SOCRA Practice Test Questions and answers already graded A+| Updated & Verified | 2024, Exams of Finance

Download SOCRA Practice Test Questions and answers already graded A+| Updated & Verified | 2024 and more Exams Finance in PDF only on Docsity! SOCRA Practice Test Questions and answers already graded A+| Updated & Verified | 2024 Which of the following is a disclosure of financial interests form? - ✔✔FDA Form 3455 Which of the following is a certification of financial interest form? - ✔✔FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - ✔✔FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - ✔✔Investigational New Drug Application (1571) In the top right corner, form have OMB number. What does it stand for? - ✔✔Office of Management and Budget The form, which is submitted to the FDA to report an Adverse Event is - ✔✔3500 Medical device adverse events/problems are reported via a form: - ✔✔3500A What is FDA form 1571? - ✔✔Cover-sheet for Investigational New Drug Applications 21 CFR 312 deals with - ✔✔Investigational New Drug Application Investigational new drug means - ✔✔A new drug or biological drug that is used in a clinical investigation The immediate package of an investigational new drug intended for human use shall bear a label with the statement - ✔✔"Caution: New Drug—Limited by Federal (or United States) law to investigational use." Which of the following is not listed on FDA form 1571: - ✔✔Approved informed consent document "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... - ✔✔Life threatening adverse drug experience What are the three main basic ethical principles of the Belmont Report? - ✔✔1. Respect for Persons 2. Beneficence 3. Justice What are the applications for the Belmont Report? - ✔✔1. Informed Consent 2. Assessment of Risk and Benefits 3. Selection of Subjects What phrase of a drug trial usually includes hundreds to thousands of volunteers? - ✔✔Phase 3: These studies gather more information about safety and effectiveness, study different populations and different dosages, and uses the drug in combination with other drugs. b. Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety, or welfare of a subject. c. for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject. Answer: All the above A purpose of monitoring clinical trials is to verify that: - ✔✔The rights, safety and well-being of human subjects are protected. A sponsor may transfer responsibility for any of all of the obligations to a - ✔✔Contract Research Organization (CRO) A contract research organization shall be responsible for : - ✔✔- Control of the Drug - Selecting Investigators - Obtaining information from the investigators The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation's course and for ____ following the study's completion. - ✔✔1 year The contract research organization shall select a monitor that is ________________. - ✔✔-Qualified by experience - Qualified by training 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. - ✔✔1. Curriculum vitae 2. Statement of qualifications of the investigator The sponsor shall monitor investigations to identify when an IRB determines that it cannot approve the research because it does not meet the criteria for exception or because of other relevant eithical concerns - ✔✔a. true X b. false Before the investigation begins, the sponsor shall give each participation clinical investigator a/an _______. - ✔✔Investigator Brochure ____ means the party who submits a marketing application to FDA for approval of a drug device or biologic product. - ✔✔Clinical Investigator The applicant must completely and accurately disclose or certify information concerning the financial interests of a clinical investigator who is a full-time or part-time employee of the sponsor for each covered clinical study. - ✔✔a. true b. false X - Must Disclose everyone, not just those who are full time or part time. What is an informed consent? - ✔✔What is informed consent? consent given by a patient to a procedure after understanding the facts and the risks What is 21 CFR 56.109 subpart C? - ✔✔IRB review of research 21 CFR 56 Subpart B is IRB documentation - ✔✔a. true b. False X - 21 CFR 56 subpart B is organization and personnel The form ___ is used for investigational new drugs (or IND) - ✔✔1571 What is 21 CFR 50.25 Subpart B? - ✔✔Elements of Informed Consent The "Doctor's Trial" prompted the Belmont Report - ✔✔a. true b. false X What is 21 CFR 50.27? - ✔✔Documentation of informed consent The objective of the ICH GCP Guideline is to provide a unified standard for the European Union (EU, Japan and the Untied States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions - ✔✔a. true X b. false 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 ____ - ✔✔Adverse drug reactions, ADR What do the HHS stand for? - ✔✔Department of Health and Human Services What is 21 CFR 50.20 subpart B? - ✔✔General Requirements for Informed Consent Requirements for Emergency Research When a short form is used for Informed Consent, the partient signs the short form ONLY and the receives a copy of both the summary and the short form - ✔✔a. true X b. false What is 45 CFR 46 subpart A? - ✔✔Basic HHS policy for Protection of Human Research Subjects This form is used for the voluntary reporting of adverse events and product problems - ✔✔3500, FDA 3500 The Code of Federal Regulations that applies to investigational new drug application is: - ✔✔21 CFR 312 What does 21 CFR 54 deal with? - ✔✔Financial Disclosure of clinical investigators A(n) ____ is an investigation or marked product, or placebo, used as a reference in a clinical trial. - ✔✔Comparator, Product What is the FDA form 3454? - ✔✔Certification - Financial Interests and Arrangements of Clinical Investigators What is a person or an organization (commercial, academic, or other) contracted by the sponsor of a clinical trial to perform one or more trial-related duty and function? - ✔✔CRO - Contracted Research Organization The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as - ✔✔Good Clinical Practice (GCP) What is 21 CFR 50/51 subpart D? - ✔✔Clinical investigations not involving greater than minimal risk- children - Remember that ALL sections under subpart D of 21 CFR 50 deal with children - the heading for all of subpart D is additional Safeguards for children in clinical Investigations What is 21 CFR 50.54 Subpart D? - ✔✔Clinical investigations not otherwise approvable that presents an opportunity to understand, prevent or alleviate a serious problem affecting the health or welfare of children. What is 21 CFR50 subpart D? - ✔✔Additional Safeguards for Children in Clinical Investigations The Code of Federal regulations that applies to the Protection of Human Subjects is - ✔✔45 CFR 46 What are the three fundamental ethical principals for human subjects research - ✔✔1. respect for persons 2. beneficience 3. justice The FDA form 483 is used for: - ✔✔Inspectional Observations 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. - ✔✔Adverse Event, AE What is 21 CFR50 subpart B? - ✔✔Protection of Human Subjects The IRB may, for some or all subject, waive the requirement hat the subject, or the subjects legally authorized representative, sign a written consent form if it finds that the research presents more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context - ✔✔a. true b. false X - The IRB may. for some or all subjects, waive the requirement that the subjects or the subject's legally authorized representative, sign a written consent form if it finds the research presents NO more than minimal risk. The IRB may not do this for research that is more than minimal risk. Which of the following is 21 CFR 56.106 Subpart B? - ✔✔Registration What is 21 CFR50.52 Subpart D? - ✔✔Clinical investigations involving greater than minimal risk, but presenting the prospect of direct benefit to individual subjects children Providing a unified standard for Europe, US, and Japan to facilitate the acceptance of clinical trials is the... - ✔✔Mission statement of GCP Guidelines What is 45 CFR46 Subpart C? - ✔✔Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects. Under 21 CFR312, this form is the statement of the investigator of a clinical trial - ✔✔1572 21 CFR 56.107 subpart B is IRB membership - ✔✔a. true X b. false The code of federal regulations that applies to Institutional Review boards is - ✔✔21 CFR 56 Which of the following is IRB Functions and Regulations - ✔✔21 CFR 56.108 Subpart C What is 21 CFR 50.50 subpart D - ✔✔IRB Duties What is 21 CFR 50.56 subpart D? - ✔✔Wards What are the three fundamental ethical principals for human subjects research? - ✔✔Justice Respect for Persons Beneficence 21 CFR 56 is IRB Functions and Operations? - ✔✔a. true X b. false - Same Heading as 21 CFR 56.108 What is 21 CFR 50.27 Subpart B? - ✔✔Documentation of informed consent