Glossary- Clinical Trials Terminology – C – F

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Glossary- Clinical Trials Terminology – C – F

C

Clinical Trial/Study Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s), with the object of ascertaining its safety and/or efficacy. The terms “clinical trial” and “clinical study” are synonymous.

Clinical Trial/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, and analyses are fully integrated into a single report

Cohort Group of subjects in a clinical trial followed up at regular, predetermined intervals

Comparative Study One in which the investigative drug is compared against another product, either active drug or placebo.

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

Compliance (in relation to trials) Adherence to all the trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements.

Confidentiality Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity.

Consent Form (CF)(also Informed Consent Form/Document  – ICD) Document used during the consent process that is the basis for explaining to potential subjects the risks and potential benefits of a study and the rights and responsibilities of the parties involved

Clinical Research Organization (CRO) A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trialrelated duties and functions.


D

Database: A collection of data, typically organized for easy search and retrieval. Data stored in computer form for
retrieval, processing, and/or analysis.

Data Monitoring Process by which case report forms are examined for completeness, consistency, and accuracy

Declaration of Helsinki A set of recommendations or basic principles that guide medical doctors in the conduct of biomedical research involving human subjects. It was originally adopted by the 18th World Medical Assembly (Helsinki, Finland, 1964)

Demographic Data Characteristics of subjects or study populations, which include such information as age, sex, family history of the disease or condition for which they are being treated, and other characteristics relevant to the study in which they are participating.

Direct Access Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor’s monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subject’s identities and sponsor’s proprietary information.

Dosage Regimen (a) The number of doses per given time period; (b) the time that elapses between doses (for example, every six hours) or the time that the doses are to be given (for example, at 8 a.m. and 4 p.m. daily); or (c) the amount of a medicine (the number of capsules, for example) to be given at each specific dosing time.


E

Effectiveness The desired measure of a drug’s influence on a disease condition as proved by substantial evidence from adequate and well-controlled investigations.

Efficacy A product’s ability to produce beneficial effects on the course or duration of a disease.

Endpoint An indicator measured in a subject or biological sample to assess the safety, efficacy, or other objective of a trial

Essential Documents Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.

Ethics Committee: An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

Exclusion Criteria A list of criteria, any one of which excludes a potential subject from participation in a study


F

Final Report Complete, comprehensive description of a completed trial that describes the experimental materials and statistical design. It also presents and evaluates the trial results and statistical analyses

Food and Drug Administration (FDA) The United States regulatory authority charged with, among other responsibilities, granting IND and NDA approvals


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