Drug Evaluation Committee 2013-20 Education and Training for Personnel in Contract Imaging Laboratories
Related classification: Other
First published: August 2013
Question
We have a question about education and training stipulated in GCP.
Our company is planning to be involved in the operation of imaging evaluation meetings (RECIST evaluation) for anticancer drugs, etc. What kind of education and training would be required for such a company and its employees? The following is a rough job description.
- Receive medical images such as CT and MRI from pharmaceutical companies and CROs and set them into RECIST measurement software.
- Hold an independent image evaluation meeting and have the images evaluated by a panel of judges (physicians).
Some of the employees are qualified radiologists and have experience in CT and MRI examinations at hospitals, etc., while others have no experience at all in handling medical images.
Pharmaceutical Association Opinion
Article 1, Guidance 2 (8) of the GCP stipulates that "Personnel involved in the conduct of clinical trials shall meet the requirements to adequately perform their duties through education, training and experience." The GCP Guidance states that
In the case of work such as the one in question, it is at the discretion of your company,
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1.Clarify the scope of work (responsibility) of each person in charge (e.g., project manager, data manager, QC person, etc.),
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2.Establish work procedure manuals for the tasks involved,
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3.Education and training on expertise, relevant laws and regulations, guidelines, standard operating procedures, etc., should be provided on an ongoing basis according to the respective duties (responsibilities),
is desirable.