Gcp

Front 1

Case report form

Back 1

Document designed to record all of the protocol required information to be reported to the sponsor on each trial subject

Front 2

Coordinating committee

Back 2

A committee that a sponsor may organize to coordinate the conduct of a multicenter trial

Front 3

Coordinating investigator

Back 3

An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenter trial

Front 4

Contract research organization (CRO)

Back 4

A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's travel-related duties and functions.

Front 5

Direct access

Back 5

Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.

Front 6

Essential documents

Back 6

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

Front 7

Monitoring board, monitoring committee, data monitoring committee

Back 7

An independent data-monitoring committee that may be established by the sponsor assess at intervals the progress of the clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor or whether to continue, modify, or stop a trial.

Front 8

Impartial witness

Back 8

A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informer consent form and any other written information supplied to the subject.

Front 9

Interim clinical trial/study report

Back 9

A report of intermediate results and their evaluation based in analyses performed during the course of a trial.

Front 10

Investigational product

Back 10

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

Front 11

Investigator

Back 11

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called a principle investigator.

Front 12

Investigator's brochure

Back 12

A compilation of the clinical and nonclinical data on the investigational products which is relevant to the study of the investigational product(s) in human subjects.

Front 13

Legally acceptable representative

Back 13

An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in a clinical trial.

Front 14

Multicentre trial

Back 14

A clinical trial conducted according to a single protocol bur at more than one site, and therefore, carried out by more than one investigator.

Front 15

Nonclinical study

Back 15

Biomedical studies not performed on human subjects.

Front 16

Protocol

Back 16

A document that describes the objectives, designs, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents.

Front 17

Protocol amendment

Back 17

A written description of a changes to or formal clarification of a protcol.

Front 18

Randomization

Back 18

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias

Front 19

Source data

Back 19

All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.