Tag Archives: applied trials

CDISC Clinical Research “A” Terminology

acronym: A word formed from the beginning letters (e.g., ANSI) or
a combination of syllables and letters (e.g., MedDRA) of a name or phrase.
admission criteria:Basis for selecting target population for a clinical trial.
Subjects must be screened to ensure that their characteristics match a list of admission criteria and that none of their characteristics match any single one of the exclusion criteria set up for the study.
algorithm: Step-by-step procedure
for solving a mathematical problem;
also used to describe step-by-step
procedures for making a series of
choices among alternative decisions to
reach a calculated result or decision.
amendment: A written description
of a change(s) to, or formal clarification
of, a protocol.
analysis dataset:An organized collection of data or
information with a common theme arranged in rows and columns and
represented as a single file; comparable to a database table.
analysis variables: Variables used
to test the statistical hypotheses
identified in the protocol and analysis
plan; variables to be analyzed.
approvable letter:An official communication from FDA to an
NDA/BLA sponsor that lists issues to be resolved before an approval can be issued.
[Modified from 21 CFR 314.3;Guidance to Industry and FDA Staff

arm: A planned sequence of elements,
typically equivalent to a treatment
group.

attribute (n): In data modeling,
refers to specific items of data that can
be collected for a class.
audit: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 accurately reported
according to the protocol, sponsor’s
standard operating procedures (SOPs),
good clinical practice (GCP), and the
applicable regulatory requirement(s).
[ICH E6 Glossary]
audit report: A written evaluation by
the auditor of the results of the audit.
[Modified from ICH E6 Glossary]
audit trail. A process that captures
details such as additions, deletions,
or alterations of information in an
electronic record without obliterating the original record. An audit trail
facilitates the reconstruction of the
history of such actions relating to the
electronic record.

Source:Applied Clinical Trials

Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical.

Clinical Trials Acronyms

ADaM – Analysis Data Model (a CDISC standard) ADR – Adverse drug reation
AE – Adverse Event CRA –Clinical Research Associate
ATC – Anatomic-Therapeutic Chemical Coding dictionary CDASH – Clinical Data Acquisition Standards Harmozation (a CDISC initiative)
CDISC – Clinical Interchange Standards Consortium CDM – Clinical Data Management
CDMS – Clinical Data Management system CF – Consent Form
CSR – Clinical Study Report CRB – Case Record book
CT – Clinical Trial CTA – Clinical Trial Agreement
CD – Common Technical Document CRB – Central Review Board
CRF – Case Report Form CRO – Contract Research Organization
CNS – Central Nervous System GMP – Good Manufacturing Practices
GRP – Good Review Practice GXP – Good Pharmaceutical Practice
eCTD – Electronic Common Technical Document EDC – Electronic Data Capture
EDI – Electronic Data Interchange IB – Investigator’s brochure
IC – Informed Consent IND – Investigational New Drug Application (FDA)
IVRS – Interactive voice response system MedDRA – Medical Dictionary for Regulatory Activities
OC – Oracle Clinical SDV – Source document (data) verification
QA – quality assurance QC – quality control
QL/QOL – Qualify of life R&D – Research and development
SAE – Serious Adverse Event SAS – Statistical Analysis System
WHO – World Health Organization  
   

Reference: Part of this post was taken from the Applied Clinical Trials website at actmagazine


Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical.