SOCRA CCRP ACTUAL EXAM 2025, Exams of Nursing

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SOCRA CCRP ACTUAL EXAM QUESTIONS AND ANSWERS 2025

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

In 21CFR50.24, when there has been exception from informed consent for emergency research, the proposed investigational plan must be based on in order for this exception to occur? - answer-Scientific Evidence What is the name of FDA Form 482? - answer-Notice of Inspection True or False? The rights, safety and well-being of the trial subjects are the most important consideration and should prevails over the interests of science and society - answer-True All principles of GCP are conducted in accordance with

. - answer-The Declaration of Helsinki True of False? ICH GCP principle 2.10 gives guidance about informed consent - answer-False. This principle covers guidelines referring to clinical trial information (data) and how it should be accurate in reporting, interpretation and verification. Principle 2.9 gives guidance about informed consent. What is the name of FDA Form 3455? - answer-Disclosures: Financial interests and arrangements of clinical investigators In 21CFR50, subpart B, there are basic elements of informed consent. - answer- 8 How many members of an IRB are required to have a non-scientific background - answer-At least 1 member What is the name of FDA Form 1572? - answer-Statement of Investigator The Assent of a child is not necessary when these 2 conditions are present: - answer-1. The capability of some or all of the children is so limited that they cannot be reasonably consulted

2. The intervention holds a prospect of direct benefit that is important to the health or well being of the child and is only available in the context of clinical investigation

What is the name of FDA Form 3500? - answer-For voluntary reporting of an adverse event and product problems Under 21CFR56, Emergency Use is defined as? - answer-The use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and which there is not sufficient time to get IRB approval IRB approval is granted when the following is determined: - answer-The determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements. True of False? Individuals invited to consult with the IRB on complex issues are allowed to vote as well. - answer-False. These members may not vote with the IRB When can the IRB determine if expedited review can be used to approve a clinical investigation? (2 responses) - answer-1) Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk

2. Minor changes in previously approved research during the period (of 1 year or less) for which approval is authorized. What is the name of FDA Form 3454? - answer-Certification: Financial interests and arrangements of clinical investigators Define Minimal Risk - answer-The probability and magnitude of the harm or discomfort anticipated in the research are not greater in and of themselves than ordinarily encountered in daily life. When can the IRB suspend or terminate approval? - answer-When research is not being conducted in accordance with IRB's requirements or that has been associated with unexpected serious harm to subjects Name the 8 basic elements of informed consent - answer-1. A statement that the study involves research

B. Clinical investigations involving greater than minimal risk and no prospect of direct benefit to the individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition - children C. Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health of welfare of children D. IRB Duties - children - answer-B. Clinical investigations involving greater than minimal risk and no prospect of direct benefit to the individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition - children True or False? The objective of the ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. - answer-True What is the person or organization (commercial, academic, or other) contracted by the sponsor of the clinical trial to perform one or more trial-related duty and function? - answer-Contract Research Organization (CRO) What is 21CFR56.106 Subpart B? A. IRB Membership (Organization and Personnel) B. IRB Functions and Operations C. IRB Records and Reports D. IRB Administration Actions for Noncompliance - answer-A. IRB Membership (Organization and Personnel) The Code of Federal Regulations that applies to Investigational New Drug Applications is 21CFR. - answer- 312

What is 21CFR56.109 Subpart C? A. IRB functions and Operations B. IRB review of research C. Criteria for IRB approval of research D. Expedited review procedures for certain kinds of research involving no more than minimal risks, and for minor changes in approved research - answer-B. IRB review of research A sponsor may transfer responsibility for any or all of the obligations to a(n)

. - answer-CRO (Contract Research Organization) What is 21CFR50.51 Subpart D? A. Wards B. Clinical Investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects - children C. Clinical investigations for not involving greater than minimal risk - children D. Clinical Investigations involving greater than minimal risk but presenting the prospect of no direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition - children - answer-C. Clinical Investigations not involving greater than minimal risk - children The code of Federal Regulations that applies to the HHS Protection of Human Subjects is . - answer-45CFR

HHS stands for. - answer-Department of Health and Human Services What is 21CFR50.55 Subpart D? A. Clinical Investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. B. IRB duties - children C. Clinical Investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition - children D. Requirements for permission by parents or guardians and for assent by children. - answer-D. Requirements for permission by parents or guardians and for assent by children. 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.

• answer- 1 year The contract research organization shall select a monitor that is qualified by and. - answer-1. Experience

2. Training Before the investigation begins, the sponsor shall give the participating clinical investigator a(n) . - answer-Investigators' Brochure A and lists the investigator's education, training and experience that qualifies the investigator as an expert in the clinical investigation of the drug for use under investigation. - answer-1. Curriculum vitae (CV)
3. Statement of qualifications of the investigator

True or False? 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 ethical concerns - answer-True The minimum number of Institutional Review Board (IRB) member is: - answer- 5 Under 21 CFR 312, form is the statement of the investigator - answer- 1572 What does 21CFR54 regulate? - answer-Financial disclosure by Clinical Investigators The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. What is the new dosage? - answer- 77 The responsibility for ensuring that the investigator understands a clinical trial lies with

. - answer-The sponsor A purpose of monitoring clinical trials to verify that: - answer-The rights, safety, and well-being of human subjects are protected What is 21 CFR 50.56 Subpart D? - answer-Wards True or False? The 'Doctor's Trial prompted the Belmont Report - answer-False. The Belmont Report was prompted by Tuskegee Syphilis Study Name significant device risks: (3 responses) - answer-1. Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to health, safety, or the well-fare of the subject

2. Is intended as an implant and presents a potential for serious risk to health, safety, or the well-fare of the subject
3. For use of the substantial importance of diagnosing, curing, mitigating or treating disease or otherwise preventing impairment and presents potential risk to health, safety, or well-fare of the subject

What is 21 CFR 50.24, subpart B? A. Exception from general requirements B. Elements of informed consent C. Exception from informed consent requirements for emergency research D. Documentation of informed consent - answer-C. Exception from Informed Consent Requirements for emergency research Which design method would be used for a study interested in keeping both the subject and the investigator (or site staff) from knowing which treatment the subject was receiving? - answer-Double Blinded What is the federal department responsible for helping people of Canada maintain and improve their health? - answer-Health Canada Which persons(s) or agency would not be informed of the treatment assignment for a given subject that was using a single blind method randomization? - answer-The subject What is 45CFR46? - answer-HHS - Protection of Human Subjects Name the responsibility that falls under the jurisdiction of the Food and Drug Administration (FDA) - answer-Oversight of regulation adherence in clinical trials Name the 21CFR the regulates IRB Functions and Operations. A. 21CFR56.1- 3 Subpart A B. 21CFR56.106 Subpart B C. 21CFR56.108 Subpart C D. 21CFR56.1115 Subpart D - answer-C. 21CFR56.108 Subpart C

means any board, committee, or other group formally designated by an institution to review biomedical research involving subjects - answer-Institutional Review Board (IRB) What is the minimum number of IRB members? - answer- 5 What does CBER stand for? - answer-Center for Biologics Evaluation and Research What is 21CFR50 Subpart B - answer-Informed Consent of Human Subjects The sponsor shall notify the FDA by telephone or fax of any unexpected fatal or life-threatening experience associated with the use of the drug as soon as possible, but no later than after the sponsor's initial receipt of the information - answer- 7 calendar days (this is NOT working days) 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 0r not related to the medicinal (investigational) product - answer- Adverse Event (AE) IDE stands for. - answer-Investigational device exemption The three fundamental ethical principles for human subjects' research are: - answer-1. Respect for Persons

2. Beneficence
3. Justice The Code of Federal Regulations that applies to electronic signatures is: - answer-21CFR What is 45CFR46 Subpart C? - answer-Additional protections pertaining to biomedical and behavioral research involving prisoners as subjects What is 21CFR50.27 Subpart B? - answer-Documentation of informed consent

What is 21CFR50.23 Subpart B? - answer-Exception from general requirements The contents of a protocols should generally contain . (3 answers) - answer-1. Trial objectives and purpose

2. Assessment of efficacy
3. Data handling and record keeping This form is used for the voluntary reporting of adverse events and product problems - answer-FDA Form 3500 What date should an investigator write when he/she failed to sign the consent form on the date of consent? - answer-Date of the investigator's signature What is 21 CFR50.50 Subpart D? - answer-IRB Duties What is 21CFR56.110 Subpart C - answer-Expedited review procedures for certain kinds of research involving no more than minimal risk for minor changes in approved research What is 21CFR50.52 Subpart D - answer-Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects - children What is the mission of the ICH? - answer-Providing a unified standards for Europe, US and Japan to facilitate the acceptance of clinical trials The states that all research must be voluntary. - answer- Nuremberg Code The was a result of the World Medical Association's (WMA's) document, Ethical Principles for Medical Research Involving Human Subjects - answer-Declaration of Helsinki

45CFR46.116 is? A. General Requirements for informed consent. b. IRB Review of research c. Documentation of Informed Consent d. Criteria for IRB approval of research - answer-A: General Requirements for informed consent 21 CFR part 11 refers to. - answer-Electronic Records, electronic signatures 21 CFR part 50 refers to. - answer-Protection of Human Subjects 21 CFR part 56 refers to. - answer-Institutional Review Board 21 CFR part 312 refers to. - answer-Investigational new drug application 21 CFR part 812 refers to. - answer-Investigational device exemptions In 21 CFR part 50, which subpart refers to informed consent of human subjects?

1. Subpart A 2 Subpart B
2. Subpart C
3. Subpart D - answer-2. Subpart B What are the 8 parts of US Code of Federal Regulations Good Clinical Practice?? - answer-Part 11 (Electronic Records; Electronic Signatures) Part 50 (Informed Consent) Part 54 (Financial Disclosure) Part 56 (Institutional Review Boards) Part 312 (Investigational New Drug Application) Part 314 (New Drug Application)

7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified persons with the highest degree of skill and care.
9. During the course of the experiment, the human subject should be at liberty to bring the experiment to an end
10. During the course of the experiment, the scientist in charge must be prepared to terminate the experiment at any stage Which statement is primarily for physicians? A. Nuremberg Code B. Declaration of Helsinki C. Belmont Report - answer-B. Declaration of Helsinki (Created by the World Medical Association) According to the general principles of the Declaration of Helsinki, the responsibility for the protection of research subjects must always rest with the. - answer-Physician What are the three basic principles of the Belmont Report? - answer-Respect for persons Beneficence Justice One of the three basic principles of the Belmont Report, Respect for persons, is done through . - answer-Informed Consent One of the three basic principles of the Belmont Report, Beneficence, is done through . - answer-Assessment of Risks and Benefits One of the three basic principles of the Belmont Report, Justice, is done through - answer-Selection of Subjects

The sponsor obtains an agreement from the investigator/institution for adherence to the protocol, to obtain IRB approval, and GCP compliance. This agreement is known as. - answer- Form 1572 How does a sponsor secure compliance of a clinical trial at the site level? - answer-Through monitoring