This document defines key terms related to clinical research and drug development: - It describes terms such as investigational product, protocol, informed consent, inclusion/exclusion criteria, adverse events, randomization, blinding, case report forms, data monitoring committees, good clinical practice guidelines, investigators, monitors, and institutional review boards. - It provides concise definitions of these important concepts to clarify roles and procedures in clinical trials and medical research involving human subjects.

1. - PRIYANKA KAMDAR

2. Systematic study of drug/device in human
subjects
Investigation in human subjects intended to
discover clinical/pharmacodynamic effects of
IP
To identify adverse reactions to IP
To study absorption, distribution, metabolism
and excretion of IP with the objective to
ascertain its safety and efficacy

3. International ethical and scientific quality
standard for designing, conducting,
monitoring, recording, reporting, auditing
clinical studies
Ensures that data reported is credible and
accurate, and that subject’s rights and
confidentiality are protected

4. A detailed plan that sets forth the objectives, study
design, and methodology for a clinical trial
A study protocol must be approved by an IRB
before investigational drugs may be administered
to humans
Protocol Amendment : Changes or clarifications
made in writing to the original protocol

5. Compilation of clinical and nonclinical data
on the investigational product relevant to
study of IP in human subjects

6. Process by which subject voluntarily confirms
his or her willingness to participate
Precedes enrollment
Documented by means of written, signed and
dated consent form

7. Inclusion: Criteria that prospective subjects
must meet to be eligible for participation in
study
Exclusion: list of criteria which excludes
potential subject from participation in study

8. An independent body constituted of
medical/scientific and non-scientific
members
To ensure protection of rights, safety and
well-being of human subjects in a trial
Provide protection by reviewing and
approving/providing favourable opinion on
the protocol
Checks the suitability of investigators,
facilities, methods to be used in obtaining
and documenting informed consent

9. Composition, functions, operations
pertaining to IEC may differ among countries
But should allow the IEC to act in agreement
with GCP

10. Individual who is a participant in research
May be either a healthy human or patient
Should have signed the informed consent
document prior to his participation in a study

11. Untoward medical occurrence in patient
administered pharmaceutical product
Does not necessarily have causal relationship
with the treatment
Can be any unintended sign
When an AE has been determined to be
related to the investigational product, it is
considered an Adverse Drug Reaction

12. Baseline assessment: assessment of subjects
as they enter a trial and before they receive
any treatment
Randomisation: process of assigning trial
subjects to treatment/control groups using
element of chance

13. A study in which all parties, (patient,
physician and study coordinator) are
informed of the drug and dose being
administered. In an open-label study, none of
the participants are given placebos

14. Study in which neither the subject nor
investigator nor research team know what
treatment subject is receiving
The expectations of the doctor/participant
about the experimental drug do not affect the
outcome
"Blinded" studies are conducted to prevent
the unintentional biases that can affect
subject data when treatment assignments are
known

15. The process through which one or more
parties to a clinical trial are unaware of the
treatment assignments
In a single-blinded study, usually the subjects
are unaware of the treatment assignments
In a double-blinded study, both the subjects
and the investigators are unaware of the
treatment assignments.

16. Printed, electronic document designed to
record protocol-required information to be
reported to sponsor
Record of clinical study observations that a
protocol designates must be completed

17. CRA:Person employed by sponsor/CRO who
monitors progress of investigator sites
CRC: person who handles most of
administrative responsibilities of trial
Acts as a liasion between the site and
sponsor
Reviews all data and records before monitor’s
visit

18. Written description of trial/study conducted
in human subjects in which clinical/statistical
description, analysis are integrated into
single report

19. In which the investigative drug is compared
against another product (active drug/placebo)
A comparator is an investigational/marketed
product or placebo used as a reference

20. Organisation contracted by sponsor to
perform one or more of sponsor’s trial-
related duties and functions

21. Researchers who periodically review data
from clinical studies
An independent committee composed of
clinical research experts
It reviews data while a clinical trial is in
progress to ensure that participants are not
exposed to undue risk
A DSMB may recommend that a trial be
stopped if there are safety concerns or if the
trial objectives have been achieved

22. Set of recommendations/basic principles that
guide medical doctors in conduct of research
involving human subjects
Published first in 1964 sought to address
ethical aspects of clinical research
Has made informed consent a central
requirement for ethical research

23. Research in vulnerable groups should be
conducted only if necessary to promote the
health of that population
Benefits, risks, effectiveness of new method
should be tested against best current
methods

24. Electronic record designed to record
information required by the protocol to be
reported to sponsor on each trial subject

25. Person who is independent of the trial who
attends the informed consent process if
subject or his LAR cannot read
Impartial witness reads the informed consent
form and any other written information
supplied to the subject

26. Individual or other body authorised to
consent on behalf of prospective subject
about the subject’s participation in clinical
trial

27. Active ingredient or placebo being
tested/used in clinical trial
Includes a product with marketing
authorisation when used for unapproved
condition, or when used to gain further
information about an approved use

28. A planned analysis intended to compare
treatment arms with regards to safety and
efficacy at any time prior to completion of
trial
Determined as part of the study protocol

29. Person responsible for conduct of clinical trial
at the site
Investigator is the responsible leader of the
team

30. Act of overseeing progress of a clinical trial
Ensuring it is conducted, recorded and
reported in accordance with protocol, SOP,
GCP
A written report submitted to the sponsor by
the monitor after each site visit is called
monitoring report

31. Term used for adverse event monitoring and
reporting
The science and activities relating to
detection, assessment, understanding and
prevention of adverse effects or any other
drug related problems

32. A new drug, antibiotic drug, or biological
drug that is used in a clinical investigation
IND application is a petition through which a
drug sponsor requests the regulatory
authority to allow human testing of its new
drug product

33. The compilation of all non-clinical, clinical,
pharmacological, pharmacokinetic and
stability information required about a drug by
the regulatory authority in order to approve
the drug for marketing

34. The standard against which experimental
observations are compared and evaluated
In many clinical trials, one group of patients
will be given an experimental drug or
treatment, while the control group is given
either a standard treatment for the illness or
a placebo

35. Before a drug may be tested on humans, pre-
clinical studies must be conducted on
animals to determine that the drug is safe

36. Study participants are usually assigned to
groups in such a way that each participant
has an equal chance of being assigned to
each treatment (or control) group

37. Official, detailed, written instructions for the
management of clinical trials. SOPs ensure
that all the functions and activities of a
clinical trial are carried out in a consistent
and efficient manner

38. Group/individual that cannot give informed
consent because of limited autonomy (e.g.,
children, mentally ill and prisoners)
Also refers to subjects who may be unduly
influenced to participate (e.g., students,
subordinates and patients)

39. Study supplies (i.e., study test article,
laboratory supplies, case report forms)
provided by the study sponsor to the
investigator

40. Study of processes of bodily absorption,
distribution, metabolism and excretion of
compounds and medicines

41. Ongoing safety monitoring of marketed drugs
Phase 4 studies

42. Treatment currently in wide use and approved
by FDA or other health authority, considered
to be effective in treatment of specific disease
or condition

43. Plan for precise procedure to be followed in
clinical trial
Includes planned and actual timing of events,
method of allocating treatments

44. Systematic and independent examination of
trial-related activities and documents
Determines if trial was conducted and data
recorded, analysed and accurately reported
acc. to protocol, GCP etc.
Audit report is written evaluation by the
sponsor’s auditor of the results of audit