SOCRA Practice Test Latest Version 2023 Questions and Correct Answers ____ meCorrect Answerthe party who submits a marketing application to FDA for approval of a drug device or biologic product. - Correct AnswerClinical Investigator
_____ is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. - Correct AnswerDirect Access
"Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred" Is... - Correct AnswerLife threatening adverse drug experience
21 CFR 56 is IRB Functions and Operations? - Correct Answera. true X
- false
- Same Heading as 21 CFR 56.108
21 CFR 56 Subpart B is IRB documentation - Correct Answera. true
- False X
- 21 CFR 56 subpart B is organization and personnel
21 CFR 56.107 subpart B is IRB membership - Correct Answera. true X
- false
21 CFR 312 deals with - Correct AnswerInvestigational New Drug Application
A ____ lists the investigator's education, training, and experience that qualifies the investigator as an expert in the clinical investigation of the drug for the use under investigation. - Correct Answer1. Curriculum vitae
- Statement of qualifications of the investigator
A (n) _____ is a printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject - Correct AnswerCase Report Form, CRF
A contract research organization shall be responsible for : - Correct Answer- Control of the Drug
- Selecting Investigators
- Obtaining information from the investigators
A Phase ___ protocol is more flexible and less detailed than the others. - Correct AnswerPhase 1
A purpose of monitoring clinical trials is to verify that: - Correct AnswerThe rights, safety and well-being of human subjects are protected. 1 / 2
A significant risk device - Correct Answer- Is intended as an implant and presents a potential for serious risk to health, safety or the well-fare of the subject.
- Purported or represented to be for a use in supporting or sustaining human life and
- For use of the substantial importance of diagnosing, curing, mitigating or treating
presents a potential risk to health, safety or the well-fare of the subject.
disease or otherwise preventing impairment of human health and presents potential risk to health, safety or well-fare of the subject.
A source document is any document found that is associated with a clinical trial. - Correct Answera. true
- false X (A source document is any document where the date are FIRST recorded)
A sponsor may transfer responsibility for any of all of the obligations to a - Correct AnswerContract Research Organization (CRO)
A sponsor will not ship a study drug until they have received all of the following documents: - Correct Answer- IRB approved protocol, IRB approved informed consent form, IRB approval letter, IRB approved recruitment materials
- Signed and completed 1572, CV's and financial disclosures from everyone listed on
- Current lab certifications and normal ranges
1572
A(n) ____ is an investigation or marked product, or placebo, used as a reference in a clinical trial. - Correct AnswerComparator, Product
A(n) ______ can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. - Correct AnswerAdverse Event, AE
Before the investigation begins, the sponsor shall give each participation clinical investigator a/an _______. - Correct AnswerInvestigator Brochure
Certification of absence of financial interest would also be known as: - Correct AnswerForm 3454
If the investigator did have financial arrangement with the sponsor, he/she would
submit the following form: - Correct AnswerFDA Form 3455
In the preapproval clinical experience with a new medicinal project or its new usages, particularly as therapuyetic dose(s) may not be established: all noxious and unintended responses to a medicianal product related to any dose should be considered ____ - Correct AnswerAdverse drug reactions, ADR
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