Internationally Qualified Clinical Research Associate Accreditation

• 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 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

The Internationally Qualified Clinical Research Associate (Q-IAOCR) professional standard was developed in conjunction with global clinical research experts from across the industry. This independently accredited program uses assessment criteria mapped to the International Standard Classification of Education developed by UNESCO. The accreditation exam is underpinned by the core competency frameworks ratified by the industry; it enables successful participants to achieve accreditation and international professional recognition as a ‘world-class’ Clinical Research Associate.

Individuals must provide evidence that they can demonstrate all the relevant core competencies expected of a competent Clinical Research Associate. The accreditation process is focused on ensuring someone has the skills, knowledge and behaviors 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.

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
• Note: Accreditation documents are normally awarded within 6 weeks of assessment submission

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).

The CRA accreditation exam is aimed at experienced clinical research professionals (with relevant experience as a CRA or a related role) seeking professional recognition, no training is included. Therefore, before enrolling for the accreditation, you will need to self-certify that your career background and experience aligns with the competency areas that will be assessed in the accreditation assessment process.

The Q-IAOCR Accreditation for Clinical Research Associates compliments and enhances any other CRA Certifications or CRA Credentials you may hold. IAOCR accreditations are the only clinical research certifications in the industry that provide formal international professional recognition due to the way they are developed (with the global industry) and mapped to the International Standard Classification of Education framework developed by UNESCO. The unique 2 step assessment and independent verification process makes IAOCR accreditations the most robust in the industry, which is why certification with IAOCR can elevate you to the highest professional status.

IAOCR is committed to working with the industry to support the formal recognition of clinical research as a profession and to help combat CV/resume fraud, which is becoming an increasingly widespread concern for employers.

Clinical research professionals achieving accreditation with IAOCR are able to demonstrate to employers that they are committed to working to global best practice standards.
Accreditation provides the highest level of professional recognition available – evidencing that you have been robustly assessed to standards agreed with leading global employers.

The distinctive quality mark and unique professional identification number provides reassurance that you are a world-class CRA.
Gain the professional recognition you deserve as highly qualified and experienced professional that’s working at the top of your field!