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.

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