No minimum duration
Maximum Allowed Duration: 3 Months
Expected Effort: 3-4 hours/week
The extensive online ICH-GCP training and certification program provides you with a thorough understanding of the ICH-GCP E6 guideline and other key knowledge areas required to work in the clinical research industry.
Next Commencement Date
Why study this program?
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:
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:
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.
What will be taught?
Following topics are covered in this program:
- 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
How will I be assessed?
Upon completion of all lessons taught in this program an examination of 1 hour duration is conducted. The examination contains multiple choice and short answer type questions from the study material provided and from the ICH GCP E6 guideline itself. The minimum score required to pass the ICH-GCP Certification exam is 60%.
In case of failing the first attempt only one more attempt is allowed.
Am I eligible?
Any person who is already working or intends to work in the clinical research industry is eligible to apply for the online GCP Training & Certification program..
What support will I receive?
As a student you can interact online with the faculty members and fellow students to network and to discuss important topics via your e-Campus.
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Being GCP certified is one of the primary requirements to work in the clinical research sector. Every sponsor, CRO, or even investigator staff wants to know whether or not you have taken any training in ICH-GCP. A GCP certification will open up a number of doors for you in the clinical research industry allowing you to explore opportunities with pharmaceutical companies, CRO's, research centers etc.
Investigator site staff, staff of contract research organizations, sponsor company's staff (practically everyone involved in the trial process) are all expected to be certified in the International Council of Harmonisation (ICH) E6 Guideline - Good Clinical Practice. Auditors and Inspectors always look for evidence of staff GCP training in the study files during audits and inspections.