Skip to main content
Quick reference for abbreviations and terms used across the playbook. Listed alphabetically.
TermDefinition
ABPIAssociation of the British Pharmaceutical Industry. UK pharmaceutical industry body whose Code of Practice governs promotional materials.
AEAdverse event. Any undesirable medical occurrence in a patient during a clinical trial, whether or not it is related to the treatment.
CIConfidence interval. A range of values within which the true treatment effect is expected to fall (e.g., 95% CI: 0.52–0.84).
CSRClinical study report. The comprehensive report of a clinical trial, including methods, results, and analysis. Primary source document for many medical writing deliverables.
EU CTREU Clinical Trials Regulation. Requires sponsors to publish lay-friendly summaries of trial results.
Fair balanceRegulatory requirement that promotional materials present both benefits and risks of a treatment in a balanced manner.
HCPHealthcare professional. Includes physicians, nurses, pharmacists, and other qualified practitioners.
HRHazard ratio. A measure of relative risk over time, commonly used in survival analysis (e.g., HR 0.67 means 33% risk reduction).
IFPMAInternational Federation of Pharmaceutical Manufacturers & Associations. Global industry body with a Code of Practice for marketing.
IMRADIntroduction, Methods, Results, and Discussion. Standard structure for scientific manuscripts.
ITTIntention-to-treat. Analysis that includes all randomised participants regardless of whether they completed the study. The primary analysis in most RCTs.
KOLKey opinion leader. A recognised expert in a therapeutic area, often engaged for advisory boards and speaker programmes.
mITTModified intention-to-treat. A variation of ITT that excludes certain participants (e.g., those who never received treatment). Definition varies by study.
MLRMedical, Legal, Regulatory review. The formal review process for promotional and medical content before external use.
NMANetwork meta-analysis. A statistical method for comparing multiple treatments indirectly through a network of studies.
OCROptical character recognition. Converts scanned document images to searchable text. Poor OCR quality can cause errors in automated reference checking.
OROdds ratio. A measure of association between an exposure and an outcome (e.g., OR 1.5 means 50% higher odds).
PIPrescribing information. The approved product labelling. See also SmPC (EU) and USPI (US).
PLSPlain language summary. A lay-friendly summary of clinical trial results, increasingly required by regulation.
PPPer-protocol. Analysis that includes only participants who completed the study as planned, without major protocol deviations.
QCQuality control. The review and verification process applied to deliverables before submission or publication.
RCTRandomised controlled trial. A study design where participants are randomly assigned to treatment or control groups.
SAESerious adverse event. An AE that results in death, hospitalisation, disability, or is otherwise medically significant.
SLRSystematic literature review. A structured, reproducible search and analysis of published evidence, following a predefined protocol.
SmPCSummary of Product Characteristics. The EU equivalent of prescribing information. Approved by the EMA or national authority.
SOPStandard operating procedure. Documented internal processes that define how work is conducted within an organisation.
USPIUnited States Prescribing Information. The FDA-approved product labelling.