Clinical Trials

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Adverse drug reaction (ADR)

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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)

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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

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Any law & reg. Addressing the conduct of clinical trial of investigational product

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Approval (in relation to institutional review boards (IRB)

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IRB approval to conduct clinical trials at institution using GCP

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Audit

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Systematic & ind. exam of trail related activities &docs according to protocol, SOP, GCP

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Audit certificate

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Declaration of conformity by the auditor that audit took place

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Audit report

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Written eval. By sponsor auditor of the results of audit

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Audit trial

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Doc. That allows reconstruction of the course of events

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Blinding/ masking

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Procedure were one or more parties are kept unaware of Tx.

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Single blinding

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Subjects being unaware

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Double blinding

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Subjects & investigators, monitor (in some cases) data analyst being unaware of Tx assign.

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Case Report Form (CRF)

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Printed, optical or electronic doc design to record all of the protocol required info. To the sponsor

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Clinical trial/ study

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Investigation in human subject intended to clinical, pharm, or pharmacodyn, of investigational product

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Clinical trial/ study report

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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

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Investigational/ marketed product/ placebo used as reference in clinical trial

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Compliance(in relation to trials)

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Adherence to trial related req. GCP, and applicable reg. Req

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Compliance(in relation to trials)

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Adherence to trial related req. GCP, and applicable reg. Req

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Confidentiality

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Prevention of disclosure

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Contract

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Written, dated and signed agreement btwn 2 or more involved parties

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Coordinating committee

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Committee that sponsor may organize to conduct multicenter trial

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Coordinating Investigator

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investigator assigned the responsibility for coordinating investigation at different centers in multicenter trial

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Contract Research Organization (CRO)

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Person/org. (Commercial/academic) contracted by sponsor to perform one or more sponsor trial related duties & fxn

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Direct Access

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Permission to examine, analyze, verify reproduce any records & reports that are important for eval of clinical trial

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Documentation

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All records, in any form (written, electric, magnetic and optical records.)

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Essential documents

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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)

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Standard for design, conduct, performance, monitoring, auditing, recording, analysis & reporting of clinical trial

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Independent Data Monitoring Committee

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IDMC

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Independent Data Monitoring Committee

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IDMC

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IDMC

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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

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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

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IEC

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Independent ethics committee

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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

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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

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When subjects confirms their willingness to participate in particular trial

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Inspection

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Reg. Authorities of conducting an official review of docs. Facilities, records, CRO facilities etc

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Institution (medical)

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Public/ private entity/ agency or medical or dental facility where clinical trials conducted

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Institution (medical)

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Public/ private entity/ agency or medical or dental facility where clinical trials conducted

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Institutional Review Board (IRB)

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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

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Report of intermediate results and their evaluation based on analysts performed during course of trial

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Institution (medical)

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Public/ private entity/ agency or medical or dental facility where clinical trials conducted

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Institutional Review Board (IRB)

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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

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Report of intermediate results and their evaluation based on analysts performed during course of trial

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Investigational product

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Pharmaceutical form or an active ingredient/ placebo being tested/ used as reference

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Institution (medical)

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Public/ private entity/ agency or medical or dental facility where clinical trials conducted

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Institutional Review Board (IRB)

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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

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Report of intermediate results and their evaluation based on analysts performed during course of trial

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Investigational product

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Pharmaceutical form or an active ingredient/ placebo being tested/ used as reference

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Investigator

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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

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The investigator and/ institution required by applicable regulatory requirements

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Investigator/ institution

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The investigator and/ institution required by applicable regulatory requirements

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Investigator brochure

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Compilation of clinical & non clinical data on investigational product that is relevant to the study of investigational product

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Investigator/ institution

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The investigator and/ institution required by applicable regulatory requirements

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Investigator brochure

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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

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Individual/ juridical or other body authorized under applicable law to consent on behalf of subject

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Investigator/ institution

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The investigator and/ institution required by applicable regulatory requirements

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Investigator brochure

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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

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Individual/ juridical or other body authorized under applicable law to consent on behalf of subject

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Monitoring

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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

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Written report from the monitor to the sponsor after each site visit &/ trial related communication to sponsors SOP

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Multicenter Trial

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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

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Biomedical studies not performed on human subjects

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Opinion ( relation to independent ethics committee )

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Judgement and/ advice provided by independent ethics committee ( IEC)

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Original medical record

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Protocol

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Doc. That describes objectives, design, methods, stats, and org. Of trial and gives background and rational for trial

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Protocol amendment

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Written description of changes to or formal clarification of protocol

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Protocol amendment

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Written description of changes to or formal clarification of protocol

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Quality assurance ( QA)

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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

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Written description of changes to or formal clarification of protocol

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Quality assurance ( QA)

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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)

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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

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Written description of changes to or formal clarification of protocol

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Quality assurance ( QA)

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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)

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Operational techniques & activities undertaken w/in quality assurance system to verify the req. for quality of trial related activities

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Randomization

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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

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Written description of changes to or formal clarification of protocol

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Quality assurance ( QA)

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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)

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Operational techniques & activities undertaken w/in quality assurance system to verify the req. for quality of trial related activities

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Randomization

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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

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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)

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Unwanted medical occurrence: death, life threatening, req. inpatient hospital, prolongs hospital visit, results in persistent/ disability, congenital abnormality

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Source Data

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All info. In original records & certified copies of org. Clinical findings, observations or other activities in clinical trial

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Source document

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Original documents,data and records ( hospital records, clinical & office charts, lab notes etc )

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Sponsor

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Individual, company, institution or org . That takes responsibility for initiation, mngt/ fiancé of clinical trial

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Sponsor- investigator

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Individual who both initiates and conducts, alone/w others a clinical trial and investigational product dispensed to subject

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Monitoring plan

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Document that describes strategy, methods, responsibility and req. for monitoring the trial

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Validation of computerized system

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Process of establishing & documenting specific requirements of computerized system can be consistently fulfilled

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Standard Operating Procedure (SOP)

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Written instructions to achieve uniformity of the performance specific function

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Subinvestigator

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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

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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

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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

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Location where trial- related activities are actually conducted

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Unexpected adverse drug reaction

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Adverse reaction, the nature or severity of which is not consistent w/ applicable product info. (Inves. Brochure, )

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Vulnerable subjects

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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)

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Physical & mental integrity, of the subjects participation in a clinical trial

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Certified copy

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A copy of the data that describes context, content and structure