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  • Book
    Ad van Dooren.
    Digital : World Scientific2018
    The past -- Medicinal products : the development process -- Clinical studies : design aspects -- The rules and the regs -- The ethical pillars of clinical research -- The players part I : ethics committee and data monitoring committee -- The players part II : the sponsor and the clinical research organisation -- The players part III : the investigator, the sub-investigator and the clinical research coordinator -- The players part IV : the pharmacy and the clinical laboratory -- The players part V : the subject or patient -- Safety assessment -- The visits -- The essential documents part I : before study start -- The essential documents part II : during trial conduct -- The essential documents part III : after completion or termination of the trial -- Data management -- A special case : medical devices -- Compliance -- The challenge of monitoring -- The future of clinical trial monitoring : some afterthoughts.