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 or the International Council on Harmonisation Good Clinical Practice guidelines are an international quality standard for the planning, execution, supervision, documentation and auditing of studies involving human subjects. Following the ICH GCP guideline means that clinical trial data collected from the US, EU and Japan will be accepted by each others regulatory agency and thus can be used in regulatory submissions for marketing approval in either of these countries. The primary aim of this guideline is to have a framework in place to protect the rights, safety and well being of study subjects while ensuring that the data collected is accurate and free from errors.
GCP training and certification is important for all individuals working in clinical research, in-fact all companies now want their staff to be GCP certified. Having a GCP certification helps you to meet the minimum requirement to be able to explore a career in the clinical research sector as it is a formal recognition of your knowledge and competence in being able to apply the GCP guidelines during various situations.
This online GCP training and certification program is very comprehensive and provides you a deep and practical understanding of various issues related to Good Clinical Practice. Upon completion of the program you will be able to apply various key concepts from the GCP guideline in your routine clinical research related work profile.
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. The faculty promptly answers all questions related to the study in the Online Campus Tutoring Center (OCTC).
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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.