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Glossary Terms
120 Day Safety Update or 4-Month Safety Update (4MSU)
Abbreviated CSR
Abbreviated New Drug Application (ANDA)
Active Pharmaceutical Ingredient (API)
Activities of Daily Living (ADL)
Adaptive design
Adaptive design clinical trial
Adaptive Operations
Addendum report (AR)
Advanced Therapy Medicinal Product (ATMP)
Adverse Drug Reaction (ADR)
Adverse Event (AE)
Adverse Event Reporting System (AERS)
Agency for Healthcare Research and Quality (AHRQ)
American Medical Writers Association (AMWA)
Annual Safety Report (ASR)
Anti-infectives
Arthritis
ArzneimittelMarktNeuOrdnungsGesetz (German Law for Reforming the Market for Pharmaceuticals) (AMNOG)
Association of the British Pharmaceutical Industry (ABPI)
Association of the British Pharmaceutical Industry Code of Practice (ABPI Code of Practice)
Authorisation of manufacturing and import
Basic Research
Behavioral health
Behavioural health
Benefit Risk (BR)
Biologic
Biological marker (Biomarker)
Biologics License Application (BLA)
Biologics User Fee Amendments Act (BsUFA)
Biosimilars
Biosimilars Biological Product (BBP)
Biotechnology (BioTech)
Blinding
Blockbuster
Blood products
Breakthrough Therapy Designation (BT)
Breakthrough Therapy Designation Request
Bremer Institut für Präventionsforschung und Sozialmedizin (BIPS)
British Medical Association (BMA)
British Medical Journal (BMJ)
Bundesinstitut fuer Arzneimittel und Medizinprodukte (The German Federal Institute for Drugs and Medical Devices) (BfArM)
Cardiology
Case Report Form (CRF)
Center for Biologics Evaluation and Research (CBER)
Center for Drug Evaluation and Research (CDER)
Centers for Disease Control and Prevention (CDC)
Central Alerting System (CAS)
Central Nervous System (CNS)
Centralised authorisation procedure
Centrally Authorised Product (CAP)
Chronic Obstructive Pulmonary Disease (COPD)
Clinical Data Interchange Standards Consortium (CDISC)
Clinical Data Interchange Standards Consortium’s Clinical Research Glossary version 9 (CDISC v 9.0)
Clinical Data Management (CDM)
Clinical Development Plan (CDP)
Clinical development programme
Clinical document
Clinical document preparation
Clinical documentation
Clinical documentation management
Clinical documentation provider
Clinical documentation requirements
Clinical dossier
Clinical outsourcing
Clinical outsourcing model
Clinical Overview (CO)
Clinical Pharmacology summary (ClinPharm summary)
Clinical Practice Research Datalink (CPRD)
Clinical Project Manager (CPM)
Clinical research and development
Clinical Research Associate (CRA)
Clinical study
Clinical Study Protocol (CSP)
Clinical Study Report (CSR)
Clinical study subject
Clinical trial
Clinical Trial Application (CTA)
Clinical trial application dossier
Clinical Trial Authorisation
Clinical Trial Facilitation Group (CTPG)
Clinical Trial Registry (CTR)
Clinical Trial Report
Clinical Trial Report (CTR)
Clinical trial subject
Clinical trial summary
Clinical Trials Coordination and Advisory Group (CTAG)
Co-ordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh)
Code of Conduct
Code of Federal Regulations (CFR)
Code of Federal Regulations Title 21 (CFR 21)
Committee for Advanced Therapies (CAT)
Committee for Advanced Therapies (CAT)
Committee for Medicinal Products for Human Use (CHMP)
Committee for Medicinal Products for Veterinary Use (CVMP)
Committee for Orphan Medicinal Products (COMP)
Common Technical Document (CTD)
Communications writing
Community authorisation procedure
Company Core Data Sheet (CCDS)
Company Core Safety Information (CCSI)
Comparative Effectiveness Research (CER)
Competent Authority (CA)
Computerised Patient Record (CPR)
Continuing Professional Development (CPD)
Contract or Clinical Research Organisation (CRO)
Contract Services Directory (CSD)
Cosmetic product
Cosmetic Product Safety Assessment
Cosmetic Product Safety Report (CPSR)
Council for International Organizations of Medical Sciences (CIOMS)
CSR Synopsis
Data Lock Point (DLP)
Data Safety Monitoring Board (DSMB)
Dear Doctor letter (DDL)
Decentralised procedure (DCP)
Dermatology
Detailed Description of Pharmacovigilance System (DDPS)
Development Core Safety Information (DCSI)
Development International Birth Day (DIBD)
Development Safety Update Reports (DSUR)
Direct Healthcare Professional Communication (DHPC)
Directive 2001/83/EC of the European Parliament and Council (2001/83/EC)
Discovery Research
Doctor leave piece
Document quality control
Document review
Document shell
Document submission
Drug
Drug approval
Drug development process
Drug efficacy
Drug Information Association (DIA)
Drug Master File (DMF)
Drug regulation
Drug safety
Drug Utilization Study (DUS)
E7 Study
Early termination of clinical trial
Efficacy
Eindhoven Cancer Registry (ECR)
electronic Case Report Form (eCRF)
electronic Common Technical Document (eCTD)
Electronic Data Capture (EDC)
Electronic Health Record (EHR)
Electronic Health Records for Clinical Research (EHR4CR)
Electronic Medical Record (EMR)
Electronic Patient Record (EPR)
electronic Patient Reported Outcome (ePRO)
End of clinical trial
Endocrinology
Endpoint
Epidemiology
Ethics Committee (EC)
EU Database
EU Portal
EudraCT
EudraLEX
European Birth Date (EBD)
European Clinical Trial Regulation (Reg. EU 536/2014)
European Council regulation 1223/2009 (EU Reg. 1223/2009)
European Council regulation 1235/2010 (EU Reg. 1235/2010)
European Council regulation 520/2012 (EU Reg. 520/2012)
European Council Regulation 726/2004 (EU Reg. 726/2004)
European Federation of Pharmaceutical Industries and Associations (EFPIA)
European Medical Writers Association (EMWA)
European Medicines Agency (EMA)
European Network for Health Technology Assessment Joint Action (EUnetHTA JA)
European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
European Paediatric Regulation (Reg. EC 1901/2006)
European Public Assessment Report (EPAR)
European Risk Management Strategy (ERMS)
European Technology Assessment Group (ETAG)
European Union directive 2010/84 (2010/84/EU)
European Union Drug Regulating Authorities Pharmacovigilance (EudraVigilance)
European Union Drug Regulatory Authorities (EUDRA)
European Union Reference Dates (EURD)
European-Risk Management Plan (EU-RMP)
EuroQol
EuroQol-5D (EQ-5D)
Evidence Review Group (ERG)
Evidence-Based Medicine (EBM)
Exclusion criteria
Experience in clinical documentation
Experienced medical writer
Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
Fatal Adverse Event (FAE)
FDA Adverse Events Reporting System (FAERS)
FDA approval
Finished Pharmaceutical Product (FPP)
First-in-man study
Food and Drug Administration (FDA)
Food and Drug Administration Amendments Act (FDAAA)
Food and Drug Administration Safety and Innovation Act (FDASIA)
Food, Drug and Cosmetic Act (FD&C Act)
Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V. (FSA)
Functional Service Provider model (FSP model)
Gemeinsamer Bundesausschuss (G-BA)
Gene therapy
General Practice Research Database (GPRD)
General Surgery (GS)
Generic drug
Generic Drug User Fee Amendments Act (GDUFA)
German Pharmacoepidemiological Research Database (GPRD)
Gesetzliche Krankenversicherung (GKV)
Global Health Observatory (GHO)
Good Clinical Practice (GCP)
Good Guidance Practice (GGP)
Good Pharmacovigilance Practice (GPvP)
Good Pharmacovigilance Practices (GVP)
Haematology
Haute Autorité de Santé (HAS)
Heads of Medicines Agencies (HMA)
Health Care Provider (HCP)
Health economics
Health Economics and Outcomes Research (HEOR)
Health Technology Assessment (HTA)
Health-related Quality Of Life (HrQOL)
Hematology
Human Cells, Tissues, and Cellular Tissue-Bassed Products (HCT/Ps)
ICH E2C (R2)
ICH E2E
ICH E2F
ICH E3
ICH M4
ICH-compliant
ICH-compliant documents
ICH-conversant
Immunogenicity Assessment report
Immunology
Inclusion criteria
Indication
Individual Case Safety Report (ICSR)
Informed Consent
Informed Consent Form (ICF)
Initiative Qualitaetsmedizin (IQM)
Innovation Task Force (ITF)
Innovator drug
Institut fuer Qualitaet und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Economic Efficiency in the Healthcare System) (IQWIG)
Institute for Clinical and Economic Review (ICER)
Institutional Review Board (IRB)
Integrated Analysis of Safety (IAS)
Integrated Development Plan (IDP)
Integrated Summary of Effectiveness (ISE)
Integrated Summary of Efficacy (ISE)
Integrated Summary of Safety (ISS)
Integrated Summary of Safety (ISS)
International Birth Date (IBD)
International Cooperation on Cosmetic Regulation (ICCR)
International Council for Harmonisation (ICH)
International Nonproprietary Name (INN)
International Society for Medical Publication Professionals (ISMPP)
Interventional Study (IS)
Investigational Medicinal Product (IMP)
Investigational Medicinal Product
Investigational Medicinal Product Dossier (IMPD)
Investigational New Drug (IND)
Investigator’s Brochure (IB)
Investigator-Initiated Trial (IIT)
Investigator-Sponsored Trial (IST)
Key Opinion Leader (KOL)
Large Simple Trial (LST)
Late phase
Lifecycle Management
Low intervention clinical trial
Manuscript
Marketing authorisation
Marketing Authorisation Application (MAA)
Marketing Authorisation Holder (MAH)
Masking
Medical communications writing
Medical Device User Fee Amendments Act (MDUFA)
Medical devices
Medical Devices Directive
Medical Dictionary for Regulatory Activities (MedDRA)
Medical editing
Medical Product Agency (MPA)
Medical website copy
Medical Writer (MW)
Medical Writing
Medical Writing consultancy
Medical Writing contractor
Medical Writing course
Medical Writing experience
Medical Writing expertise
Medical Writing job
Medical Writing services
Medical Writing skills
Medical Writing specialist
Medical Writing training
Medical Writing workshop
Medicinal Product
Medicine Evaluation Committee (MEDEV)
Medicines and Healthcare products Regulatory Agency (MHRA)
messenger RiboNucleic Acid (mRNA)
Metabolism
Ministry of Health, Labour and Welfare (MHLW)
Multiple Technology Appraisal (MTA)
Mutual Recognition Procedure (MRP)
National Agency for Medicines (NAM)
National authorisation procedures
National Cancer Research Network (NCRN)
National Competent Authority (NCA)
National Health Service (NHS)
National Institue for Biological Standards and Control (NIBSC)
National Institute for Health and Clinical Excellence (NICE)
National Institute for Health Research (NIHR)
Nationally Authorised Product (NAP)
Neurology
New Chemical Entity (NCE)
New Drug Application (NDA)
New Molecular Entity (NME)
Non-clinical study
Non-eCTD electronic submission (NeeS)
Non-Interventional Study (NIS)
Nutraceutical
Observational study
Office of New Drugs (OND)
Oncology
Online-Plattform für Akademisches Lehren und Lernen (OPAL)
Ophthalmology
Orphan disease
Orphan drug
Orphan medicinal product (OMP)
Outcomes research
Outsourced documentation
Outsourced medical writing
Over the counter (OTC)
Package Information Leaflet/ Patient Information Leaflet (PIL)
Paediatric Committee (EMA) (PDCO)
Paediatric Investigation Plan (PIP)
Paediatric Use Marketing Authorisation (PUMA)
Paediatrics
Patient “How to use” card (Patient "How to use" card)
Patient leave piece
Patient Question & Answer booklet (Patient Q&A booklet)
Patient Reported Outcome (PRO)
Patient Support Programme (PSP)
Pediatric Committee (EMA) (PDCO)
Pediatric Investigation Plan (PIP)
Pediatric Research Equity Act (PREA)
Pediatric Study Plan (PSP)
Pediatrics
Periodic Adverse Drug Experience Report (PADER)
Periodic Adverse Experience Report (PAER)
Periodic Benefit-Risk Evaluation Report (PBRER)
Periodic Safety Update Report (PSUR)
Personal Health Record (PHR)
Personalised Medicine
Pharmaceutical
Pharmaceutical and Food Safety Bureau (PFSB)
Pharmaceutical industry sales aid
Pharmacodynamics (PD)
Pharmacoeconomics
Pharmacogenetics
Pharmacogenomics (Pgx)
Pharmacokinetics (PK)
Pharmacology
Pharmacovigilance (PV)
Pharmacovigilance Risk Assessment Committee (PRAC)
Pharmacovigilance System Master File (PSMF)
PHARMO Institute for Drug Outcomes Research (PHARMO)
Phase 0 clinical trial
Phase I clinical trial (phase 1 clinical trial) (phase I clinical trial (phase 1 clinical trial))
Phase II clinical trial (phase 2 clinical trial) (phase II clinical trial (phase 2 clinical trial))
Phase IIa clinical trial (phase 2a clinical trial) (phase IIa clinical trial (phase 2a clinical trial))
Phase IIb clinical trial (phase 2b clinical trial) (phase IIb clinical trial (phase 2b clinical trial))
Phase III clinical trial (phase 3 clinical trial) (phase III clinical trial (phase 3 clinical trial))
Phase IV clinical trial (phase 4 clinical trial) (phase IV clinical trial (phase 4 clinical trial))
Placebo
Placebo effect
Post Approval Development Plan (PADP)
Post-Authorisation Efficacy Study (PAES)
Post-authorisation safety study (PASS)
Post-marketing study
Post-Marketing Surveillance (PMS)
Post-submission study
Poster
Postmarketing study commitments (PMCs)
Pre-Market Approval
Preclinical development
Preclinical study
Pregnancy Prevention Plan (PPP)
Pregnancy Prevention Programme (PPP)
Prescription Drug User Fee Amendments Act (PDUFA)
Prescription Medicines Code of Practice Authority (PMCPA)
Primary Immunodeficiency (PID)
Product Information (PI)
Product Information File (PIF)
Proofreading
Proposed Pediatric Study Request (PPSR)
Psychiatry
Pulmonary
Qualified Person for PharmacoVigilance (QPPV)
Quality of Life (QOL)
Quality System (QS)
Quality-Adjusted Life Year (QALY)
Randomized Controlled Trial (RCT)
Reference Safety Information (RSI)
Referral procedure
Registry of Patient Registries (RoPR)
Regulatory Authority (RA)
Regulatory documentation
Reimbursement dossier
Respiratory
Rheumatoid Arthritis (RA)
Rheumatology
Risk Evaluation and Mitigation Strategies (REMS)
Risk Management Plan (RMP)
RiskMAP
RMP Summary for lay readers
Safe Cosmetics Act of 2011
Safety
Sales force training materials
Scientific advice
Scientific Advice Working Party (SAWP)
Senior medical writer
Serious Adverse Event (SAE)
Side effect
Signal Detection (SD)
Signal of Disproportionate Reporting (SDR)
Single Technology Appraisal (STA)
Site Management Organisation (SMO)
Skeletal disease
Special Interest Area Community (SIAC)
Special Protocol Assessment (SPA)
Sponsor
Standard Operating Procedure (SOP)
Start of clinical trial
Statement of Work (SOW)
Statistical Analysis Plan (SAP)
Study protocol
Study report
Submission dossier
Substantial modification of a clinical trial
Summary Bridging Report (SBR)
Summary of Biopharmaceutics (BioPharm summary)
Summary of Clinical Efficacy (SCE)
Summary of Clinical Safety (SCS)
Summary of Product Characteristics (SmPC)
supplemental New Drug Application (sNDA)
Supplementary Protection Certificate (SPC)
Suspected unexpected serious adverse reaction (SUSAR)
Suspension of clinical trial
Synopsis
Tandvards-ich lakemedelsformansverket (TLV)
Target Product Profile (TPP)
Temporary halt of clinical trial
The UK Clinical Research Collaboration (UKCRC)
Therapeutic area
Therapeutic experience
Threshold of Toxicological Concern (TTC)
Time to Onset (TTO)
Tissue engineered product
Transactional outsourcing model
Translational research
Unexpected adverse drug reaction
United States Prescribing Information (USPI)
Urology
User Fee Amendment (UFA)
Vaccine
Vaccine Adverse Event Reporting System (VAERS)
World Health Organization (WHO)
