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Clinical Trial Agreement Template

Prepared for:

[Client.FirstName][Client.LastName]
[Client.Company]

Created by:

[Sender.FirstName][Sender.LastName]
[Sender.Company]

This clinical trial agreement is binding and effective as of [Agreement.Date]. The parties to this agreement are as follows, collectively known as the “Parties”:

Sponsor

[Client.FirstName][Client.LastName][Client.Company]
NameCompany
[Client.StreetAddress][Client.Email]
StreetEmail
[Client.City], [Client.State], [Client.Zip][Client.Phone]
City, State, ZipPhone

Institution

[Sender.FirstName][Sender.LastName][Sender.Company]
NameOrganization
[Sender.Street][Sender.Email]
StreetEmail
[Sender.City], [Sender.State], [Sender.Zip][Sender.Phone]
City, State, ZipPhone

Whereas the Institution wishes to conduct research in the field of [Field.Name], and the Sponsor has an interest in such field, the parties agree to collaborate according to the terms of this Clinical Trial Agreement. 

Clinical Trial Details

The Institution will carry out the clinical trial as follows:

Date(s):[Trial.Dates]
Clinical Trial Location:[Trial.Location]
Number of Participants:[Trial.ParticipantNumber]
Managing Director:[ManagingDirector.Name]

Additional clinical trial details:

Sponsor Support

Financial Support

The Sponsor has agreed to supply financial support for the clinical trial as follows:

DescriptionAmount 
Setup 
Enrollment 
Study Visits 
Completion Fees

All above payments should be made payable to :

These payment amounts are based solely on a reasonable market value of likewise trails taking place in the same geographical location. At any point the institution may request additional funding at the time of the expense with written notification as well as proof of expense. Institution is under no obligations to participate in the above clinical trial based on sponsors financial offerings. Sponsor shall not be responsible for any unforeseen fees if written notification has not been made prior to costs incurring. 

Non-Monetary Support

In addition to the above listed financial support, the Sponsor agrees to provide the following non-monetary support to the Institution:

Terms & Conditions

Confidentiality 

Both institution and sponsor are in complete understanding that the transfer and sharing of confidential information regarding the study shall occur. Both parties are in agreement that during the term of this clinical trial agreement as well a 5-year period after the conclusion of this agreement both parties will adhere to the following:

  • No information deemed confidential shall be shared without prior authorization and written consent from both parties.
  • No information regarding the trial shall be shared or published to third parties without all participating parties’ knowledge and prior consent. 
  • All precautions deemed necessary can and will be taken to protect confidential information at all times.

Miscellaneous Terms

Institution shall remain the principal investigator for the entire duration of trail period. 

The study shall begin upon agreement to this contract and will conclude either upon termination of said contract or study completion. 

The Study shall enroll a maximum of [Trial.ParticipantNumber] research subjects meeting all requirements agreed by the Parties. If number of participants is increased, both parties must agree in writing to both the increase and any additional requirements. 

All participating parties agree that payment made is in fair market value for such participation and no payment has been made for outcome of trial. No parties involved have been paid unfairly or paid for certain results. 

Sponsor has agreed to offer all the mentioned funds in this agreement on the dates provided as mentioned. 

Proprietary Rights 

All deliverables conducted by Sponsor shall remain property of sponsor both during and upon completion of trial. 

All other products and documents will be property of Institution and shall remain so upon completion and for the duration of the trial. 

New Inventions or Discoveries developed solely by trial will be considered royalties and made available to all participating parties as such.  

The Institution shall reimburse all parties for any out-of-pocket costs and expenses occurring from trial during or after trial period. 

Any and all Data conclusive from this Study shall be the sole property of  the Institution. 

Publications 

Sponsor as well as any Principal Investigators shall have given rights to publish study findings as deemed necessary.  Prior to any publications, Institution will provide sponsor with notification in writing no later than 30 days from recital of publication and allow sponsor no less than 15 days for review of said documents.  

All parties agree that in the instance of a multi point study no publications will be made prior to consent from all parties in regard to all study areas. Study results will be published and will be made readily available following a period of 12 months without written consent. 

Protocol Changes and Monitoring 

 In the instance that any party becomes aware of the need for a deviation from the Protocol listed that individual will immediately inform the other party to this Study Agreement of the facts causing the deviation as soon as the facts are known to the party.  

Participants will require notification upon any condition in which they become aware of that may affect the safety or medical care of Subjects or their willingness to continue as Subjects, alter the risk/benefit ratio of the Study, or alter the conduct of the Study or represent serious or continuing non-compliance. 

Sponsor agrees that during the period of the study and for a period of 2 years following the conclusion of the Study, Sponsor will notify the Institution of observed Study Drug/Device effects that may affect any patients involved.

Furthermore, the Sponsor reserves the right to audit the institution during business hours without prior notification.

Indemnification

Sponsor agrees to hold defend and hold all parties entered into this agreement not responsible for any and all liabilities that may incur from the improper packaging, documentation or delegation of any property related to the trial in question. If at any point legal proceeding take place due to lack of FDA guidelines being followed sponsor will hold no parties responsible for proceedings. 

Insurance 

Sponsor has proper insurance coverage as needed for said trials and will maintain coverage throughout the remainder of trail period. At any time participating members of this agreement may request in proof of insurance as deemed necessary. 

Termination 

This Study Agreement may be terminated only under the following terms:  

  • Written notification not less than 30 days prior to cancellation date by any participating member.  
  • If principle investor is not capable of completing the study.
  • Upon the occurrence of an event qualifying as a termination event as described in the Protocol.
  • Immediately upon receipt of a notice of termination this agreement.

Termination of this Study Agreement by either party shall not affect the rights and obligations of the parties accrued prior to the effective date of the termination.

Amendments 

This Study Agreement may only be amended by the mutual written consent of authorized representatives of all members presently entered into this clinical trial agreement.  

Severability

The invalidity or unenforceability of any term or provision will in no way effect any and all other terms listed in this clinical trial agreement. In the instance any term is found unenforceable or invalid all remaining terms shall remain in full effect. 

Force Majeure  

Institution shall not, under any circumstances, be held responsible for termination or delay of the clinical trial caused by circumstances reasonably beyond Institution’s control, civil disturbances, acts of god, or other interference.  

Acceptance

IN WITNESS WHEREOF, the parties hereto have caused their duly authorized representatives to execute this Study Agreement as of the date first written above.

[Sender.Company]

Signature

MM/DD/YYYY

[Sender.FirstName][Sender.LastName]

[Client.Company]

Signature

MM/DD/YYYY

[Client.FirstName][Client.LastName]

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