Vocab

Question 1

Adverse Drug Reaction (ADR)

Answer 1

an appreciably harmful or unpleasant reaction resulting from an intervention related to the use of a medicinal product

Question 2

Adverse Event

Answer 2

An event in which care resulted in an undesirable clinical outcome-an outcome not caused by underlying disease-that prolonged the patient stay, caused permanent patient harm, required life-saving intervention, or contributed to death.

Question 3

ADR vs. AE

Answer 3

An adverse reaction, in contrast to an adverse event, is characterised by the fact that a causal relationship between a medicinal product and an occurrence is suspected.

Question 4

Audit

Answer 4

An audit is a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s SOPs, GCP, and the applicable regulatory requirement(s).

Question 5

Case Report Form (CRF)

Answer 5

-electronic or paper document which is used in a clinical trial
-records the protocol and required information about each participant
-enables efficient and complete data collection, processing, analysis and reporting.

Question 6

Comparator (Product)

Answer 6

A comparator is an investigational or marketed product (active control) or placebo (inactive control) used as a reference in a clinical trial.

Question 7

Contract Research Organization (CRO)

Answer 7

an organization contracted by another company to take the lead in managing that company’s trials and complex medical testing responsibilities.

Question 8

Direct Access

Answer 8

Permission to examine, analyze, verify, and reproduce any records and reports that are important
to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities,
sponsor’s monitors, and auditors) with direct access should take all reasonable precautions
within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality
of subjects’ identities and sponsor’s proprietary information.

Question 9

Essential documents

Answer 9

Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced

Examples: ICF, CRF, investigator’s brochure

Question 10

Independent Data Monitoring Committee (IDMC) (Data and Safety Monitoring
Board, Monitoring Committee, Data Monitoring Committee)

Answer 10

An independent data monitoring committee that may be established by the sponsor to assess at
intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to
recommend to the sponsor whether to continue, modify, or stop a trial.

Question 11

Impartial Witness

Answer 11

A person, who is independent of the trial, who cannot be unfairly influenced by people involved
with the trial, who attends the informed consent process if the subject or the subject’s legally
acceptable representative cannot read, and who reads the informed consent form and any other
written information supplied to the subject.

Question 12

Independent Ethics Committee (IEC)

Answer 12

An independent body (a review board or a committee, institutional, regional, national, or
supranational), constituted of medical professionals and non-medical members, whose
responsibility it is to ensure the protection of the rights, safety and well-being of human subjects
involved in a trial and to provide public assurance of that protection, by, among other things,
reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the
investigator(s), facilities, and the methods and material to be used in obtaining and documenting
informed consent of the trial subjects.
The legal status, composition, function, operations and regulatory requirements pertaining to
Independent Ethics Committees may differ among countries, but should allow the Independent
Ethics Committee to act in agreement with GCP as described in this guidance

Question 13

Informed Consent

Answer 13

A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the
subject’s decision to participate. Informed consent is documented by means of a written, signed,
and dated informed consent form.

Question 14

Inspection

Answer 14

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 (CROs) facilities, or at other establishments deemed appropriate by the regulatory
authority(ies).

Question 15

Institution (medical)

Answer 15

Any public or private entity or agency or medical or dental facility where clinical trials are
conducted.

Question 16

Institutional Review Board (IRB)

Answer 16

An independent body constituted of medical, scientific, and nonscientific members, whose
responsibility is to ensure the protection of the rights, safety and well-being of human subjects
involved in a trial by, among other things, reviewing, approving, and providing continuing
review of trial protocols and amendments and of the methods and material to be used in
obtaining and documenting informed consent of the trial subjects. Needs at least 5 members.

Question 17

Interim Clinical Trial/Study Report

Answer 17

A report of intermediate results and their evaluation based on analyses performed during the course of a trial.

Question 18

Investigational Product

Answer 18

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.

Question 19

Investigator’s Brochure

Answer 19

A compilation of the clinical and nonclinical data on the investigational product(s) that is
relevant to the study of the investigational product(s) in human subjects (see section 7.
“Investigator’s Brochure”).

Question 20

Monitoring

Answer 20

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), GCP, and the applicable regulatory requirement(s). Monitor creates monitor reports and provides them to the sponsor

Question 21

Multicenter Trial

Answer 21

One protocol, multiple sites and investigators

Question 22

Nonclinical Study

Answer 22

Biomedical studies not performed on human subjects.

Question 23

Opinion (in relation to Independent Ethics Committee)

Answer 23

The judgment and/or the advice provided by an Independent Ethics Committee (IEC).

Question 24

Protocol

Answer 24

A document that describes the objective(s), design, methodology, statistical considerations, and
organization of a trial. The protocol usually also gives the background and rationale for the trial,
but these could be provided in other protocol referenced documents. Throughout the ICH GCP
Guidance, the term protocol refers to protocol and protocol amendments. Amendments are changes and clarifications made to the protocol.

Question 25

Quality Assurance (QA)

Answer 25

All those planned and systematic actions that are established to ensure that the trial is performed
and the data are generated, documented (recorded), and reported in compliance with GCP and
the applicable regulatory requirement(s).

Question 26

Quality Control (QC)

Answer 26

The operational techniques and activities undertaken within the quality assurance system to
verify that the requirements for quality of the trial-related activities have been fulfilled.

Question 27

QA vs QC

Answer 27

QA is the guidelines, QC is the test

Question 28

Regulatory Authorities/Competent Authorities

Answer 28

Bodies having the power to regulate. In the ICH GCP guidance, the expression “Regulatory Authorities” includes the authorities that review submitted clinical data and those that conduct inspections.

Question 29

Serious Adverse Event (SAE)/Serious Adverse Drug Reaction (Serious ADR)

Answer 29

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.

Question 30

Source Data

Answer 30

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.
Source data are contained in source documents (original records or certified copies).

Question 31

Source Document

Answer 31

Original documents, data, and records

Question 32

Sponsor

Answer 32

An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.

Question 33

Sponsor-Investigator

Answer 33

An individual who both initiates and conducts, alone or with others, a clinical trial, and under
whose immediate direction the investigational product is administered to, dispensed to, or used
by a subject. The term does not include any person other than an individual (e.g., it does not
include a corporation or an agency). The obligations of a sponsor-investigator include both those
of a sponsor and those of an investigator.

Question 34

Standard Operating Procedures (SOPs)

Answer 34

Detailed, written instructions to achieve uniformity of the performance of a specific function.

Question 35

Subinvestigator

Answer 35

Any individual member of the clinical trial team designated and supervised by the investigator at
a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). See also Investigator.

Question 36

Unexpected Adverse Drug Reaction

Answer 36

An adverse reaction, the nature or severity of which is not consistent with the applicable product
information (e.g., Investigator’s Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product).

Question 37

Vulnerable Subjects

Answer 37

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the
expectation, whether justified or not, of benefits associated with participation, or of a retaliatory
response from senior members of a hierarchy in case of refusal to participate. Examples are
members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing
students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects
include patients with incurable diseases, persons in nursing homes, unemployed or impoverished
persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

Question 38

Well-being (of the trial subjects)

Answer 38

The physical and mental integrity of the subjects participating in a clinical trial.

Question 39

Certified Copy

Answer 39

A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original.

Question 40

Monitoring Plan

Answer 40

A document that describes the strategy, methods, responsibilities, and requirements for
monitoring the trial.

Question 41

Validation of Computerized Systems

Answer 41

A process of establishing and documenting that the specified requirements of a computerized
system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The approach to validation should be based on a risk assessment that takes into consideration the intended use of the system and the potential of the system to
affect human subject protection and reliability of trial results.

Question 42

Pharmacodynamics

Answer 42

the effects of the agent while in the body.

Question 43

Pharmacogenomics

Answer 43

the use of genetic information to predict whether a drug will help make a patient well or ill.

Question 44

Pharmacokinetics

Answer 44

how the agent moves through and is excreted from the body