Good Clinical Practices Regulatory Guidelines for the Conduct of Clinical research

1. Good Clinical PracticesRegulatory Guidelines for the Conduct of Clinical research Introduction to Research Pharmacy Services Javier Palacios, R.Ph. Sponsored by the Research Committee of the Medical Dental Staff at UHS

2. Learning Objectives • Define Good Clinical Practice and • Explain GCP guidelines in handling of drugs. • Understand role and services of UHS Research Pharmacy Department.

3. 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.

4. 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

5. Investigational DrugHandling Policy at UH • Studies at UH • Investigational drugs will be managed by the Research Pharmacy Department • Studies 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.

6. 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

7. 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

8. 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.

9. 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

10. 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