Definition
The application seeking authorisation to run a clinical trial in a given territory. It bundles the protocol, investigator's brochure, IMP dossier, informed consent documents, and site and investigator information for regulatory and ethics review.
Related terms
GCP
The international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects, set out in ICH E6. Compliance protects participant rights and safety and makes trial data credible to regulators.
CTR 536/2014
The regulation harmonising clinical trial authorisation and supervision across the EU. It introduced a single submission through CTIS, coordinated assessment between member states, defined assessment timelines, and public transparency of trial information.
CTIS
The single EU portal and database for clinical trial applications under CTR 536/2014. Sponsors submit one dossier for all concerned member states and manage the full lifecycle there: authorisation, substantial modifications, safety reporting, and results.
CER
The MDR deliverable that documents the systematic appraisal of clinical data for a medical device. It weighs literature, clinical investigations, and post-market data against the intended purpose to confirm safety, performance, and an acceptable benefit-risk profile.
PMCF
The proactive collection and evaluation of clinical data from a CE-marked device in normal use, planned to confirm safety and performance, keep the benefit-risk determination current, and detect emerging risks or off-label use.
Investigator's Brochure
The compilation of clinical and non-clinical data on an investigational product that is relevant to its study in humans. It gives investigators the dosing, safety, and monitoring information they need and is updated as new data emerge.
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