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 or GLP 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.
- A copy of applicant's Curriculum vitae must be submitted with the exam application. If your CV does not demonstrate your performance of direct quality assurance tasks, your application may be declined.
- Experience: To document experience in quality assurance, applicants are required to provide their supervisor or manager's signature or the signature of an Active level SQA member (if the applicant does not have a supervisor or manager) on the application.