1) Glossary

Question 1

Adverse Drug Reaction (ADR)

Answer 1

For pre-approved/new medicinal products:
All noxious and unintended responses to a medicinal product related to any dose. A causal relationship between a medicinal product and an adverse event is at least a reasonable possibility (ie, the relationship cannot be ruled out).

For marketed medicinal products:
A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function.

Question 2

Adverse Event (AE)

Answer 2

Any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Can therefore by any unfavorable and unintended sign (including an abnormal lab finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to said IP.

Question 3

Applicable regulatory requirement

Answer 3

Any law and regulation addressing the conduct of clinical trials of investigational products.

Question 4

Approval (in relation to IRB)

Answer 4

The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, GCP, and the applicable regulatory requirements.

Question 5

Audit

Answer 5

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 accurate reported according to the protocol, sponsor’s standard operating procedures (SOPs), GCP, and the applicable regulatory requirements.

Question 6

Audit certificate

Answer 6

A declaration of confirmation by the auditor that an audit has taken place.

Question 7

Audit Report

Answer 7

A written evaluation by the sponsor’s auditor of the results of the audit.

Question 8

Audit Trail

Answer 8

Documentation that allows reconstruction of the course of events.

Question 9

Blinding/Masking

Answer 9

When one or more parties of the trial are kept unaware of the treatment assignments.

Question 10

Single-blinding

Answer 10

When the subjects are unaware of the treatment assignment.

Question 11

Double-blinding

Answer 11

When the subjects, investigator(s), monitor, and in some cases, data analyst(s) are unaware of the treatment assignments.

Question 12

Case Report Form (CRF)

Answer 12

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.

Question 13

Clinical Trial/Study

Answer 13

An investigation in human subjects intended to discover or verify:

1) The clinical, pharmacological, and/or pharmacodynamic effects of an investigational product

2) To identify any adverse reactions to an IP

3) To study absorption, distribution, metabolism, and exertion of an IP

All to ascertain the IP’s safety and /or efficacy.

Question 14

Clinical Trial (Study) Report

Answer 14

A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report.

Question 15

Comparator (Product)

Answer 15

An investigational or marketed product (ie, active control), or placebo, used as a reference in a clinical trial.

Question 16

Compliance

Answer 16

Adherence to all the trial-related requirements, GCP requirements, and the applicable regulatory requirements.

Question 17

Confidentiality

Answer 17

Prevention of disclosure to other than authorized individuals of a sponsor’s proprietary information or of a subject’s identity.

Question 18

Contract

Answer 18

A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.

Question 19

Coordinating Committee

Answer 19

A committee that a sponsor may organize to coordinate the conduct of a multi-center trial.

Question 20

Coordinating Investigator

Answer 20

An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multi-center trial.

Question 21

Contract Research Organization (CRO)

Answer 21

A person or an organization contracted by the sponsor to perform one or more of a sponsor’s trail-related duties and functions.

Question 22

Direct Access

Answer 22

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 monitor and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirements to maintain the confidentiality of subjects’ identities and sponsor’s proprietary information.

Question 23

Documentation

Answer 23

All records, in any form, that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.

Question 24

Essential Documents

Answer 24

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

Question 25

Good Clinical Practice (GCP)

Answer 25

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of the trial subjects are protected.

Question 26

Independent Data-Monitoring Committee (IDMC)

Answer 26

AKA Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee A 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 27

Impartial Witness

Answer 27

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

Question 28

Independent Ethics Committee (IEC)

Answer 28

An independent body (a review board or a committee) 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 subject involved in a trial. They are also 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.

Question 29

Informed Consent

Answer 29

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. It is documented by means of a written, signed, and dated ICF.

Question 30

Inspection

Answer 30

The act by a regulatory authority of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or CRO facilities, or at other establishments deemed appropriate by regulatory authorities.

Question 31

Institution (medical)

Answer 31

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

Question 32

Institutional Review Board (IRB)

Answer 32

An independent body consisted of medical, scientific, and non-scientific members whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

Question 33

Interim Clinical Trial Report

Answer 33

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

Question 34

Investigational Product

Answer 34

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 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 35

Investigator

Answer 35

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the PI.

Answer 36

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the PI.

Question 37

Investigator’s Brochure (IB)

Answer 37

A compilation of the clinical and non clinical data on the investigational product(s) which is relevant to the study of the IP in human subjects.

Question 38

Legally Acceptable Representative

Answer 38

An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial.

Question 39

Monitoring

Answer 39

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the following: 1) The protocol 2) Standard Operating Procedures (SOPs) 3) Good Clinical Practice (GCP) 4) Applicable regulatory requirements

Question 40

Monitoring Report

Answer 40

A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor SOPs.

Question 41

Multi-center Trial

Answer 41

A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.

Question 42

Non clinical Study

Answer 42

Biomedical studies not performed on human subjects.

Question 43

Opinion (in relation to IEC)

Answer 43

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

Question 44

Protocol

Answer 44

A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. It usually also gives the background and rationale for the trial.

Question 45

Protocol Amendment

Answer 45

A written description of a change(s) to or formal clarification of a protocol.

Question 46

Quality Assurance (QA)

Answer 46

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 requirements.

Question 47

Quality Control (QC)

Answer 47

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 48

Randomization

Answer 48

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

Question 49

Regulatory Authorities

Answer 49

Bodies have the power to regulate. In the ICH GCP guideline, they include the authorities that review submitted clinical data no those that conduct inspections. Sometimes referred to as competent authorities.

Question 50

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

Answer 50

Any untoward medical occurrence that at any dose: 1) Results in death 2) Is life threatening 3) Requires inpatient hospitalization or prolongation of existing hospitalization 4) Results in persistent or significant disability/incapacity 5) Is a congenital anomaly/birth defect

Question 51

Source Data

Answer 51

Original documents, data, and records. Examples: Hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial

Question 52

Sponsor

Answer 52

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

Question 53

Sponsor-Investigator

Answer 53

An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the IP 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). Obligations include both those of a sponsor and of an investigator.

Question 54

Standard Operating Procedures (SOPs)

Answer 54

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

Question 55

Subinvestigator

Answer 55

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.

Question 56

Subject

Answer 56

An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.

Question 57

Subject Identification Code

Answer 57

A unique identifier assigned by the investigator to each trial subject to protect the subject’s identity and used in lieu of the subject’s name when the investigator reports adverse events and/or other trial related data.

Question 58

Trial Site

Answer 58

The location(s) where trial-related activities are actually conducted.

Question 59

Unexpected Adverse Drug Reaction

Answer 59

An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., IB for an unapproved IP).

Question 60

Vulnerable Subjects

Answer 60

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.

Question 61

Well-being

Answer 61

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

Question 62

Certified Copy

Answer 62

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 63

Monitoring Plan

Answer 63

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

Question 64

Validation of Computerized Systems

Answer 64

A process of establishing and documenting that the specified requirements of a computerized system can be consistently full fixed 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.