Examinations

Certificate of Clinical Research & GCP

Qualification: attendance on the Foundation Course in Clinical Research (Cert CRGCP Part 1) course. We are unable to accept as qualification, courses delivered by other organisations as we are unable to ensure the quality and content of these. Certification by the Academy is evidence of satisfactory training and testing of basic knowledge by examination.

Format of examination: online closed book examination consisting of multiple choice questions testing a wide range of topics including: trial design and methodology, consent, ethics, safety reporting, GCP responsibilities, documentation, clinical trial process. A dictionary may be used by those whose mother tongue is not English. No time limit is imposed to allow participants to read carefully each question and understand it before answering. The examination is undertaken online using the Academy's learning management system. Participants require access to the Internet. (How to undertake this exam). Special arrangements can be made for those candidates unable to sit the examination in the usual way.

Venue and time: participants sit this examination in their own environment in formal examination conditions under the supervision of a nominated and approved supervisor of management status. The candidate and supervisor agree a suitable time and place to conduct the examination. It is recommended that the exam is undertaken no more than four weeks after attending the course. Each candidate receives unique login information by email. This information is then used to access and undertake the online exam. If a paper based system is to be used, the exam papers are sent directly to the supervisor and the completed papers returned to the Academy for marking.

Marking: the Academy's online learning management system provides instant feedback about the candidates examination results. Each online examination is reviewed by a member of the Academy. The examination system is validated by members of the Academy's independent Faculty Board. When a paper based system is used, examiners mark each paper. Candidates who do not reach the required standard will be invited to re-sit the exam, or re-answer relevant examination questions following further study with the supervisor. All communications are conducted discretely with respect for confidentiality.

Apply for the exam online: Candidates may fill in an online application (sorry out of use at the moment -- please contact us for an application form) and submit this to the Academy. Candidate and supervisor contact information is required. On receipt, the candidate will be sent log-on details in one email and an invitation to access the exam in a second email. Please allow 7 days for your application to be processed.

Certificate of Advanced GCP

Qualification: attendance on the Advanced Course in Clinical Research course. We are unable to accept as qualification, courses delivered by other organisations as we are unable to ensure the quality and content of these. Certification by the Academy is evidence of satisfactory training and testing of basic knowledge by examination.

Format of examination: Multiple choice examination consisting of multiple choice and short answer questions testing a wide range of topics including (but not restricted to) trial project management, solutions to GCP - related problems, the European clinical trial process, electronic records and signatures, data protection. A 3 hour time limit is imposed.

Venue and time: participants sit this examination in their own environment in formal examination conditions under the supervision of a nominated and approved supervisor of management status. The candidate and supervisor agree a suitable time and place to conduct the examination. It is recommended that the exam is undertaken no more than four weeks after attending the course. The exam papers are sent directly to the supervisor and the completed papers returned to the Academy for marking. Special arrangements can be made for those candidates unable to sit the examination in the usual way.

Marking: the short answer part of the paper is marked automatically and participants receive an instant result. Participants may retake the exam if they fail to reach the required standard.

General Considerations

Certificates are validated by the Academy and a member of the Faculty Board.
Examination papers of candidates who do not reach the required standard are studied carefully to determine the reasons for failure. A course of action is discussed with the candidate/supervisor based on this review.
The Academy reserves the right to require candidates to undertake a viva voce examination in the event of borderline marks or failure to attain the required standard.
Any violation of the Academy's conditions for examination conduct will render the examination null and void. When serious breaches have occurred, candidates will not be allowed to retake the examination.


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