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25.36 — The Acronym Dictionary
This industry runs on abbreviations, and most of them are never explained to a newcomer because everyone assumes they were. Here they all are, grouped by where you will meet them, with the chapter that explains each one properly.
One habit before the lists. When an abbreviation appears that is not here, ask what it means at that company rather than guessing — coordinator titles, internal system names and departmental shorthand vary between organisations and even between sites, and a confident wrong guess is worse than a question.
The rulebooks
| Term | Meaning | Chapter |
|---|---|---|
| GxP | Any good practice rulebook | 25.1 |
| GLP | Good Laboratory Practice | 25.7 |
| GCP | Good Clinical Practice | 25.9 |
| GMP | Good Manufacturing Practice | 25.12 |
| GDP | Good Distribution Practice | 25.12 |
| GVP | Good Pharmacovigilance Practices | 25.22 |
| CFR | Code of Federal Regulations (US) | 25.13 |
| ICH | International Council for Harmonisation | 25.14 |
| PIC/S | Inspection co-operation scheme | 25.14 |
| ISO 13485 | Device quality system standard | 25.16 |
| ISO 14971 | Device risk management standard | 25.16 |
| IEC 62304 | Device software lifecycle standard | 25.16 |
| GAMP 5 | Validation good practice guide | 25.21 |
Regulators and their parts
| Term | Meaning | Chapter |
|---|---|---|
| FDA | US Food and Drug Administration | 25.13 |
| CDER | FDA drugs centre | 25.13 |
| CBER | FDA biologics centre | 25.13 |
| CDRH | FDA devices centre | 25.13 |
| OII | FDA inspections office, formerly ORA | 25.13 |
| EMA | European Medicines Agency | 25.14 |
| CHMP | EMA human medicines committee | 25.14 |
| MHRA | UK regulator | 25.14 |
| PMDA | Japanese regulator | 25.14 |
| NMPA | Chinese regulator | 25.14 |
| CDSCO | Indian regulator | 25.14 |
| DCGI | Head of the Indian regulator | 25.14 |
| CMS | US Medicare and Medicaid agency | 25.27 |
| OCR | US health privacy enforcement office | 25.33 |
| ASTP / ONC | US health IT policy office | 25.31 |
Development and trials
| Term | Meaning | Chapter |
|---|---|---|
| API | Active pharmaceutical ingredient | 25.3 |
| ADME | Absorption, distribution, metabolism, excretion | 25.6 |
| NOAEL | No-observed-adverse-effect level | 25.7 |
| IND | Investigational New Drug application | 25.7 |
| IB | Investigator's Brochure | 25.7 |
| CMC | Chemistry, manufacturing and controls | 25.7 |
| SEND | Nonclinical data exchange standard | 25.7 |
| CRO | Contract research organisation | 25.9 |
| CDMO | Contract development and manufacturing organisation | 25.3 |
| PI | Principal investigator | 25.9 |
| CRC | Clinical research coordinator | 25.9 |
| CRA | Clinical research associate, the monitor | 25.9 |
| IRB / EC | Ethics review body | 25.2 |
| ICF | Informed consent form | 25.9 |
| CRF / eCRF | Case report form | 25.9 |
| EDC | Electronic data capture | 25.9 |
| CTMS | Clinical trial management system | 25.9 |
| eTMF | Electronic trial master file | 25.9 |
| IRT / RTSM | Randomisation and supply system | 25.9 |
| eCOA / ePRO | Patient-entered outcome data | 25.9 |
| SDV | Source data verification | 25.9 |
| DSMB / DMC | Independent data monitoring board | 25.10 |
| SAP | Statistical analysis plan | 25.10 |
| ITT | Intention to treat analysis | 25.10 |
| CSR | Clinical study report | 25.10 |
| CDISC | Clinical data standards body | 25.10 |
| SDTM / ADaM | Collected and analysis dataset standards | 25.10 |
Manufacturing and supply
| Term | Meaning | Chapter |
|---|---|---|
| MES | Manufacturing execution system | 25.11 |
| LIMS | Laboratory information management system | 25.12 |
| ERP | Enterprise resource planning system | 25.12 |
| IQ / OQ / PQ | Installation, operational, performance qualification | 25.12 |
| OOS / OOT | Out of specification / out of trend | 25.17 |
| CPV | Continued process verification | 25.11 |
| PAT | Process analytical technology | 25.11 |
| DSCSA | US drug supply chain security law | 25.12 |
| EPCIS | Supply chain event data standard | 25.12 |
| UDI | Unique device identifier | 25.16 |
| FAR | Field Alert Report (US drugs) | 25.17 |
Regulatory submissions
| Term | Meaning | Chapter |
|---|---|---|
| NDA | New drug application | 25.3 |
| BLA | Biologics licence application | 25.3 |
| ANDA | Abbreviated application, generics | 25.15 |
| 510(k) | Device premarket notification | 25.16 |
| PMA | Device premarket approval | 25.16 |
| PCCP | Predetermined change control plan | 25.16 |
| CTD / eCTD | Common Technical Document | 25.14 |
| PDUFA | US user fee law; the agreed decision date | 25.13 |
| CRL | Complete response letter | 25.13 |
| REMS | Risk evaluation and mitigation strategy | 25.13 |
| RMP | Risk management plan (EU) | 25.22 |
| SPC / SmPC | EU product information documents | 25.24 |
| RIM | Regulatory information management | 25.24 |
| IDMP | Product identification data standards | 25.24 |
| CTIS | EU clinical trials portal | 25.14 |
| MDR | EU Medical Device Regulation | 25.16 |
| IVDR | EU In Vitro Diagnostic Regulation | 25.16 |
| QMSR | US device quality regulation | 25.16 |
Quality and compliance
| Term | Meaning | Chapter |
|---|---|---|
| QA / QC | Quality assurance / quality control | 25.12 |
| CAPA | Corrective and preventive action | 25.17 |
| NC | Nonconformance | 25.17 |
| SOP | Standard operating procedure | 25.12 |
| SME | Subject matter expert | 25.17 |
| RCA | Root cause analysis | 25.19 |
| FMEA | Failure mode and effects analysis | 25.19 |
| RPN | Risk priority number | 25.19 |
| APR / PQR | Annual product quality review | 25.12 |
| EIR | Establishment inspection report | 25.18 |
| NAI / VAI / OAI | Inspection outcome classifications | 25.18 |
| AIP | Application integrity policy | 25.18 |
| ALCOA+ | Data integrity principles | 25.20 |
| CSV | Computer system validation | 25.21 |
| CSA | Computer software assurance | 25.21 |
| URS / FS / DS | Requirement, functional, design specifications | 25.21 |
| RTM | Requirements traceability matrix | 25.21 |
| SaMD | Software as a medical device | 25.16 |
| SBOM | Software bill of materials | 25.16 |
Safety and medical
| Term | Meaning | Chapter |
|---|---|---|
| AE / ADR | Adverse event / adverse drug reaction | 25.22 |
| SAE | Serious adverse event | 25.22 |
| SUSAR | Suspected unexpected serious adverse reaction | 25.22 |
| ICSR | Individual case safety report | 25.22 |
| E2B | Safety case exchange standard | 25.22 |
| MedDRA | Medical terminology dictionary | 25.22 |
| PBRER / PSUR | Periodic benefit-risk report | 25.22 |
| PADER | US periodic safety report | 25.22 |
| DSUR | Development safety update report | 25.22 |
| PSMF | Pharmacovigilance system master file | 25.22 |
| QPPV | EU qualified person for pharmacovigilance | 25.22 |
| FAERS | FDA adverse event database | 25.22 |
| MSL | Medical science liaison | 25.23 |
| KOL | Key opinion leader | 25.23 |
| HEOR | Health economics and outcomes research | 25.23 |
| IIS | Investigator-initiated study | 25.23 |
US healthcare, payment and coding
| Term | Meaning | Chapter |
|---|---|---|
| PBM | Pharmacy benefit manager | 25.27 |
| HMO / PPO / EPO / POS | Managed care plan types | 25.27 |
| MA | Medicare Advantage | 25.27 |
| CHIP | Children's Health Insurance Program | 25.30 |
| FPL | Federal poverty level | 25.30 |
| MCO | Managed care organisation | 25.30 |
| MLTSS | Managed long-term services and supports | 25.30 |
| RCM | Revenue cycle management | 25.28 |
| ICD-10-CM / PCS | Diagnosis and inpatient procedure codes | 25.28 |
| CPT | Procedure and service codes | 25.28 |
| HCPCS | Supplies, drugs and services codes | 25.28 |
| E&M | Evaluation and management coding | 25.28 |
| NDC | National drug code | 25.28 |
| DRG / MS-DRG | Inpatient payment grouping | 25.28 |
| RVU | Relative value unit | 25.28 |
| 837 / 835 | Claim and remittance transactions | 25.28 |
| 270 / 271 | Eligibility enquiry and response | 25.28 |
| 278 | Prior authorisation transaction | 25.28 |
| PA | Prior authorisation | 25.28 |
| CARC / RARC | Claim adjustment and remark codes | 25.28 |
| AR | Accounts receivable | 25.28 |
| HEDIS | Health plan quality measure set | 25.29 |
| CAHPS | Patient experience surveys | 25.29 |
| ACO | Accountable care organisation | 25.29 |
| HCC / RAF | Risk adjustment categories and score | 25.29 |
| FWA | Fraud, waste and abuse | 25.29 |
| FCA | False Claims Act | 25.29 |
| AKS | Anti-Kickback Statute | 25.29 |
Health data
| Term | Meaning | Chapter |
|---|---|---|
| EHR / EMR | Electronic health record | 25.31 |
| HL7 | Health data standards body and its v2 messages | 25.31 |
| CDA / C-CDA | Clinical document standard | 25.31 |
| FHIR | Modern health data API standard | 25.31 |
| US Core | US profile of FHIR | 25.31 |
| SMART on FHIR | App launch and authorisation standard | 25.31 |
| USCDI | Required interoperable data elements | 25.31 |
| SNOMED CT | Clinical terminology | 25.31 |
| LOINC | Laboratory and measurement codes | 25.31 |
| RxNorm | Normalised medication naming | 25.31 |
| MPI | Master patient index | 25.31 |
| HIE | Health information exchange | 25.32 |
| TEFCA | US national exchange framework | 25.32 |
| QHIN | Designated national exchange network | 25.32 |
| RCE | Recognized Coordinating Entity | 25.32 |
| HIPAA | US health privacy and security law | 25.33 |
| PHI / ePHI | Protected health information | 25.33 |
| BAA | Business associate agreement | 25.33 |
| GDPR | EU data protection regulation | 25.14 |
The ones people mix up
Five pairs cause most of the confusion in this Part, and getting them right is a quick way to sound like somebody who has done this before.
Severity and seriousness. Severity is how intense a side effect is; seriousness is a legal category with reporting deadlines. A severe headache is not serious; a mild event causing hospital admission is.
A Form 483 and a warning letter. A 483 lists an investigator's observations at the end of an inspection. A warning letter is a formal agency determination, published, and a much more serious event.
Deviation and nonconformance. A deviation is a departure from a process; a nonconformance is a product or result failing its requirement.
Rejection and denial in claims. A rejection is a format failure that never reached the payer; a denial is a payment decision the payer made.
And validation and verification. Verification asks whether you built it to the specification. Validation asks whether it does what it is intended to do in real use. They are used loosely in conversation and precisely in documents, and the documents are what get inspected.
That is the whole Part. You now have the map of the industry, the path a medicine takes from a suspected cause to a patient, the regulators and their rules, the quality and data machinery that most of your work will touch, the money and the systems on the American healthcare side, and the vocabulary to follow any conversation in the room.