Acta Médica del Centro (Oct 2022)
Design of The Manual of rules and procedures for clinical trials in pharmacy
Abstract
Introduction: there are no procedures to manage the product of clinical research in Pharmacy. There are antecedents of elaboration in the institution of the documentary system of the processes of evaluation and treatment of patients in clinical trial, but successive evaluations of the same and other factors evidenced its insufficiency. Objective: to create and implement a record of institutional procedures for clinical trials in Pharmacy. Methods: an intervention study was conducted on systems and services in the management and use of clinical trial investigational products at the "Arnaldo Milián Castro" Hospital during 2018 and 2021. The processes of handling and use of the product were modeled and described. The documentary system was structured in three stages: design, elaboration and implementation. Results: the clinical trial investigational product handling and use process map was designed and described the overall process and sub-processes, as well as inputs and outputs in the clinical trial pharmacy in the form of product or documentation. The product flow diagram included the specific subprocesses of receipt, custody, dispensing and return/destruction. The document series was designed with eleven specific procedures, twenty records and three other documents. Procedures were designed for the protection of the research product in case of disasters/emergencies, an unprecedented element in the manuals consulted. Conclusions: the existence of the institution's own documentation represents a step forward in the design according to individual needs, ensuring the performance of clinical trials with quality standards adjusted to the hospital's particularities in order to achieve compliance with Good Clinical Practices.
