Description
This Clinical Trials Management (US & EU) Program is for regulatory affairs personnel, clinical managers, project managers, investigators, and clinical research associates. It is also valuable for those with the desire to grow their career from CRA or CRC positions into clinical research and regulatory management positions.
Good Clinical Practice (GCP) is a set of internationally recognized 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 authorization of clinical trials and the acceptance of their data. The International Council for Harmonization’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice. This program introduces GCP and sets it in the context of typical collaborative work in clinical research. We discuss the role and goals of the International Council for Harmonization and the principles of GCP. We describe the roles of members of a team working on a clinical trial. We set out the documentation that must be created and maintained. We specify the responsibilities of trial sponsors, clinical investigators and monitors. We explain the rationale and execution of the informed consent process, and discuss issues that arise in practice. The module is fully up to date with Revision 2 of ICH GCP.
The purpose of investigational site evaluation and set-up is to ensure that the site has access to the required patient population, has appropriately qualified, trained and committed staff with adequate time and facilities, and that it is fully prepared for the safe and successful conduct of the clinical trial. In this program we set out the criteria, procedures and documentation for evaluating a site and setting up a trial there.
This program teaches the students about how clinical trials fit into the process of drug development. Key historical events which have led to the development of controlled clinical trials are outlined. The purpose of clinical trials are specified and further explored through the regulations that apply to them, specifically, the identification of appropriate codes, and outlining their features. The program goes on to discuss the environment of cost control in which the pharmaceutical industry of today operates. Upon completing this program, students will have a strong understanding of how to accomplish the following: Provide an outline of the environmental cost control in which the pharmaceutical industry of today operates; give a description of how clinical trials fit into the process of drug development; outline the ethical and legislative framework; describe the purpose behind clinical trials; provide a summary of the key historical events which led to the development of controlled clinical trials.
This program describes what investigational medicinal product sponsors, contract research organizations and clinical investigators can expect when they undergo inspection or audit. It focuses in particular on inspection by European and US regulators. It moves on to describe general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. It describes post-inspection actions by the regulator and the inspected party.
The application process to conduct FDA-regulated clinical trials in USA and how to obtain approval to conduct clinical trials in the EU are described in detail.
Assure Employee Compliance and Understanding for the GCP and the Regulatory Standards and Guidelines for Conducting Clinical Trials in US and EU:
Courses included with this program are the following: 1) GCP: Preparing for an Audit or Inspection; 2) Clinical Trial Monitoring: Documentation Enclosure; 3) Clinical Trial Monitoring: Site Evaluation and Set-Up; 4) Clinical Trials and Drug Development; 5) Clinical Trial Preparation and Design; 6) ICH Good Clinical Practice (ICH: GCP); 7) The IND, How to Gain Approval for Clinical Trials in the USA; and 8) How to Obtain Approval to Conduct Clinical Trials in the EU.
