Internationally Qualified CRA Accreditation

80 CPE Points
8 Learning Credits

Internationally Qualified Clinical Research Associate Accreditation

The industry-leading and internationally recognized professional accreditation standard for Clinical Research Associates that sets you apart as ‘best-in-class’ in the industry. Suitable for professionals already working as a Clinical Research Associate as well as  for those looking to transition into the role (who already have the required experience from working in a related position). Validates competence and reassures sponsors, CROs and patients of your ability to work to global best-practice standards. As added value, this program also includes the ICH-GCP Accreditation to further elevate your professional standing.

Accreditation Program Outline

The Internationally Qualified Clinical Research Associate (Q-IAOCR) professional standard was developed in conjunction with global clinical research experts from across the industry and enables successful participants to achieve accreditation and professional recognition as a Clinical Research Associate. If you are looking to elevate your professional status as a CRA, then this prestigious, industry-leading and internationally recognized accreditation will formally demonstrate your ability to work to global-practice standards and position you as ‘best-in-class’ in your field.

Individuals must provide evidence that they can demonstrate all the relevant core competencies expected of a competent Clinical Research Associate*. As an added value to showcase your professional status, the CRA accreditation program also includes the ICH-GCP accreditation assessment, as competency in this area is essential for ALL Clinical Research Professionals.

The accreditation process is focused on ensuring someone has the skills, knowledge and behaviours to fulfil their role safely and credibly, measured against a set of robust accredited assessment criteria which have been developed from the core competency framework validated by the industry.

This independently accredited program uses assessment criteria mapped to the International Standard Classification of Education developed by UNESCO. Participants successfully passing the accreditation assessment are awarded IAOCR Internationally Qualified Status (Q-IAOCR), which is internationally recognized across the industry.

*IMPORTANT NOTES

  1. Please note that IAOCR does not provide training. The purpose of our accreditation programs is to validate competence in already experienced individuals, who have gained this experience from previous training and actively working in the role (see entry requirements for further details).
  2. All our accreditation programs are developed from global core competency frameworks that have been developed and endorsed by the industry for that specific role. Please note however, that variations in local regulatory requirements are not assessed, and it is your responsibility to ensure that you are familiar with and competent in managing these local variations.

What Does the Accreditation Assessment Involve?

What does the Accreditation assessment involve?

Once you have enrolled, normally one working day before the program start date, you will be sent a link to access your online assessment portal. The assessment is a blend of multiple-choice questions, questions requiring free text answers and scenarios designed to assess your competence as a Clinical Research Associate. Upon completion of your assessment, your answers will be submitted to the IAOCR Assessment team for review and independent verification.

  •  A Certificate of Accreditation
  • A Professional Accreditation Mark (displaying your award date, unique registration number and the title of your accreditation)
  • The Designatory letters Q-IAOCR – Internationally Qualified Clinical Research Associate

Accreditation documents are normally awarded within 6 weeks of assessment submission (see Program Registration section for details).

How Long Does it Take to Complete the Assessment?

On average, the CRA Accreditation assessment takes up to 4 hours to complete for an experienced CRA. The ICH-GCP Accreditation assessment (which is completed separately) takes up to 1 hour.  

You can complete the assessments in your own time (within the timeframe provided) and you do not have to complete it all at once as you will have access to your portal until the submission deadline. You must ensure that your final submission adheres to the deadline for assessment submission according to your program start date (see table in program registration section).

Entry Requirements

Before enrolling for the Q-IAOCR Internationally Qualified Clinical Research Associate accreditation, it is important that you confirm that your career and educational background has provided you with the necessary experience to complete the competence assessment areas listed below for both the CRA Accreditation Assessment and the ICH-GCP Accreditation assessment.  For the CRA Assessment, as a guideline, we would normally say this is after a minimum of 2 years working in the role. Please ensure that you have self-certified your ability to complete the accreditation assessment before enrolling on the program.

You will be assessed in the following competence areas in relation to your role and responsibilities as a Clinical Research Associate:

  • Legislation and regulation of clinical trials
  • Ethics and ICH-GCP
  • Rights and wellbeing of patients in a clinical trial
  • Managing site and investigator relationships
  • Principles of clinical study management
  • Principles of clinical trial site management
  • Principles of pharmacovigilance
  • Principles of data management
  • Document control and record keeping (including TMF/eTMF)
  • Management of the investigational medicinal product (IMP)
  • Principles of contracts and financial management
  • Principles of quality assurance and quality control

You will be assessed in the following competence areas in relation to ICH-GCP

  • 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)
  • Ramdomization and unblinding in a clinical trial

Fees*

£ 715.00

To celebrate the launch of the upgraded CRA Accreditation we are offering a special launch price of £715.00 GBP for any cohort date booked in 2024, providing you enrol for your chosen start date by 31st August 2024. 

See ‘Program Dates’ for 2024 cohorts below.

*If you require an invoice please email accreditation@iaocr.com once you have your booking confirmation

Registration Dates

The 2024 cohort registration dates for Q-IAOCR Internationally Qualified Clinical Research Associate are below:

Award of Accreditation Certificates and Professional Certification Marks normally happens within 6 weeks of assessment submission.

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.

PLEASE ENSURE YOU HAVE READ THE ENTRY REQUIREMENTS BEFORE REGISTERING – THANK YOU. 

Closing date for registration Program Start Date Deadline for Assessment Submission
Register by 16 Apr 2024 18 Apr 2024 16 May 2024
Register by 28 May 2024 30 May 2024 27 Jun 2024
Register by 23 Jul 2024 25 Jul 2024 22 Aug 2024
Register by 17 Sep 2024 19 Sep 2024 17 Oct 2024
Register by 12 Nov 2024 14 Nov 2024 12 Dec 2024

 

IMPORTANT NOTEBefore enrolling for this program, as well certifying you have met the entry requirements, you must also read the Terms and Conditions of sale. You will be asked to accept these terms and conditions at checkout. Thank you.