A (5) | B (1) | C (14) | D (2) | E (14) | F (4) | G (1) | H (2) | I (14) | J (1) | L (1) | M (4) | N (4) | O (1) | P (15) | Q (2) | R (2) | S (7) | T (2) | V (2)

Latest Glossary Definitions

Substantial amendment (SA)

A substantial amendment (SA) is a change to the conduct of the clinical trial that has a significant impact on the safety of the subjects or the scientific value of the study.

EudraCT form

A harmonized application form is used for clinical trial applications across the European Union.

Post-Authorization Safety Study (PASS)

A Post-Authorization Safety Study (PASS) is a study performed after the marketing authorization and aiming principally to further evaluate the safety of the medicinal product or to measure the effectiveness of risk-management.

Non-substantial amendment

A non-substantial amendment is a change to the conduct of the clinical trial that does not have a significant impact on the safety of the subjects or the scientific value of the study.

Post-Authorization Efficacy Study (PAES)

A Post-Authorization Efficacy Study (PAES) is a study performed after the marketing authorization and aiming principally to further evaluate the efficacy of the medicinal product.

Case Report Form (CRF)

Data collected in the frame of a clinical trial must be recorded in order to ensure that the protocol is complied with and as a basis for the analysis of the study results.

Investigator's Brochure

Investigators need to be provided with information about the investigational medicinal product (IMP) data, in order to facilitate their understanding of the rationale for, and their compliance with, key features of a clinical trial protocol.

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