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
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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
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