Category: C

Crossover Study

A trial design for which subjects function as their own control and are assigned to receive investigational product and controls in an order determined by

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Controlled Study

A clinical study that includes a comparison (control) group. The comparison group receives a placebo, another treatment, or no treatment at all. Source: NCI

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Control

The control or “standard” treatment is compared against the investigational treatment. It is there to show that an approved treatment in the trial works, and

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Comparator

An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. Source: ICH E6

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Combination Product

1. A product comprising two or more individual products. 2. Two or more separate products packaged together in a single package or as a unit.

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Clinicaltrials.gov

ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health.

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Clinical Study Report

A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations,

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Clinical Study

A research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies: interventional

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Certified Copy

A copy of original information that has been verified as having the same metadata and data as the original. The copy may be verified by

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Case Report Form

A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject. NOTE:

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Core Data Sheet (CDASH)

Core Data Sheet is an unofficial working document prepared by marketing authorization holders typically containing material relating to safety, indications, dosing, pharmacology, and other information

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Complete Response Letter

[FDA] A written communication to an applicant from FDA usually describing all of the deficiencies that the agency has identified in an application or abbreviated

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Common Technical Document (CTD)

The Common Technical Document (CTD) is a format for marketing applications submitted to ICH participating regions, controlling the organization of information in an application.

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Commitment

“Activities to be performed by or on behalf of a Party or its Affiliates as a condition or in connection with receipt of Regulatory Approval

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CMC Supplement

See Manufacturing Supplement. [FDA] a supplement to an approved application which includes a change(s) to the manufacturing process, including product testing or changes to the

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Checksum

A checksum is a sequence of numbers and letters used to check data for errors. If the checksum of an original file is known, an

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Certificate of Suitability (CEP)

Certificate of Suitability to the monographs of the European Pharmacopoeia. A certificate that certifies compliance of the active pharmaceutical ingredients (API) or pharmaceutical ingredients with

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Centralised Procedure (CP)

“An EU Procedure type in which the EMA (European Medicines Agency) reviews and approves the application on behalf of all European Union countries.Certain drugs, such

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CE Mark (CE)

Authorisation in the European Economic Area (EEA) for the marketing and sale of devices, and specifically within Life Sciences, Medical Devices.

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