SOCRA CCRP Exam Practice Test Questions With Complete Solutions

SOCRA CCRP Exam Practice Test Questions With Complete Solutions 21 CFR part 11 regulates? - ANSWER Electronic Signatures What is the name of FDA Form 483? - ANSWER Inspectional Observation What does 21CFR56 regulate? - ANSWER Institutional Review Boards An application for Investigational Device Exemption is part of 21 CFR part ____________? - ANSWER 812 Define Electronic Signature - ANSWER A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding equivalent of an individual's handwritten signature 21CFR50, subpart D refers to safeguards for which population? - ANSWER Children in Clinical Investigations True or False? The regulations in CFR part 11 set forth the criteria under which that agency considers electronic records, electronic signatures, and handwritten signatures to electronic records to be trustworthy, reliable and generally equivalent to paper records and handwritten signature executed on paper. - ANSWER True What does 21CFR50 regulate? - ANSWER FDA Protection of Human Subjects In 21CFR11.1, subpart A, what requirements must electronic records meet? - ANSWER They must be in accordance with part 11.2, unless paper records are specifically required Define Clinical Investigation: - ANSWER Any experiment that involves a test article and one or more human subjects and that either: - Is subject to requirements for prior submission to the FDA under section 505(i) or 520(g) - Or is not subject to requirements for prior submission but the results of which are intended to be later submitted - Or held by inspection by the FDA as a part of an application for a research or marketing permit True or False? 21CFR11.2, subpart A is only for electronic records required to be maintained that must be submitted to an agency. - ANSWER False. CFR part 11.2, subpart A is for electronic records maintenance when submitting to an agency and also when not submitting to an agency. What does 21CFR11, subpart B cover? - ANSWER Electronic Records What is another name for ICH guideline is E6? - ANSWER GCP (Good Clinical Practice) True or False? 21CFR50 refers to protection of human rights that also regulate food additives - ANSWER True. This regulation governs: - Foods, including dietary supplements, that bear a nutrient content claim or a health claim - Infant formulas - Food and color additives - Drugs for human use - Medical devices for human use - Biological products for human use - Electronic products. CFR part 50 section 312 regulates? - ANSWER Investigational New Drug When it comes to electronic signatures, how many identification components are required? Please list examples: - ANSWER At least two; identification code and password In 21CFR50, subpart A, under general provisions, which part refers to an investigational new drug? - ANSWER Part 312 IRB must register under which federal department? - ANSWER Department of Health and Human Services 21CFR50 subpart B refers to ____________________? - ANSWER Informed consent List 4 requirements that make informed consent feasible when a signature cannot be obtained prior to investigation listed in 21CFR50: - ANSWER 1. The human subject is confronted by a life-threatening situation necessitating the use of the test article. 2. Informed consent cannot be obtained from the subject because of an inability to communicate with the subject. 3. Time is not sufficient to obtain consent from the subject's LAR. 4. There is no available alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject