The Investigational Pharmacy ensures patient safety through adherence to protocol-specific drug treatment and monitoring parameters. Compliance with regulatory requirements for clinical drug trials is maintained through appropriate data collection and monitoring. An experienced staff provides expertise on drug study set-up and procedures, providing support from start-up to completion of the clinical trial.
Pharmacists are members of the Pharmacy and Therapeutics Committee of the Committee for the Protection of Human Subjects (CPHS), and are active members of national co-operative study groups.
- Secure drug storage provided 24/7.
- Sterile product preparation area with laminar flow hoods.
- Safe handling and preparation of chemohazard and biohazard drugs, utilizing segregated Level 2 biological safety cabinets.
- Continuous documentation of study drug storage via electronic monitoring of ambient room temperature, refrigerator, freezer, and deep freezer storage facilities.
- Protocol review to determine Pharmacy feasibility, resource utilization, and cost.
- Handling of study drugs is conducted in accordance with the U.S. Food and Drug Administration (FDA) regulations; the International Conference on Harmonisation (ICH) E6 Guideline for Good Clinical Practice (GCP); and applicable local, state, and federal Pharmacy laws.
- Collaboration with PIs and members of the Research Team, CPHS, and Clinical Trials Office, as necessary.
- Drug information and in-service education to staff as needed.
- Preparation of individual doses of injectable drug products or outpatient prescriptions.
- Non-sterile compounding, including preparation of placebo products as specified in individual protocols.
- Verification of all patient drug orders for accuracy and compliance with study protocol parameters prior to study drug dose preparation.
- Participation in Site Initiation Visit, monitor visits, and close-out visits.
- Pharmacy usually acts as the site staff for unblinded studies.
- Accurate and permanent records of drug receipts, dispensing, discrepancies, and returns.
- Quarterly internal auditing of Investigational Pharmacy records.
Contact the Investigational Pharmacy
Dartmouth-Hitchcock Medical Center
One Medical Center Drive
Lebanon, NH 03756
Location: Rubin Building Level 4, Room 463N3
Phone: (603) 650-7890
Fax: (603) 650- 6814
David Chan, RPh, PhD, Investigational Drug Pharmacist
Joel Brown, PharmD, PhD
Doug Parr, PharmD, Clinical Pharmacist Specialist Investigational Pharmacy
Neal Wilson, CPhT
- Find a Clinical Trial
- New Study Start Up
- Contracting Office
- Managing a Study
- Protocol Amendments
- Closing a Study
- Investigational Pharmacy
- Education & Training
- Clinical Research Compliance Program
- Regulatory Information
- Research Links
- Frequently Asked Questions
- Contact Information