Description
GCP, or Good Clinical Practice, refers to a set of scientific and ethical quality standards for reporting, recording, conducting, and designing trials that involve human subjects. GCP compliance ensures the well-being, safety, and the rights of clinical trial subjects, as well as the integrity and credibility of clinical trial data. E6-GCP defines monitoring as, “The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s)”.
The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to be evaluated, and the trial has to be set up at each site.
This Clinical Research Associate (CRA) Professional Certification Program describes the processes involved, focusing particularly on the role of a Clinical Research Associate (CRA) employed or contracted by the sponsor to monitor the trial.
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.
The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements. In this program we describe how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion. After a brief overview, the program consists of topics such as the following: closeout visit, essential documents, source document verification, CRF review, monitoring visit, fraud and scientific misconduct, and a key point summary at the end.
Good Clinical Practice (GCP) inspections and audits are carried out to provide assurance that: the rights, safety and welfare of clinical trial subjects are protected; the data that constitute the results of the trials are accurate and reliable; and the trials are carried out in compliance with relevant legal requirements. 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. The course 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. Finally it describes post-inspection actions by the regulator and the inspected party.
Assure employee understanding and importance of compliance with GCP standards, and how these apply to monitoring clinical studies:
This Clinical Trials Monitoring Professional Certification Program will review informed consent, GCP guidelines, and the important tasks involved in maintaining GCP compliance when monitoring clinical trials. This program may be used as a refresher for project managers and clinical research associates (CRAs), or taken by registered nurses (RNs), nursing assistants (CNA), licensed practical nurses (LPNs) or others, such as clinical research coordinators (CRCs) or investigators, seeking to move into a clinical trial monitoring or project management position.
The five (5) individual courses included in this program include: 1) ICH Good Clinical Practice (ICH-GCP); 2) Clinical Trials: Preparation and Design; 3) GCP: Clinical Trial Monitoring – Site Evaluation and Set Up; 4) GCP: Clinical Trial Monitoring – Documentation and Closure; and 5) GCP: Clinical Trial Monitoring – Preparing for an Audit or Inspection.
Students can take the final assessment any number of times, as needed, to achieve a passing grade. Once all course requirements have been satisfied, a professional certification has been achieved.
