FDA / ICH Good Clinical Practice Glossary

Associate Chief of Staff for Research and Development (ACOS for R&D)

Typically an Individual with authority for management of the research program at facilities with large, active programs. At many research facilities with smaller research programs, the title given to this position is Research Coordinator.

Adverse event (AE)

Any untoward medical occurrence in a patient or clinical investigation subject. An AE does not necessarily have a causal relationship with the treatment or study participant. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with participation in a study, whether or not related to that participation.

Amendment

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

Case Report Form (CRF)

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.

Clinical Trial

Any investigation involving human subjects, including trials that do not involve drugs or devices.

Common Rule

A common set of regulations related to human subjects protections adopted by 17 federal departments and agencies in 1991. It includes required review of research by an IRB, informed consent of subjects and assurances of compliance by research institutions receiving federal support. Federal agencies have adopted the rule in regulatory form at 38 CFR Part 16.

Compliance (in relation to trials)

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

Data and Safety Monitoring Board

See Independent Data Monitoring Committee (IDMC)

The Declaration of Helsinki

The Declaration of Helsinki states that in any research on humans, potential subjects must be adequately informed of the aim, methods, anticipated benefits, and potential hazards of the trial and the discomfort it may entail. They should be informed that they can abstain from participating in the trial and that they are free to withdraw their consent to participate at any time without compromising their medical treatment. Only after providing this information, should the Investigator obtain the subject’s freely given consent, in writing.

Diversion

The act of diverting investigational drugs or devices from use in the clinical investigation for which they were intended.

Documentation

All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records; and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.

Essential Documents

Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. These are defined in the Good Clinical Practice Guideline of the International Conference on Harmonization.

Expedited Review

A review of research performed by the chairman of the Institutional Review Board or other designated individual on behalf of the IRB prior to a convened meeting of the IRB. Research reviewed in this manner must present no more than minimal risk to human subjects. Minor changes to previously approved research may also be approved through the expedited review process.

Federalwide Assurance (FWA)

A written document provided by a research institution that assures the Office of Human Research Protection (OHRP) that the institution will comply with the requirements set forth in the Common Rule (38 CFR Part 16).

Food and Drug Administration (FDA)

Agency within the Department of Health and Human Services that enforces the Food, Drug, and Cosmetic Act and related public health laws.

Good Clinical Practice (GCP)

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

Independent Data Monitoring Committee (IDMC)

An independent data monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. (Also called: Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee)

Informed Consent

A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.

Institutional Review Board (IRB)

An independent body constituted of scientific and nonscientific 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 trials, of protocols and amendments, and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The IRB is the local committee charged with the oversight of all research activities involving the use of human subjects.

Investigational Product

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. An investigational product can also be a medical device.

Investigator

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 the principal investigator. See also Subinvestigator.

Investigator Agreement

An agreement provided by the Investigator to the Sponsor, IRB, or regulatory authority to comply with applicable rules for the conduct of research. Examples of Investigator Agreements include the Statement of Investigator (FDA Form 1572) completed and signed by the Investigator and various pledges of compliance signed by the Investigator and provided to the Sponsor or IRB.

Investigator Brochure

A compilation of clinical and non-clinical data on the investigational product provided by the Sponsor to the Investigator to facilitate understanding of the protocol, the drug, safety monitoring, and clinical management of subjects during the trial.

Investigator Study File

A file maintained by the Investigator containing all records and reports necessary to document methods, conduct and results of the trial. This file may also be called the Study File or Investigator File.

Investigator Study Team

A group of researchers assembled by an Investigator to conduct a clinical trial. Study teams vary in size and composition depending on the needs of the trial. The responsibilities of study teams member will vary.

Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

A private not-for-profit organization that evaluates and accredits more than 17,000 health care organizations and programs in the United States. JCAHO is the nation's predominant standards-setting and accrediting body in health care.

Monitoring

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s).

National Committee for Quality Assurance (NCQA)

A private not-for-profit accrediting organization dedicated to improving health care quality.

Office of Human Research Protection (OHRP)

The federal organization responsible for overseeing human research subjects protection and related functions where research involves the use of human subjects. This office resides within the Department of Health and Human Services but under the principles of the Common Rule has jurisdiction in all federally funded human research.

Protocol

A document that describes the objective(s), design, 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 reference documents. Throughout the ICH GCP Guidance, the term protocol refers to protocol and protocol amendments.

Quality Assurance (QA)

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirement(s).

Research and Development Committee (R&D)

The local committee charged with oversight of all R&D activities within a typical research facility.

Safety Report

A report generated by an Investigator or Sponsor during a clinical trial to alert IRBs and other Investigators to Serious Adverse Events or other new information concerning risks to patients participating in the trial.

Scientific Misconduct

Fabrication, falsification, or plagiarism in proposing, performing or reviewing research, or in reporting research results.

Serious Adverse Event (SAE)

Any untoward medical occurrence that at any dose:

• Results in death,
• Is life-threatening,
• Requires inpatient hospitalization or prolongation of existing hospitalization,
• Results in persistent or significant disability/incapacity, or
• Is a congenital anomaly/birth defect.
• Or any other important medical event that may jeopardize the subject and may require a medical or surgical intervention to prevent one of the above outcomes

Source Data

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. Source data are contained in source documents (original records or certified copies).

Source Documents

Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial).

Sponsor

An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.

Study Coordinator

An individual that oversees and manages daily clinical trial operations under the direction of the Investigator. This person may also be called clinical research coordinator, research nurse, or protocol nurse.

Study Team

See Investigator Study Team.

Subcommittee on Human Studies (IRB)

See Institutional Review Board .

Subinvestigator

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). See also Investigator.