# 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](https://www.syntaqx.com/books/health-tech/trial-systems-and-part-11#data-standards-cdash-sdtm-adam-and-define-xml)).
- **AEMS (FDA Adverse Event Monitoring System):** FDA's adverse event database, formerly FAERS, with a public dashboard and quarterly data files ([Pharmacovigilance & Regulatory Submissions](https://www.syntaqx.com/books/health-tech/pharmacovigilance-and-regulatory#e2b-r3-and-fda-s-adverse-event-system)).
- **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](https://www.syntaqx.com/books/health-tech/clinical-trials#clinicaltrials-gov)).
- **CDASH:** the CDISC standard for collecting trial data on case report forms, traceable to SDTM ([Trial Systems & 21 CFR Part 11](https://www.syntaqx.com/books/health-tech/trial-systems-and-part-11#data-standards-cdash-sdtm-adam-and-define-xml)).
- **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](https://www.syntaqx.com/books/health-tech/pharma-commercial#copay-cards-patient-assistance-and-the-anti-kickback-statute)).
- **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](https://www.syntaqx.com/books/health-tech/clinical-trials#sponsors-cros-sites-and-investigators)).
- **CTMS (clinical trial management system):** the system for study and site milestones, enrollment, monitoring and site payments ([Trial Systems & 21 CFR Part 11](https://www.syntaqx.com/books/health-tech/trial-systems-and-part-11#the-systems)).
- **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](https://www.syntaqx.com/books/health-tech/pharmacovigilance-and-regulatory#safety-reporting-clocks)).
- **Decentralized elements:** trial activities performed remotely through telehealth, home visits and local providers, under FDA's September 2024 guidance ([Clinical Trials](https://www.syntaqx.com/books/health-tech/clinical-trials#econsent-and-decentralized-elements)).
- **E2B(R3):** the ICH message standard for individual case safety reports, required for FDA postmarketing reports from October 1, 2026 ([Pharmacovigilance & Regulatory Submissions](https://www.syntaqx.com/books/health-tech/pharmacovigilance-and-regulatory#e2b-r3-and-fda-s-adverse-event-system)).
- **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](https://www.syntaqx.com/books/health-tech/pharmacovigilance-and-regulatory#ectd-submissions-and-esg-nextgen)).
- **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](https://www.syntaqx.com/books/health-tech/trial-systems-and-part-11#the-systems)).
- **eTMF (electronic trial master file):** the repository of a trial's essential documents, organized by the TMF Standard Model (formerly the TMF Reference Model) ([Trial Systems & 21 CFR Part 11](https://www.syntaqx.com/books/health-tech/trial-systems-and-part-11#the-systems)).
- **Form FDA 1572:** the investigator statement a sponsor must obtain before an investigator participates, with the investigator's commitments, facilities and IRB ([Clinical Trials](https://www.syntaqx.com/books/health-tech/clinical-trials#sponsors-cros-sites-and-investigators)).
- **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](https://www.syntaqx.com/books/health-tech/pharma-commercial#hub-services-and-patient-support)).
- **ICSR (individual case safety report):** one adverse event case as reported to a regulator, versioned with each follow-up ([Pharmacovigilance & Regulatory Submissions](https://www.syntaqx.com/books/health-tech/pharmacovigilance-and-regulatory#inside-a-safety-database)).
- **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](https://www.syntaqx.com/books/health-tech/clinical-trials#phases-and-the-ind)).
- **IRB (institutional review board):** the committee of at least five members that approves and oversees research and its consent forms ([Clinical Trials](https://www.syntaqx.com/books/health-tech/clinical-trials#sponsors-cros-sites-and-investigators)).
- **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](https://www.syntaqx.com/books/health-tech/pharma-commercial#open-payments)).
- **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](https://www.syntaqx.com/books/health-tech/trial-systems-and-part-11#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](https://www.syntaqx.com/books/health-tech/pharma-commercial#samples-under-the-pdma)).
- **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](https://www.syntaqx.com/books/health-tech/pharmacovigilance-and-regulatory#rems-labeling-and-product-identifiers)).
- **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](https://www.syntaqx.com/books/health-tech/trial-systems-and-part-11#the-systems)).
- **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](https://www.syntaqx.com/books/health-tech/trial-systems-and-part-11#data-standards-cdash-sdtm-adam-and-define-xml)).
- **Sponsor:** the company, institution or agency that takes responsibility for a trial and files the IND ([Clinical Trials](https://www.syntaqx.com/books/health-tech/clinical-trials#sponsors-cros-sites-and-investigators)).
- **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](https://www.syntaqx.com/books/health-tech/trial-systems-and-part-11#validation)).

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