Comprehensive, thoughtful annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it

Data lock for data analyses.

Date of approval of the first authorization for conducting an interventional clinical trial in any country. Determines the start of regulatory requirement. The first data

Intentional off-label use of a medicinal product. Although the drug is not being used according to the marketing authorization or physician’s recommendation, abuse can result

Serious and rare medical event that is often causally associated with drugs across multiple pharmacological / therapeutic classes. Even small number of reports of such

Screening of ICSR databases for statistical associations between products and events whereby the observed frequency is different than the expected frequency. For ADRs caused by

Plan to conduct the detection, assessment, understanding, reporting and prevention of AEs of medicinal products during clinical trials.

This section of an Investigator’s Brochure (IB) is identical in structure to the CCSI and contains a summary of all relevant safety information (described in

Dechallenge is the withdrawal of a drug from a patient to observe: The continuity of an AE (negative dechallenge – causal relationship less likely) The

Synonyms: Independent Data Monitoring Committee, Data and Safety Monitoring Board This committee is established by the sponsor to: Assess the progress of a clinical trial,

A subject in a clinical trial who for any reason fails to continue in the trial until the last visit required of him/her by the

A study in which neither the participant nor the researcher knows whether the participant is in the treatment or control groups. Source: FDA Patient Glossary

A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose

The amount of medicine taken, or radiation given, at one time. Source: NCI

A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the

[A] finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other

A drug master file (DMF) is a master file that provides a full set of data on an API. In some countries, the term may

(1) The proportion of active drug substance to excipient, measured in units of volume or concentration.(2) The strength of a drug product, which indicates the

The physical state in which a drug is dispensed for use. For example: a frequent dosage form of procaine is a sterile solution of procaine.

A DTD defines the structure and the legal elements and attributes of an XML document. In particular, the XML eCTD DTD (Document Type Definition) defines

An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the

Network project led by EMA which will replace current PDF based electronic application forms with new web forms.

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended

“Define-XML is a file tha metadata that describes any tabular dataset structure. When used with the CDISC Foundational Standards, it provides the metadata for human

An EU Procedure Type in which the competent authority of the lead country reviews and approves the application. Participating EU member states review the application

Data tabulations are datasets in which each record is a single observation for a subject. Source: Study Data Specifications (FDA)

“Data listings are datasets in which each record is a series of observations collected foreach subject during a study or for each subject for each

The data definition file describes the format and content of the submitted datasets. Source: Study Data Specifications (FDA)

DailyMed contains labeling for prescription and nonprescription drugs for human and animal use, and for additional products such as medical gases, devices, cosmetics, dietary supplements,

[FDA] [An] active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease