GCP Certification

GCP Training and Certification Program

As a result of a series of ineffective clinical trials and the consequent disasters in the past, certain guidelines and regulations have been developed to assure the safety and efficacy of newly developed compounds and devices. ICH-GCP emerged as a harmonized standard to bring about increased ethical awareness and improved trial methods. These guidelines have now become a global law and are considered the ‘bible’ of clinical trials.

What is ICH-GCP?

Good Clinical Practice (GCP) can be defined as a set of international standards pertaining to ethical and scientific quality of clinical trials involving human subjects. The guidelines are provided by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and include standards on the design and conduct of the trial, performance, monitoring, auditing, analyses and reporting of the trial. Guidelines on protection of human rights for the subjects participating in a clinical trial are included in GCP. It also defines the roles and responsibilities of personnel involved such as clinical trial sponsors, clinical research investigators monitors, pharmacist, subjects and the committee.

ISO 14155 is a similar harmonized standard for clinical trials of medical devices. Hence the standards are usually referred to as ICH-GCP and ISO-GCP to differentiate between the guidelines for drug compounds and medical devices respectively.

How important is GCP training and certification?

Now-a-days, all clinical research companies have mandated GCP training and certification for all employees working in clinical research. The training and certification not only help individuals gain overall knowledge on the regulations and guidelines but embed skills to implement the GCP guidelines during various scenarios. Apart from clinical research centres, an ICH-GCP trained and certified personnel find opportunities to work with pharmaceutical companies and contract research organizations.

So as to meet the requirements of this dynamic industry as well as the individuals who aspire to explore a career in the clinical research industry, various clinical research institutes are offering online training and certification courses in ICH-GCP.

GCP training and Certification Program at James Lind Institute

James Lind Institute, a pioneer in online training programs, offers ICH-GCP training and certification program to provide a thorough understanding of the ICH-GCP E6 guideline and other related vital areas that are important to establish your presence in a clinical research organization. The curriculum for this program is highly comprehensive and imparts a deep practical knowhow of various issues related to Good Clinical Practice.

The program structure is customized to meet the ever growing needs of the clinical research industry and covers key concepts from the GCP guideline which include, but not limited to basics and history of clinical research, new drug development, principles of GCP, ethics in clinical research, informed consent process, overview of ICH, HIPPA, clinical research regulatory bodies, FDA regulations, documentation, responsibilities of personnel involved in a trial, conflict of interest, adverse events, monitoring visits, drug accountability and compliance and quality assurance audits and inspections overview.

Upon completion of the course, the individuals are evaluated on the basis of their performance in the examination on ICH GCP E6 guideline.

Who can take up this GCP course?

Since auditors and inspectors always look for proof of staff GCP training in the study files, this program is highly recommended for those who are already working in the clinical research industry. Besides, the training and certificate add more weightage to the resume of clinical research career aspirants.

Students can interact with the faculty members and fellow students through our technologically advanced e-campus which acts as a contemporary substitute to standard classrooms. In addition, personalized interactions take place at the Online Campus Tutoring Centre (OCTC) between faculty and the students.  

For more details on program duration, program structure, assessment and academic support please visit www.Jliedu.com

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