This package combines the 2 accreditations – ICH-GCP and Foundations in Clinical Research, and is suitable for everyone already working in clinical research wanting to achieve a formal professional recognition, or for individuals who have already completed ICH-GCP and foundation level training or certification and are looking to evidence their competence to help them progress their clinical research career.
Accreditation Program Outline
The ICH-GCP Accreditation and Foundations in Clinical Research Accreditation are the essential foundation stones for anyone already working in the clinical research industry, or looking to step into a clinical research career having already completed foundation level training*.
Participants successfully achieving both accreditations can can advance their career and increase employability by providing evidence to employers and the industry that they can demonstrate the core competencies required by all clinical research professionals.
The Foundations in Clinical Research Accreditation is a key foundation stone for everyone working in clinical research, regardless of their position. Participants who successfully achieve this accreditation have demonstrated a solid understanding of the clinical research landscape.
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. To successfully complete this accreditation, participants must provide evidence that they can demonstrate all the relevant ICH-GCP core competencies expected of a competent clinical research professional.
These independently accredited programmes use 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. (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 for both programs is a series of multiple-choice questions designed to test your competence in the key foundation areas of clinical research and ICH-GCP (See entry requirements). This assessment becomes 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 both accreditations you will be awarded the following:
1. Certificates of Accreditation for Foundations in Clinical Research, for ICH-GCP Essentials AND F-IAOCR Internationally Qualified Clinical Research Professional.
2. Electronic Accreditation Marks displaying your award date and your unique registration number for Foundations in Clinical Research and ICH-GCP Essentials
3. An electronic Professional Certification Mark with the designatory letters F-IAOCR Internationally Qualified Clinical Research Professional, also displaying your award date and unique registration number.
How long will it take to complete the assessments?
On average, both assessments take 2 to 4 hours to complete in total (approximately 1 to 2 hours for each assessment). You can complete the assessments in your own time, but you must ensure that your final submission adheres to the deadline for assessment submissions according to your registration date (see table in Program Registration section).
Before enrolling for the Accreditation assessment, it is important that you confirm that your career and/or your educational and training background has provided you with the necessary experience to complete the competence assessment areas listed below. These accreditations do not include any training – it is designed to verify your competence. Please ensure that you have self-certified your ability to complete the accreditation assessments for both foundation programs before submitting an application and payment.
Competence Areas for ICH-GCP Essentials Accreditation:
- 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 trials
Competence areas for Foundations in Clinical Research Accreditation:
- Understanding of clinical research and the key requirements in conducting clinical trials, from start up to close out
- Understand clinical trial regulatory and ethical requirements
- Understand clinical trial consent, reporting processes and maintenance of data integrity
- Understand the relevant documents required in a clinical trial
- Knowledge of quality management processes and practices involved in a clinical trial
- An understanding of the Investigational Medicinal Product (IMP) and its appropriate management
- Understand stakeholder management within a clinical trial
- An understanding of decentralized trials
15% discount on the IAOCR Foundations Package (any program date) (when booked by 28 February 2023). Use code: FNDPKJAN23 at checkout. T&Cs Apply.
Note: These programs are also available to purchase individually here for ICH-GCP and here for Foundations in Clinical Research. This combined program of both foundation courses achieves a saving of £10 compared to purchasing the programs individually.
There are normally 4 registration dates per year for this combined program.
Award of Accreditation Certificates, Accreditation Marks and Professional Certification Marks normally happens within 4 weeks of program 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 by 11 Feb 2023||15 Feb 2023||22 Feb 2023|
|Register by 12 Apr 2023||17 Apr 2023||24 Apr 2023|
|Register by 09 Jun 2023||12 Jun 2023||19 Jun 2023|
|Register by 11 Aug 2023||14 Aug 2023||21 Oct 2023|
|Register by 13 Oct 2023||16 Oct 2023||23 Oct 2023|