Glossary

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. The CRF is the way the Clinical Data for Patients is collected.

CDMS

Clinical Data Management System (For example, Oracle Clinical)

Central Laboratory

A location, under contract to a Clinical Trial sponsor, where samples are sent from multiple sites for analysis.

Clinical Data

Data pertaining to the medical characteristics or status of a patient or subject.

Clinical Research Organization

A company or organization that conducts all or part of a clinical trial under contract to a Clinical Trial sponsor.

Clinical Study

See Clinical Trial

Clinical Trial

Before a pharmaceutical or biotech company can initiate testing on humans, it must conduct extensive pre-clinical or laboratory research. This research typically involves years of experiments on animal and human cells. The compounds are also extensively tested on animals. If this stage of testing is successful, a pharmaceutical company provides this data to the Food and Drug Administration (FDA), requesting approval to begin testing the drug on humans. This is called an Investigational New Drug application (IND). A clinical trial is a carefully designed investigation of the effects of drug, medical treatment, or device on a group of patients (also called Subjects).

compound

The product being tested or researched within the Clinical Trial.

CRA

Clinical Research Associate. An employee of the Sponsor, responsible for getting a site prepared to conduct a trial and getting cleaned data back from the site to the Sponsor.

CRF

See Case Report Form

CRF Book

A set of paper forms or electronic forms that record the results of the set of assessments performed on a subject taking part in a clinical trial.

CRF Page

A single form within a CRF Book.

CRO

Clinical Research Organization

CTMS

Clinical Trial Management System (For example, Oracle's Siebel Clinical)

discrepancy

Problems found with data reported in the CRF pages by Investigators for specific Patients

eCRF

A single electronic CRF.

EDC

Electronic Data Capture system (For example, Oracle Remote Data Capture (RDC))

informed consent

A discussion of all procedures, benefits, risks, and expectations of a clinical trial between clinical investigators and potential patients. The FDA requires all patients to sign an informed consent form before participating in a trial.

investigator

A person responsible for the conduct of the clinical trial at a trial site. When a Clinical Trial is conducted at a Site by a team the Investigator is the responsible leader of the team and may be called Principal Investigator (PI). Other investigators are called Sub-investigators. Investigators are qualified health care professionals, often are MDs, PhDs or Pham Ds.

patient

A person who participates in a Clinical Study and is the focus of the Clinical Trial's research.

patient visits

A series of scheduled visits by a Patient to an Investigator based interval specified in the Clinical Trial's Protocol. During the Patient visits the Investigators undertakes the required medical procedures defined in the Clinical Trial Protocol and completes the corresponding CRFs.

phase

Phase of trial, typically 1,2,3 or 4.

program

Groups of Clinical Studies or Clinical Trials for the same compound.

projects

Groups of Studies within a Program (Oracle Clinical Only)

Protocol

A Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. It is a plan that states what will be done in the study and why. It outlines how many people will take part in the study, what types of Subjects may take part, what tests they will receive how often, and the treatment plan. The Sponsor of the Clinical Trial typically designs the Protocol.

Protocol amendment

A written description of a change(s) to or formal clarification of a protocol.

queries

Each query is a request for information, sent to an Investigator, to resolve a Discrepancy detected in data signed for by that Investigator.

randomization

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.

region

A geographic region in which the Clinical Study or Clinical Trial will be carried out.

Regulatory Authority

An authority such as FDA and EMEA regulating clinical development processes.

site coordinator

The individual who manages the conduct of the clinical trial. Coordinators are often nurses.

site visit

A visit or trip by a CRA to a Site for monitoring and support activities.

sites

Sites are locations where clinical trials are conducted. They are typically a clinic or hospitals where investigators see subjects and perform study procedures, such as medical checks.

Sponsor

The organization funding the clinical trial. This is typically the Pharmaceutical company whose product is being tested with the clinical trial.

study document

A required Document to initiate or start a Clinical Trial at a Site (For example, Investigator Resume.)

study

See Clinical Trial

subject

See patient