Abstract

ALVAREZ GUERRA, S; RODRIGUEZ ALVAREZ, J; SABORIDO MARTIN, L  and  GONZALEZ HERNANDEZ, Z. Contribution of the Cuban pharmaceutical to the quality of a clinical trial. Rev. OFIL·ILAPHAR [online]. 2021, vol.31, n.2, pp.224-225.  Epub Aug 16, 2021. ISSN 1699-714X.  https://dx.doi.org/10.4321/s1699-714x2021000200023.

One of the culminating stages of the development of a product under investigation is the clinical trial. This research is carried out in human subjects and is aimed at verifying or discovering the clinical, pharmacological and/or pharmacodynamic effects of the product or equipment being studied.

To guarantee the quality of these investigations, the Good Clinical Practices are used as standard, where requirements are established to be met by the participants, to ensure data quality and protection of the rights, integrity and confidentiality of the subjects.

An important partner is the pharmacist. This work focused on showing the elements to be taken into account by the Cuban pharmacist to help raise the quality of a clinical trial.

Among the elements to meet were found; the qualification, compliance and mastery of the protocol in relation to the handling of the product, the adequate and timely completion of the documentation that is generated according to the functions in the test, ensure the storage conditions, expiration and return of the product, in addition to be prepared to receive monitoring, audit and/or inspection activities, work with a risk approach and for continuous improvement.

The pharmacist participating in a clinical trial must master and apply the elements identified to contribute to the protection of the subjects and the reliability of the data, raising the quality of the clinical trials.

Keywords : Clinical trial; pharmacist; quality.

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