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Online ICH-GCP Training & Certification Program

Good Clinical Practice Training | Online GCP Training | Online GCP Certification | GCP Courses

Good Clinical Practice Training | Online GCP Training | Online GCP Certification | GCP Courses

The ICH-GCP guidelines are meant to be an international ethical and scientific quality standard for planning, executing, supervising, documenting, auditing, examining and reporting bio-medical and behavioral research studies concerning human population.

The background of Good Clinical Practice (GCP) guideline can be traced back to the Hippocratic Oath. As the guiding ethical code, the Hippocratic Oath is mainly regarded for its edict to do no harm to the patient. However, as medicine and science continue to evolve, the complexities of research processes call for a more comprehensive set of guidelines that handle ethical and scientific accountabilities while conducting biomedical research.

ICH-GCP guidelines were put in place with an objective to provide one single standard to facilitate the conduct of clinical trials across the US, European Union & Japan. This guideline came into effect in 1997 as ‘guidance’ by a steering group termed the Tripartite International Council on Harmonization (ICH) which included regulatory agencies of the three major regions mentioned above. The ICH-GCP guidelines provide the industry with two primary standards: protecting the rights, safety and welfare of human subjects; and the genuineness of the data generated by the research.

For any one conducting clinical trials or working in the any area of clinical research it is a requirement to have undergone Good Clinical Practice (GCP) training. Although ICH-GCP guidelines are the standard for conducting clinical trials in all major markets globally, their importance is also continually growing in developing economies such as India, China and Brazil. ICH-GCP training is most relevant to the following individuals:

  • Investigators from research centers, hospitals, drug companies etc.
  • Clinical research staff involved in administration, approval and monitoring clinical studies, such as study coordinators, research associates, trial managers etc.
  • Ethics committee members.
  • Students looking forward to working in the clinical research industry.
  • Good Clinical practice (GCP) training and certification is highly recommended throughout the world, as it is the basic acceptable standard for working as a clinical research professional. Getting Good Clinical Practice (GCP) certified has multiple advantages such as:

    • All pharmaceutical/biotech and Contract Research Organizations now recommend GCP certification to their employees.
    • Certification equips the participant with the knowledge of the regulations that are applicable to clinical research.
    • GCP Certification is the formal acknowledgement of a professional's eligibility as a clinical research professional globally.
    • Good clinical practice (GCP) training is important for organizations in the business of clinical research so that they can comply with the industry guidelines, and regulations.
    • James Lind Institute conducts a robust online GCP Training & Certification program for individuals who wish to get GCP Certified. The online training provides participants a thorough understanding not just of the ICH-GCP guideline but also of the various processes and requirements determined by the FDA and ICH for Sponsors, Monitors, and Investigators for successful conduct of clinical research guided by the ethical principles.

      Topics Covered

    • Introduction to Clinical Research
    • History and Milestones in Clinical Research
    • Overview of New Drug Development
    • Principles of Good Clinical Practice (GCP)
    • International Council for Harmonization (ICH)
    • Ethics in Clinical Research
    • Informed Consent Process, Documentation and HIPAA
    • Overview of Clinical Research Regulatory Bodies
    • FDA Regulations (21 CFR Parts 11, 50, 54, 56, 312, 812, 814)
    • Investigator Responsibilities
    • Sponsor-Vendor Responsibilities
    • IRB Responsibilities
    • Conflict of Interest
    • Documenting Adverse & Serious Adverse Events
    • Monitoring Visits and its Types
    • Drug Accountability & Compliance
    • Quality Assurance (QA) Audits & Inspections Overview

    • Training duration

      Self Paced No minimum duration (Maximum duration 3 months)

      In case of failure to complete the GCP Certification Exam within 3 months of admission, or in case of failing the Certification Exam a reactivation of the students training account (for 3 more months) is required. Reactivation fee is 50% of the initial fee paid.

      Certification Exam

      Upon completion of the training an online certification examination of 1 hour duration is conducted. The examination contains multiple choice and short answer type questions. The overall passing score for obtaining the GCP Certification is 60%.

      Eligibility Criteria

      • Any individual (graduate or postgraduate) who is already working or intends to work in the clinical research industry is eligible for the online GCP Training & Certification program.

      Fee Structure

      Course fee for all JLI courses is very reasonable. Please use our Course Fee Calculator below to know the course fee applicable to you.

      If you are not sure about the fee applicable to you for the online GCP Training & Certification program please send an email to or chat with our online counsellor.

      For more details about the admission procedure please click here.

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