The review of clinical trial differs from other research projects because their proposals are different. The related sections under Clinical Trials Management provide definitions related to clinical trials, and information about the review process of clinical trials, the pre- and post award procedures for managing clinical trials, as well as define the responsibilities of principal investigators and OGC.
Clinical Trials are research studies that involve human subjects and which are conducted under conditions controlled by a medical doctor and/or scientist referred to as Principal Investigator (PI). Clinical Trials should be designed, conducted and analyzed according to sound scientific and ethical principles, such as the Helsinki Declaration, to achieve the desired objectives.
Clinical Trials are designed to determine whether new drugs or treatments are safe and effective and/or evaluate a new medical treatment, a drug or a medical device. Their purpose is to find new and improved methods of treating diseases and special conditions. In most cases private companies (referred to as Sponsors), mainly pharmaceutical companies, sponsor such trials.
Clinical Trials are designed either as a “Single Center” or “Multi-Center” trials, with, in the latter case, AUB becomes one of the sites among other national and/or international sites participating in the conduct of the trial.
Principal Investigator (PI): The PI is the project director and assumes full responsibility for the research project or Clinical Trial conduct. The PI is in charge of preparing the Clinical Trial proposal, securing internal approval for the conduct of the Clinical Trial including institutional ethical committee approval, and overseeing the scientific and technical aspects of the Study. The PIs are responsible for the management of Clinical Trials including patient recruitment, and submission of original case report forms ("CRFs") for each patient or subject participating in the Study (“Study Subject”) and, if applicable, regular narrative reports to the Sponsor.
Clinical Trial Protocol: A Clinical Trial Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and the organization of a Clinical Trial. The protocol should contain a study plan on which the Clinical Trial is based. The plan is designed to safeguard the health of the participants (while limiting their financial liability) as well as answer specific research questions. It should also describe what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the time line of the study. It is expected that during a Clinical Trial, study participants are seen regularly by the research staff (usually medical doctors and/or nurses) to monitor their health and to determine the safety and effectiveness of the treatment(s) they are receiving.
The Clinical Trial Protocol could be solely formulated by the sponsoring company; or by the Principal Investigator (PI). In either case, Clinical Trials are considered sponsored projects and are reviewed and approved as such.
Approved Clinical Research Protocol: This is a sponsor-supplied protocol that has been approved by the Institutional Ethical Committee, in AUB’s case the “Institutional Research Board (IRB) and the PI.
Institutional Review Board (IRB): IRB is an administrative body established to protect the rights, safety and well being of all human subjects recruited to participate in research activities conducted by members of AUB Faculty, regardless of the funding source. IRB pays special attention to studies that may include vulnerable subjects.
Declaration of Helsinki Protocol:
The Declaration of Helsinki Protocol
is a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. The Declaration includes principles on safeguarding research subjects, informed consent, minimizing risk, and adherence to an approved research plan/protocol.
Good Clinical Practice:
Good Clinical Practice is an international quality standard that is provided by the International Conference on Harmonization (ICH)
; an international body that defines standards, which governments can transpose into regulations for clinical trials
involving human subjects. Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. Good Clinical Practice Guidelines include standards on how clinical trials should be conducted; define the roles and responsibilities of clinical trial
sponsors, clinical research investigators, and monitors.
Adverse Event/Reaction: An adverse event is any occurrence that a person in a Clinical Trial is subjected to during and/or after drug administration. Such event could be directly related to the drug administered to a patient or to the dose. A serious adverse event (SAE) is an event that occurs during the Clinical Trial and which is deemed life threatening, such as illness requiring hospitalization, or involving cancer or fetal exposure or even death, and must be reported to the regulatory authorities immediately, whether the SAE is thought to be directly or indirectly related to the Clinical Trial.
Liability / Malpractice Insurance: This insurance is a coverage for a professional practitioner against liability in the case of malpractice and is not related to the drug, its administration or dosage.
Indemnification: This is a contractual obligation by which one person or organization agrees to secure another against loss or damage from specified liabilities. Compensation is usually made to a victim of a loss by the repayment, repair, or replacement in whole or in part.
Agreement: This is a document made between two parties or more for the purpose of defining their business relationship and responsibilities. Agreements address issues such as time line for patient recruitment, responsibilities of the PI and the Sponsor, publication rights and restriction, ownership of intellectual property, confidentiality of information, payment and payment schedules, record keeping, termination, warranty, liability, indemnification, assignment and subcontracting, amendment, notices, relationship of parties, governing law and governing priorities.
Clinical Research Associate (CRA): A CRA is an agent/employee of the Sponsor, whose main function is to monitor clinical trials. He or she may work directly with the Sponsor, as an independent freelancer or for a Contract Research Organization (CRO). A CRA ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with the Principal Investigators.