Clinical Research Glossary
Quick Reference to Essential Clinical Research Terms
Explore concise explanations of important terms and concepts commonly used across clinical research in Switzerland.
Answers to common queries are in our FAQs.
Academic Clinical Research
Research studies initiated and conducted by universities, hospitals, or public institutions rather than pharmaceutical companies.
Adverse Event (AE)
Any undesired medical occurrence in a study participant during a clinical trial, whether or not it is related to the study treatment.
Bias
A systematic error in study design, data collection, or analysis that can distort study results.
Blinding (Masking)
A method of keeping study participants, investigators, or both unaware of which treatment a participant is receiving, to reduce bias.
Case Report Form (CRF)
A document (paper or electronic) used to collect data from each trial participant.
Clinical Research
Research involving human participants to evaluate medical, surgical, or behavioural interventions.
Clinical Research Centre (CRC)
A specialised centre within a university or hospital that supports the planning, conduct, and analysis of clinical studies.
Clinical Trial
A type of clinical research study that tests new treatments, drugs, or interventions to determine safety and effectiveness.
Compliance
Following all relevant regulations, standards, and study protocols during the conduct of a trial.
Data Management
The process of collecting, validating, storing, and protecting study data to ensure accuracy and reliability.
Data Monitoring Committee (DMC) / Independent Data Monitoring Committee (IDMC)
An independent group of experts that monitors participant safety and study progress during a clinical trial.
Endpoint
A primary or secondary outcome measured in a study to evaluate the effect of a treatment.
Ethics Committee (EC)
An independent group of experts that reviews and approves research projects to protect participant rights, safety, and wellbeing.
Good Clinical Practice (GCP)
An international quality standard that governs how clinical trials are designed, conducted, and reported.
Human Research Ordinance (HRO)
Swiss legislation that regulates how research involving humans is conducted, ensuring ethical and scientific quality.
Informed Consent
The process by which a participant voluntarily confirms willingness to take part in a study, after being fully informed of its purpose, procedures, risks, and benefits.
Investigator
The person responsible for conducting a clinical trial at a site, usually a physician or researcher.
Monitoring
The oversight of a clinical trial to ensure it is conducted according to the protocol, GCP, and regulatory requirements.
Patient and Public Involvement (PPI)
The active involvement of patients and the public in the design, conduct, and dissemination of research.
Peer Review
The evaluation of scientific work by independent experts before it is published, ensuring quality and validity.
Phase I–IV Trials
The stages of clinical research, from early safety testing (Phase I) to large-scale effectiveness and post-market surveillance (Phase IV).
Placebo
An inactive substance or treatment designed to look like the intervention being tested, used to compare results in controlled trials.
Platform (Clinical Research Platform)
A coordinated area of expertise within the SCTO network that develops solutions and provides resources for clinical research.
Principal Investigator (PI)
The lead researcher responsible for the overall conduct of a clinical study at a site.
Protocol
The written plan that describes the objectives, design, methodology, and organisation of a clinical trial.
Quality Management (QM)
Processes and standards that ensure research is conducted with accuracy, safety, and regulatory compliance.
Randomisation
Assigning participants to different study groups by chance, reducing bias in treatment comparisons.
Recruitment
The process of enrolling participants into a clinical study.
Regulatory Affairs
The area of clinical research concerned with compliance to laws, guidelines, and approvals from authorities like Swissmedic.
Safety Monitoring
Ongoing review of data to identify any risks or adverse effects in study participants.
Sponsor
An individual, company, or organisation that takes responsibility for initiating, managing, and financing a clinical study.
Sponsor-Investigator
A researcher who both initiates and conducts a clinical study and takes on the responsibilities of a sponsor.
Standard Operating Procedure (SOP)
Written instructions that describe how to carry out specific tasks consistently and correctly in clinical research.
Statistics and Methodology
The application of statistical techniques and study design principles to ensure reliable, reproducible, and meaningful research results.
Swissmedic
The Swiss agency for therapeutic products, responsible for the authorisation and supervision of medicines and medical devices.
Trial Design
The overall structure of a clinical study, including how participants are allocated, treated, and assessed.
Validation
The process of ensuring that tools, methods, or software used in a study perform as intended and meet regulatory standards.
Academic Clinical Research
Research studies initiated and conducted by universities, hospitals, or public institutions rather than pharmaceutical companies.
Adverse Event (AE)
Any undesired medical occurrence in a study participant during a clinical trial, whether or not it is related to the study treatment.
Bias
A systematic error in study design, data collection, or analysis that can distort study results.
Blinding (Masking)
A method of keeping study participants, investigators, or both unaware of which treatment a participant is receiving, to reduce bias.
Case Report Form (CRF)
A document (paper or electronic) used to collect data from each trial participant.
Clinical Research
Research involving human participants to evaluate medical, surgical, or behavioural interventions.
Clinical Research Centre (CRC)
A specialised centre within a university or hospital that supports the planning, conduct, and analysis of clinical studies.
Clinical Trial
A type of clinical research study that tests new treatments, drugs, or interventions to determine safety and effectiveness.
Compliance
Following all relevant regulations, standards, and study protocols during the conduct of a trial.
Data Management
The process of collecting, validating, storing, and protecting study data to ensure accuracy and reliability.
Data Monitoring Committee (DMC) / Independent Data Monitoring Committee (IDMC)
An independent group of experts that monitors participant safety and study progress during a clinical trial.
Endpoint
A primary or secondary outcome measured in a study to evaluate the effect of a treatment.
Ethics Committee (EC)
An independent group of experts that reviews and approves research projects to protect participant rights, safety, and wellbeing.
No glossary terms for this letter.
Good Clinical Practice (GCP)
An international quality standard that governs how clinical trials are designed, conducted, and reported.
Human Research Ordinance (HRO)
Swiss legislation that regulates how research involving humans is conducted, ensuring ethical and scientific quality.
Informed Consent
The process by which a participant voluntarily confirms willingness to take part in a study, after being fully informed of its purpose, procedures, risks, and benefits.
Investigator
The person responsible for conducting a clinical trial at a site, usually a physician or researcher.
No glossary terms for this letter.
No glossary terms for this letter.
No glossary terms for this letter.
Monitoring
The oversight of a clinical trial to ensure it is conducted according to the protocol, GCP, and regulatory requirements.
No glossary terms for this letter.
No glossary terms for this letter.
Patient and Public Involvement (PPI)
The active involvement of patients and the public in the design, conduct, and dissemination of research.
Peer Review
The evaluation of scientific work by independent experts before it is published, ensuring quality and validity.
Phase I–IV Trials
The stages of clinical research, from early safety testing (Phase I) to large-scale effectiveness and post-market surveillance (Phase IV).
Placebo
An inactive substance or treatment designed to look like the intervention being tested, used to compare results in controlled trials.
Principal Investigator (PI)
The lead researcher responsible for the overall conduct of a clinical study at a site.
Quality Management (QM)
Processes and standards that ensure research is conducted with accuracy, safety, and regulatory compliance.
Randomisation
Assigning participants to different study groups by chance, reducing bias in treatment comparisons.
Recruitment
The process of enrolling participants into a clinical study.
Regulatory Affairs
The area of clinical research concerned with compliance to laws, guidelines, and approvals from authorities like Swissmedic.
Safety Monitoring
Ongoing review of data to identify any risks or adverse effects in study participants.
Sponsor
An individual, company, or organisation that takes responsibility for initiating, managing, and financing a clinical study.
Sponsor-Investigator
A researcher who both initiates and conducts a clinical study and takes on the responsibilities of a sponsor.
Standard Operating Procedure (SOP)
Written instructions that describe how to carry out specific tasks consistently and correctly in clinical research.
Statistics and Methodology
The application of statistical techniques and study design principles to ensure reliable, reproducible, and meaningful research results.
Swissmedic
The Swiss agency for therapeutic products, responsible for the authorisation and supervision of medicines and medical devices.
Trial Design
The overall structure of a clinical study, including how participants are allocated, treated, and assessed.
No glossary terms for this letter.
Validation
The process of ensuring that tools, methods, or software used in a study perform as intended and meet regulatory standards.
No glossary terms for this letter.
No glossary terms for this letter.
No glossary terms for this letter.
No glossary terms for this letter.