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Pre-Award Procedures for The Conduct of Clinical Trials

OGC provides administrative support for all clinical and/or basic medical research projects performed by faculty members and staff at AUB.

The set procedures are designed to ensure sound management and execution of Clinical Trial (CT) Agreements and to ensure compliance.

This section will describe the responsibilities of the Principal Investigators (PI) and the Office of Grants and Contracts (OGC) in pre-award management of clinical trials.


I. Principal Investigator Responsibilities

PIs participating in CTs are requested to obtain approval for and submit all of the items, listed below, that forms a complete “Clinical documentation File” before any negotiation with the pharmaceutical company can be initiated at OGC.  

The “Clinical Documentation File” consists of these documents:

1. The Clinical Research Protocol/and or Proposal submitted or to be submitted to the sponsor for review and evaluation.

2. OGC Proposal Transmittal & Approval Form: The proposed Clinical Trial must be approved by the Chair of the Department and the Dean/ or Dean Designee before it is sent to OGC for review and approval and to the provost for final approval. The form can be found on http://www.aub.edu.lb/ogc/Pages/forms.aspx.

3. The Draft Agreement between the sponsor and the University if available.

4. The Estimated Budget: The PI must ensure that sufficient funds are requested to cover the proposed tasks. The PI should submit a budget breakdown of the direct and indirect costs needed for the implementation of the proposed CT. Direct costs shall include costs such as investigator fees, laboratory tests, materials and supplies, cost of medication (if applicable), transportation costs, record storage fees, IRB annual renewal fees (if applicable) and other similar costs, in addition to AUB’s indirect costs of 20% applied to total budget. Usually, a cost per patient is negotiated between OGC and the Sponsor. Once the Sponsor approves the Budget it becomes an integral part of the Agreement.

Upon negotiating the budget with sponsors, the PI should get the exact fees ‘amounts that are to be included in the budget, approved from AUBMC Finance Department. This approved budget should be communicated by email to OGC, while  in the negotiation phase of the proposed terms of the agreement.

The Sponsor will make a startup fee payment upon signature of the agreement for Investigator to initiate clinical trial’s activities as deemed necessary and at her/ his discretion. In case of delays in the trial start date, payments to ensure covering the effort put by the Principal investigator beforehand, as well as the hiring of personnel needed in initiating activities, should be made by the Sponsor

For pharmaceutical initiated trials, it is the responsibility of the PI to inform the company that IRB fees should be paid directly to the IRB office prior to the CT agreement signature. 

5. Details of the Insurance offered by the Sponsor to cover the patient against any adverse effects that might occur during the course of the Clinical Trial.

6. Patient Consent Forms: The PI should make sure that the full and informed consent forms, of participating human subjects, as approved by IRB, are included.

7. Copy of IRB Approval Letter: All research involving human subjects conducted at AUB must be reviewed by IRB. A detailed description of the rules governing IRB functions and the responsibilities of a Principal Investigator (PI) can be found in the section entitled: "Principles and Policies" under the Faculty of Medicine Research. IRB reviews and approvals must be obtained either before the proposal is submitted or before a deadline set by the sponsoring agency. CT agreements will be not be negotiated with the sponsoring company before IRB approval is issued.

8. Information about the Sponsor Company: The Sponsor contact name, phone number, and e-mail address.

9. Contract Research Organization: If sponsor has delegated authority to a “Contract Research Organization” (CRO), to coordinate research work with AUB, OGC requests a copy of the letter of delegation, which should include the agreed-upon activities and responsibilities of the CRO. The agreement should also specify the required quality and safety program provided by the CRO on behalf of the sponsor.

10. All other Sponsor-supplied information about the proposed clinical research not detailed in (A) through (H).


II. OGC Responsibilities

1. Receipt and Review of Clinical Documentation File

Upon receipt of the Clinical Documentation File, OGC shall review it and if approved, forwards the file to the Provost for final approval.  

To ensure the smooth administration of the planned trial, it is important to inform OGC at an early stage of discussion between the PI and Sponsor regarding a specific trial. Upon receipt of the Clinical Documentation File from the PI, OGC checks that all documents are in order , vet collaborators, institutions, sub-awardees etc... (if applicable), (SAM, UN and Ofac), where a copy of the results is saved in the project files, then proceed with the agreement negotiation process with the Sponsor.

2. Review of Clinical Trial Agreements

The PI is not authorized to enter into an agreement with a Sponsor or to commit AUB into an agreement and a budget. OGC is responsible for verifying that the agreement appropriately addresses legal issues, including indemnification and patient insurance provisions and checks whether the agreement clearly defines the responsibilities of the PI and AUB, as well as that of the Sponsor. OGC also reviews and negotiates with the Sponsor, if needed, the final requested budget and payment schedule.

3. Negotiation of Clinical Trial Agreements

The Sponsor and OGC work together to ensure that arrangements are in place for the research team to access resources and support and to implement the Study. OGC and the Sponsor will negotiate an agreement, which defines responsibilities for managing, monitoring and reporting of research, as well as define the procedures to record, report and review significant developments as the Study progresses. The agreement shall also include procedures particularly those related to the safety of individuals at risk and to improve modifications to the design. 

Budget Negotiation: OGC requires and will request from sponsor companies a 3 months advance payment for the time effort of research fellow coordinators or assistants and subsequently will request advances on three months basis until completion of the trial.

AUB requests that all Clinical Trial agreements shall include the following clauses:

 

    • Indemnification - AUB requests that the Sponsor always defends, indemnifies and holds harmless the PI
      and the University and its employees from any and all liabilities, claims, actions or suits for personal injury or death, including reasonable attorneys' fees directly arising out of or in connection with the administration or use of the Study Drug given by the PI in accordance with the Study Protocol.
    • Intellectual Property - The Sponsor may be granted a certain range of rights to intellectual property
      such as copyright, made in the direct performance of the Clinical Trial protocol. However, patent rights are reviewed on a case-by-case basis depending on the type of Clinical Trial and the scope of work.
    • Publication - Timely publication and dissemination of research/study results are important principles
      behind the academic freedom afforded to faculty members. OGC will only negotiate the time needed for the Sponsor to review a proposed publication ONLY to secure that none of the Sponsor's confidential information is included.
    • Insurance - AUB usually requests that the Sponsor covers all subjects participating in a Clinical Trial for
      all medical costs in diagnosing and treating research-related injury.
    • Professional Ability and Research Competence - OGC requests that in the signed agreement, the
      sponsor is assured that the principal investigator, his/her sub investigators and research team is trained, qualified and have the ability and professional competence to carry out the research work.
    • If Sponsor has Delegated Authority to a Contract Research organization (CRO), the letter of
      delegation must be submitted to OGC. Duties and functions of the CRO must be specified and must be included in the letter of delegation. The letter of delegation becomes an integral part of the Agreement between AUB and Sponsor (or CRO).
    • The agreement shall include the Required Quality and Safety Program provided by the sponsor. OGC
      requests that the sponsor is responsible for monitoring the contract and the quality and integrity of the research.

4. Signature of Agreement

Once negotiation with Sponsor is completed and the agreement is finalized and agreed upon, OGC sends the agreement to the PI for his/her final approval before signature.

Any agreement between funding company and AUB is only binding when approved and signed through the Office of Grants and Contracts. AUB's policies prohibit PIs from conducting a study before an agreement is signed by both AUB and the Sponsor, therefore, PIs must not begin clinical trial implementation until they have confirmation from OGC that the agreement has been signed.

The time required to finalize and sign on an agreement varies depending upon several factors, so PIs are encouraged to submit the Clinical Documentation File material well in advance of the anticipated study start date.

 

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