Study Coordinator Training Program - Barnett

Clinical studies are essential for testing new drugs and medical devices to ensure their safety and effectiveness. They adhere to Good Clinical Practice (GCP) guidelines, an international standard ensuring ethical research and credible data. The International Conference on Harmonization (ICH) provides guidelines endorsed by European, Japanese authorities, and the FDA. Study coordinators, also known as clinical research coordinators, manage the day-to-day activities of these studies, working with investigators to ensure accurate information and efficient, safe operations. This program, including a video and workbook, highlights the coordinator's responsibilities.

Drug development starts with laboratory and animal testing. Once sufficient safety and efficacy data are gathered, regulatory agencies (like the FDA) are notified to begin human trials. Phase one studies test drug safety in 20-80 healthy volunteers. Phase two studies determine effectiveness in a few hundred patients with the target condition. Phase three studies are large, multi-centered, randomized, and well-controlled trials involving up to several thousand subjects. Study coordinators may participate in one or more of these phases, ensuring thorough testing before medications are prescribed.

Before a study begins, the coordinator organizes and maintains the investigator study file, which includes important documents like the protocol, case report forms, investigator CVs, IRB approvals, and correspondence. Other pre-study activities include reviewing the protocol and investigator's brochure, negotiating the budget with the sponsor, informing other departments, submitting regulatory documents to the IRB, and compiling pre-study documents for the sponsor. A site initiation visit by the Clinical Research Associate (CRA) explains the protocol and sponsor expectations, after which subject enrollment can begin, typically following receipt of the investigational drug.

During the study, key responsibilities include continuously maintaining the investigator's study file and source documents, completing case report forms (CRFs) accurately, managing and reporting adverse events, and maintaining drug accountability. CRFs record all required subject information, transcribed from original source documents (e.g., hospital records, lab notes). Clear and complete source documentation is crucial for data verification. Close attention is paid to adverse events for patient safety. Drug accountability involves keeping precise records of drug quantities received, dispensed, stored, and returned.

IRBs (or Independent Ethics Committees, IECs) are independent bodies ensuring the protection of human subjects' rights, safety, and well-being. They review and approve trial protocols, investigator suitability, and facilities. The study coordinator manages correspondence with the IRB to ensure compliance. Informed consent is a critical aspect, where subjects voluntarily agree to participate after being fully informed of all trial aspects, including experimental nature and potential side effects. The coordinator must ensure the consent form includes all required elements and is presented clearly, avoiding pressure, and obtaining a signed, dated form before participation.

After data collection, a study termination visit retrieves supplies, addresses data queries, and ensures record retention. The investigator submits a study summary to the IRB, and the coordinator ensures proper storage of all study documents, including signed informed consents. Regulatory and sponsor audits occur to ensure adherence to GCP. Auditors check for complete CRFs and source documents, signed informed consents, data verifiability, up-to-date investigator files, documented protocol deviations, audit trails for corrections, consistency with sponsor databases, and proper IRB notification of adverse events. Being prepared for audits ensures smooth inspections.