Creating a Clinical Trial Agreement

Note: Want to skip the guide and go straight to the free templates? No problem - scroll to the bottom.
Also note: This is not legal advice.

Introduction

Clinical trial agreements are vital for any clinical trial, establishing a legal contract between all parties involved and guaranteeing that regulatory requirements are met. By providing a secure framework to the process, these agreements ensure that the interests of each party are protected and that study participants understand their rights.
The Genie AI team understand the importance of creating effective clinical trial agreements, which outline compensation procedures in the event of any adverse events occurring during the trial and keep intellectual property rights secure. They can also prevent disputes from arising, with terms being used to quickly resolve disagreements if necessary - avoiding costly litigation processes.
Crucially, these agreements help to make sure that all trials adhere to applicable regulations; without an effective agreement in place, research may be at risk of fines or cancellation. Through our step-by-step guidance and free template library we provide expert support - with no need for a Genie AI account - on how best to craft an appropriate agreement for your study. Read on below for more information on how you can access our resources today.

Definitions (feel free to skip)

Legal Business Name: The official name of a company or organization, usually as it appears on legal documents, such as contracts.

Contact Information: Details like a phone number, mailing address, or email address that can be used to contact a person or organization.

Scope of Agreement: The range of topics and activities that are covered by a contract or agreement.

Purpose and Deliverables: The goal of an agreement as well as what is expected to be done or produced.

Terms and Assumptions: Specific conditions or requirements that must be met in order for an agreement to be successful.

Responsibilities: Tasks or duties that are assigned to a specific person or organization in an agreement.

Allocating and Assigning: To divide up tasks and assign them to different people or organizations.

Roles and Accountability: Describing the roles of each person or organization in an agreement, as well as their level of responsibility and accountability.

Methodology: The set of procedures and techniques that are used to conduct research or complete a task.

Criteria: A set of standards or requirements that must be met in order for something to be successful.

Payment Structure: The details of how money will be exchanged between the parties involved in an agreement.

Discounts or Incentives: Special offers or rewards that are offered as a part of an agreement.

Milestones and Deadlines: Specific points in time when tasks must be completed or goals must be reached.

Confidentiality: An agreement that ensures that certain information will remain private.

Intellectual Property Rights: The legal rights associated with inventions or creative works.

Draft and Execute: To create and sign a document or contract.

Signatures and Notarizations: Official signatures and stamps that are required for a document or contract to be legally binding.

Resolving Conflicts: Taking the necessary steps to deal with disagreements or disputes between parties.

Third-Party Mediators: An independent person or organization that is involved in resolving disputes between parties.

Applicable Laws and Standards: Rules and regulations that are relevant to a given agreement.

Contents

• Identifying the Parties Involved
• Researching each party’s legal business name
• Obtaining contact information for each party
• Outlining the Scope of the Agreement
• Establishing the purpose and expected deliverables
• Defining any terms or assumptions
• Specifying the Responsibilities of Each Party
• Allocating and assigning tasks
• Establishing roles and levels of accountability
• Describing the Trial Protocol
• Outlining the specific methodology
• Defining any necessary criteria
• Determining Payment Terms
• Agreeing upon the payment structure
• Defining any applicable discounts or incentives
• Setting Milestones and Deadlines
• Establishing measurable benchmarks
• Scheduling specific due dates
• Establishing Confidentiality and Intellectual Property Rights
• Outlining the rules for sharing confidential information
• Defining ownership of any created products
• Finalizing the Agreement
• Drafting and executing a final contract
• Obtaining necessary signatures and notarizations
• Preparing for Potential Disputes
• Establishing a process for resolving conflicts
• Determining the role of any third-party mediators
• Understanding the Regulatory Environment
• Researching applicable laws and standards
• Consulting with legal counsel as needed

Get started

Identifying the Parties Involved

• Identify the parties involved in the clinical trial agreement, including the sponsor and the research site.
• Determine if there are any other parties that need to be included, such as the contract research organization (CRO) or any subcontractors.
• Make a list of all the parties involved and their contact information.
• Once all the parties have been identified and their contact information gathered, you can move on to the next step.

Researching each party’s legal business name

• Find out the legal name of each party involved in the clinical trial agreement.
• If either or both parties are businesses, their legal name is required.
• Look up the legal name of the party in the company’s certificate of incorporation or in their articles of organization.
• If either party is an individual, you will need to know their full name.
• You can check off this step when you have the legal name for each party involved in the agreement.

Obtaining contact information for each party

• Research the contact information for each party involved in the clinical trial agreement
• Contact the legal representative of each party to confirm contact information
• Document the contact information of each party in the clinical trial agreement
• Once all contact information is documented and confirmed, you can move on to the next step of outlining the scope of the agreement.

Outlining the Scope of the Agreement

• Develop a clear and concise description of the project and the services to be provided
• Identify the study protocols, including who is responsible for them and any regulatory requirements
• Specify the parties’ respective roles and responsibilities throughout the project
• Provide a timeline for the research activities and when each party will receive the deliverables
• Identify any applicable laws and regulations, including HIPAA and GDPR
• Include an indemnification clause, which outlines each party’s responsibility in the event of a breach

When you have completed this step, you will have a clear understanding of the goals and objectives of the trial, as well as the roles and responsibilities of the parties involved. You will also have a timeline for completing the project and any applicable laws and regulations.

Establishing the purpose and expected deliverables

• Clearly identify the purpose of the agreement, including the primary objectives
• Outline the expected deliverables from both parties
• Identify the timeline and milestones for completion
• Clarify any milestones that are contingent on certain actions or events
• Assign responsibility for any costs associated with the agreement

Once you have identified the purpose and expected deliverables, you can move on to the next step of the process: defining any terms or assumptions.

Defining any terms or assumptions

• Identify any terms or assumptions that need to be defined for the trial
• Make sure the definitions are clear and concise
• Make sure all terms and assumptions are agreed upon by all parties
• Record all terms and assumptions in the Clinical Trial Agreement
• Once all terms and assumptions are defined, you can move on to the next step of specifying the responsibilities of each party.

Specifying the Responsibilities of Each Party

• Identify the roles and responsibilities of each party involved in the clinical trial agreement.
• Specify the responsibilities of the Sponsor, CRO, and other parties in the agreement.
• Ensure that all parties understand and agree to their roles and responsibilities.
• Draft a document outlining the responsibilities of each party.
• Have each party sign the document to confirm their acceptance of the roles and responsibilities.

Once each party has signed the document, you can move on to the next step.

Allocating and assigning tasks

• Identify and assign tasks to each party in the agreement
• Make sure that all tasks are agreed upon by all parties involved
• Outline the timeline for each task and any relevant expectations
• Include any subcontractors involved in the agreement and their roles
• Include any documents that need to be signed off on by each party

When you have identified and assigned tasks to each party in the agreement, you can check this off your list and move on to the next step of establishing roles and levels of accountability.

Establishing roles and levels of accountability

• Determine the roles and responsibilities of each party involved in the clinical trial.
• Outline the lines of communication between each party, including contact information as necessary.
• Identify the decision-making process and levels of authority for each party.
• Describe the process for resolving any disagreements or disputes.

When you have identified the roles and levels of accountability and have outlined the lines of communication, you can move on to the next step - Describing the Trial Protocol.

Describing the Trial Protocol

• Draft a thorough description of the clinical trial protocol
• This should include the study population, protocol objectives, study design, study procedures, and other pertinent information
• Develop a timeline for the clinical trial
• Ensure the timeline is realistic and achievable
• Consult with a medical professional to review the protocol and timeline for accuracy
• Once you have finalized the protocol and timeline, you can move on to the next step in creating your Clinical Trial Agreement

Outlining the specific methodology

• Outline the specific methodology that will be used to carry out the clinical trial
• Outline any steps that must be taken in order to complete the clinical trial
• Provide a timeline of when each step will be completed
• Ensure that the methodology is compliant with all relevant laws and regulations
• Once the methodology has been outlined and approved, the clinical trial agreement can be completed and signed
• This step should be completed before defining any necessary criteria for the clinical trial

Defining any necessary criteria

• Review the research protocol and determine any criteria or variables that need to be included in the agreement
• Create a list of criteria and variables that should be addressed in the agreement
• Discuss any criteria or variables with the sponsor and come to an agreement
• Include all agreed upon criteria and variables in the agreement

Once all criteria and variables have been included in the agreement, the step is complete and you can move on to determining payment terms.

Determining Payment Terms

• Discuss any payments related to the clinical trial, including payments for services, delivery of therapeutic products, and any other payments related to the trial
• Establish a payment schedule, such as determining the payment amount and when the payment is due
• Establish any additional payment terms, such as who is responsible for any payment processing fees
• Outline any payment dispute resolution process
• Confirm that all payment terms are agreed upon and signed by both parties

How you’ll know when you can check this off your list and move on to the next step:

• When all payment terms have been discussed, agreed upon and signed by both parties, you can move on to the next step of the process.

Agreeing upon the payment structure

• Identify the payment structure and amount, including the fee structure, payment timing, and reimbursement procedures
• Negotiate and finalize the payment structure and amount
• Draft and have both parties sign the Clinical Trial Agreement that includes the payment structure and amount
• Once the agreement has been signed by both parties, this step is complete and you can move on to the next step, Defining any applicable discounts or incentives.

Defining any applicable discounts or incentives

• Determine whether any discounts or incentives should be offered to the parties involved in the clinical trial agreement
• Consult with the legal team to ensure that any discount or incentive offered is compliant with applicable laws and regulations
• If discounts or incentives are to be offered, outline the criteria that must be met for the discounts or incentives to be applied
• Specify the amount or type of discount or incentive that will be offered
• Finalize the terms of any discounts or incentives in the clinical trial agreement
• Check off this step and move on to the next step of setting milestones and deadlines.

Setting Milestones and Deadlines

• Identify and agree on the milestones and deadlines for the clinical trial.
• Discuss and define the timeline for key activities such as when the protocol will be initiated, when data collection will begin, and when the trial will be completed.
• Establish a timeline for the review and approval of documents, such as the protocol and the informed consent forms.
• Determine the date by which the research team should provide any additional requested information to the sponsor.
• Negotiate and determine the date by which the sponsor is expected to approve any amendments to the protocol.
• Establish the date by which all associated payments should be made.
• Agree on the date and duration of any follow-up visits.
• Specify the timeline for closure and reporting of the clinical trial.
• Document the agreed-upon milestones and deadlines in the CTA.

How you’ll know when you can check this off your list and move on to the next step:

• Once all of the agreed-upon milestones and deadlines have been documented in the CTA, you can move on to the next step in creating a clinical trial agreement.

Establishing measurable benchmarks

• Agree on specific target outcomes of the clinical trial
• Clearly define the terms of success and failure
• Decide on a method for measuring the success or failure of the trial
• Ensure that all parties involved agree on the benchmarks for success and failure
• When all parties have agreed on the benchmarks for success and failure, check this step off the list and move on to scheduling specific due dates.

Scheduling specific due dates

• Set deadlines for when drafts of the agreement should be submitted
• Make sure the due dates are realistic
• Determine when the agreement needs to be finalized and signed
• Set a timeline for when payments should be made
• Establish deadlines for when progress reports should be provided
• Review the timeline for any adjustments that need to be made
• Once all deadlines are agreed upon, the parties are ready to move on to the next step
• Check this step off the list once all deadlines are established and agreed upon

Establishing Confidentiality and Intellectual Property Rights

• Review the terms and conditions of the Clinical Trial Agreement
• Determine which party owns the intellectual property rights
• Specify in the agreement the rights and responsibilities of each party regarding the intellectual property rights
• Establish what type of confidential information will be shared between the parties
• Include a confidentiality clause that outlines the parties’ obligations to protect confidential information
• Sign the agreement to make it legally binding
• You will know you have completed this step when the agreement is signed and both parties are in agreement about the intellectual property rights and confidentiality clause.

Outlining the rules for sharing confidential information

• Determine the information that needs to be kept confidential
• Identify who will have access to the confidential information
• Decide how the confidential information will be shared, stored, and destroyed
• Outline the sanctions that will be imposed for unauthorized access, use, or disclosure of confidential information
• Specify the procedures for updating and amending the agreement
• Sign and date the agreement

You will know when you can check this step off your list and move on to the next step when the agreement is completed, signed, and both parties have agreed to all the outlined rules for sharing confidential information.

Defining ownership of any created products

• Review the scope of the agreement to determine which products are subject to ownership by either party
• Establish who will own the intellectual property and any additional applicable rights
• Decide if the agreement should include clauses addressing transfer of ownership and other related matters
• Confirm that the agreement includes any necessary language regarding the ownership of products created during the course of the trial
• When the ownership of products has been established and documented in the agreement, it will be ready to move on to the next step in the process.

Finalizing the Agreement

• Review the draft agreement and make any required edits to ensure accuracy
• Have all parties involved sign the agreement
• Ensure all signatures are legally binding
• Make a copy of the agreement for each party
• Check off the step when all signatures are collected and the agreement is finalized.

Drafting and executing a final contract

• Prepare a draft agreement based on the terms and conditions discussed between the parties
• Review the contract for accuracy and completeness
• Make revisions and modifications as needed to ensure accuracy
• Ensure that all parties involved have reviewed and agreed to the contract before execution
• Execute the contract in accordance with the laws of the state or country in which the contract is being made
• Once the agreement is executed by all parties, you are ready to move on to the next step of obtaining necessary signatures and notarizations

Obtaining necessary signatures and notarizations

• Obtain the signatures of all parties involved in the agreement
• Ensure the signatures are witnessed and notarized
• Have the notary public sign the document and affix their seal
• Make copies of the agreement with all signatures and notarizations attached
• File the originals in a safe place
• Check off this step and move on to the next step when all signatures and notarizations are complete.

Preparing for Potential Disputes

• Draft a dispute resolution clause in the Clinical Trial Agreement (CTA). This clause should outline procedures for handling any potential disputes that may arise.
• If the CTA is being entered into by two parties located in different countries, consider including a choice of law provision in the CTA. This will ensure that all parties agree to the same laws and regulations if a dispute arises.
• Consider including a mediation clause in the CTA, which provides for an informal means of resolving conflicts outside of the formal court system.
• If the CTA is being entered into by two parties located in different countries, consider including an arbitration clause in the CTA, which provides for an alternative dispute resolution process that is often faster and less expensive than court proceedings.

You will know this step is completed when you have included a dispute resolution clause in the CTA and, if necessary, any additional clauses such as a choice of law provision, a mediation clause, and/or an arbitration clause.

Establishing a process for resolving conflicts

• Establish a process that outlines a step-by-step plan for resolving conflicts should they arise during the course of the clinical trial.
• Be sure to include a timeline for resolving conflicts and the potential outcomes.
• Consider any potential third-party mediators who might need to be involved and how they will be contacted in the event of a conflict.
• Make sure all parties involved in the clinical trial agree to the process for resolving conflicts before the trial begins.
• When you have a process for resolving conflicts that all parties agree to and understand, you can check this off your list and move on to the next step.

Determining the role of any third-party mediators

• Identify any third-party mediators who need to be involved in the clinical trial agreement.
• Determine the roles and responsibilities of each third-party mediator in the agreement.
• Confirm that all third-party mediators involved in the agreement are legally authorized to act on behalf of the parties involved.
• Confirm that all third-party mediators are aware of the terms of the agreement.
• When all of the above points have been confirmed, you can check this step off your list and move on to understanding the regulatory environment.

Understanding the Regulatory Environment

• Review the regulations that govern clinical trials, such as the International Conference on Harmonization (ICH) and the European Medical Agency (EMA).
• Consider any local laws, regulations, or standards that may apply to the study.
• Check the clinical trial agreement to make sure it is compliant with all applicable regulations.
• Check with partners, sponsors, and other stakeholders to ensure that all regulations are being followed.
• When you are certain that all applicable regulations have been taken into consideration, you can move on to the next step.

Researching applicable laws and standards

• Read up on relevant clinical trial laws and standards, such as FDA guidelines, International Conference on Harmonization (ICH) guidelines, and Good Clinical Practice (GCP) requirements
• Consult with legal counsel as needed to ensure full compliance
• Use any resources available to ensure a thorough understanding of the applicable laws and standards
• When finished, make sure you have a comprehensive understanding of the laws and standards that apply to the clinical trial agreement you are creating.

Consulting with legal counsel as needed

• Contact and consult with legal counsel to ensure the agreement meets all applicable requirements for the trial
• Schedule a meeting and get advice on the agreement and what needs to be added or revised
• Discuss any legal questions or issues you may have and get clarification
• Once all requirements have been met and advice taken, you can move on to the next step.

FAQ:

Q: What is the difference between a Clinical Trial Agreement and an Informed Consent Form?

Asked by Kyle on 1st January 2022.
A: A Clinical Trial Agreement (CTA) is a legal contract between the sponsor of a clinical trial and the host institution or research site. It lays out the responsibilities of each party, including rights and obligations to protect the safety of participants and ensure the integrity of the data being collected. An Informed Consent Form (ICF) is a document that provides information about a clinical trial to potential participants, and outlines their rights as a participant. The ICF also provides instructions for signing up for the trial and includes a signature page for participants to sign in order to confirm their voluntary participation.

Example dispute

Lawsuits involving Clinical Trial Agreements

• The plaintiff can raise a lawsuit if they believe the terms of the clinical trial agreement were not followed, or if they believe they are entitled to compensation for damages due to negligence or malpractice on the part of the defendant.
• The plaintiff must provide evidence that the defendant breached the agreement, as well as evidence of any damages that were caused due to the breach.
• The court may consider any existing legal precedents or regulations related to clinical trials, such as the Declaration of Helsinki, in making its decision.
• The court may award any damages based on the amount of harm caused to the plaintiff and any other costs that resulted from the breach.
• The court may also order the defendant to pay for the plaintiff’s legal costs, if the plaintiff is able to prove that the defendant was negligent or otherwise at fault.
• Settlement may also be reached between the parties outside of court, where the defendant agrees to pay the plaintiff a certain amount of money in exchange for the plaintiff dropping the lawsuit.

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