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Glossary

Our glossary provides you with precise definitions of key terms from clinical research, clinical trials and the work of contract research organizations (CROs). Learn more about essential concepts, regulatory requirements and technical terms that play a role in drug and medical device development.

    • Adaptive Design Clinical Trial

      A study type that allows modifications to the trial procedures or protocols based on interim results, providing flexibility for changes during the trial to enhance efficiency and effectiveness.

    • Advanced Therapy Medicinal Products (ATMPs)

      Gene therapy, tissue-engineered products, and somatic cell therapy products regulated by the EMA in the EU and the FDA in the US, representing a specialized subset of biologics.

    • Adverse Events (AE)

      Any undesirable experience timely associated with the use of an investigational medicinal product or procedure in a clinical trial participant.

    • Biologics

      Medical products derived from living organisms, including vaccines, blood products, and therapeutic proteins made using biotechnology.

    • CDISC

      A global, non-profit organization that develops data standards to streamline clinical research and improve the quality, consistency, and interoperability of clinical data.

    • Clinical Trial

      A research study assigning human subjects to one or more interventions to evaluate their effects on health-related biomedical or behavioral outcomes.

    • Clinical Trial Application (CTA)

      A regulatory submission required before initiating a clinical trial, containing comprehensive information about the trial protocol, investigational product, and safety measures.

    • Clinical Trial Regulation (CTR)

      An EU regulatory framework (No 536/2014) aiming to streamline the approval process and harmonize regulatory requirements for clinical trials across member states.

    • Clinical Trials Information System (CTIS)

      A centralized platform developed by the EMA to streamline the submission, assessment, and monitoring of clinical trials in the EU and EEA, part of the Clinical Trial Regulation (CTR).

    • Contract Research Organization (CRO)

      A company that provides outsourced clinical research services, managing clinical trials on behalf of sponsors.

    • Control Group

      A group in clinical studies that does not receive the experimental treatment, serving as a baseline for comparison to determine the treatment's efficacy and safety.

    • Decentralized Clinical Trials (DCTs)

      Trials utilizing digital technologies and decentralized methods, allowing for remote data collection, virtual visits, and home-based participation.

    • Digitale Gesundheitsanwendungen (DiGA)

      "Digital Health Applications," a regulatory framework integrating digital health technologies into the German healthcare system, introduced by the Digital Healthcare Act.

    • Dose-Response Relationships

      The relationship between the dose of a drug and its effects on the body.

    • Electronic Case Report Form

      A digital tool used in clinical research to collect and manage data from clinical trial participants.

    • Electronic Patient Reported Outcome

      A digital method for collecting self-reported health information directly from trial participants, typically through electronic devices such as smartphones.

    • Ethics Committee (EC)

      A group that reviews and monitors biomedical research involving human subjects, ensuring the study's ethical standards and participant safety.

    • European Medicines Agency (EMA)

      A regulatory agency responsible for evaluating and supervising medicinal products in the EU and EEA.

    • Gene Therapy Medicinal Products

      Treatments that involve altering genetic material within a patient's cells to treat or prevent diseases.

    • General Data Protection Regulation (GDPR)

      A comprehensive EU regulation aimed at protecting personal data and regulating its processing by organizations, applicable within the EU and EEA.

    • Good Clinical Practice (GCP)

      An international ethical and scientific quality standard for designing, conducting, and reporting clinical trials involving human participants.

    • ICH Guideline E6 (GCP)

      Guideline on "Good Clinical Practice", an international ethical and scientific quality standard for planning, initiating, performing, recording, oversight, evaluation, analysis and reporting clinical trials involving human participants.

    • Informed Consent

      The process by which individuals voluntarily agree to participate in a clinical trial after being informed of the trial's purpose, procedures, risks, and benefits.

    • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

      A global initiative to harmonize guidelines for the pharmaceutical industry, including those related to clinical development.

    • Investigational New Drug (IND)

      A new (biological) drug used in clinical investigations but not yet approved for marketing by the FDA.

    • Investigator

      The individual responsible for conducting a clinical trial at a trial site, often leading a research team.

    • ISO 14155:2020

      International guidelines for conducting clinical investigations of medical devices in humans, ensuring ethical and scientific integrity.

    • Legal Representative

      A local sponsor representative (entitiy) in the EU/EEA, which a non-EU/EEA sponsor company must appoint to carry out a clinical study there when lacking an own subsidiary in the desired study country.

    • Medical Device Regulation (MDR)

      An EU regulation (2017/745) governing the marketing, distribution, and use of medical devices within the EU/EEA, replacing the previous Medical Device Directive.

    • Medicines and Healthcare products Regulatory Agency (MHRA)

      The UK agency responsible for regulating medicines, medical devices, and blood components for transfusion.

    • Monitoring

      The act of overseeing the progress of a clinical trial to ensure compliance with protocols, SOPs, GCP, and regulatory requirements.

    • Orphan Designation

      A status granted in Europe for medicinal products intended to treat rare diseases, providing incentives to stimulate research and development for unmet medical needs.

    • Pharmacodynamics (PD)

      The study of how drugs affect the body, including mechanisms of action and biological responses.

    • Pharmacokinetics (PK)

      The study of how the body absorbs, distributes, metabolizes, and excretes a drug.

    • Pharmacovigilance (PV)

      The science and activities related to detecting, assessing, and preventing adverse effects or drug-related problems after a drug has been marketed.

    • PK/PD Assessment

      Integration of pharmacokinetics and pharmacodynamics to understand the relationship between drug concentration and effects, optimizing dosing regimens and therapeutic efficacy.

    • Post-Marketing Surveillance (PMS)

      The ongoing monitoring of the safety and effectiveness of pharmaceutical products after they are granted marketing authorization.

    • Preclinical study

      Research conducted to assess the safety, efficacy, and biological activity of a treatment before testing in humans.

    • Protocol

      A document detailing the objectives, design, and methodology of a clinical trial.

    • Randomization

      Assigning clinical trial subjects to treatment or control groups using an element of chance to reduce bias and support the validity of study conclusions.

    • Risk-Based Monitoring (RBM)

      An approach to clinical trial monitoring that focuses resources on high-risk areas for patient safety and data integrity.

    • Serious Adverse Event (SAE)

      An untoward medical occurrence that results in death, life-threatening conditions, hospitalization, disability, or birth defects.

    • Small and Medium-Sized Enterprise (SME)

      Regulatory benefits for SMEs conducting clinical trials in the EU, as defined by the European Commission.

    • Somatic Cell Therapy Medicinal Products

      Medical treatments that use living or non-living cells to treat various diseases and conditions, such as stem cell therapy.

    • Sponsor

      An individual or organization responsible for initiating, managing, and financing a clinical trial.

    • Standard Operating Procedures (SOPs)

      Detailed instructions to achieve uniformity in the performance of specific functions.

    • Study Endpoint

      The primary or secondary outcome used to judge the effectiveness of a treatment in a clinical trial.

    • Subject / Study Participant

      An individual participating in a clinical trial, receiving the investigational product or serving as a control.

    • Tissue Engineered Products

      Products developed from tissues or organs for implantation or grafting into patients.

    • Trial Master File

      A collection of essential documents that support the conduct, management, and compliance of a clinical trial, serving as the central repository for all trial-related documentation.

    • Trial Site / Study Site

      The locations where clinical trial activities are conducted.