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Investigational New Drug (IND)
Paediatric Investigation Plan (PIP)
Pediatric Study Plan (PSP)
Responses to Authority Questions
Clinical Evaluation Report (CER)
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Postmarketing Studies
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120 Day Safety Update (4 Month Safety Update)
Development Safety Update Report (DSUR)
Periodic Adverse Drug Experience Report (PADER)
Periodic Safety Update Report (PSUR)
Periodic Benefit Risk Evaluation Report (PBRER)
Risk Evaluation and Mitigation Strategies (REMS)
Risk Management Plan (RMP)
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Menu
Services
Regulatory
Clinical Documentation
Briefing Book
Clinical Development Plan
Clinical Study Protocol (CSP)
Clinical Study Report (CSR)
Lay Summaries
Common Technical Document (CTD)
Informed Consent Form (ICF)
Investigator’s Brochure (IB)
Investigational Medicinal Product Dossier (IMPD)
Investigational New Drug (IND)
Paediatric Investigation Plan (PIP)
Pediatric Study Plan (PSP)
Responses to Authority Questions
Clinical Evaluation Report (CER)
Other Documents
Postmarketing
Postmarketing Studies
Pharmacovigilance
PV & Product Safety
120 Day Safety Update (4 Month Safety Update)
Development Safety Update Report (DSUR)
Periodic Adverse Drug Experience Report (PADER)
Periodic Safety Update Report (PSUR)
Periodic Benefit Risk Evaluation Report (PBRER)
Risk Evaluation and Mitigation Strategies (REMS)
Risk Management Plan (RMP)
Communications
Scientific Communications
Abstracts and Manuscripts
Posters and Slide Sets
Training
Training Overview
Training Portfolio
Foundation Skills Training Programme
Preparing Specific Clinical Documents
Strategic Communication Skills
Why Trilogy?
What is Medical Writing?
Why use Trilogy?
Outsourcing
Expertise
Therapeutic Areas
Development Areas
Trilogy Benefits
How We Work
Trilogy Style Guide & Tools
Document Review Process
Customer References
Trilogy Brand Brochure
TriloDocs
TriloDocs | The AI Tool
About Us
Our Story
Trilogy Management Board
FAQ
Resources
TriloTalk | Podcast
Publications
Medical Writing Special Editions
Special Edition: Medical Writing: The Backbone of Clinical Development
Special Edition: Medical Writing – A Bold New Path: The Future Awaits Us
Clinical Study Protocols: The Pillars of Clinical Development
Think Tanks
Glossary of Clinical Research Terms
News: Regulations & Standards
Careers
Come join us
Life at Trilogy
Contact
Glossary Terms
Skeletal disease
Abbreviation: Skeletal disease
A disease that affects bone.
Use our tool to look up the definition of terms in our glossary.
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)
Adaptive design clinical trial (Adaptive design clinical trial)
Adaptive Operations (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 (Anti-infectives)
Arthritis (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 (Basic Research)
Behavioral health (Behavioral health)
Behavioural health (Behavioural health)
Benefit Risk (BR)
Biologic ()
Biological marker (Biomarker)
Biologics License Application (BLA)
Biologics User Fee Amendments Act (BsUFA)
Biosimilars (Biosimilars)
Biosimilars Biological Product (BBP)
Biotechnology (BioTech)
Blinding (Blinding)
Blockbuster (Blockbuster)
Blood products (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 (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 (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 development programme)
Clinical document (Clinical document)
Clinical document preparation (Clinical document preparation)
Clinical documentation (Clinical documentation)
Clinical documentation management (Clinical documentation management)
Clinical documentation provider (Clinical documentation provider)
Clinical documentation requirements (Clinical documentation requirements)
Clinical dossier (Clinical dossier)
Clinical outsourcing (Clinical outsourcing)
Clinical outsourcing model (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 and development)
Clinical Research Associate (CRA)
Clinical study (Clinical study)
Clinical Study Protocol (CSP)
Clinical Study Report (CSR)
Clinical study subject (Clinical study subject)
Clinical trial (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 (CTR)
Clinical Trial Report ()
Clinical trial subject (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 (Communications writing)
Community authorisation procedure (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)
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 (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 (Discovery Research)
Doctor leave piece ()
Document quality control (Document quality control)
Document review (Document review)
Document shell (Document shell)
Document submission (Document submission)
Drug ()
Drug approval (Drug approval)
Drug development process (Drug development process)
Drug efficacy (Drug efficacy)
Drug Information Association (DIA)
Drug Master File (DMF)
Drug regulation (Drug regulation)
Drug safety (Drug safety)
Drug Utilization Study (DUS)
E7 Study ()
Early termination of clinical trial ()
Efficacy (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 (Endocrinology)
Endpoint (Endpoint)
Epidemiology ()
Ethics Committee (EC)
EU Database ()
EU Portal ()
EudraCT (EudraCT)
EudraLEX (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)
EuroQol-5D (EQ-5D)
Evidence Review Group (ERG)
Evidence-Based Medicine (EBM)
Exclusion criteria (Exclusion criteria)
Experience in clinical documentation (Experience in clinical documentation)
Experienced medical writer (Experienced medical writer)
Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
Fatal Adverse Event (FAE)
FDA Adverse Events Reporting System (FAERS)
FDA approval (FDA approval)
Finished Pharmaceutical Product (FPP)
First-in-man study (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 (Gene therapy)
General Practice Research Database (GPRD)
General Surgery (GS)
Generic drug (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 (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 (Hematology)
Human Cells, Tissues, and Cellular Tissue-Bassed Products (HCT/Ps)
ICH E2C (R2) (ICH E2C (R2))
ICH E2E (ICH E2E)
ICH E2F (ICH E2F)
ICH E3 (ICH E3)
ICH M4 (ICH M4)
ICH-compliant (ICH-compliant)
ICH-compliant documents (ICH-compliant documents)
ICH-conversant (ICH-conversant)
Immunogenicity Assessment report ()
Immunology (Immunology)
Inclusion criteria (Inclusion criteria)
Indication (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 (Lifecycle Management)
Low intervention clinical trial ()
Manuscript (Manuscript)
Marketing authorisation (Marketing authorisation)
Marketing Authorisation Application (MAA)
Marketing Authorisation Holder (MAH)
Masking (Masking)
Medical communications writing (Medical communications writing)
Medical Device User Fee Amendments Act (MDUFA)
Medical devices (Medical devices)
Medical Devices Directive (Medical Devices Directive)
Medical Dictionary for Regulatory Activities (MedDRA)
Medical editing (Medical editing)
Medical Product Agency (MPA)
Medical website copy (Medical website copy)
Medical Writer (MW)
Medical Writing (Medical Writing)
Medical Writing consultancy (Medical Writing consultancy)
Medical Writing contractor (Medical Writing contractor)
Medical Writing course (Medical Writing course)
Medical Writing experience (Medical Writing experience)
Medical Writing expertise (Medical Writing expertise)
Medical Writing job (Medical Writing job)
Medical Writing services (Medical Writing services)
Medical Writing skills (Medical Writing skills)
Medical Writing specialist (Medical Writing specialist)
Medical Writing training (Medical Writing training)
Medical Writing workshop (Medical Writing workshop)
Medicinal Product (Medicinal Product)
Medicine Evaluation Committee (MEDEV)
Medicines and Healthcare products Regulatory Agency (MHRA)
messenger RiboNucleic Acid (mRNA)
Metabolism (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 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 (Neurology)
New Chemical Entity (NCE)
New Drug Application (NDA)
New Molecular Entity (NME)
Non-clinical study (Non-clinical study)
Non-eCTD electronic submission (NeeS)
Non-Interventional Study (NIS)
Nutraceutical (Nutraceutical)
Observational study ()
Office of New Drugs (OND)
Oncology (Oncology)
Online-Plattform für Akademisches Lehren und Lernen (OPAL)
Ophthalmology (Ophthalmology)
Orphan disease (Orphan disease)
Orphan drug (Orphan drug)
Orphan medicinal product (OMP)
Outcomes research ()
Outsourced documentation (Outsourced documentation)
Outsourced medical writing (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 (Paediatrics)
Patient “How to use” card (Patient "How to use" card)
Patient leave piece (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 (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 (Personalised Medicine)
Pharmaceutical (Pharmaceutical)
Pharmaceutical and Food Safety Bureau (PFSB)
Pharmaceutical industry sales aid (Pharmaceutical industry sales aid)
Pharmacodynamics (PD)
Pharmacoeconomics (Pharmacoeconomics)
Pharmacogenetics ()
Pharmacogenomics (Pgx)
Pharmacokinetics (PK)
Pharmacology (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 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)
Placebo effect (Placebo effect)
Post Approval Development Plan (PADP)
Post-Authorisation Efficacy Study (PAES)
Post-authorisation safety study (PASS)
Post-marketing study (Post-marketing study)
Post-Marketing Surveillance (PMS)
Post-submission study (Post-submission study)
Poster (Poster)
Postmarketing study commitments (PMCs)
Pre-Market Approval ()
Preclinical development (Preclinical development)
Preclinical study (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 (Proofreading)
Proposed Pediatric Study Request (PPSR)
Psychiatry (Psychiatry)
Pulmonary (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 (Referral procedure)
Registry of Patient Registries (RoPR)
Regulatory Authority (RA)
Regulatory documentation (Regulatory documentation)
Reimbursement dossier ()
Respiratory (Respiratory)
Rheumatoid Arthritis (RA)
Rheumatology (Rheumatology)
Risk Evaluation and Mitigation Strategies (REMS)
Risk Management Plan (RMP)
RiskMAP (RiskMAP)
RMP Summary for lay readers ()
Safe Cosmetics Act of 2011 (Safe Cosmetics Act of 2011)
Safety (Safety)
Sales force training materials (Sales force training materials)
Scientific advice (Scientific advice)
Scientific Advice Working Party (SAWP)
Senior medical writer (Senior medical writer)
Serious Adverse Event (SAE)
Side effect (Side effect)
Signal Detection (SD)
Signal of Disproportionate Reporting (SDR)
Single Technology Appraisal (STA)
Site Management Organisation (SMO)
Skeletal disease (Skeletal disease)
Special Interest Area Community (SIAC)
Special Protocol Assessment (SPA)
Sponsor (Sponsor)
Standard Operating Procedure (SOP)
Start of clinical trial ()
Statement of Work (SOW)
Statistical Analysis Plan (SAP)
Study protocol (Study protocol)
Study report (Study report)
Submission dossier (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 (Synopsis)
Tandvards-ich lakemedelsformansverket (TLV)
Target Product Profile (TPP)
Temporary halt of clinical trial ()
The UK Clinical Research Collaboration (UKCRC)
Therapeutic area (Therapeutic area)
Therapeutic experience (Therapeutic experience)
Threshold of Toxicological Concern (TTC)
Time to Onset (TTO)
Tissue engineered product ()
Transactional outsourcing model (Transactional outsourcing model)
Translational research (Translational research)
Unexpected adverse drug reaction (Unexpected adverse drug reaction)
United States Prescribing Information (USPI)
Urology (Urology)
User Fee Amendment (UFA)
Vaccine (Vaccine)
Vaccine Adverse Event Reporting System (VAERS)
World Health Organization (WHO)