List of abbreviations

AMWA: American Medical Writers Association

CEP: clinical evaluation plan

CER: clinical evaluation report

CIP: clinical investigation plan

CONSORT: Consolidated Standards of Reporting Trials

CRF: case report forms

CRO: clinical research organization

CSR: clinical study reports

DSUR: development safety update reports

CV: curriculum vitae

EASE: European Association of Science Editors

EBM: evidence-based medicine

eCRF: electronic case report forms

EMA: European Medicines Agency

EMWA: European Medical Writers Association

EU: European Union

FDA: Food and Drug Administration

GCP: good clinical practice

GDPR: General Data Protection Regulation

GPP3: Good Publication Practice for Communicating Company-Sponsored Medical Research

IB: investigator brochures

ICF: informed consent forms

ICH: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

ICH E3: Guideline for Industry: Structure and Content of Clinical Study Reports

ICH E6: Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance

ICMJE: International Committee of Medical Journal Editors

IF: impact factor

IMPD: investigational medicinal product dossiers

IMRAD: Introduction, Methods, Results, and Discussion

ISMPP: International Society for Medical Publication Professionals

ISO: International Organization for Standardization

ISPOR: International Society for Pharmacoeconomics and Outcomes Research

MDR: Medical Device Regulation

PASS: post-authorisation safety studies

PMS: post-marketing studies

PMW: Proper Medical Writing

PRO: patient-reported outcome

PSUR: periodic safety update reports

QMS: quality management system

QoL: quality of life

SAP: statistical analysis plan

SOP: standard operating procedure

STROBE: Strengthening the Reporting of Observational Studies in Epidemiology

UK: United Kingdom

URPL: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych I Produktów Biobójczych in Poland)