Weill Medical College of Cornell University

A: When approached by a sponsor to participate in a Clinical Trial, the first thing to do is determine whether your study will be handled by the Grants and Contracts Office, or by the Office of Clinical Trials Administration.

The Office of Clinical Trials Administration (OCTA) processes and negotiates grants and contracts for clinical trials. The Grants and Contracts office handles grants and contracts that are not clinical trials. A clinical trial is defined as a study that involves the following elements:

• Intervention (either biomedical or behavioral)
• Human Interaction (beyond the informed consent process)
• Outcome variables (measures safety and effectiveness of intervention)
• Prospective Design (phases I, II, III, IV)

Once you have determined the appropriate office, contact the Senior Grants & Contract Specialist for your department or division to let them know that you are interested in submitting a proposal. If the sponsor has given you a Confidentiality Disclosure Agreement, send it to your contract specialist for review before signing it.

A: Clinical Trial Agreement (CTA; also called a contract)
A CTA is a legally binding agreement that manages the relationship between the Sponsor [typically industry-based], who may be providing

• Study Drug, or Device
• Financial Support
• Proprietary Information

and the Institution, [Weill Cornell] who may be providing

• Data and/or results
• Publication, input into publication
• Input into further intellectual property

Amendment
An amendment is a legally binding agreement that changes a portion – or portions – of a previously signed CTA.

Federal Grants
Typically initiated by the investigator/institution, very little negotiation is allowed, or required. Usually granted for a 1-5 year period of performance, federal grants require a progress report upon annual review.

Subcontracts (non-Federal)
These agreements are typically issued from an academic medical center (AMC) to Weill Cornell, or from Weill Cornell to another AMC to share in the work from a non-Federal (industry-sponsored) contract. In clinical trials, these are used to increase patient recruiting, or to allow a doctor who specializes in a particular field to analyze data or see a specific patient population.

Subawards (Federal)
Like subcontracts, subawards are used to allocate funding & responsibility for a grant-funded activity from one AMC to another.

Subcontract/Subaward Amendments
Like amendments to contracts, modifications to subcontracts or subawards are used to change a portion(s) of terms previously agreed upon by the designated parties of the Agreement.

Confidentiality Disclosure Agreements/Non-Disclosure Agreements (CDA/NDA)
These Agreements ensure confidentiality of proprietary data that the Sponsor gives to the Investigator in order to make a determination as to whether or not he/she will participate in the trial/research. Typically, agreements are made only between the Sponsor and Investigator. (The OCTA will offer guidance to PIs in order to negotiate better terms). However, many companies require that Weill Cornell (Institution) also sign agreements.

Foundation Agreements
A CTA with a foundation typically resembles a grant more than a contract. Terms are seldom negotiable, but the CTO will review the agreements to be sure that we are not prohibited from acting in accordance with the bylaws of an academic medical center as they apply to publishing, intellectual property, etc.

Should the foundation state that no negotiation is allowed, it will become a policy/business decision as to whether, or not Weill Cornell will be able to accept the award.

A: The following agreements are negotiated within RASP's Grants & Contracts Office:

• Registry Agreements: Patient data collected in a registry/database for larger analysis
• Retrospective Studies: Review of patient charts to correlate for new findings
• Sponsored Research Agreement (SRA): Other research agreements sponsored externally, not clinical trials
• Material Transfer (MTA): Transfer of material, e.g., Laboratory mice, tissue samples, cell lines. from one institution to another

A: Each Senior Grants and Contracts Specialist is responsible for several departments and divisions. Find your Grants and Contracts Specialist

A: The Clinical Trial Synopsis Form provides us with the information we need to begin processing and negotiating a Clinical Trial Agreement. Be sure to complete and e-mail the completed form to octa@med.cornell.edu.

Download the Clinical Trial Synopsis Form

In order to begin negotiations with a sponsor, your Senior Grants and Contracts Specialist also needs the following documents:

• A copy of the protocol
• A copy of the clinical trial agreement (preferably in electronic format)
• A copy of the proposed preliminary budget for the study
• Contact information for the sponsor's representative

A: Once a Senior Grants and Contract Specialist receives the appropriate paperwork the negotiations can begin.

The Specialist reviews the contract and modifies the contract to ensure that the agreement meets all regulatory and institutional requirements. The revised draft of the contract is then submitted to the sponsor for review.This process continues back and forth as changes are suggested, and then accepted or rejected, on both sides. This is where delays often occur.

Once the agreement is considered acceptable to both parties, the draft of the agreement is submitted to a Senior Contract Manager for approval. When this approval has been received, the final copies of the agreement are submitted for approval and signature to the PI and an Institutional Signatory, and then signed by the Sponsor.

Prior to signature, the CTO staff makes sure that we have all of the following:

• A fully-completed and Billing Compliance Form (HRBAF) with all signatures
• Fully-completed and signed financial disclosure agreements for the PI and all co-Investigators working on the trial
• A fully-completed and signed Research Application Routing Form

A contract is considered to be fully executed when the above three documents have been received along with a final copy of the Clinical Trial Agreement, signed by the Sponsor, the PI, and an authorized Institutional Representative of Cornell University

After all the necessary documents have been received, the Institutional Review Board (IRB) is notified via e-mail of the execution of the agreement. The file is sent to the Finance Department to establish an account for the PI. The open account will enable the PI to receive funds and charge expenses to the study account. This account set-up process generally takes 2 to 3 weeks. See diagram.

A: The IRB committee must review and approve the study and the informed consent form. The IRB Committee will not release the stamped approval letter until it receives notification from the CTO that the contract has been fully executed.

Visit the IRB page in the Forms and Policies section of the Weill Cornell Research web site for links to the forms required for a submission to the IRB.

A: Under no circumstances should you sign an agreement without first submitting it to the CTO for review and approval. In order for the clinical trial agreement to be a legally binding document, it must be signed by an authorized Institutional signatory. Principal Investigators are not considered Institutional Signatories.

A: All industry-sponsored clinical trials without exception, are assessed a 33% indirect cost rate. This rate is applied to all direct costs associated with clinical research trials with the exception of our $1,500 IRB review fee and any applicable pass through fees, ie. advertising fees.

This indirect cost (F&A) is essential to covering Facilities expenses such as: heat, light, power, the depreciation of equipment, as well as Administrative expenses.

All indirect costs are taken directly from the payments and retained by the Institution; therefore none of the indirect percentage is used towards directly compensating the Investigator.

A: The Board of Trustees

A: The IDC rate is non-negotiable.

A:

1. Institution name (federal vs non-federal; tax ID name)
   The official name for Weill Cornell Medical College that should be used in all agreements to which we are a party is:
   • Industry: "Cornell University for and on behalf of its Joan & Sanford I. Weill Medical College."
   • Non-Industry: "Joan & Sanford I. Weill Medical Cornell College of Cornell University"
2. Indemnification
   The Joan and Sanford I. Weill Medical College of Cornell University is a leading academic medical research center. With all clinical research, there is a certain degree of risk associated with conducting trials on experimental drugs/devices and compounds. This means that the Company is much more aware of the potential risks and rewards of conducting these studies then the Institution. Any potential lawsuits that may arise against us will be a direct result of our conducting a study with company's explicit instructions and experimental drugs/devices. Therefore, the Institution can only be liable for losses that are determined to have arisen from, or resulted out of, or are directly attributable to the negligence or willful misconduct of an Institutional indemnitee. The Institution is willing to be responsible for its own actions. However, the Institution will not indemnify an industrial sponsor.
3. Insurance
   The Sponsor is responsible for the primary burden of risk, therefore they are required to have minimum levels of insurance set by the Risk Management Office before the Institution is able to participate in the Study. These are:
   • $3Million per Occurrence
   • $5Million in the Annual Aggregate
4. Publication
   

   Scholarly publication is the fundamental right and responsibility of researchers and the Institution. Sponsors may review manuscripts prior to publication, but may not require terms that allow for 'approval" by the Sponsor.

   Publication clauses typically grant the sponsor the right to delay publication up to 30 days for the removal of confidential information and an additional 60 days for the filing of a patent application.

5. Confidentiality
   States the terms under which Investigator/Institution are responsible for non-disclosure when Sponsor provides proprietary or confidential information to the Investigator/Institution. Terms include:
   • Length of Confidentiality
   • What is and is not included in the Confidential Information
   • How the information may be used.
6. Intellectual Property (IP)
   As a matter of policy, wcmc retains exclusive ownership of patents resulting from inventions made solely by wcmc personnel. Inventions may be protected by patents in the US and in foreign countries.
   
   
7. Disclosure requirements
   
   • The Institution will have requirements as to making disclosures of inventions, potentially patentable developments to the Sponsor,
   • The Sponsor will decide how to proceed with such information
   • The Institution & investigator will work with Office of Technology Development to assist Sponsor and/or negotiate licenses for use of the IP.

A: While we respect all working relationships between Investigators and Sponsors, the Senior Grants and Contracts Specialists are ultimately responsible for negotiating Clinical Trial Agreements with Sponsors. Investigators are welcome at any time to request a current draft of an agreement. Once language has been finalized, the Investigator will receive copies for review and signature. If you have any questions, or concerns about the negotiation of a particular agreement, you should contact the Senior Grants and Contracts Specialist who is responsible for your Department or Division.

A: The CTO retains one original copy of every agreement and the Sponsor retains one original copy. Principal Investigators and their study coordinators each receive a PDF copy via email of the fully-executed agreement for their administrative files.

A: Like an original agreement, an amendment must be submitted to a Senior Grants and Contracts Specialist for review. If revisions are necessary, an amendment must go through a negotiation process just like an original agreement. If there are changes to the budget or other financial aspects of the agreement, a copy of the amendment will be submitted to Research Accounting to have the appropriate changes made. Except in special instances, the IRB is not notified when an amendment is fully executed.

A: Arrangements have been made in the past to expedite approval for critically-ill patients. Please contact the CTO and we will do our best to accommodate you.

A: Please notify the IRB and the CTO of the completion of your study. The Clinical Trial Agreement for your study might contain specific provisions on how to proceed once a trial has been completed. By making the CTO aware of your study completion, you allow us to keep our database current as well as collect any remaining closeout fees for the study. Your Senior Grants and Contracts Specialist will have more information if you have any questions, or concerns.

A: You should contact the IRB as well as the CTO and inform them of the study termination. The Clinical Trial Agreement for your study might contain specific provisions on how to conduct a termination of a study, or even whether early termination is permitted. Please contact your Senior Grants and Contracts Specialist if you need to terminate a trial.