The elements from the investigator section of the ich e6 good clinical. An essential course for all clinical research professionals. Background note for guidance on good clinical practice is an internationally accepted standard for the design, conduct, recording and reporting of clinical trials tga therapeutic goods administration. The principles of good clinical practice clinical trials should be conducted in accordance with the ethical principles that have their origin in the declaration of helsinki, and that are consistent with gcp. The 12 modules included in the course are based on ich gcp principles and the code of federal regulations cfr for clinical research trials in the u. Introduction to good clinical practice gcp acrp elearning. Overview of good clinical practice training the good clinical practice gcp online training consists of 12 modules. Be sure to check with your departmental gcp training. Consolidated guideline, and is organized as a reference and educational tool to.
Oversight of other parties involved in study conduct protecting the rights, safety and welfare of. The citi good clinical practice gcp basic course is an overview of gcp. Thus, investigators and site staff may receive gcp training multiple times each. Good clinical practice gcp gcp consists of basic and refresher courses that provide essential good clinical practice training for research teams involved in clinical trials of drugs, biologics, and devices, as well as those involved in behavioral intervention and social science research studies. Gcp guidelines include standards for designing, conducting, recording and reporting. In 1997, the food and drug administration fda endorsed the. Good clinical practice training mcmaster university, hamilton health sciences and st. The purpose of this policy is to identify training requirements and guidelines regarding human subjects protections hsp and good clinical practice gcp, for niaid and. Basics of gcp good clinical practice good research practice. Introduction to good clinical laboratory practice is a standalone short course for all those wanting to gain an understanding of gclp and its application in laboratories. Identifying key elements and strategies for increasing training efficiency article pdf available in therapeutic innovation and regulatory science 504 march.
Some units on campus require this course, but it is optional for the hrpp. Good clinical practice is an international quality standard for conducting clinical trials that involves human subjects. Good clinical practice gcp training is a key requirement for individuals involved in clinical research, and is designed to ensure that those involved in conducting a trial are. Be provided to all study personnel engaged in a clinical trial of a drug, device, biologic andor behavioral intervention as defined by the national institutes of health. Effective january 1, 2017, training in good clinical practice gcp is required for all nihfunded investigators and staff who are involved in. Meet the minimum criteria for international conference on harmonisation ich gcp training. This ich gcp course will give you a current and comprehensive guide to the principles of good clinical practice. Good clinical practice gcp training is required for all individuals involved in the conduct of clinical trials in any of the following categories. Good clinical practice gcp training nihfunded clinical trials.
Consolidated guideline, and is organized as a reference and educational. Good clinical practice gcp is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Documentation that allows reconstruction of the course of events. Online gcp training courses good clinical practice. Good clinical practice in research occurs when ethical principles are combined with the collection of quality. Josephs healthcare hamilton, are providing the hamilton research community access to the citicanada. Fda basic course covers good clinical practice gcp and u. Uk good clinical practice gcp interactive online training course featuring miniexams designed to help the trainee assess the gcp rules in real life situations.
This completely free ichgcp training is sponsored by the better industry initiative and is a compilation of the international good clinical practice gcp guidelines, as presented in guideline for good. Effective january 1, 2017 nih expects all nihfunded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be trained in good clinical practice gcp. Good clinical practice training required for nihfunded. Good clinical practice gcp includes basic courses tailored to the different types of clinical research. Note for guidance on good clinical practice is an internationally. Good clinical practice gcp is an international standard for the design, conduct.
Good clinical practice gcp is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and. Good clinical practice provides a framework of principles which aim to ensure the safety of research participants and the integrity and validity of data. Recommendations on gcp training for investigators the clinical. The department of medicine clinical research unit has prepared this document is to provide guidance to all faculty and staff involved in the conduct of research on the best practices related to documentation. Free good clinical practice pharmaceutical training. Good clinical practice gcp is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical. Food and drug administration fda essential topics for clinical trials with investigational drugs, biologics, andor. Good clinical practice study documentation medicine. A procedure in which one or more parties to the trial are kept unaware of. These courses also include corresponding refresher courses for retraining and advanced learning. Good clinical practice is the international industry standard for designing, conducting, recording, and reporting clinical trials. The declaration of helsinki was responsive to the revelations of the. Good clinical practice gcp is the international ethical, scientific and practical standard to which all clinical research is conducted.
Introduction to good clinical laboratory practice global. Good clinical practice gcp a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported. This short course aims to provide the researcher with. The good clinical practice gcp course is designed to prepare research staff in the conduct of clinical trials with human participants. Good clinical practice overview presented by jennifer sharpe potter, ph. Faq good clinical practice training university of washington.
This training is important for all staff involved in clinical research and ensures an understanding of the principles adopted in. What is good clinical practice gcp 0 gcp is defined as a. This handbook is issued as an adjunct to whos guidelines for good clinical practice gcp for trials on pharmaceutical products 1995, and is intended to assist national regulatory authorities, sponsors, investigators and ethics committees in implementing gcp for industry. Ich gcp good clinical practice training course online gcp. The gcp course certificate has been modified to include the current course version and date. Good clinical practice gcp in australia australian. Good clinical practice facetoface and blended learning for corporate clients whitehall training also offers facetoface training for companies who need to train groups of fifteen and over.
Recipients of gcp training are expected to retain documentation of their training. September 16, 2016 related announcements notod18212. Clinical trials should be conducted in accordance with the ethical principles that have their. Good clinical practice, version 5, effective 03mar2017. Good study documentation will allow for an individual with basic knowledge of the particular project to recreate the events of the study. It is essential that principal investigators and site principal investigators of clinical trials receive good clinical practice gcp training prior to the initiation of a clinical trial as they are responsible for. This course can be tailored to your specific requirements. This training has been funded in whole or in part with federal funds from the national institute on drug abuse, national institutes of health, department of health and human services, under contract no. Good clinical practice gcp training and certification. The principles of good clinical practice gcp have their origin in the world medical associations declaration of helsinki.
267 1549 1115 1440 392 1224 729 1405 601 1475 1432 435 208 1281 1436 195 191 1172 1559 366 190 1315 1368 475 910 1516 339 1084 881 1404 1210 419 26 1156 339 807 775 750 1095 201 564