Investigational Drug Service
Overview
Who We Are
Investigational Drug Services (IDS) is a specialized unit within Morehouse School of Medicine (MSM) that manage all aspects of drug handling for clinical research studies involving investigational (i.e., not yet FDA-approved or used outside their approved indication) drugs. Our primary role is to ensure that investigational products are managed according to regulatory, ethical, and institutional standards. We play a critical role in protecting research participants, maintaining study integrity, and supporting successful trial execution.
What We Do
IDS oversees the storage, dispensing, and proper disposal of investigational drugs and study medications used in clinical trials.
Impact
By managing investigational drug accountability, IDS ensures protocol standardization and enhances participant safety and regulatory compliance.
Key Functions of IDS
Regulatory Compliance and Documentation
- Ensure compliance with FDA, Good Clinical Practice (GCP), ICH guidelines, and Institutional Review Board (IRB) requirements.
- Maintain accurate drug accountability records for audits and inspections.
- Assist with investigational new drug (IND) requirements and sponsor correspondence.
Drug Procurement and Storage
- Receive, verify, and store investigational products according to sponsor and protocol specifications.
- Maintain secure, temperature-controlled, and access-restricted storage areas.
Drug Preparation, Dispensing, and Labeling
- Prepare and dispense investigational drugs following protocol and blinding requirements.
- Label investigational products according to federal and sponsor requirements.
- Ensure accurate randomization and subject-specific dispensing.
Blinding and Randomization
- Manage blinding procedures to maintain study integrity.
- Oversee randomization schedules and maintain confidentiality.
Education and Support
- Track drug inventory from receipt to final disposition.
- Manage returns, destruction, or reconciliation of unused drug per protocol and regulatory standards.
Accountability and Disposal
- Track drug inventory from receipt to final disposition.
- Manage returns, destruction, or reconciliation of unused drug per protocol and regulatory standards.
Quality Assurance
- Conduct routine audits and quality checks.
- Ensure all processes meet institutional and federal standards for research pharmacy operations.
Investigational Drug Service Gallery
Investigational Drug Service Team
Noor Mohamed, Pharm D., RPh
Director of Investigational Drug Service & Clinical Research Pharmacist
Kay Woodson
Clinical Research Pharmacist
Tetriana Banks
Clinical Research Pharmacy Technician
Contact Information
Email: IDS@msm.edu
Phone: (404) 756-5007
Location: Clinical Research Center (CRC), Building F, Room F-117 and F-123