ICH-GCP – an essential foundation stone for everyone working in clincal research, regardless of their role.
Accreditation Program Outline
The ICH-GCP Accreditation is a key foundation stone for everyone working in clinical research, regardless of their role.
Participants successfully achieving this accreditation can advance their career and increase employabiltiy by providing evidence to employers and the industry that they can demonstrate all the relevant ICH-GCP core competencies expected of a competent clinical research professional*.
ICH-GCP is an international ethical and scientific quality standard developed to protect the rights, safety and welfare of patients participating in clinical research. Whether you’re working in delivery or support, you play an important role in protecting patients. Therefore competence in Good Clinical Practice is essential for everyone working in the clinical research sector.
The ICH-GCP professional standard was updated in 2022. This independently accredited program uses assessment criteria mapped to the International Standard Classification of Education developed by UNESCO, which is recognizable by educational establishments and employers globally.
*Please note that IAOCR does not provide training. The purpose of our accreditations is to competence verify individuals who have received training through another provider, and/or gained the necessary ‘on the job’ experience to complete the accreditation assessment. (See entry requirements for further details).
What does the accreditation assessment involve?
After program registration and enrolment, you will be sent a link by email to access your online assessment portal. You will normally receive this link one working day before your program start date. The assessment is a series of multiple-choice questions designed to test your competence in ICH-GCP. (This is your ‘Portfolio of Evidence’).
Upon completion of your assessment, your portfolio will be sent to the IAOCR Assessment team for review and independent verification. If you have successfully passed the accreditation you will be awarded the following:
- Certificate of Accreditation
- An electronic Accreditation Mark containing your unique professional registration number and award date
- 20 Continuing Professional Education (CPE) points and 2 accredited learning credits
How long does it take to complete the assessment?
On average, the assessment takes 1 to 2 hours to complete. You can complete the assessment in your own time, but you must ensure that your final submission adheres to the deadline for assessment submission (see table in program registration section).
Entry Requirements
Before enrolling on the ICH-GCP Essentials Accreditation it is important you confirm that your career and educational/training background has provided you with the necessary experience to complete the competence assessment areas listed below. Please ensure that you have self-certified your ability to complete the accreditation assessment before enrolling on the programme:
- International Conference of Harmonization – Good Clinical Practice (ICH-GCP) and the historical reasons for implementation
- The Declaration of Helsinki
- Protection of rights, safety and wellbeing of clinical trial participants
- Ethics committee/Institutional Review Board (IRB) roles in clinical trials
- Regulatory Authorities and their roles in clinical trial inspections
- Importance of data integrity and patient confidentiality in a clinical trial
- Experience and qualifications required by study staff in clinical trials
- Good Manufacturing Practice (GMP) in relation to the Investigational Medicinal Product (IMP)
- Randomization and unblinding in a clinical trial
Fees
£ 72.00
*If you require an invoice please email accreditation@iaocr.com once you have your booking confirmation
NOTE: This program can also be purchased as part of a package (the Foundations Package) which also includes the Foundations in Clinical Research Accreditation. Successfully completing both the ICH-GCP and Foundations in Clinical Research Accreditation leads to the award of F-IAOCR Internatiaonlly Qualified Clinical Research Professional status.To view the Foundations Package Program click here.
Program Registration
The 2025 cohort registration dates for the ICH-GCP Accreditation are listed below.
Award of Accreditation Certificates and Professional Certification Marks normally happens within 4 week of programe start date.
If your preferred start date is not currently listed below, you can contact us to register your interest and we will email you when registration opens.
| Registration Dates | Program Start Date | Deadline for Assessment Completion |
| Register up to 03 Jan 2025 | 08 Jan 2025 | 15 Jan 2025 |
| Register up to 07 Feb 2025 | 12 Feb 2025 | 19 Feb 2025 |
| Register up to 07 Mar 2025 | 12 Mar 2025 | 19 Mar 2025 |
NOTE: Please ensure you have read the Terms and Conditions of Sale for IAOCR Accreditation Programs, as this contains important information about program completion, cancellations and deferrals. You will be asked to confirm that you have read these before completing the purchase check out process.
