Protocols: When the protocol is developed and the work is performed by the investigator, GW and PI will maintain ownership of the study documentation and data.
       
5. Subject Injury
   1. For Sponsor-Initiated Protocols: Except in rare cases, all research-related subject injuries resulting directly from study drug or device administration, or procedures carried out in accordance with the sponsor-designed protocol are the financial obligation of the sponsor.
   2. For Investigator-Initiated Protocols: Generally, industry sponsors will not be responsible for any study-related subject injuries. However, injury liabilities will be examined on a case-by-case basis for investigator-initiated protocols, and will be dependent upon the specifics of the work being performed and the drugs or devices provided by the sponsor.
       
6. Insurance
   To support the indemnification detailed in this section, including subject injury liabilities, the sponsor must maintain a sufficient level of insurance. GW will maintain in force adequate insurance to cover its indemnification obligations.
    
7. Governing Law
   Contracts accepted by GW will be interpreted under applicable laws of the District of Columbia. GW will also consider contractual silence regarding this issue, but generally will not subject itself to the laws of any other jurisdiction.
    
8. Payment Term
   Generally, clinical trial budgets are based on a fixed price-per-subject amount with a payment schedule. Such schedules usually provide for regular payments upon the completion of milestones (e.g., enrollment of a certain percentage of subjects, submission of a certain number of case report forms, etc.). These payments should include all applicable indirect costs.

When the contract and budget negotiations have concluded, a finalized agreement will be sent to the Sr. Contracting Officer from the sponsor to route for signatures.

When BOU receives the finalized agreement, GW’s PI will be the first to sign the agreement and will only sign the agreement as “Read and Understood” or “Read and Acknowledged,” and will not be a party to the agreement.  In turn, the agreement will be signed by GW, and MFA’s and Hospital’s official authorized signatories. In turn, the partially executed agreement will be sent by the Sr. Contracting Officer to the sponsor for the sponsor to sign.

Once the agreement is fully executed, the SR. Contracting Officer will notify the PI and study team and send a copy of the fully executed CTA via email.  The Sr. Contracting Officer will request an MFA  account number and include start up invoicing details which will be setup for the project and a notification email will be sent to the PI, study coordinator, and post grants team. 

For information on OnCore, see the Research Toolbox.

The Post Grants Team in GWOCR facilitates invoicing services for all clinical research studies.

To invoice a sponsor, please complete the following steps:

1. A study coordinator shall complete the invoice template (Insert hyperlink to the Invoice Request Form)  with the items that require invoicing, and submit it to gcasinvoice@gwu.edu
2. A financial analyst within the GW Office of Grants & Contracts Accounting Services (“GCAS”) provides invoicing services for all clinical research studies.

A GCAS Clinical Research Financial Analyst will follow-up with the sponsor until the invoice is paid.