Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

[Pharmacy Department standard procedures for clinical trial development].

C Pérez Peiró1, B Porta Oltra, M Cholvi Llovell

  • 1Servicio de Farmacia, Hospital Universitario Doctor Peset, Valencia. perez_carpei@gva.es

Farmacia Hospitalaria : Organo Oficial De Expresion Cientifica De La Sociedad Espanola De Farmacia Hospitalaria
|March 12, 2004
PubMed
Summary

Clinical trial protocols often lack essential details for drug sample management. This study highlights critical gaps, leading to the development of standardized procedures for hospital pharmacy departments to ensure effective clinical trial execution.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

[Parenteral administration medicines: recommendations of preparation, administration and stability].

Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria·2014
Same author

[Measurement of continuous improvement in the safety of oncologic patients].

Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria·2013
Same author

[Exposure to cytotoxic drugs among health care professionals].

Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria·2012
Same author

[Oxaliplatin-associated neurotoxicity in clinical practice].

Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria·2011
Same author

Genetic polymorphisms and individualized tacrolimus dosing.

Transplantation proceedings·2010
Same author

[Preliminary prediction model for identifying patients with the possibility of pharmacotherapy improvement].

Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria·2010

Area of Science:

  • Clinical Pharmacy
  • Clinical Trial Management
  • Regulatory Compliance

Context:

  • Good Clinical Practice (GCP) regulations mandate normalized working procedures for hospital pharmacy departments in clinical trials.
  • These procedures are crucial for managing all processes involving research drug samples, from reception to dispensing.

Purpose:

  • To analyze the information content of clinical trial protocols regarding drug sample handling.
  • To develop standardized working procedures for a hospital pharmacy department based on protocol analysis.

Summary:

  • Analysis of 39 clinical trial protocols revealed significant deficiencies in information regarding research sample management.
  • Key areas lacking detail included sponsor data, storage conditions, labeling compliance, sample reception, handling, preparation, and dispensation.

Related Experiment Videos

  • Procedures for sample return, maintenance, trial closing, and explicit mention of the pharmacy department were also frequently inadequate.

    • Impact:

    • Identified gaps underscore the need for improved clinical trial protocols to ensure secure, effective, and efficient trial conduct.
    • The findings directly informed the creation of normalized working procedures for the hospital pharmacy department, enhancing clinical trial operations.