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96 Cards in this Set
- Front
- Back
Adverse drug reaction (ADR) |
During preapproval clinical exp. all noxious and unintended responses related to causal relationship btwn medical product and adverse event |
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Adverse Event (AE) |
Any unfavorable/unintended sign (abn. Lab findings) symptom, or dx temp. Associated with investigational product a |
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Amendment (to protocol) |
—— |
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Applicable reg. Requirement |
Any law & reg. Addressing the conduct of clinical trial of investigational product |
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Approval (in relation to institutional review boards (IRB) |
IRB approval to conduct clinical trials at institution using GCP |
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Audit |
Systematic & ind. exam of trail related activities &docs according to protocol, SOP, GCP |
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Audit certificate |
Declaration of conformity by the auditor that audit took place |
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Audit report |
Written eval. By sponsor auditor of the results of audit |
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Audit trial |
Doc. That allows reconstruction of the course of events |
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Blinding/ masking |
Procedure were one or more parties are kept unaware of Tx. |
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Single blinding |
Subjects being unaware |
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Double blinding |
Subjects & investigators, monitor (in some cases) data analyst being unaware of Tx assign. |
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Case Report Form (CRF) |
Printed, optical or electronic doc design to record all of the protocol required info. To the sponsor |
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Clinical trial/ study |
Investigation in human subject intended to clinical, pharm, or pharmacodyn, of investigational product |
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Clinical trial/ study report |
Written description of trial/study of any therapeutic, prophylactic, or dx agent in human subjects. Report has clinical, stats, presentation, and analysis |
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Comparator |
Investigational/ marketed product/ placebo used as reference in clinical trial |
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Compliance(in relation to trials) |
Adherence to trial related req. GCP, and applicable reg. Req |
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Compliance(in relation to trials) |
Adherence to trial related req. GCP, and applicable reg. Req |
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Confidentiality |
Prevention of disclosure |
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Contract |
Written, dated and signed agreement btwn 2 or more involved parties |
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Coordinating committee |
Committee that sponsor may organize to conduct multicenter trial |
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Coordinating Investigator |
investigator assigned the responsibility for coordinating investigation at different centers in multicenter trial |
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Contract Research Organization (CRO) |
Person/org. (Commercial/academic) contracted by sponsor to perform one or more sponsor trial related duties & fxn |
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Direct Access |
Permission to examine, analyze, verify reproduce any records & reports that are important for eval of clinical trial |
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Documentation |
All records, in any form (written, electric, magnetic and optical records.) |
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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 |
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Good clinical practice (GCP) |
Standard for design, conduct, performance, monitoring, auditing, recording, analysis & reporting of clinical trial |
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Independent Data Monitoring Committee |
IDMC |
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Independent Data Monitoring Committee |
IDMC |
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IDMC |
Independent data monitoring committee established by sponsor to asses @ intervals of clinical trials, safety data decreased clinical efficacy endpoint |
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Impartial Witness |
Person independent of the trial, can’t be unfairly influenced by people involved in the trial who attends informed consent process of subject/legal rep. Can’t read |
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Independent ethics committee |
IEC |
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Independent ethics committee |
Independent body/ review board or committee of medical prof. To ensure protection of rights and well being of human subjects |
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Independent ethics committee |
Independent body/ review board or committee of medical prof. To ensure protection of rights and well being of human subjects |
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Informed consent |
When subjects confirms their willingness to participate in particular trial |
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Inspection |
Reg. Authorities of conducting an official review of docs. Facilities, records, CRO facilities etc |
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Institution (medical) |
Public/ private entity/ agency or medical or dental facility where clinical trials conducted |
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Institution (medical) |
Public/ private entity/ agency or medical or dental facility where clinical trials conducted |
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Institutional Review Board (IRB) |
Independent body that has medical, scientific & non-scientific members resp. To protect the rights safety and well being of human subjects involved in trial |
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Interim clinical trial/study report |
Report of intermediate results and their evaluation based on analysts performed during course of trial |
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Institution (medical) |
Public/ private entity/ agency or medical or dental facility where clinical trials conducted |
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Institutional Review Board (IRB) |
Independent body that has medical, scientific & non-scientific members resp. To protect the rights safety and well being of human subjects involved in trial |
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Interim clinical trial/study report |
Report of intermediate results and their evaluation based on analysts performed during course of trial |
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Investigational product |
Pharmaceutical form or an active ingredient/ placebo being tested/ used as reference |
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Institution (medical) |
Public/ private entity/ agency or medical or dental facility where clinical trials conducted |
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Institutional Review Board (IRB) |
Independent body that has medical, scientific & non-scientific members resp. To protect the rights safety and well being of human subjects involved in trial |
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Interim clinical trial/study report |
Report of intermediate results and their evaluation based on analysts performed during course of trial |
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Investigational product |
Pharmaceutical form or an active ingredient/ placebo being tested/ used as reference |
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Investigator |
Person responsible for the conduct or clinical trial @ trial site (if done by team, then investigator is the leader) |
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Investigator/ institution |
The investigator and/ institution required by applicable regulatory requirements |
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Investigator/ institution |
The investigator and/ institution required by applicable regulatory requirements |
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Investigator brochure |
Compilation of clinical & non clinical data on investigational product that is relevant to the study of investigational product |
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Investigator/ institution |
The investigator and/ institution required by applicable regulatory requirements |
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Investigator brochure |
Compilation of clinical & non clinical data on investigational product that is relevant to the study of investigational product |
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Legally acceptable representatives |
Individual/ juridical or other body authorized under applicable law to consent on behalf of subject |
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Investigator/ institution |
The investigator and/ institution required by applicable regulatory requirements |
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Investigator brochure |
Compilation of clinical & non clinical data on investigational product that is relevant to the study of investigational product |
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Legally acceptable representatives |
Individual/ juridical or other body authorized under applicable law to consent on behalf of subject |
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Monitoring |
Act of overseeing the progress of clinical trial, ensuring it’s conducted, recorded and reported in accordance w/ protocol m, SOP, GCP |
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Monitoring report |
Written report from the monitor to the sponsor after each site visit &/ trial related communication to sponsors SOP |
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Multicenter Trial |
Clinical trial conducted according to single protocol but at more than one site, and carried out by more than one investigator |
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Non clinical study |
Biomedical studies not performed on human subjects |
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Opinion ( relation to independent ethics committee ) |
Judgement and/ advice provided by independent ethics committee ( IEC) |
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Original medical record |
——- |
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Protocol |
Doc. That describes objectives, design, methods, stats, and org. Of trial and gives background and rational for trial |
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Protocol amendment |
Written description of changes to or formal clarification of protocol |
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Protocol amendment |
Written description of changes to or formal clarification of protocol |
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Quality assurance ( QA) |
Planned & systematic actions to ensure the trial is performed & data are generated, doc recorded, reported in compliance w/ GCP and applicable requirements |
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Protocol amendment |
Written description of changes to or formal clarification of protocol |
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Quality assurance ( QA) |
Planned & systematic actions to ensure the trial is performed & data are generated, doc recorded, reported in compliance w/ GCP and applicable requirements |
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Quality control ( QC) |
Operational techniques & activities undertaken w/in quality assurance system to verify the req. for quality of trial related activities |
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Protocol amendment |
Written description of changes to or formal clarification of protocol |
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Quality assurance ( QA) |
Planned & systematic actions to ensure the trial is performed & data are generated, doc recorded, reported in compliance w/ GCP and applicable requirements |
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Quality control ( QC) |
Operational techniques & activities undertaken w/in quality assurance system to verify the req. for quality of trial related activities |
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Randomization |
Process of assigning trial subjects to treatment/ control group using element of chance to determine the assign in order to reduce bias |
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Protocol amendment |
Written description of changes to or formal clarification of protocol |
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Quality assurance ( QA) |
Planned & systematic actions to ensure the trial is performed & data are generated, doc recorded, reported in compliance w/ GCP and applicable requirements |
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Quality control ( QC) |
Operational techniques & activities undertaken w/in quality assurance system to verify the req. for quality of trial related activities |
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Randomization |
Process of assigning trial subjects to treatment/ control group using element of chance to determine the assign in order to reduce bias |
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Regulatory authorities |
Bodies having the power to regulate. ICH GCP guidance, authorities that review submitted clinical data and those that conduct inspections called Competent authorities |
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Serious adverse events (SAE) |
Unwanted medical occurrence: death, life threatening, req. inpatient hospital, prolongs hospital visit, results in persistent/ disability, congenital abnormality |
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Source Data |
All info. In original records & certified copies of org. Clinical findings, observations or other activities in clinical trial |
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Source document |
Original documents,data and records ( hospital records, clinical & office charts, lab notes etc ) |
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Sponsor |
Individual, company, institution or org . That takes responsibility for initiation, mngt/ fiancé of clinical trial |
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Sponsor- investigator |
Individual who both initiates and conducts, alone/w others a clinical trial and investigational product dispensed to subject |
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Monitoring plan |
Document that describes strategy, methods, responsibility and req. for monitoring the trial |
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Validation of computerized system |
Process of establishing & documenting specific requirements of computerized system can be consistently fulfilled |
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Standard Operating Procedure (SOP) |
Written instructions to achieve uniformity of the performance specific function |
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Subinvestigator |
Any individual member of clinical trial team designated and supervised by investigator at trial site to perform critical trial related procedure |
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Subject/trial subject |
An individual who participates in a clinical trial, either as a recipient of the investigational product or as a control |
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Subject identification code |
Unique identifier assigned but investigation to each trial subject to protect the subjects identity & used in lieu of the subjects name |
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Trial site |
Location where trial- related activities are actually conducted |
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Unexpected adverse drug reaction |
Adverse reaction, the nature or severity of which is not consistent w/ applicable product info. (Inves. Brochure, ) |
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Vulnerable subjects |
Individual whose willingness to volunteer in trial can be influenced to participate (ex: medical students, military, nursing homes, incurable dx) |
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Well-being (of trial subjects) |
Physical & mental integrity, of the subjects participation in a clinical trial |
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Certified copy |
A copy of the data that describes context, content and structure |