Page 35 - Terminology-Clinical-Research

defines its purpose. Note: For example, the Admission, A monitor’s duties may include but are not limited to
Discharge and Transfer (ADT) Message type is used to helping to plan and initiate a trial, assessing the conduct
transmit portions of a patient’s ADT data from one system of trials, and assisting in data analysis, interpretation, and
to another. In HL7, a three-character code contained within extrapolation. Monitors work with the clinical research
each message identifies its type. coordinator to check all data and documentation from the
trial.
Meta-analysis: Systematic methods that use statistical
techniques for combining results from similar studies to Monitoring (environmental assessment): 1. confirms
obtain a quantitative estimate of the overall effect of a predictions of potential environmental impact and
particular intervention or variable on a defined outcome. effectiveness of mitigation measures, and ensures that
This type of analysis is typically hypothesis generating. unforeseen and/or unacceptable impacts do not occur;
2. helps determine the validity and accuracy of the
Metabolism: The biochemical alteration of substances information presented in the environmental assessment
introduced into the body. screening; 3. depicts the effectiveness of proposed
mitigation techniques or site restoration and estimates
Metadata: Data that describe other data, particularly XML cumulative effects. Cumulative effects means the combined
tags characterizing attributes of values in clinical data
fields. effects, good or bad, of components of a development (or a
series of developments) and other activities occurring either
Micro-level data: See Participant-level data. simultaneously, sequentially, or in an interactive manner.
Monitoring measures may include: air quality testing,
Migration: The act of moving a system or software survey of species at risk, water quality testing, etc.
product (including data) from an old to new operational
environment in accordance with a software quality system. Monitoring committee: See Independent data-monitoring
committee.
Minimum residual disease (MRD): The presence of
residual malignant cells that remain in the patient during or Monitoring report: A written report from the monitor to
after treatment. It is a major cause of relapse in cancers like the sponsor after each site visit and/or other trial-related
leukemia. communication according to the sponsor’s SOPs.

Missing data: 1. Data not completed or corrupted in Monitoring visit: A visit to a study site to review the
reports and case report forms. 2. Particularly the data not progress of a clinical study and to ensure protocol
captured when a subject withdraws from a trial. Note: adherence, accuracy of data, safety of subjects, and
Reviewers are concerned about missing data (meaning 2) compliance with regulatory requirements and good clinical
since patients who are not improved or who believe they practice guidelines.
have experienced side effects may be particularly prone
to leave a trial, thus skewing the analysis of results if such Monitoring: The act of overseeing the progress of a
clinical trial and of ensuring that it is conducted, recorded,
analysis were to be done only on the subjects who had and reported in accordance with the protocol, standard
continued with the trial. Trial designs therefore specify operating procedures (SOPs), good clinical practice (GCP),
plans for how such missing data will be treated in analysis.
and the applicable regulatory requirement(s).
Mode: The most frequently occurring value in a data set.
Monoclonal antibody: An antibody produced by a single
Model: A formal structure for representing and analyzing a clone of cells. A monoclonal antibody is a single pure type
process such as a clinical trial or the information pertaining of antibody.
to a restricted context (e.g., clinical trial data).
MTA: Material Transfer Agreement.
Modem: From modulator/demodulator; a device Multicenter trial: Clinical trial conducted according to a
that converts digital data into analog data that can
be transmitted via telephone or cable lines used for single protocol but at more than one site, and, therefore,
carried out by more than one investigator. Synonym:
communications.
multicenter study.
Monitor: Person employed by the sponsor or CRO who is Multinational trial: A multinational research trial is a
responsible for determining that a trial is being conducted clinical trial conducted in more than one country at the
in accordance with the protocol and GCP guidance. Note:
same time.

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