Clinical Research Standard Operating Procedure for Investigational Drug Management
This Clinical Research Standard Operating Procedure (SOP) is important for clinical site personnel to fulfill the Good Clinical Practice (GCP) requirements for the distribution, storage, and maintainence of inventory of investigational drugs.
An investigational drug is a pharmaceutical agent that is not approved by the FDA for testing through a clinical trial for safety and efficacy. This is generally tested against a placebo unless not feasible. The investigation drug can also be a an FDA approved drug already approved. These can include approved drugs being tested for a different route of delivery, strength, formulation, labeling, packaging, for a new indication or to gain further information.
The Principal Investigator is responsible and accountable for the distribution, storage, and inventory of the investigational drug involved in the approved clinical study. The PI may delegate responsibility for the investigational drug to another qualified researcher involved in the study, but may not delegate accountability.
Delegation of responsibility, (not Authority!) can include the following depending on state requirements:
• Study compliance with the investigational drug
• Receipt and storage of the investigational drug
• Documentation of the receipt, storage, and management, distributing
• Training to use the investigational drug
• Disposal and destruction of the investigation drug
The critical takeaway for compliance with this Clinical Research Standard Operating Procedure is to first and foremost document, document, document. Once documentation is in place the clinical investigator must ensure processes are in place and oversight is in place to ensure FDA and GCP compliance.
gamechangershow
2087
yousharknotpass
