Protokol akademické klinické studie - průvodce na cestě od myšlenky k publikaci

Title in English Protocol of the investigator-initiated clinical trial - guide on the tour from the idea to the publication


Year of publication 2019
Type Conference abstract
MU Faculty or unit

Faculty of Medicine

Description The Clinical Trial Protocol is a key document in the process of planning, approving, conducting and evaluating a study. A well-written protocol facilitates the assessment of the scientific and ethical requirements of the study by regulatory authorities and provides practical support for the work of the study team at the study center and for the sponsor. A Clinical Trial Protocol initiated by a large pharmaceutical company is created by a team of experienced specialists focusing on individual aspects of the study, either within the company itself or within a Contract Research Organization. Information from individual experts usually converges with one person (a medical writer) who will give the document its final form. In an investigator-initiated clinical research environment, similar capacities are not available and so only the examining doctors themselves propose and write the protocol. Several freely available national and international recommendations for protocol design and synopsis are currently available, including templates. The paper presents useful guidelines, the most important aspects of each part of the protocol, tips and examples. From the doctor's point of view, the preparation of the protocol may seem problematic, especially in terms of time. Therefore, the paper introduces support activities of the CZECRIN research infrastructure in the field of protocol and other documents creation. Investigators who initiate their own clinical trial and contact CZECRIN can save their time while increasing the chances of approval of the study by regulatory authorities.
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