09-25-0207 SYSTEMS LISTING
Subject-Participants in Pharmacokinetic Studies on Drugs of Abuse and on Treatment Medications, HHS/NIH/NIDA.
University of California, San Francisco, Langley Porter Psychiatric Institute, San Francisco, CA 94143
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Normal, healthy adults who voluntarily participate in studies on the pharmacokinetics and pharmacodynamics of psychoactive drugs at Langley Porter Psychiatric Institute, during the period September 1987 through June 1997.
CATEGORIES OF RECORDS IN THE SYSTEM:
Research records on each subject-participant contain the following information: name; clinician's records including medical history, laboratory test results, physical examinations, psychological profile, and drug use profile; drug study data including records of drugs administered, exposures to radioactivity, and drug reactions; and date of study in which the subject participated.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Public Health Service Act, Sections 301(a), 503 and 405 (42 U.S.C. 241 and 284).
The primary purpose of this system is to support research on the pharmacokinetics and pharmacodynamics of drugs of abuse as well as treatment drugs. The term "pharmacokinetics" refers to the manner in which the human body processes a drug. "Pharmacodynamics" refers to the manner in which the drug affects the human body.
The clinical investigator used data of a medical nature that is contained in the system to make determinations regarding drug dosages and/or radiochemical exposures appropriate to the individual human subject-participants, in order to preserve and protect the health of each. The system also provides baseline data for studying the drug effects.
The Food and Drug Administration (FDA) also may use the records in routine inspections FDA conducts in accordance with its responsibilities to develop standards on the composition, quality, safety, and efficacy of drugs administered to humans, and to monitor experimental usage of drugs.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES:
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM:
The contractor maintains the records on paper in file folders.
The contractor indexes and retrieves the records by the subject-participant's name.
RETENTION AND DISPOSAL:
The records will be kept for at least two years after FDA approves the new drug application for the study medication or the IND is withdrawn. At that time, the NIDA project officer will authorize in writing the clinical investigators to destroy the records by shredding or burning.
SYSTEM MANAGER(S) AND ADDRESS(ES):
Project Officer, Pharmacokinetic Studies on Drugs of Abuse, Medications Development Division, National Institute on Drug Abuse (NIDA), Neuroscience Center, Room 4123, 6001 Executive Boulevard, Bethesda, MD 20892-9551.
To determine if a record exists, write to the System Manager listed above.
Provide the following information: subject-participant's full name and a letter of request (or permission, if the requester is not the subject-participant) with notarized signature of the individual who is the subject of the record, approximate date(s) of experiment(s) in which the individual participated, and drug name (if known). In addition, an individual who requests notification of, or access to, a medical record shall, at the time the request is made, designate in writing a responsible representative who will be willing to review the record and inform the subject individual of its content at the representative's discretion.
RECORD ACCESS PROCEDURE:
Same as Notification Procedures. Requesters should also reasonably specify the record contents being sought. An individual may also request an accounting of disclosures of his/her record, if any.
CONTESTING RECORD PROCEDURE:
Contact the System Manager at the address above and reasonably identify the record, specify the information to be contested, the corrective action sought, with supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant.
RECORD SOURCE CATEGORIES:
The subject-participants and the contractor personnel conducting the research studies.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: