275 Pharmacology courses

A clinical trial monitor acts on behalf of the sponsor to support investigational site personnel, verify the accuracy of data recorded, and ensure that the trial is conducted in compliance with the protocol, GCP and other study specific requirements. He or she acts as the ‘eyes and ears’ of the sponsor at the investigational site and provides the main channel of communication between sponsor and investigator. This short course explores the responsibilities of the monitor and provides insight into key challenges. We discuss assessment of investigators and investigational sites, education and trial initiation, monitoring of clinical conduct, including CRF review and source document verification, and trial close-out. We discuss noncompliance and how to deal with it.

Informed consent in clinical research is an ethical and regulatory requirement. A research subject must enter a study voluntarily, be informed about risks and benefits, and understand the difference between investigation and treatment. Subjects must not be coerced into enrolment, nor must they be enticed by exaggerated claims of benefit. Before they can enrol, all potential subjects must agree, in writing, to participate. In addition to ethical and regulatory imperatives, the potential for litigation by subjects further highlights the importance of rigorous adherence to informed consent principles. In this short course we set out the principles and requirements and provide examples of practical issues confronting healthcare professionals and subjects.

A clinical investigator is responsible for conducting the clinical trial in compliance with the study protocol, GCP, medical ethics, and applicable legal requirements. The clinical research community expects that investigators and clinical staff are fully trained in GCP. Duties and functions discussed in this short course include: provision of adequate resources; liaison with IRB/IEC; compliance with protocol; management of investigational product(s), informed consent and data records; and safety reporting.

The sponsor of a clinical trial takes responsibility for its initiation, management, and/or financing. A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a contract research organisation, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. Duties and functions discussed in this short course include trial design, selection of investigators, QA and QC, data handling and record keeping, finance and compensation, regulatory submissions, management of investigational product(s), safety reporting, monitoring, audit, dealing with noncompliance, and clinical trial reports. ICH guideline E6 (revision 2) encourages sponsors to adopt a risk-based approach to managing the quality of trials. We discuss this approach in general, and aspects such as risk-based monitoring in particular.

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data in applications for marketing approval. The International Council for Harmonisation's guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice. In this short course we describe the ICH’s role in the harmonisation of regulations, introduce its guideline E6, and set out the principles of GCP.

Comprehensive documentation of procedures, formulas, work instructions, and specifications, and thorough recording of batch data, are fundamental requirements of GMP. In this short course we explain why documentation is so important, identify different types of document required, and set out some simple rules for recording and correcting data.

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