Skip Headers

Oracle® Argus Safety BIP Aggregate Reporting User's Guide Release 8.0 E54664-01 |
Home | Book List | Contents | Contact Us

Previous
| View PDF

15/15

# Glossary

compassionate use

In certain situations, the Food and Drug Administration (FDA) allows companies to provide their experimental drugs to people outside of clinical trials. This is referred to as compassionate use. Basically, compassionate use to the treatment of a seriously ill patient using an unapproved drug (investigational drug) when no other treatments are available.

development international birth date (dibd)

The date of first authorization for the conduct of an interventional clinical trial in any country.

international birth date (idb)

The date of the first marketing authorization for any product containing the active substance granted to any company in any country in the world.

investigational drug

The term investigational drug indicates only the experimental product under study or development. This term is more specific than investigational medicinal product, which includes comparators and placebos.

medicinal product

Medicinal product is a product containing a substance or a combination of substances produced and intended for the treatment or prevention of diseases in humans or in animals, for diagnostic purposes, improvement or modification of physiological functions or for achieving other medically justified objectives.

non-interventional trials

Non-interventional trials are not within the scope of the regulations, that is, those where the medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorization. In these cases the assignment of a patient to a particular therapeutic strategy is not decided in advance by a trial protocol, but falls within current practice, and the prescription of the medicine is clearly separated from the decision to include the patient in the study. Also, no additional diagnostic or monitoring procedure related to the therapeutic strategy is applied to the patients and epidemiological methods that are to be used for the analysis of data.

ongoing clinical trial

Trial where enrolment has begun, whether a hold is in place or analysis is complete, but for which a final clinical study report is not available.

solicited reports

Solicited reports are those derived from organized data collection systems, which include clinical trials, registries, post-approval named patient use programs, other patient support and disease management programs, surveys of patients or healthcare providers, or information gathering on efficacy or patient compliance.

spontaneous report or spontaneous notification

An unsolicited communication to a company, regulatory authority, or other organization that describes an adr in a patient given one or more medicinal products and which does not derive from a study or any organized data collection scheme.