Abstract

MARANON CARDONNE, Tatiana; LEON ROBAINA, Rosario  and  FUENTES GONZALEZ, Homero Calixto. Procedures Manual for hospital wards where clinical trials are executed. AMC [online]. 2017, vol.21, n.2, pp.181-190. ISSN 1025-0255.

Background: the growing development and competitiveness during the clinical evaluation of a drug worldwide imposes greater demands on compliance with the standards for registration of medical products. Objective: to present the design of the Procedures Manual for hospital wards where clinical trials are executed. Methods: a series of stages were fulfilled, starting in first place with the analysis of difficulties found in the evaluations in the visit of the National Coordinating Center for Clinical Trials. The second stage was a document review, the third a group discussion, and the fourth was an expert consultation. Development: a procedures manual for wards where clinical trials are executed was elaborated. It was first structured with a series of contents of general nature and then the different procedures were established: nursing, execution of clinical trials, metrology, equipment maintenance and verification and the Nutritionist work at the ward. Its elaboration was contextualized in clinical site preparation for recertification in GCP by the Center for State Quality Control of Drugs and Medical Devices. Conclusions: an instrument, based on updated national and international regulations, was established, using a uniform methodology of different processes that are carried out in hospital wards while executing clinical trials in compliance with Good Clinical Practice methodology.

Keywords : GOOD MANIPULATION PRACTICES; CLINICAL TRIAL; HANDBOOKS; HEALTH PLANNING GUIDELINES; METHODOLOGY.

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