GCP Eligibility Requirements
To be eligible for the GCP Quality Assurance Professional Registry Examination, applicants must fulfill one of the two following requirements:
- Have the equivalent of four (4) years of full-time clinical quality assurance experience as defined below prior to the examination date; OR
- Have a baccalaureate degree AND the equivalent of two (2) years of full-time clinical quality assurance experience as defined below prior to the examination date.
A full-time QA Professional is one who conducts audits of, evaluates, and inspects activities as described in the GCP regulations noted in the
Study References. The QA Professional’s work experience must encompass auditing, evaluating and inspecting. Any candidate specializing in a subset of these activities must demonstrate experience in all activities as outlined in the applicable Detailed Content Outline (on page 15 of the
Candidate Handbook).
- A QA Professional is one who, through qualification experience and training, performs audits, evaluates, and inspects against compliance requirements.
- An audit is a systematic and independent examination of activities and documents to determine compliance with applicable requirements.
- Independent means one who is not involved in the investigation’s design, development, execution or reporting.
Documentation Required
- A copy of applicant's Curriculum vitae must be submitted with the exam application. Your CV must include the years and months worked in each job position, a specific list of your job responsibilities/duties for each job position, and the percentage of time devoted to clinical QA/audit work in each job position. If your CV does not demonstrate your performance of direct quality assurance tasks, your application may be declined.
- Experience: Applicants are required to provide a professional reference who is able to verify applicant's experience and eligibility to take the exam.