Good Clinical Practice is mandatory and the utmost requirement for conducting clinical research in any part of the world.
The International Council on Harmonisation Good Clinical Practice guidelines is an international quality standard for planning, implementation, supervision, and documentation and auditing of various studies involving human subjects. It is essential to follow the ICH GCP guideline and this means that clinical trial data collected from the US, EU, and Japan will be accepted by each other regulatory agency and can be used in regulatory submissions for getting an approval of marketing in either of these countries.
GCP training and certification is a must for everyone working in clinical research, rather all companies want their staff to be GCP certified. Having a GCP certification is the minimum requirement to pursue a career in clinical research sector as it happens to be a formal recognition of your knowledge and competence in the field.
This is a good clinical practice online course, very detailed and offers you a thorough and practical understanding of various issues related to GCP.
Any person with work experience or working in the clinical research industry is eligible for the online GCP Training & Certification program.
Following topics are included:
- Introduction to Clinical Research
- History and Milestones in Clinical Research
- Principles of GCP
- Ethics in Clinical Research
- Informed Consent Process, Documentation and HIPAA
- Overview of Clinical Research Regulatory Bodies
- FDA Regulations
- Conflict of Interest
- Monitoring Visits and its Types
- Drug Accountability & Compliance
- Quality Assurance
Training in Good Clinical Practice (GCP) is a key requirement for individuals involved in clinical research and is created to make sure that those involved in conducting a trial are well qualified and also, have sufficient experience to perform their job. If you cannot undertake a classroom coaching, you can opt for a good GCP online course
The NIAA supports GCP training for every clinical research and also endorses courses offered by the NIHR (National Institute for Health Research). The NIHR offers both online and classroom opportunities via an introductory e-learning module and well designed full-day workshops.
How to get an access to it?
To access this training you have to register for the NIHR’s Learning Management System using an NHS or university email address.
Post training, participants should be able to do the following:
Demonstrate knowledge of the importance of interwoven laws, frameworks and guidelines which govern the setup and carrying out of clinical research
Explain the understanding of the roles and responsibilities of different individuals and organizations in a clinical trial
Understand the regulatory applications needed before clinical trials are started
Identify several essential documents and the reason to maintain a trial master file
To be able to accurately complete case report forms and other necessary documentation
Know where to get further advice and support and how to remain updated.
With this, we conclude. Stay connected with this space for more discussions on Clinical Research and Clinical Trials.
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