GLOSSARY OF CLINICAL RESEARCH TERMS
1572
FDA form which identifies the Principal Investigator, CoInvestigator, Sub-Investigators, and staff of a study. This can be
computer-generated document. The sponsor requires a copy singed
by the PI.
Accepted CRF
Case Report Form, which is accepted as complete by the sponsor
(study monitor). A CRF may have been submitted and had requests
for corrections or additional material before it was accepted.
Adverse Event (AE)
An undesirable and unintended, although not necessarily
unexpected, result of therapy or other intervention.
Case Report Form (CRF)
Documents used to record protocol data. This is an extraction from
the source documents (medical record and additional documents, i.e.
subject diaries, coordinator notes) that the coordinator prepares, and
the PI confirms. Case Report Forms are carefully monitored by the
sponsor in regard to constancy with the source documents. ALL
DATA RECORDED ON A CRF MUST BE VERIFIABLE ON SOURCE
DOCUMENTATION.
Confidential Disclosure Agreement (CDA)
Document which we sign prior to receiving confidential
information, such as a research protocol, promising not to disclose
confidential and proprietary information about the trial or sponsor.
Clinical Trial
A carefully designed investigation of the effects of drug, medical
treatment, or device on a group of patients.
Clinical Investigator
A medical researcher in charge of carrying out a clinical trial's
protocol. Researchers are usually doctors, nurses, pharmacists or
other health care professionals.
Coordinator
The person who brings together all aspects of the study. Usually this
person is in charge of all documentation, and acts as a liaison
between the sponsor and the Principal Investigator in the day-to-day
activities of the clinical trial.
Device, Class I
Least regulated category of devices. The regulations address device
registration, record keeping, labeling, adverse event reporting, and
premarket notification. These guidelines provide reasonable
assurances for device safety and efficacy
Device, Class II
Additional controls are necessary to assure safety and effectiveness.
Until special controls are enacted, general control measures of Class
I devices apply.
Device, Class III
Most regulated category of devices. This class is represented to be
life sustaining or supporting, implantable or carry an unreasonable
risk of illness or injury.
Food and Drug Administration
A government agency that enforces laws on the manufacture,
testing, and use of drugs and medical devices. The FDA must
approve all drugs and medical devices before the general public can
use them.
Form FDA 1571
First page of an Investigation New Drug Application (IND) that
provides the basic information about the new drug and its sponsor.
Form FDA 1572
Document(s) filed with an IND that provides FDA with a list of
investigators and subinvestigators, their credentials, site(s) where the
study is being conducted, laboratories used for tests, and assurance
of RB review.
Form FDA 482
Document that provides a "Notice of Inspection" to the investigator
prior to a FDA audit. This form serves to identify the FDA inspector
conducting the audit, along with the authority to review study
related documents.
Form FDA 483
Document that may be presented to the investigator by the FDA
inspector at the conclusion of the FDA audit. This form lists the
objectionable practices found during the FDA inspection of the
clinical site.
Good Clinical Practice (GCP)
Describes the actions and responsibilities of the sponsor,
investigator, and monitors to assure quality data from scientifically
sound and safe clinical investigations.
Investigation New Drug Application (IND)
Application mandated by the Kefauver-Harris Amendment requiring
that sponsors submit to FDA a detailed protocol, preclinical data, and
investigator credentials prior to initiating phase I clinical trials.
Informed Consent
A discussion of all procedures, benefits, risks, and expectations of a
clinical trial between clinical investigators and potential patients.
The FDA requires all patients to sign an informed consent form
before participating in a trial.
Institutional Review Board (IRB)
A board consisting of health care professionals from the institution
where the clinical trial takes place, as well as members of the local
community. The board scrutinizes all trial activities including
recruitment, advertising, and potential risks. The IRB also makes
sure that FDA regulations are being followed in a particular trial.
Institutional Review Board submission (IRB)
A form request, by the PI to the Institution Review Board, to review
clinical protocol and approve its performance at the site. IRB
submissions are usually submitted on standardized forms. These
forms may be computerized.
Investigational Treatment
The drug or medical device that is tested during a clinical trial.
New Drug Application (NDA)
Marketing application mandated by the Food, Drug and Cosmetic
Act that requires sponsors submit to FDA all clinical and laboratory
data supporting a request for drug approval prior to marketing.
Phases
Drugs and medical devices must pass three segments or phases of
testing before they can be eligible for FDA approval.
Phase I/II Study
Earliest phase of drug development in which a limited number of
human subjects are exposed to the test article. The objective of this
phase or a clinical trial is to establish a drug's safety and toxicity
profile. Phase II studies expand the numbers of patients exposed to
the drug, and begin to collect data suggesting efficacy.
Phase III Study
Phase of study designed to demonstrate drug efficacy in patient
populations with specific disease indications and to collect additional
safety data in a larger cohort of patients. These studies are usually
multicentered, involving hundreds to thousands of patients.
Phase IV Study
Post-marketing studies may be requested by the FDA to provide
additional data, or are intended to expand labeling to other
populations or other indications, or simply to market the drug in a
variety of clinical settings.
Principle Investigator
A medical professional who is overseeing the treatment of the
patients in the clinical trial.
Protocol
A plan that sets guidelines for a trial and usually involves several
different trial locations. A protocol is usually designed by the sponsor
of a clinical trial.
Record storage
A secure locked cabinet in a locked room where records for the
clinical study are stored. Long term record storage is also required
for clinical trial
REGULATORY DOCUMENTS
Protocol, protocol amendments, investigator's confidentiality
agreement and contract with sponsor, signed FDA 1572(s), CV (s)
for all investigator's and sub-investigators, IRB Documents (letter of
approval) informed consent (IRB approval required), lab
certification and normal ranges, Serious Adverse Experience Reports
("Safety Reports"), sponsor correspondence, monitoring record,
signature sheet, shipping forms for drug, drug log, dispensing logs,
randomization sheets, Investigational
Material Shipping (IMS) Forms, drug return form.
Serious Adverse Event (SAE)
Any untoward medical occurrence that at any dose: results in death;
is life threatening; requires inpatient hospitalization or prolongation
of existing hospitalization; results in persistent or significant
disability or incapacity or is a congenital anomaly/birth defect.
Screening chart
A list of patients who have been screened but were not entered as
subjects into a clinical study.
Screening
A process whereby potential subjects are reviewed to see if they meet
the inclusion criteria of a study.
Site
The place of business where a clinical study is being conducted. A
site may be a stand-alone place of business or part of a larger
institution. The site/institution is usually the employer of the PI.
Source documents
Documents from which data is extracted to the CRF. Source
documents include materials duplicated from the charts, subject
diaries, laboratory reports, consent forms, coordinator's notes, etc.
In large institutions where there are regulations that limit materials
entered into medical charts, a separate file that duplicates and
references all pertinent information is essential.
Sponsor
The pharmaceutical company, research institution, or other health
organization that funds a clinical trial and designs its protocol.
The organization that initiates (and ultimately pays for) the clinical
trial.
Standard Treatment
A FDA-approved treatment currently in wide use. In trials
involving new treatments, there may be no pre-existing treatment at
all. In these cases, the lack of any treatment is considered the
standard treatment. Generally, the goal of a clinical trial is to
introduce an investigational treatment that is safer and more
effective than the standard treatment.
Unscheduled events
Medical procedures/laboratories that are not budgeted items but
occur because of the subject's participation in the clinical trial.
These expenses are charged to the clinical trial account. The
contract should describe the financial responsibility for these events.
The consent form should reiterate the description that is in the
contract.