CLINICAL TRIAL MANAGEMENT

PRE-AWARD PROCEDURES FOR THE CONDUCT OF CLINICAL TRIALS

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

The set procedures are designed to provide a framework to ensure the smooth management and execution of Clinical Trial Agreements and to ensure compliance.

Pre-award Procedures

This section will describe the responsibilities of the PI and the Office of Grants and Contracts in processing the pre-award stage of clinical trials.

 Researchers participating in Clinical Trials are responsible for processing and /or obtaining approval for all of the following items prior to initiating the trial. Work on all of the items listed below should be initiated simultaneously as soon as the PI is interested in participating in the trial.

The PI should submit to OGC, before the trial is initiated, a complete Clinical  Documentation File which consists of the below listed documents: 

A. The Clinical Research Protocol/and or Proposal submitted or to be submitted tot he sponsor for evaluation and funding.

B. OGC Proposed Transmittal & Approval Form. The proposed Clinical Trial must be approved by the Chair of the Department , the Assistant Dean for research (Chair, Faculty Research Committee) and/or the Dean before it is sent to OGC for review and approval and finally to the provost for its final approval. The form can be found on http://www.aub.edu.lb/ogc/Pages/forms.aspx.

C. Proposed Agreement between the sponsor and the University; if available.

D. Estimated Budget. The PI must provide a budget breakdown of the costs needed for Clinical Trial implementation. The PI must ensure that sufficient funds are requested to cover the proposed study. The budget should include direct costs such as investigator fees, laboratory  tests, materials and supplies, cost of medication (if applicable), transportation costs, record storage fees, IRB review fees and others, as well as indirect costs of 20% applied on total budget. usually, a cost per patient is negotiated between OGC and the Sponsor. Once the Budget is pproved by the Sponsor it becomes an integral  part of the Agreement.

E. 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.

F. Patient Consent Forms. The PI should make sure that the full and informed consent forms of participating human subjects are included.

G. Copy of IRB Approval Letter. All research involving human subjects conducted at the AUB must be reviewed by the 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. Faculty members are required to include the IRB approval with their proposals, as no proposal will be processed by OGC unless the human subject protocol has been either submitted for review or has been already approved.

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

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

Pre-award Procedures - OGC Responsibilities

I. Receipt and Review of Clinical Documentation File

While the PI may discuss the scope of work of the trial, the number of patients to be recruited, and the expenses needed with the Sponsor, he/she is not authorized to commit AUB into a final agreement and a set budget. OGC must review and approve the Clinical Documentation File and recommends it for the Provost's signature.

To insure 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 and will then proceed with the agreement negotiation process with the Sponsor.

II. Review of Clinical Trial Agreements

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 negotiate with the Sponsor, if needed, the final requested budget and payment schedule.

III. Negotiation of Clinical Trial Agreements

The Sponsor and the Office of Grants and Contracts 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 will also include procedures particularly those which are related to the safety of individuals at risk and to improve modifications to the design.

For a Clinical Trial agreement to be negotiated with AUB it must include the following clauses:

• Indemnification - AUB requests that the Sponsor always (especially in Clinical Trials) 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.

IV. 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 and thus the PI has no authority to sign on behalf of the University. 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.