A clinical trial agreement is an agreement between an academic institution and a party who is sponsoring the clinical trial. It is a legally binding agreement that manages the relationship between the sponsor that may be providing the study drug or device, the financial support and / or proprietary information and the institution that may be providing data and/or results, publication, input into further intellectual property. The agreement outlines the details of what the clinical trial will cover and puts into writing the formal understandings of each party for the conduct of the study. It also contains the legal and financial terms related to the clinical study.
When Do You Need a Clinical Trial Agreement
A clinical trial agreement is required when a clinical trial is to be undertaken by an institution and a sponsor provides the drug or device for which the clinical trial is to be conducted. The purpose of a clinical trial agreement is to outline the governing terms and obligations that apply to all parties when a clinical trial is conducted. The creation of the agreement is necessary to protect the interests of both parties to the agreement.
It is important to have this agreement for allocation of risk, responsibility, funds, obligations, and the protection of academic, legal, intellectual property rights and integrity.
Inclusions in a Clinical Trial Agreement
The agreement must clearly state the names of the parties between whom the agreement is entered into. This will include the institution where the trial shall be conducted and the sponsor of the clinical trial. The date on which the agreement is entered into must also be mentioned along with the territory in which the agreement is enforceable.
The agreement should cover the responsibilities of both parties, terms of collaboration, requirements for payment and reimbursement, publication and intellectual property terms, indemnification and insurance, subject injury coverage along with, guidelines for dispute resolution.
Apart from this, the agreement must clearly mention under which law will it be governed and how the agreement shall be terminated. The manner in which the agreement is to be modified should also be described.
How to Draft a Clinical Trial Agreement
The following are the steps to follow while drafting a clinical trial agreement:
- The term of the agreement should be decided.
- The payment terms and payment schedules should be decided.
- The important clauses such as ownership of the data resulting from the clinical trial and the publication rights of such data should also be negotiated.
- The other important clause to be negotiated is the ownership of the intellectual property rights attached to the clinical trial.
- Clauses such as subject injury, indemnification and confidentiality must also be negotiated between the parties before the agreement is to be drafted.
- Once the agreement is drafted, it must be reviewed thoroughly to make sure that the rights and interests of both parties are protected.
Benefits of a Clinical Trial Agreement
- If a clinical trial agreement is in place, it helps to decide the publication rights of the results of the clinical trial. This will avoid a conflict between both the parties in the future.
- The agreement will clearly lay down which party shall have the intellectual property rights in the clinical trial. This is extremely important as the party that has the intellectual property rights will have the right to assign those rights in the future and earn money from it.
- The rights and obligations of each party will be clearly laid down to prevent any confusion or misunderstanding between the parties.
- The agreement will have a dispute resolution mechanism in place, in case any of the party commits an event of default.
- The agreement will cover how confidential information is to be treated by the parties. This will protect the interests of the parties.
Key Clauses in a Clinical Trial Agreement
The following are the key terms of a clinical trial agreement:
- Description of the project
- Payment terms and schedule
- Sponsor, CRO and site responsibilities
- Ownership of clinical study results
- Publication and intellectual property terms
- Quality assurance and control
- Obligations and responsibilities of the institution
- Obligations and responsibilities of the sponsor
- Representations and warranties of the institution
- Representations and warranties of the sponsor
- Confidentiality and return of confidential information
- Limitation of liability
- Record keeping and inspection
- Indemnification and insurance
- Modification of the agreement
- Dispute resolution
- Governing law and jurisdiction
- Termination of the agreement
What Happens When You Violate a Clinical Trial Agreement
Generally, clinical trial agreements have a clause that talks about the actions to be taken when a party to the agreement breaches the clauses of the said agreement. An arbitration clause is present in most agreements and states that if a clause of the agreement is breached or if any dispute arises with respect to the terms of the agreement, the matter will be resolved by arbitration. The clause mentions where the arbitration proceedings will take place i.e. seat of arbitration, the language in which the proceedings shall be conducted and the manner in which the arbitrators shall be appointed.
Alternatively, any other form of dispute resolution such as mediation may also be mentioned in the agreement.
The agreement can also mention that all disputes arising out of the agreement will be subject to the exclusive jurisdiction of a specified court.
Sample of a Clinical Trial Agreement
If you require a template of a clinical trial agreement, you can download a sample here.
Download this USA Attorney made Original Agreement for only $9.99
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This agreement is made between the “Sponsor” and “Institution” on the effective date of 15th November, 2011.
Sponsor represented by
Ms. Rose Dawn
Address: 143 Saint Margaret Street, Charleston SC 29403
Contact number: (843) 714-5331
Institution represented by:
Dr. Michael Madsen
Medical University of South Carolina (MUSC)
Address: 135 Cannon Street, Ste. 403, Charleston, SC 29425
Contact number: (843) 792-3621
Terms and Conditions:
- The “Sponsor” desires that the “Institution” study the efficacy or safety of Methalomin [DRUG] henceforth known as the “Study Drug” and the Institution be willing to perform an in-depth clinical study of the “Study Drug”.
- The “Institution” will make complete efforts for carrying out this clinical trial study and research in accordance to the terms and conditions of this Clinical Trial Agreement. This agreement developed by the “Sponsor” is dated 15 November 2011 and entitled Methalomin Efficacies (the “Study”), contains study protocols attached hereto as Exhibit C for reference.
- Under this Clinical Trial Agreement, the period of study or performance shall begin on 20 November 2011 (date) through 10 July 2012 (end date), unless the study deadline is extended through addition of an amendment to the Agreement or if the agreement is terminated in accordance to terms and conditions stated in Article 19.
- The “Sponsor” will reimburse the “Institution” all direct as well as indirect costs that the “Institution” incurred, during course of study, and in accordance with the budget attached.
IN WITNESS WHEREOF, the parties “Sponsor” and “Institution” have executed this Clinical Trial Agreement as on the date set forth which is 11/15/2011 (MM/DD/YY).
SIGNED FOR AND ON BEHALF OF SPONSOR BY:
SIGNED FOR AND ON BEHALF OF INSTITUTION BY: