Foundations Package: Internationally Qualified Clinical Research Professional (Foundation Level) – Encompassing ICH-GCP Accreditation and Foundations in Clinical Research Accreditation

Accreditation 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.

*IMPORTANT NOTES

1. Please note that IAOCR does not provide training. The purpose of our accreditations is to competence verify individuals who have already received training through another provider, and/or gained the necessary ‘on the job’ experience. (See entry requirements for further details).

2. All our accreditation programs are developed from global core competency frameworks ratified by the industry for that specific role. However, they do not assess competency in local/country laws or regulations that may be applicable to your role in your region/country. Please ensure that you take responsibility to be competent in any relevant local/country legislation in addition to receiving IAOCR international accreditation.

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:

• Certificates of Accreditation for Foundations in Clinical Research, for ICH-GCP and F-IAOCR Internationally Qualified Clinical Research Professional.
• Electronic Accreditation Marks displaying your award date and your professional registration number for Foundations in Clinical Research and ICH-GCP
• An electronic Professional Accreditation Mark with the designatory letters F-IAOCR Internationally Qualified Clinical Research Professional (Foundation Level), also displaying your award date and professional registration number.
• 40 Continuing Professional Education (CPE) points and 4 accredited learning credits

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).