Clinical-trials regulation · 14 pages
Clinical-trials regulation & pharmacovigilance
Answer-first explainers of the regulatory systems and reporting infrastructure for clinical trials and drug safety — adverse-event databases, data management, terminology and signal detection — as neutral process definitions, never clinical advice.
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All 14 clinical-trials regulation & pharmacovigilance pages
FAERS
FAERS — the FDA Adverse Event Reporting System — is the United States database of adverse-event and medication-error reports that supports the FDA’s post-marketing drug-safety surveillance. It holds spontaneous reports submitted voluntarily by consumers and health professionals, and reports submitted mandatorily by manufacturers. A report in FAERS records a suspected association only and does not by itself establish that a product caused the event.
DefinitionEudraVigilance
EudraVigilance is the European Medicines Agency’s system for managing and analysing reports of suspected adverse reactions to medicines authorised or studied in the European Economic Area. It is the single point of receipt for individual case safety reports from national regulators and marketing-authorisation holders, supporting EU-wide pharmacovigilance, signal detection and safety monitoring throughout a medicine’s life cycle.
DefinitionClinical data management (CDM)
Clinical data management (CDM) is the process of collecting, cleaning and managing clinical-trial data so that the resulting dataset is high-quality, reliable and statistically sound. It covers designing data-capture tools, validating and querying entries to resolve discrepancies, coding terms to standard dictionaries, and locking the database before analysis. CDM commonly applies CDISC data standards to keep trial data structured and interoperable.
DefinitionClinical Trial Management System (CTMS)
A CTMS — Clinical Trial Management System — is software used to plan, track and manage the operational conduct of a clinical trial. It centralises information about sites, subjects, milestones, visits, monitoring activities and budgets, giving study teams a single operational view of trial progress. A CTMS manages how a trial is run; it is distinct from the systems that capture and clean the trial’s clinical data.
DefinitionClinicalTrials.gov
ClinicalTrials.gov is the United States public registry and results database of clinical studies, run by the National Institutes of Health through the National Library of Medicine. It lets researchers, regulators and the public find studies and view summary results. For applicable trials, registration and results reporting are legally required under the Food and Drug Administration Amendments Act of 2007 (FDAAA 801).
DefinitionAdverse event reporting
Adverse event reporting is the documentation and submission of untoward medical occurrences in patients or trial subjects to sponsors, manufacturers and regulators. It supplies the case-level information that pharmacovigilance relies on to monitor medicine safety. Reports may be spontaneous — submitted voluntarily outside a study — or solicited within a clinical trial or programme, and an adverse event is recorded regardless of whether a causal link to the product is established.
DefinitionSerious adverse event (SAE)
A serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires or prolongs hospitalisation, causes persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, or is another medically important event. This regulatory definition comes from ICH E2A. "Serious" is defined by these outcome-based criteria, not by how severe the event feels.
DefinitionSignal detection
Signal detection is the process of identifying new or changing safety signals — possible causal associations between a medicine and an adverse event — from pharmacovigilance data. It combines quantitative methods such as disproportionality analysis (for example PRR or ROR) with clinical review of case reports. A detected signal is a hypothesis flagged for further assessment, not a confirmed risk or established causal relationship.
DefinitionMedDRA
MedDRA — the Medical Dictionary for Regulatory Activities — is the standardised international medical terminology used for regulatory reporting of medicines. It provides a consistent, multilingual vocabulary for coding adverse events, symptoms, diagnoses, indications and procedures, so that data can be exchanged and analysed across companies and regulators. Its hierarchy runs from System Organ Class through HLGT and HLT to Preferred Term and Lowest Level Term.
DefinitionPharmacovigilance System Master File (PSMF)
A PSMF — Pharmacovigilance System Master File — is the EU-required document describing the pharmacovigilance system that a marketing-authorisation holder operates for one or more medicines. It sets out the system’s structure, the qualified person responsible for pharmacovigilance, the organisation, processes, resources and quality system used to monitor safety. The PSMF must be kept current and made available to regulators on request or at inspection.
DefinitionCIOMS form
The CIOMS form — specifically CIOMS I — is the internationally recognised paper format for reporting an individual case safety report (ICSR) of a suspected adverse drug reaction. Developed by the Council for International Organizations of Medical Sciences, it standardises the core information exchanged between regulators and companies, such as patient details, the suspect product, the reaction and the reporter, supporting consistent international safety reporting.
DefinitionRisk Management Plan (RMP)
A Risk Management Plan (RMP) is a document describing a medicine’s safety profile and how its risks will be prevented, minimised and monitored over time. Required in the EU, it identifies important known and potential risks and missing information, and specifies the pharmacovigilance activities and risk-minimisation measures planned to manage them. The RMP is product-specific and is updated as new safety knowledge accumulates.
DefinitionEU Clinical Trials Regulation
The EU Clinical Trials Regulation is Regulation (EU) No 536/2014, which harmonises the authorisation and oversight of clinical trials of medicines across the European Union. It replaces the earlier Clinical Trials Directive with a single coordinated assessment and a shared portal and database, the Clinical Trials Information System (CTIS). Use of CTIS became mandatory for new trials, completing the transition in 2023.
ComparisonSerious vs non-serious adverse event
The difference is whether the event meets an ICH E2A seriousness criterion. A serious adverse event results in death, is life-threatening, requires or prolongs hospitalisation, causes persistent or significant disability, a congenital anomaly, or is another medically important event. A non-serious adverse event meets none of these. Seriousness is an outcome-based classification, separate from severity, and it determines whether expedited reporting timelines apply.
