Overview of the Clinical Trial Process

CONFIDENTIALITY AGREEMENTS (CDA)

The first step in initiating a clinical trial is obtaining the protocol from the sponsor or the contract research organization (CRO). Ususally before the sponsor or the CRO is willing to release a copy of the confidential protocol they will require that a confidentiality agreement (CDA) be signed. The CDA should be signed by a University representative on behalf of its employee, the potential investigator. As soon as the potential investigator receives the CDA, it should be forwarded by email or fax to the Office of Clinical Trial Adminstration (OCTA) along with the contact information for the sponsor or CRO. The OCTA analyst will then review the CDA to ensure the terms and conditions of the document are in compliance with University policies. Should revisions be necessary, the OCTA analyst will contact the sponsor or CRO to negotiate langauge acceptable to both parties. To ensure any unnecessary delay in getting the protocol to the potential investigator, the initial sponsor or CRO contact and CDA review will occur within 24 hours of the OCTA receiving the CDA.

Problem areas with CDA's may include:

  • Sponsor Ownership of Intellectual Property arising out of the trial;
  • Potentail investigator indemnifies sponsor for breach of confidentialtiy;
  • Governing law is a state other than California;
  • No end date to the CDA;
  • Publication restrictions.

After the CDA is signed and the potential investigator receives the protocol, he/she will determine the feasiblity of conducting the clinical trial at UCSD.

Some of the issues that should be considered are:

  • Does the investigator have the necessary patient population;
  • Is the protocol well designed;
  • Are the study timelines reasonable;
  • Does the investigator's staff have the time to take on another study.

Once the decision is made to conduct the clinical trial, the investigator should start the IRB submission and in parallel submit the appropriate paperwork to the OCTA. Please provide OCTA with the IRB number.


CLINICAL TRIAL AGREEMENT SUBMITTAL PROCESS

A clinical trial agreement is the contract between an industry sponsor and UCSD outlining the obligations of each party for the conduct of a sponsor-authored protocol that involves human subjects and the testing of a drug or medical device. Please note: PI authored protocols will be reviewed and processed by the Office of Contract and Grant Administartion.

The following steps outline the most efficient process for initiating a private industry supported clinical trial for testing biomedical drugs or devices in accordance with FDA regulations. This process enables OCTA to negotiate a clinical trial agreement while the Principal Investigator secures other campus and compliance committee approvals.

While submitting an industry sponsored clinical trial for review, the following paperwork must be received before a contract can be signed: (*These can be located under our FORMS page*)

  • Clinical Trial Agreement Request Form (signed);
  • Draft Contract from Sponsor (if available);
  • Draft Budget;
  • 700-U Statment of Economic Interests for Principal Investigators;
  • HIPAA Authorization Form (if a third party IRB is utilized).

All paperwork should be submitted in order for the Contract Negotiator to begin contract negotiations.

A FEW THINGS TO KEEP IN MIND DURING THE SUBMITTAL PROCESS

CONTACT INFORMATION

In addition to the Principal Investiator's contact information, it is important to provide complete contact information of the sponsor or CRO, if applicable, representative, especially a phone number or email address. The more information the contract negotiator has, the faster and more efficiently the sponsor or CRO may be contacted in order to begin the contract negotiations.

LOCATION OF THE STUDY

If the study will be conducted at more than one location, each location must be listed. If the locations change after the contract negotiation begins, inform the contracts negotiator as soon as possible. If this information is not accurate, it will delay the execution of the contract and may subject the University to unknown risks and liability.

SIGNATURES

The Clinical Trial Agreement Request form must be signed by teh Principal Investigator, Department Chair and Department Business Officer before the contract may be signed. Incomplete forms will delay the execution of the contract.

700-U FORM (PI'S STATEMENT OF ECONOMIC INTEREST)

Instructions on how to complete this form and to download it from the web, can be found at http://coi.ucsd.edu. California law requires University faculty members to disclose whether or not they have a financial interest in outside entities that sponsor research. This disclosure is made using the 700-U form. If there is a positive disclosure, i.e. the faculty member has an economic interest in the sponsor, the conflict of interest must be reviewed and approved by the UCSD Conflict of Interest (COI) Committee. This approval process is monitored by your contracts negotiator and no action on your part is required. Keep in mind that the COI only meets once a month. No agreement can be signed until the COI approval is obtained.

BUDGET

A budget must be submitted showing all anticipated costs of the clinical trial and the overhead rate of 26%. Costs that should be included are: Total Direct costs, i.e. patient care costs, special procedures, supplies and expenses, pharmacy fees, IRB review fees, etc., as well as indirect costs. There is a separate mandatory IRB fees for the IRB review and ongoing monitoring of the project (subject to indirect costs). There fees are invoiced to the sponsor with the initial review, with the annual review and the four-year renewal.

For more information about budget preparation contact the OCTA (octafinancials@ucsd.edu).

IRB APPROVAL LETTER

A contract cannot be signed and a study cannot begin until there is IRB approval. The application process for IRB approval should be submitted simultaneously with the OCTA submittal process. IRB approval and final contracts will not be released until both are approved for signature.

For more information on the Institutional Review Board (IRB) and the submission process, visit the Human Research Protections Program Website.


ACTIONS BY THE OCTA

PRE-AWARD PROCESS

The OCTA Contract Negotiator will:

  • Contact the sponsor to initiate contract negotiations;
  • Provive the sponsor with the standard UCSD agreement if sponosor agreement is not provided;
  • Obtain a copy of previous agreeement (if applicable);
  • Review and propose revisions to the contract;
  • Negotiate final revisions to the contract;
  • Forward the final agreement to the Principal Investigator for signature (the PI will then send the signed contract back to the contract negotiator);
  • Sign the Agreement on the behalf of The Regents;
  • Forward the signed contract to the Sponsor (the Sponsor will then then sign the signed contract back to the contract negotiator).

CONTRACT NEGOTIATIONS

Negotiations involving a contract can sometimes be quite complex and lengthy, depending upon the sponsoring organization and the nature of the work to be performed:

Contracts with clinical trial sponsors (e.g., pharmaceuticals or medical device companies, clinical research organizations) cover human testing activities related to an investigational drug, compound or device leading to approval by the Food and Drug Administration for commercial distribution.

As a public, nonprofit educational institution, the University is bound by certain policies and regulations regarding what it can and cannot accept in a clinical trial contract. These policies are designed to protect the welfare of individuals participating as reserach subjects; foster the University's basic mission of teaching, reserach and public service; and minimize the various forms of liability associated with human subject research.

For-profit private sponsors, such as pharmaceutical companies, are motivated by different forces than the University. As a result, they sometimes do not understand the ideals and principals behind our policies. Consequently, additional time may be required for contract negotiations while the contracts negotiator works with the sponsor to arrive at a mutually acceptable agreement.

When negotiating clinical trial contracts, the University primarily focuses on securing acceptable contract clauses regarding high-risk issues such as subject injury, indemnification, confidentiality, ownership of data, patent rights and publication rights.

The University's standard clinical trial agreement and the clauses proposed by the University during contract negotiations are based on the following assumptions:

  • That the clinical investigation is conducted under a protocol that is a FDA Phase I, II, III, or IV drug study or a FDA regulated medical device study.
  • That the Sponsor provides its proprietary product and study protocol to the University for the purpose of conducting a clinical trial; and
  • That the sponsor will fully fund the cost of the trial (i.e., no work will be supported in whole or in part with other fund, including Federal funds).

POST-AWARD PROCESS

  • The index number will be assigned within 1 business day.
  • Distribution of a copy of the executed agreement to the Principal Investigator and study team.

CONTRACT MAINTENANCE

Amendments, modifications and Addenda should be directed to the OCTA (octa@ucsd.edu).

 


ACTIONS REQUIRED BY THE PRINCIPAL INVESTIGATOR

CLOSING A CLINICAL TRIAL

Upon the closure or termination of a clinical trial, there are certain steps taht must be taken in order to complete the closign process. The following departments need to be notified of the study closure:

  • HRPP should be notified in a written format that the trial is being closed, the date and the reason for the closure. Include the number of participants enrolled (if any), the nubmer of withdrawls and the number of adverse events. HRPP will then update their records accordingly.
  • OCTA must be copied on one of the above notifications so that the OCTA can update the contract records at octa@ucsd.edu.
  • Conflict of Interest should be notified by completing the 700-U and marking in section 2 that this is a complete statement. The updated 700-U should be sent to Conflict of Interest at mail code 0992.

Staying abreast of the financial status of the clinical trial is always important but it is even more important when it's time to close the study. This includes ensuring the sponsor has provided payment for all the work performed, reconciliation of institutional accounts, etc.