Clinical Trial Regulations

A demonstration that two products show comparable bioavailability under similar conditions, supporting substitution for generics and some formulation changes.

A design feature where treatment assignment is concealed from participants and/or study personnel to reduce bias.

A comprehensive report of a clinical trial’s methods, results, and interpretation prepared for submissions and scientific review.

Any investigation in human subjects intended to discover or verify effects of one or more medicinal products. Requires regulatory and ethics approval.

The EU portal and database used for submitting and maintaining clinical trial applications and related lifecycle events under the EU CTR.

An independent group that reviews accumulating safety and efficacy data during a trial and recommends whether to continue, modify, or stop the study.

A precisely defined outcome measure used to assess treatment effect in a clinical study.

EU Regulation (EU) No 536/2014 governing authorization and oversight of clinical trials in the EU, including harmonized processes and transparency expectations.

Rapid reporting to regulators of serious safety information meeting specific criteria (e.g., seriousness, expectedness, suspected causality) during clinical development or post-market as applicable.

A form signed by clinical investigators in US IND studies documenting investigator commitments and site/investigator information.

International ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Ensures rights and safety of subjects and data reliability.

A committee that safeguards the rights, safety, and well-being of trial participants by reviewing trial documents and ongoing conduct (common international term).

A process and documentation ensuring a participant voluntarily confirms willingness to participate in a trial after being informed of all relevant aspects.

An analysis performed before study completion, requiring prespecification and control of error rates to avoid biased conclusions.

A compilation of clinical and nonclinical data on an investigational product relevant to its study in humans, used to support investigators and ethics review.

A committee that reviews and approves clinical research involving human subjects to ensure ethical conduct and protection of participants (US term).

The main outcome used to answer the primary objective of a trial; drives sample size and statistical testing strategy.

A document describing the objectives, design, methodology, statistical considerations, and organization of a clinical trial.

A change to the clinical trial protocol. Substantial amendments require approval from the competent authority and favourable opinion from the ethics committee before implementation.

A departure from the approved protocol, SOPs, or regulatory requirements that may require assessment of impact on safety, rights, and data integrity.

Assignment of trial participants to treatment arms using a chance mechanism to reduce bias and balance confounders.

The reference used to assess expectedness of reactions for expedited reporting in clinical trials (often the Investigator’s Brochure or approved product information).

An adverse event that results in death, is life-threatening, requires hospitalization or prolongation, results in disability/incapacity, congenital anomaly, or other medically important condition.

An additional outcome used to evaluate other effects of treatment; interpretation often depends on multiplicity control and hierarchy.

In EU frameworks, a breach of the protocol or regulations likely to affect to a significant degree the safety or physical/mental integrity of subjects or the scientific value of the trial.

A prespecified document detailing planned statistical analyses, populations, endpoints, and handling of missing data and intercurrent events.

An amendment to a clinical trial that significantly affects subject safety, scientific value, or conduct. Requires regulatory and ethics approval before implementation.

Under EU CTR, a post-authorization change likely to have a substantial impact on participant safety/rights or on the reliability and robustness of trial data.

A biomarker or intermediate measure used as a substitute for a clinical endpoint when it is expected to predict clinical benefit.

A serious adverse reaction suspected to be related to the investigational product that is unexpected based on the reference safety information, requiring expedited reporting.

A set of essential documents that permits evaluation of the conduct of a trial and the quality of the data produced, maintained by sponsor/parties.

Revealing treatment assignment, typically controlled by procedures to protect study integrity and patient safety (e.g., emergency unblinding).