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88 Cards in this Set
- Front
- Back
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Adverse Drug Reaction |
New medicinal products or new usages: all noxious and unintended responses to a medicinal product related to any dose Marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, treatment, or therapy of diseases or for modification of physiological functionadver |
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Adverse Event (AE) |
Any untoward medical occurrence in a patient For clinical implications subject administered his pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal lab report finding), symptoms, or disease temporary associated with the use of a medicinal (investigational) products, whether or not related to the medicinal products |
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Applicable regulatory requirement |
Any laws and regulations addressing the conduct of clinical trials of investigation of products |
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Approval |
The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site with any constraint set forth by the IRB, The institution, good clinical practice, and applicable regulatory requirement |
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Audit |
A systematic and independent examination of trial-related activity and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to protocol, sponsor standard operating procedures, good clinical practice, and the applicable regulatory requirements |
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Audit certificate |
A declaration of confirmation by the auditor that an audit has taken place |
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Audit report |
A written evaluation of the sponsors auditor of the results of the audit |
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Audit trail |
Documentation that allows reconstruction of the course of events |
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Blinding/masking |
A procedure in which one or more parties to the trial are kept on aware of the treatment assignment. Single blinding usually refers to the subject being unaware, and double blinding and usually refers to the subject, investigator, monitor, and, in some cases, data analyst being unaware of the treatment assignment |
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Case Report Form (CRF) |
We printed, optical, or electronica document designed to record all of the protocol required information to be reported to the sponsor on each trial subject |
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Clinical trial/study |
Any investigation and human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic affects of an investigational product, and/or to identify any adverse reaction to an investigational product, and/or to study absorption, distribution, metabolism, and excretion of an investigational product with the object of ascertaining it safety and/or efficacy. The term clinical trial and clinical study are synonymous |
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Comparator (product) |
An investigational or marketed product (ie active control), or placebo, used as a reference in a clinical trial |
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Compliance (in relation to trials) |
Adherence to all the trial-related requirements, good clinical practice requirements, and the applicable regulatory requirements |
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Confidentiality |
Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity |
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Contract |
A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract |
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Coordinating committee |
The committee that I sponsor me organize to coordinate the conduct of a multi center trial |
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coordinating investigator |
An investigator assigned the responsibility for the coordination of investigators a different centers participating in a multi center trial |
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Contract research organization |
A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions. |
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Direct Access |
Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (eg 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 requirements to maintain the confidentiality of the subjects’ identities and sponsor’s proprietary t |
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Direct Access |
Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (eg 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 requirements to maintain the confidentiality of the subjects’ identities and sponsor’s proprietary t |
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Documentation |
All records, in any form (including, but not limited to , written, electronic, magnetic, and optical records, and scans, X-rays, and electrocardiograph) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken |
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Essential documents |
Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced |
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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 the trial subjects are protected |
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Independent data monitoring committee (IDMC) (data safety monitory board, monitoring committee, data monitoring committee) |
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 |
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Independent data monitoring committee (IDMC) (data safety monitory board, monitoring committee, data monitoring committee) |
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 |
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Impartial witness |
A person, who is independent of the trial, who cannot be unfairly influenced by Ripken involved with the trial, who attends the informed consent process of the subject or subjects legally authorized representative cannot read, and who reads the informed consent form and any other written information supplied to the subject |
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Independent Ethics Committee (IEC) |
An independent body (a review board or a committee, institutional, regional, national, or supranational), 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 provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigators, the facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects |
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Informed consent |
The 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. Inform consent is documented by means of a written, sign, and dated informed consent form |
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Inspection |
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 (CROs) facilities, or at other establishments deemed appropriate by the regulatory authority(ies) |
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Institution (medical) |
Any public or private entity or agency or medical or dental facility where clinical trials are conducted |
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Institution (medical) |
Any public or private entity or agency or medical or dental facility where clinical trials are conducted |
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Institutional review board (IRB) |
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 protocols and amendments and of the methods and materials to be used in obtaining and documenting informed consent of the trial subjects |
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Interim clinical trial/study report |
A report of intermediate results and their evaluation based on analyses performed during the course of a trial |
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Interim clinical trial/study report |
A report of intermediate results and their evaluation based on analyses performed during the course of a trial |
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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 a jagged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an improved use |
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Interim clinical trial/study report |
A report of intermediate results and their evaluation based on analyses performed during the course of a trial |
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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 a jagged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an improved use |
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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 |
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Investigator/institution |
An expression meaning the “investigator and/or institution, where required by the applicable regulatory requirements” |
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Investigator’s brochure |
A complication of the clinical and non clinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects |
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Investigator’s brochure |
A complication of the clinical and non clinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects |
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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 |
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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, GCP, and the applicable regulatory requirements |
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Monitoring report |
A written report from the monitor to the sponsor after each site visit and/or trial-related communication according to the sponsor’s SOPs |
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Monitoring report |
A written report from the monitor to the sponsor after each site visit and/or trial-related communication according to the sponsor’s SOPs |
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Multicenter trial |
A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator |
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Monitoring report |
A written report from the monitor to the sponsor after each site visit and/or trial-related communication according to the sponsor’s SOPs |
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Multicenter trial |
A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator |
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Nonclinical study |
Biomedical studies not performed on human subjects |
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Opinion (in relation to independent ethics committee) |
The judgement and/or the advice provided by an independent ethics committee |
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Opinion (in relation to independent ethics committee) |
The judgement and/or the advice provided by an independent ethics committee |
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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 another protocol referenced documents. Throughout the ICH GCP guidance, the term protocol refers to protocol and protocol amendments |
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Opinion (in relation to independent ethics committee) |
The judgement and/or the advice provided by an independent ethics committee |
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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 another protocol referenced documents. Throughout the ICH GCP guidance, the term protocol refers to protocol and protocol amendments |
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Protocol amendment |
A written description of a change(s) to or formal clarification of a protocol |
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Opinion (in relation to independent ethics committee) |
The judgement and/or the advice provided by an independent ethics committee |
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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 another protocol referenced documents. Throughout the ICH GCP guidance, the term protocol refers to protocol and protocol amendments |
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Protocol amendment |
A written description of a change(s) to or formal clarification of a protocol |
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Quality assurance (QA) |
All those planned and systematic actions that are established to ensure that the trial is performed and the data are gathered, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirements |
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Opinion (in relation to independent ethics committee) |
The judgement and/or the advice provided by an independent ethics committee |
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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 another protocol referenced documents. Throughout the ICH GCP guidance, the term protocol refers to protocol and protocol amendments |
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Protocol amendment |
A written description of a change(s) to or formal clarification of a protocol |
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Quality assurance (QA) |
All those planned and systematic actions that are established to ensure that the trial is performed and the data are gathered, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirements |
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Quality control (QC) |
The operational techniques and activities undertaken with the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled |
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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 |
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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 |
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Regulatory Authorities |
Bodies having the power to regulate. In the ICH GCP guidance, 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 |
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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 -is a congenital anomaly/birth defect |
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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 -is a congenital anomaly/birth defect |
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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) |
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Source document |
Original documents, data, and records (eg 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, at the laboratories and at medico-technical departments involved in the clinical trial |
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Sponsor |
An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial |
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Sponsor-Investigator |
An individual who both initiated and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (eg it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator |
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Standard operating procedures (SOPs) |
Detailed, written instructions to achieve uniformity of the performance of a specific function |
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Subinvestigator |
Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform clinical trial-related procedures and/or to make important trial-related decisions (eg associates, residents, research fellows) |
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Subinvestigator |
Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform clinical trial-related procedures and/or to make important trial-related decisions (eg associates, residents, research fellows) |
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Subject/trial subject |
An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control |
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Subject identification code |
A unique identifier assigned by the investigator to each trial subject to protect the subjects identify and used in lieu of the subject’s name when the investigator reports adverse events and/or other trial-related data |
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Subject identification code |
A unique identifier assigned by the investigator to each trial subject to protect the subjects identify and used in lieu of the subject’s name when the investigator reports adverse events and/or other trial-related data |
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Trial site |
The location(s) where trial-related activities are actually conducted |
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Unexpected adverse drug reaction |
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (eg Investigator’s Brochure for an approved product) |
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Unexpected adverse drug reaction |
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (eg Investigator’s Brochure for an approved product) |
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Vulnerable subjects |
Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent |
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Well being (of the trial subjects) |
The physical and mental integrity of the subjects participating in a clinical trial |
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Certified copy |
A copy (irrespective of the type of media used) of the original record that had been verified (ie by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original |
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Certified copy |
A copy (irrespective of the type of media used) of the original record that had been verified (ie by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original |
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Monitoring plan |
A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial |
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Validation of computerized systems |
A process of establishing and documenting that the specified requirements of a computerized system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The approach to validation should be based on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results |
