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

Adverse Drug Reaction (ADR)

Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients.

Individual Case Safety Report (ICSR)

An Individual Case Study Report is an adverse event report for an individual patient.

Periodic Safety Update Report (PSUR)

The PSUR provides an evaluation of the risk-benefit balance of a medicinal product defined time points post-authorization.

Pharmacovigilance System Master File (PSMF)

A Pharmacovigilance System Master File is a document describing the pharmacovigilance system used by the marketing authorisation holder (MAH) with respect to one or more authorized medicinal produc

Risk Management Plan (RMP)

A detailed description of the set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products including the assess

Safety Data Exchange Agreement (SDEA)

A Safety Data Exchange Agreement is a legal written contract which ensures that all safety data regarding a medicinal product makes its way quickly and reliably back to the marketing authorisation

Serious Adverse Event (SAE)

Adverse event (AE) means any untoward medical occurrence associated with the use of a drug or pharmaceutical product in humans, whether or not considered drug related.

MedWatch

MedWatch is the US Food and Drug Administration's reporting program for product complaints.

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