Electronic Records SoCRA Flashcards
63 test answers
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Investigational new Drug Application
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CFR Title 21: 312
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New Drug Application
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CFR Title 21: 314
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Investigational Device Exemption
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CFR Title 21: 812
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Pre- Market Approval of Medical Devices
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CFR Title 21: 814
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Protection of Human Subjects
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CFR Title 45 Part 46
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Notice of Inspection
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Form 482
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Inspectional observations
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Form 483
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Statement from the Investigator
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Form 1572
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Certification of Financial Interests
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Form 3454
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Disclosure of Financial Interests
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Form 3455
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Voluntary Adverse Events
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Form 3500
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Mandatory Adverse Events
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Form 3500A
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Cover sheet for IND
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Form 1571
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Protection of Human Subjects, \"the Common Rule\"
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CFR Title 45 Part 46
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Pregnant Women and Fetuses
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CFR Title 45 Part 46 - Part B
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Prisoners
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CFR Title 45 Part 46 - Part C
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Children
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CFR Title 45 Part 46 - Part D
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IRB's
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CFR Title 45 Part 46 - Part E
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1996
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Date of GCP and HIPPA guidelines
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1979
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Date of Belmont Report
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1947
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Date of Nuremberg Code
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1964
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Date of Declaration of Helenski
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The term includes drugs and medical devices for human use.
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Test Article
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In a single-blind experiment, the individual subjects do not know whether they are so-called \"test\" subjects
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Single Blind
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In a double-blind experiment, neither the participants nor the researchers know which participants belong to the control group, as opposed to the test group
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Double Blind
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Any law(s) and regulations(s) addressing the conduct of clinical trials of investigational products
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Applicable Regulatory Requirements
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A systematic and independ examination of trial related activities and documents to determine whether th evaluated trial realted activiites were conducted and the data were recorded, anaylzed and accurately reported according to the protocol, SOPs, GCPs, and regulatory requirements.
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Audit
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Declaration of confirmation that an audit has taken place
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Audit Certificate
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A written evaluation by the sponsor's autidotr of the results of the audit
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Audit Report
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Documentation that allows reconstruction of the course of events
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Audit Trail
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Any investigation in human subject inteded to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s) and/or identify any adverse reactions to an investigational product(s)
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Clinical Trial or Study
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An investigational or marketed product, or placebo, used as a reference in a clinical trial
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Comparator (Product)
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Adherence to all the trial-related requirements
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Compliance
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A committe that a sponsor may organize to coordiante the conduct of the multicentre trial
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Coordinating Committee
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An investigator assigned the responsiblity for the cooridnation of investigators and different centres participaing in amulticentre trial
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Coordinating Investigator
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Permission to examine, analyze, verify, and reproduce any reocrds and reports taht areimportant to evaluation of a clinical trial.
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Direct Access
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Documents which individually and collectively permit evaluation of the conduct of a studyand teh quality fo the data produced.
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Essential Documents
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a committe established by the sponsor to assess at itervals the progress of a clincial trial, the safety data, and the critical efficacy endpoints, and to recommed to the sponsor whether to continue, modify, or stop a trial
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IDMC - Indpendent Data Monitoring Committee
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an independed bodythat is constituted of medical and non-medical members, whose responsiblity is to ensure the protection of the rights, safety and well-being of human subjects invovled in a trial and to provide public assurance of that protection by, among other things reviewing and approving the trial protocol, the suitability of the investigators, facilities, methods of consent
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Independ Ethics Committee (IEC)
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any public or private entity or agency or meical or dental facility where clinical trials are conducted
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Institution
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An independent body constituted of medical, scientific, and non-scientific members, whose responsiblity is to ensure the protection of the rights, safety, and well-being of human subject invovled ian trail by, among other things, reviewing approving and prividing continuing review of trial protocol
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Institutional Review Board (IRB)
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A report of intermediate results and their evalutions during the course of a trial
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Interim clincial Trial/Study Report
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A pharmaceutical form of an active ingredient or placebo, being tested or used as a reference in a clincial trial, including a product with a amrketing authroization when used or assembled in a way different from the approvedform.
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Investigational Product
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A person responsible for the conduct of the clincial trial at a trial site.
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Investigator
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A compilation of the clincial and nonclincal data on the investigational prodcuts
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Investigational Brochure
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An individual or juridical or other body authroized under applicable law to consent on behalf of a prospective subject
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Legally Acceptable Representitive
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The act of overseeing the progress of a clinical trial, and ensuring that it is ocnducted, recorded, and reported in a accordiance with the protocol, SOPs, GCP, and regulatory requirements
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Monitoring
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Biometric studies not performed on human subects
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Non Clinical Trial
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All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documetned, and reported in compliance with GCP and regulatory requirements
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Quality Assurance (QA)
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The operational techniques and activities, undertaken within the quality assurance system to verify the requriements for quality of the trial-related activities ahve been fulfilled
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Quality Control
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A untward emdical occurrences that may result in death, be life threatining, requires impatient or pro-longed hospitatilzation, results in persisten disaiblity/incapacity
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Serious Adverse Event
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All information in orignal records and certified copies of original records of clincal findings, observations, or other activities ina clinical trial necessary for the reconstruction and evaluation of the trial
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Source Data
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Orignial docuemnts, data, and records (hospital records)
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Source Documents
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An individual, company, institution, or organization which takes responsilbity for the initiation, management, and/or financing of a clinical trial
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Sponsor
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And inidividual who both initiates and conducts a clinical trial
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Sponsor - Investigator
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The location(s) where trial-related activiites are actualy conducted
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Trial Site
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An adverse reaction, the nature of severeity of which is not ocnsistent with the applicable product information
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Unexpected Adverse Drug Reaction
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15 Calendar Days
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Serious, unexpected Adverse Drug Reactions have to be reported in how many days?
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7 Calendar Days
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Fatal or Life-Threating Unexpected ADR's have to be reported in how many days?
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