SoCRA (Actual Exam Graded A+)

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