Page 6 - Terminology-Clinical-Research

several simultaneous measurements to form a derived governing grants and awards, as per the statement Meaning
assessment (e.g., BMI) or a result of statistical analysis. of Signatures on Application Forms outlined in the CIHR
Grants and Awards Guide.
ATC: Anatomic, therapeutic, chemical. International
system for classification of medicines maintained by World Awards: Direct salary support to individual research
Health Organisation. personnel or stipend support to individual research trainees.

Attributable: A quality by which records and data can be Award (pending): Projects that have been approved for
traced back to the subject to whom they pertain, as well as funding by CIHR however before funds can be released,
to those persons who have acted on the records. the Nominated Principal Applicant has to resolve issues
with their application. Pending awards have a status of
Attribute (n): In data modeling, refers to specific items of “Pending” on the funding decision announcement and the
data that can be collected for a class. Notice of Decision.

Attrition: The loss of participants during the course of a Award holder: See Holder (award).
study (also called patients loss to follow - up). Participants
that are lost during the study are often call dropouts.

Audit: A systematic and independent examination of
trial-related activities and documents to determine whether B
the evaluated trial-related activities were conducted and
the data were recorded, analyzed, and accurately reported
according to the protocol, sponsor’s standard operating
procedures (SOPs), good clinical practice (GCP), and the Back translation (natural language): The process of
applicable regulatory requirement(s). translating a document that was translated from one
language to another back to the original language. Used to
Audit certificate: Document that certifies that an audit ensure that consent forms, surveys, and other clinical trial
has taken place (at an investigative site, CRO, or clinical documents will be clear and accurate in the translated form.
research department of a pharmaceutical company).
Background material: Information pertinent to the
Audit report: A written evaluation by the auditor of the understanding of a protocol. Note: Examples include
results of the audit. investigator brochure, literature review, history, rationale,
or other documentation that places a study in context or
Audit trail: A process that captures details such as presents critical features.
additions, deletions, or alterations of information in an
electronic record without obliterating the original record. Balanced study: Trial in which a particular type of subject
An audit trail facilitates the reconstruction of the history of is equally represented in each study group.
such actions relating to the electronic record.
Bandwidth: An indicator of the throughput (speed) of
Authorization: The process of giving someone permission data flow on a transmission path; the width of the range
to do or have something. In multi-user computer systems, a of frequencies on which a transmission medium carries
system administrator defines for the system which users are electronic signals. All digital and analog signal channels
allowed access to the system and what privileges of use are have a bandwidth.
permitted.
Baseline assessment: Assessment of subjects as they enter
Authorized official: An individual who has the authority to a trial and before they receive any treatment.
bind the Institution or organization to the general conditions
governing grants and awards, as per the statement Meaning Baseline characteristics: Data collected at the beginning
of Signatures on Application Forms outlined in the CIHR of a clinical study for all participants and for each arm
Grants and Awards Guide. or comparison group. These data include demographics,
such as age and gender, and study specific measures (for
Authorized official (primary): An individual who has the example, systolic blood pressure, prior antidepressant
authority to: 1. Provide access to the Electronic Approval treatment). Note: Randomized, controlled trials aim to
Tool to other individuals at their institution (i.e., authorized compare groups of participants that differ only with respect
officials). 2. Bind the institution to the general conditions to the intervention (treatment). Although proper random

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