Medical, nursing and scientific staff involved in clinical trials, students as well as individuals who support clinical research activities, such as laboratory personnel, IT and finance professionals.
Overview
Good Clinical Practice (GCP) is an international ethical and quality standard for the design and conduct. performance, monitoring, auditing, recording, analyses, and reporting of clinical that provides assurance that the rights, safety, and well-being of human research participants are well protected, data and reported results are credible and accurate. Creating awareness of GCP is mandatory when it comes to innovation in medicine and healthcare. The recent launch of the New Drugs and Clinical Trials Rules, 2019 (NDCT), on March 19. 2019 opens up a new set of opportunities to accelerate innovations in India. Poor understanding of the current regulatory requirements mixed with inadequate compliance to best global practices may lead to delays and failures which can be significantly reduced through awareness programs.
Successful performance in this exam implies that the participant has in-depth knowledge and clear understanding of industry guidelines and regulations. The study material has been carefully designed to introduce the attendee to various aspects and basics of GCP, its need and benefits in assuring the ethical and scientific integrity of clinical trials.GCP compliance provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible.
Course Objective :
- Upon completion of this online training course learners will be able to understand the basics of GCP and the current legal regulations and guidelines;
- Get familiar with the essential documents related to GCP and understand the essence and purpose of important files such as the informed consent forms, the investigator’s brochure and the clinical trial protocol.
- Investigator Qualifications and Agreements
- Randomization Procedures and Unblinding
- To understand the principles of quality assurance and quality control and their implementation in clinical studies, including the importance of Standard Operating Procedures, study monitoring and audits
- To understand the different study designs of clinical trials, the prevention of bias and the basic principles of statistics as well as protocol optimization
- To gain an understanding of the role of ethics committees, in particular their mandate to protect the patient’s well-being, integrity and autonomy
Who is it for?
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ISDE ACADEMY INDIA PRIVATE LIMITED
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