Health TechHealth Tech GlossaryPart 8 of 10
Pharma and Clinical Trials Glossary
26 terms from the Health Tech book's Pharma and Clinical Trials part, each defined in a line and linked to the chapter that explains it.
- ADaM (Analysis Data Model): the CDISC standard for analysis datasets derived from SDTM, anchored by the subject-level ADSL (Trial Systems & 21 CFR Part 11).
- AEMS (FDA Adverse Event Monitoring System): FDA's adverse event database, formerly FAERS, with a public dashboard and quarterly data files (Pharmacovigilance & Regulatory Submissions).
- Applicable clinical trial: a trial that must be registered on ClinicalTrials.gov and report results under FDAAA 801 and 42 CFR Part 11 (Clinical Trials).
- CDASH: the CDISC standard for collecting trial data on case report forms, traceable to SDTM (Trial Systems & 21 CFR Part 11).
- Copay card: manufacturer-funded assistance paying a commercially insured patient's cost-share, excluded for federal program beneficiaries under the Anti-Kickback Statute (Pharma Commercial & Patient Support).
- CRO (contract research organization): a company a sponsor hires to run trial obligations, subject to the same FDA actions for obligations transferred in writing (Clinical Trials).
- CTMS (clinical trial management system): the system for study and site milestones, enrollment, monitoring and site payments (Trial Systems & 21 CFR Part 11).
- Day zero: the first receipt by anyone in a company or its agents of a valid adverse event report, which starts every reporting clock (Pharmacovigilance & Regulatory Submissions).
- Decentralized elements: trial activities performed remotely through telehealth, home visits and local providers, under FDA's September 2024 guidance (Clinical Trials).
- E2B(R3): the ICH message standard for individual case safety reports, required for FDA postmarketing reports from October 1, 2026 (Pharmacovigilance & Regulatory Submissions).
- eCTD (electronic common technical document): the dossier format for regulatory submissions, sent as lifecycle sequences; FDA accepts v3.2.2 and v4.0 (Pharmacovigilance & Regulatory Submissions).
- EDC (electronic data capture): the system where sites enter trial data into electronic case report forms, with audit trails and investigator signatures (Trial Systems & 21 CFR Part 11).
- eTMF (electronic trial master file): the repository of a trial's essential documents, organized by the TMF Reference Model (Trial Systems & 21 CFR Part 11).
- Form FDA 1572: the investigator statement a sponsor must obtain before an investigator participates, with the investigator's commitments, facilities and IRB (Clinical Trials).
- Hub services: manufacturer-funded support taking a specialty prescription to first fill: benefits investigation, prior authorization help, assistance enrollment and pharmacy referral (Pharma Commercial & Patient Support).
- ICSR (individual case safety report): one adverse event case as reported to a regulator, versioned with each follow-up (Pharmacovigilance & Regulatory Submissions).
- IND (investigational new drug application): the FDA filing that allows an unapproved drug to be tested in people, in effect 30 days after receipt unless on clinical hold (Clinical Trials).
- IRB (institutional review board): the committee of at least five members that approves and oversees research and its consent forms (Clinical Trials).
- Open Payments: CMS's public database of manufacturer payments and transfers of value to physicians, certain other practitioners and teaching hospitals, under the Sunshine Act (Pharma Commercial & Patient Support).
- Part 11: 21 CFR Part 11, FDA's rule on electronic records and signatures: validation, audit trails, access and signature controls (Trial Systems & 21 CFR Part 11).
- PDMA (Prescription Drug Marketing Act): the law behind FDA's sample rules: written requests, receipts, annual inventory, loss reporting and lot tracking (Pharma Commercial & Patient Support).
- REMS (Risk Evaluation and Mitigation Strategy): an FDA-required drug safety program that can require certified prescribers and pharmacies, safe-use evidence, monitoring or a registry (Pharmacovigilance & Regulatory Submissions).
- RTSM (randomization and trial supply management): the system that randomizes subjects to blinded arms and manages drug supply; also called IRT (Trial Systems & 21 CFR Part 11).
- SDTM (Study Data Tabulation Model): the CDISC standard for organizing trial data in domains for submission, required by FDA and PMDA (Trial Systems & 21 CFR Part 11).
- Sponsor: the company, institution or agency that takes responsibility for a trial and files the IND (Clinical Trials).
- Validation: documented evidence that a regulated system does what it is intended to do, now done risk-based under GAMP 5 and computer software assurance (Trial Systems & 21 CFR Part 11).