Name: Score:
89 Multiple choice questions
Definition 1 of 89
All information in original records and certified copies of original records of clinical findings,
observations, or other activities in a clinical trial necessary for the reconstruction and evaluation
of the trial. _________________ are contained in source documents (original records or certified copies).
Source Data
Documentation
Primary Variable
Source Documents
Term 2 of 89
Regulatory agencies should be notified (e.g., by phone, fax transmission, or in writing) of fatal or
life-threatening unexpected ADRs in clinical investigations as soon as possible but no later than ___
calendar days after first knowledge by the sponsor that a case qualifies, followed by as complete
a report as possible within ___ additional calendar days.
22, 8
3, 5
6, 8
7, 8
,Definition 3 of 89
- an identifiable patient
- a suspect medicinal product
- an identifiable reporting source
- an event or outcome that can be identified as serious and unexpected, and for which, in clinical
investigation cases, there is a reasonable suspected causal relationship
Minimum criteria for reporting serious, unexpected ADRs (4)
IRB Composition Recommendations (3)
The purposes of trial monitoring are to verify that (3):
Clinical Trial/Study Report
Term 4 of 89
Treatment Emergent
A(n) ______________ may be established by the sponsor to assess at intervals the progress of a
clinical trial, safety data, and critical efficacy variables and recommend to the sponsor
whether to continue, modify or terminate a trial.
An event that emerges during treatment having been absent pre-treatment, or worsens
relative to the pre-treatment state.
A printed, optical, or electronic document designed to record all of the protocol required
information to be reported to the sponsor on each trial subject.
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/incapacity,
or
- is a congenital anomaly/birth defect
,Definition 5 of 89
The term "severe" is often used to describe the intensity (severity) of a specific event (as in mild,
moderate, or severe myocardial infarction); the event itself, however, may be of relatively minor
medical significance (such as severe headache). This is not the same as "serious," which is based
on patient/event outcome or action criteria usually associated with events that pose a threat to a
patient's life or functioning. Seriousness (not severity) serves as a guide for defining regulatory
reporting obligations.
Generalizability
Severe vs. Serious
Phase iii
Non-inferiority trial
Term 6 of 89
Monitoring
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted,
recorded, and reported in accordance with the protocol, Standard Operating Procedures
(SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
All records, in any form (including, but not limited to, written, electronic, magnetic, and
optical records, and scans, x-rays, and electrocardiograms) that describe or record the
methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions
taken.
If a single primary variable cannot be selected from multiple measurements associated
with the primary objective, another useful strategy is to integrate or combine the multiple
measurements into a single or '___________' variable, using a pre-defined algorithm.
The act by a regulatory authority(ies) of conducting an official review of documents,
facilities, records, and any other resources that are deemed by the authority(ies) to be
related to the clinical trial and that may be located at the site of the trial, at the sponsor's
and/or contract research organization's (CRO's) facilities, or at other establishments
deemed appropriate by the regulatory authority(ies).
, Definition 7 of 89
In some cases, '__________ ___________' variables are developed to measure the overall safety, overall
efficacy, and/or overall usefulness of a treatment. This type of variable integrates objective
variables and the investigator's overall impression about the state or change in the state of the
subject, and is usually a scale of ordered categorical ratings.
Global assessment variables
Vulnerable subjects
Essential documents
Protocol
Definition 8 of 89
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a
clinical trial, including a product with a marketing authorization when used or assembled
(formulated or packaged) in a way different from the approved form, or when used for an
unapproved indication, or when used to gain further information about an approved use.
Investigator's Brochure
Investigator
Superiority Trial
Investigational Product
Definition 9 of 89
- At least five members.
- At least one member whose primary area of interest is in a nonscientific area.
- At least one member who is independent of the institution/trial site.
IRB Composition Recommendations (3)
Objectives of Human Pharmacology Studies
Minimum criteria for reporting serious, unexpected ADRs (4)
Objectives of Therapeutic Exploratory Studies
