good clinical practices regulatory guidelines for the conduct of clinical research introduction to...
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Good Clinical PracticesRegulatory Guidelines for the Conduct of Clinical research
Introduction to
Research Pharmacy Services
Javier Palacios, R.Ph.
Sponsored by the Research Committeeof the Medical Dental Staff at UHS
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Learning Objectives
Define Good Clinical Practice and
Explain GCP guidelines in handling of drugs.
Understand role and services of UHS Research Pharmacy Department.
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Good Clinical Practice
GCP international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects
Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible.
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Drug HandlingMust comply with GCP
Secure, locked storage limited access. Dispensing and product labeling
Compliant with State and Federal requirements Storage temperature monitoring with proper
record keeping Accountability
proper records
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Investigational DrugHandling Policy at UH
Studies at UH Investigational drugs will be managed by the
Research Pharmacy DepartmentStudies outside of UH
Managed by Investigator If patients are admitted into UH the Study medications
will be brought to the Research Pharmacy for proper labeling.
A Patient Consent Form and Drug Information Sheet will be provided by the investigator or research coordinator and placed in the patient’s chart.
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Research Pharmacy: Services
7 day, 24 hour coverage Receive, ship, pack Dispense to patients, Investigators, Research
coordinators and nursing staff. Deliver drugs to inpatients Inventory, destroy, handle patient drug returns,
interact with monitors, regulators, sponsors, investigators, coordinators
Provide Drug Information
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UH Research Pharmacy:Services
Services Inpatient and outpatient dispensing of research medication
(IV and oral) Formulation work, preparation of novel sterile IV products,
capsules and tablets. Drug distribution center for multi-center drug studies.
(Start Center and VA Hospital)
Clients All hospital divisions and departments Drug companies University Health Science Center
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UH Research Pharmacy: Dispensing Location
UH Inpatient Pharmacy, 1st floor,
across A service elevators
Javier V. Palacios, R.Ph;
Michael J. Andersen, R.Ph; Bryan Davis, RPh.
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Routine FDA Inspection Findings
Most Common Deficiencies Consent form problems Protocol non-adherence
Infusion time incorrect Administration time not within dosing window
Drug accountability problems No drug administration records to document
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UH Research Pharmacy:Final Comments
Contact the Research Pharmacy when looking for a study medication dose.
Use only medications which are labeled for study. Do not use medications from other sources such as the Pyxis
Contact the Research Pharmacy with any questions concerning the investigational drug and its handling
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