Page 28 - Terminology-Clinical-Research

IEC Opinion of amendment: Independent Ethics scientific professionals and non-scientific members, whose
Committee opinion. responsibility it is to ensure the protection of the rights,
safety, and wellbeing of human subjects involved in a
IM: Intra-muscular. trial and to provide public assurance of that protection by,
among other things, reviewing and approving/providing
Immediate family member: The recipient’s spouse
(including same-sex spouse), parent, step-parent, foster favorable opinion on the trial protocol, the suitability of the
parent, child, step-child, foster child, or sibling. investigator(s), facilities, and the methods and material to
be used in obtaining and documenting informed consent
Immunoglobulin: A protein produced by plasma cells and of the trial subjects. Note: The legal status, composition,
lymphocytes and characteristic of these types of cells. They function, operations, and regulatory requirements
attach to foreign substances, such as bacteria, and assist in pertaining to independent ethics committees may differ
destroying them. among countries but should allow the independent ethics
committee to act in agreement with GCP as described in the
Immunological medicinal product: Any medicinal ICH guideline.
product consisting of vaccines, toxins, serums or allergen
products used to produce an immunological response. Independent researcher: See Researcher (independent).

IMP (Investigational Medicinal Product): A Indication: A health problem or disease that is identified as
pharmaceutical form of an active substance or placebo likely to be benefited by a therapy being studied in clinical
being tested or used as a reference in a clinical trial, trials. Note: Where such a benefit has been established and
including products already with a marketing authorization approved by regulatory authorities, the therapy is said to be
but used or assembled in a different way from the approved for such an indication.
authorized form, or when used for an unauthorized
indication, or when used to gain further information about Informed consent document: A document that describes
the authorized form. the rights of the study participants, and includes details
about the study, such as its purpose, duration, required
Impartial witness: A person who is independent of the procedures, and key contacts. Risks and potential benefits
trial, who cannot be unfairly influenced by people involved are explained in the informed consent document. The
with the trial, who attends the informed consent process if participant will be asked to sign this document if they agree
the subject or the subject’s legally acceptable representative to participate in the trial. The informed consent document is
cannot read, and who reads the informed consent form and not a contract. Participation in the clinical trial is voluntary
any other written information supplied to the subject. and the participant may withdraw from the trial at any
time without penalty or loss of benefits to which he/she is
In the whole clinical trial: Details of the planned number otherwise entitled.
of subjects in the entire world to be included.
Informed consent: A process used by researchers to
Inclusion criteria: The factors, or reasons, that allow a communicate with potential and enrolled participants about
person to participate in a clinical study. a clinical study. As part of the informed consent process,
researchers: 1. Make sure that potential participants
Note: Exclusion and inclusion criteria define the study understand the risks and potential benefits of participating
population. in the study and the alternatives to the research being
conducted; 2. Provide all the important information about
IND: See Investigational New Drug and Treatment the study, so potential participants can decide whether to
Investigational New Drug.
enroll or, if they are already enrolled, whether to continue
Independent data monitoring committee (IDMC): A to participate; and 3. Stress that enrolling in, and staying
committee established by the sponsor to assess at intervals in, a clinical study is completely voluntary. Because
the progress of a clinical trial, safety data, and critical giving consent to participate in research is not a contract,
efficacy variables and recommend to the sponsor whether participants may leave a study at any time. Note: The goal
to continue, modify, or terminate the trial. of the informed consent process is to protect participants.
It begins when a potential participant first asks for
Independent ethics committee (IEC): An independent information about a study and continues throughout the
body (a review board or a committee, institutional, study until the study ends. The researcher and potential
regional, national, or supranational) constituted of medical/ participant have discussions that include answering the

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