Investigational Drugs, Agents, Biologics

POLICY

It is the policy of UTHealth that research involving a drug, other than the use of a marketed drug in the course of medical practice, must have an investigational new drug (IND) provided by the FDA, unless the protocol meets FDA exemptions.

It is the policy of UTHealth that investigational drugs, agents or biologics are stored appropriately and used only in approved research protocols under the direction of approved investigators.

Key Terms

Test article means any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 or 354-360F of the Public Health Service Act.

Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. An experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.

Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms "investigational drug" and "investigational new drug" are synonymous.

Sponsor-Investigator means an individual who both initiates and conducts an investigation and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual.

PROCEDURE

Submission: When the research involves a drug, agent or biologic, the Principal Investigator provides information on the drug, agent or biologic in the initial application via iRIS including but not limited to:

Review: IRB staff will verify the IND number provided by matching the information on the sponsor protocol, communication from sponsor or communication from FDA.  In case the investigator holds the IND, the IRB staff will verify the number provided by the investigator with the information provided by FDA.

If the research involves a drug, agent or biologic, and an IND number has not been provided, Research compliance staff will review all protocols scheduled for full board review and determine if an IND is required or whether the research meets one of the FDA exemptions from the requirement to have an IND.

The clinical investigation of a marketed drug or biologic does not require submission of an IND if all six of the following conditions are met:

A clinical investigation involving the use of placebo is exempt if it does not otherwise require IND submission.

A clinical investigation involving an in vitro diagnostic biological product (blood grouping serum; reagent red blood cells; anti-human globulin) is exempt if the diagnostic test was intended to be used in a diagnostic procedure that confirms the diagnosis made by another, medically established diagnostic product or procedure and the diagnostic test was shipped in compliance with 21 CFR 312.60.

Communication: The research compliance staff recommendations to the IRB members will be entered in iRIS. If CPHS determines that an IND is required, IRB staff will communicate this to the Principal Investigator and CPHS approval will not be granted until the Principal Investigator submits the IND number or written communication from FDA that IND is not required.

CPHS shall ensure that the Principal Investigator’s plan for control of investigational material is appropriate. In general, pharmacy service should be used for storage and dispensing of the investigational material. CPHS may approve of a plan to store and dispense investigational material by an experienced Investigator or Study Coordinator in certain situations such as industry sponsored research with a plan for monitoring.

APPLICABLE REGULATIONS

1.  21 CFR 312.23(a)(4)

2.  21 CFR 312.53(c)

3.  21 CFR 312.60-62

4.  21 CFR 312.66

REFERENCES TO OTHER SOP

1.  None.

ATTACHMENTS

1.   Study Drug Panel – CPHS Application Form.

If you find errors in this document, contact clinicaltrials@uth.tmc.edu

Document Number:

101-D01

Document Name:

Investigational Drugs, Agents and Biologics

Approved by:

Executive Director, Research Compliance, Education and Support Services

Effective:

1 Aug 2008

Revision History:

1 Jan 2009, 1 Aug 2011, 1 Jun 2016


CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

How can we improve this site?


Committee for the Protection of Human Subjects
6410 Fannin, Suite 1100
Houston, Texas 77030

Phone 713-500-7943
Fax     713-500-7951
Email cphs@uth.tmc.edu 

IRIS Support 713-500-7960

aahrpp logo

CLINICAL TRIALS RESOURCE CENTER      OFFICE OF RESEARCH     ENVIRONMENTAL HEALTH & SAFETY   

CORE LABORATORIES       SPONSORED PROJECTS       TECHNOLOGY MANAGEMENT