Friday, December 24, 2010
(ICH definition – International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use)
(ICH definition – International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use)
Adverse Drug Reaction (ADR)
In the pre-approval clinical experience with a new medicinal product or a product’ s new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions (the phrase ‘ responses to a medicinal product’ meaning that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out).
Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function.
Adverse event (AE)
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Applicable regulatory requirement(s)
Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.
Approval (in relation to Institutional Review Boards)
The affirmative decision of the Institutional Review Board (IRB) that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.
A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data recorded, analysed and accurately reported, according to the protocol, sponsor's SOPs, GCP, and the applicable regulatory requirement(s).
A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s), being unaware of the treatment assignment(s).
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.
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 (see ICH Guideline for structure and content of Clinical Study Reports).
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.
A written, dated, and signed agreement between two or more involved parties that sets out any arrangements regarding delegation and distribution of tasks and obligations and, if appropriate, financial matters. The protocol may serve as the basis of a contract.
Permission to examine, analyse, 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 subjects' identities and the sponsor’ s proprietary information.
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.
Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
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.
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 informed consent form and any other written information supplied to the subject.
Independent Ethics Committee (IEC)
An independent body (an institutional, regional, national, or supranational review board or committee), constituted of medical professionals and non-medical members, whose responsibility it is to ensure protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favourable opinion on the trial protocol, suitability of the investigator(s), facilities, and methods and materials to be used in obtaining and documenting informed consent of the trial subjects.
The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline.
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.
The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization’ s (CRO’ s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).
Any public or private entity or agency or medical or dental facility where clinical trials are conducted.
Institutional Review Board (IRB)
An independent body constituted of medical, scientific, and non-scientific members, whose responsibility 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 amendments and of the methods and materials to be used in obtaining and documenting informed consent of the trial subjects.
Interim clinical trial/study report
A report of intermediate results and their evaluation based on analyses performed during the course of a trial.
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.
A person responsible for the conduct of a 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 Sub-investigator.
An expression meaning ‘ the investigator and/or institution, where required by the applicable regulatory requirements’ .
Investigator's Brochure (IB)
A compilation of the clinical and nonclinical data on the investigational product(s) relevant to the study of the investigational product(s) in human subjects.
Legally acceptable representative
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 the clinical trial.
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), Good Clinical Practice (GCP), and applicable regulatory requirement(s).
A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’ s SOPs.
A clinical trial conducted according to a single protocol but at more than one site, and therefore carried out by more than one investigator.
Opinion (in relation to Independent Ethics Committee)
The judgement and/or advice provided by an Independent Ethics Committee (IEC). Subject/trial subject An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
Subject identification code
A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial- related data.
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 referenced documents. Throughout the ICH GCP Guideline the term ‘ protocol’ refers to protocol and protocol amendments.
A written description of a change(s) to, or formal clarification of, a protocol.
Quality assurance (QA)
All those planned and systematic actions that are established to ensure that a trial is performed and data generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and applicable regulatory requirement(s).
Quality control (QC)
The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.
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.
Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory authorities includes the authorities that review submitted clinical data and those that conduct inspections. These bodies are sometimes referred to as competent authorities.
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)
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,
- is a congenital anomaly/birth defect
- results in important medical events that may not be immediately life-threatening or results in death or hospitalization but may jeopardize the patient or may require intervention to prevent the other outcomes listed above.
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).
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 copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, laboratories and medico-technical departments involved in the clinical trial).
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
Standard Operating Procedures (SOPs)
Detailed, written instructions to achieve uniformity of performance of a specific function.
Study site/Trial site
The location(s) where trial-related activities are actually conducted
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 make important trial-related decisions (e.g. associates, residents, research fellows). See also Investigator.
Trial site/Study site
The location(s) where trial-related activities are actually conducted. Unexpected
Adverse Drug Reaction
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) (see the ICH guideline for clinical safety data management: Definitions and standards for expedited reporting).
Well-being (of the trial subjects)
The physical and mental integrity of the subjects participating in a clinical trial.