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Sponsor Responsibilities in Clinical Trials

Clinical trial results determine whether drugs are approved by the Food and Drug Administration (FDA) for widespread use by the public. Sponsors are companies that fund clinical trials of investigational drugs. The FDA lists sponsor responsibilities under Title 21 of the Code of Federal Regulations. Responsibilities are delineated to assure the health and safety of clinical trial subjects. Sponsors must ensure that study overseers are subject-matter knowledgeable and that study results are constantly monitored by objective third parties.

  1. Study Overseer Selection

    • A primary sponsor responsibility prior to the initiation of a clinical trial is the choice of a principal investigator. The principal investigator is the scientist who oversees the conduction of a trial. A qualified investigator must submit his curriculum vitae, a copy of the study protocol, personal contact information, a list of sub-investigators, study locations, information about associated institutional review boards, financial disclosure information and a signed commitment to follow the study's protocol. Before a trial begins, a sponsor must select and employ a study monitor who will periodically appear at the site of a trial to ensure protocol is being followed.

    Informing Investigators

    • Before study initiation and after selecting an investigator, a sponsor must provide the investigator with a brochure that details the findings of prior research on a drug. If a drug has never been tested in humans before, the brochure will entail information about animal studies of the investigational drug. Investigators must also be continually informed during the execution of a clinical trial. When study monitors report adverse, dangerous or otherwise unusual findings to a sponsor, the sponsor must inform investigators of these findings to ensure the safety of human subjects.

    Delineate Monitor Expectations

    • Sponsors mandate study monitor procedures. Monitors report to sponsors throughout every phase of a clinical trial. Before a trial begins, monitors conduct site initiation visits, where they meet with all trial staff to make sure they understand and accept the responsibilities of an investigation. They also visually inspect trial facilities to make sure they are adequately supplied with whatever implements are needed to conduct a trial. Study drugs often must be kept in locked, temperature- and light-controlled facilities. Periodic monitor visits ensure that protocol specifications are being adhered to. Sponsors must review all monitor findings to determine whether a trial needs to be modified, stopped or allowed to continue as is.

    Record Keeping

    • Sponsors must maintain study records for up to two years after the termination of a trial. Sponsors must also allow the FDA access to these records. Records do not just show individual subject drug courses; records of the investigational drugs themselves must be securely kept. Many investigational drugs are not FDA-approved and pose a danger if consumed without investigator supervision. Investigational drug records show dates of receipt, transport, quantities and assigned batch numbers. Drug records also have to account for unused drugs in terms of dates of their return to the sponsor and/or their destruction.

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