SoCRA (Actual Exam Questions and Answers)

Electronic Records, Electronic Signatures - ANSWER CFR Title 21: Part 11 Informed Consent - ANSWER CFR Title 21: Part 50 Financial Disclosure - ANSWER CFR Title 21: Part 54 Instiutional Review Board - ANSWER CFR Title 21: Part 56 Investigational new Drug Application - ANSWER CFR Title 21: 312 New Drug Application - ANSWER CFR Title 21: 314 Investigational Device Exemption - ANSWER CFR Title 21: 812 Pre- Market Approval of Medical Devices - ANSWER CFR Title 21: 814 Protection of Human Subjects - ANSWER CFR Title 45 Part 46 Notice of Inspection - ANSWER Form 482 Inspectional observations - ANSWER Form 483 Statement from the Investigator - ANSWER Form 1572 Certification of Financial Interests - ANSWER Form 3454 Disclosure of Financial Interests - ANSWER Form 3455 Voluntary Adverse Events - ANSWER Form 3500 Mandatory Adverse Events - ANSWER Form 3500A Cover sheet for IND - ANSWER Form 1571 Protection of Human Subjects, "the Common Rule" - ANSWER CFR Title 45 Part 46 Pregnant Women and Fetuses - ANSWER CFR Title 45 Part 46 - Part B Prisoners - ANSWER CFR Title 45 Part 46 - Part C Children - ANSWER CFR Title 45 Part 46 - Part D IRB's - ANSWER CFR Title 45 Part 46 - Part E 1996 - ANSWER Date of GCP and HIPPA guidelines 1979 - ANSWER Date of Belmont Report 1947 - ANSWER Date of Nuremberg Code 1964 - ANSWER Date of Declaration of Helenski The term includes drugs and medical devices for human use. - ANSWER Test Article In a single-blind experiment, the individual subjects do not know whether they are so-called "test" subjects - ANSWER Single Blind 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 - ANSWER Double Blind Any law(s) and regulations(s) addressing the conduct of clinical trials of investigational products - ANSWER Applicable Regulatory Requirements 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. - ANSWER Audit Declaration of confirmation that an audit has taken place - ANSWER Audit Certificate A written evaluation by the sponsor's autidotr of the results of the audit - ANSWER Audit Report Documentation that allows reconstruction of the course of events - ANSWER Audit Trail 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) - ANSWER Clinical Trial or Study An investigational or marketed product, or placebo, used as a reference in a clinical trial - ANSWER Comparator (Product) Adherence to all the trial-related requirements - ANSWER Compliance A committe that a sponsor may organize to coordiante the conduct of the multicentre trial - ANSWER Coordinating Committee An investigator assigned the responsiblity for the cooridnation of investigators and different centres participaing in amulticentre trial - ANSWER Coordinating Investigator Permission to examine, analyze, verify, and reproduce any reocrds and reports taht areimportant to evaluation of a clinical trial. - ANSWER Direct Access Documents which individually and collectively permit evaluation of the conduct of a studyand teh quality fo the data produced. - ANSWER Essential Documents 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 - ANSWER IDMC - Indpendent Data Monitoring Committee 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 - ANSWER Independ Ethics Committee (IEC) any public or private entity or agency or meical or dental facility where clinical trials are conducted - ANSWER Institution 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 - ANSWER Institutional Review Board (IRB) A report of intermediate results and their evalutions during the course of a trial - ANSWER Interim clincial Trial/Study Report 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. - ANSWER Investigational Product A person responsible for the conduct of the clincial trial at a trial site. - ANSWER Investigator A compilation of the clincial and nonclincal data on the investigational prodcuts - ANSWER Investigational Brochure An individual or juridical or other body authroized under applicable law to consent on behalf of a prospective subject - ANSWER Legally Acceptable Representitive 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 - ANSWER Monitoring Biometric studies not performed on human subects - ANSWER Non Clinical Trial 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 - ANSWER Quality Assurance (QA) 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 - ANSWER Quality Control A untward emdical occurrences that may result in death, be life threatining, requires impatient or pro-longed hospitatilzation, results in persisten disaiblity/incapacity - ANSWER Serious Adverse Event 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 - ANSWER Source Data Orignial docuemnts, data, and records (hospital records) - ANSWER Source Documents An individual, company, institution, or organization which takes responsilbity for the initiation, management, and/or financing of a clinical trial - ANSWER Sponsor And inidividual who both initiates and conducts a clinical trial - ANSWER Sponsor - Investigator The location(s) where trial-related activiites are actualy conducted - ANSWER Trial Site An adverse reaction, the nature of severeity of which is not ocnsistent with the applicable product information - ANSWER Unexpected Adverse Drug Reaction 15 Calendar Days - ANSWER Serious, unexpected Adverse Drug Reactions have to be reported in how many days? 7 Calendar Days - ANSWER Fatal or Life-Threating Unexpected ADR's have to be reported in how many days?