---
title: "Informed Consent — Definition | QbD Group"
description: "The documented process by which a participant voluntarily confirms willingness to take part in a trial, after being informed of its purpose, procedures,..."
url: https://qbdgroup.com/en/knowledge-center/glossary/informed-consent
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"Informed Consent — Definition | QbD Group\", https://qbdgroup.com/en/knowledge-center/glossary/informed-consent"
---

[Back to the glossary](https://qbdgroup.com/en/knowledge-center/glossary) Regulatory Glossary

# Informed Consent

Clinical

## Definition

The documented process by which a participant voluntarily confirms willingness to take part in a trial, after being informed of its purpose, procedures, risks, benefits, and their right to withdraw at any time without penalty.

## Related terms

[GCPThe 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.](https://qbdgroup.com/en/knowledge-center/glossary/gcp)[CTR 536/2014The 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.](https://qbdgroup.com/en/knowledge-center/glossary/ctr-536-2014)[CTISThe 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.](https://qbdgroup.com/en/knowledge-center/glossary/ctis)[CTAThe 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.](https://qbdgroup.com/en/knowledge-center/glossary/cta)[CERThe 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.](https://qbdgroup.com/en/knowledge-center/glossary/cer)[PMCFThe 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.](https://qbdgroup.com/en/knowledge-center/glossary/pmcf)

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