Module 12 Presentations

Acronym List

Acronym

Meaning

Acronym

Meaning

Medical Device UDI

Medical Device Unique Device Identifier

ADaM

Analysis Data Model

ALCOA

Attributable, Legible, Contemporaneous, Original, Accurate Computer Assisted New Drug Application Clinical Data Acquisition Standards Harmonization Clinical Data Interchange Standards Consortium

NIH

National Institutes of Health

CANDA CDASH CDISC

OOS

Out of Specification

PQ/CMC

Pharmaceutical Quality/Chemistry Manufacturing and Control

cGMP CRF CRO DMP eCRF eCTD GDRP GLP GMP GXP ICSR IDMP FMD GCP

current Good Manufacturing Practice

RDE

Remote Data Entry

Case Report Form

SDTM

Study Data Tabulation Model

Contract Research Organisation

SEND

Standard for Exchange of Non-clinical Data

Data Management Plan

SPL

Structured Product Labeling

electronic Case Report Form

electronic Common Technical Document

SPOR Substance, Product, Organisations and Referentials US Dept of HHS US Department of Health and Human Services

Falsified Medicines Directive

Good Clinical Practice

Good Data and Record management Practice

Good Laboratory Practice Good Manufacturing Practice

Good Practice quality guidelines and regulations

Individual Case Safety Report Identification of Medicinal Products

The Organisation for Professionals in Regulatory Affairs