It lists the documentation to be submitted in support - on the quality and manufacture of the investigational medicinal product, any toxicological and pharmacological tests, the protocol and clinical information on the investigational medicinal product including the investigator's brochure
. It lists the requirements for an applicant to be eligible to apply, the languages that must be used, where else applications have been made, and with what outcome (including copies of any ethics committee opinions).
He will be responsible for the operational management of clinical research activities, including preparation of clinical strategies, regulatory and ethics submissions, compliance with local and foreign regulations (ICH guidelines, protocol design, preparation of consent forms and investigator's brochures
) and overseeing NDI's Clinical Trial Management System (CMS) and Electronic Data Capture (EDC) systems for clinical trials.