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CCRP SOCRA Exam | 100% Correct
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The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 B) 5 A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject 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. D) All the above D ) All of the above With respect to IRB/IEC membership, both the FDA and the ICH require that: A) A majority of the members' primary area of interest is in a scientific area B) At least one member holds a Ph.D. degree or equivalent C) At least one member's primary area of interest is in a nonscientific area D) A majority of the members are from or have ties to the institution of record C) At least one member's primary area of interest is in a nonscientific area In a non-emergency situation, under which of the following conditions, if any, may subjects been rolled into a study prior to IRB/IEC approval? A) The investigator provides his/her written approval B) The study drug has an FDA approved marketing application C) The FDA provides written approval of the IND D) Subjects cannot be enrolled until IRB/IEC approval has been obtained D) Subjects cannot be enrolled until IRB/IEC approval has been obtained
B) Back date the corrected entry with the date of the original entry C) Initial using the initials of the sponsor's representative who reviewed the change D) Add the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the change D) Add the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the change 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. True The contents of a Protocol should generally contain: A) Trial objectives and purpose B) Assessment of efficacy C) Data handling and record keeping D) All of the above E) Only A & C D) All of the above True or False:
Only the principle investigator is allowed to transcribe data from the source document to the CRF? False Why: True or False: When a short form is used for Informed Consent, the witness must sign either the short form or the summary. False Why: They must sign both Form___________ is the investigator statement. A) 1571 B) 1572 C) 3500 D) 3500A B) 1572 What is 45 CFR Part 46? A) HHS - Protection of Human Subjects B) FDA - Protection of Human Subjects
B) The National Research Act C) The Nuremberg Code D) The Declaration of Helsinki D) The Declaration of Helsinki The Code of Federal Regulations that applies to Institutional Review Boards is: A) 45CFR B) 21CFR C) 21CFR D) 21CFR D) 21 CFR 56 The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as: A) The ICH B) Good Clinical Practices (GCP) C) The Declaration of Helsinki D) Fundamental Ethical Principles (FEP) B) Good Clinical Practices (GCP) This form is used for the voluntary reporting of adverse events and product problems: A) 1571 B) 1572
C) 3500
D) 3500A
C) 3500
Reminder: 3500 is for voluntary; 3500A is for mandatory Each IRB that reviews studies involving children as subjects is covered by: A) 21CFR Part 56, Sub part A B) 21CFR Part 56, Sub part B C) 21CFR Part 50, Sub part C D) 21CFR Part 56, Sub part D D) 21CFR Part 56, Sub part D This form is used for the mandatory reporting of serious adverse events: A) 1571 B) 1572 C) 3500 D) 3500A D) 3500A What is covered in 21CFR50 Subpart B? A) Informed consent of Human Subjects
B) 1 year C) 2 years D) 5 years B) 1 Year The 3 fundamental ethical principles for human subjects' in research are: A) Respect for persons, beneficence, justice B) Respect for subjects, their safety and their time C) Respect for sponsor, IRB and FDA guidelines D) Respect for data, welfare and discovery A) Respect for persons, beneficence, justice Each IRB that uses an expedited review procedure must adopt a method for keeping all members advised of research proposals which have been approved under the expedited review procedure _________. A) 45 CFR 46.110; CFR 56.110(c) B) 45 CFR 46.110(c); 21 CFR 56. C) 45 CFR 46.110(c); 21 CFR 56.110(c) D) 45 CFR 46.110(b); 21 CFR 56.110(c) C) 45 CFR 46.110(c); 21 CFR 56.110(c) Explanation: Section B In general, an AE observed during the conduct of a study should be considered an unanticipated problem involving risk to human subjects, and reported to the IRB, only if it were _________.
A) expected B) serious C) would have implications for the conduct of the study D) B & C E) A, B & C D) B & C B - serious C - would have implications for the conduct of the study Once the sponsor evaluates data from a clinical trial and decides the drug presents an immeasurable and significant risk to the subjects; the sponsor has _____________ to discontinue the study. A) 24 hours B) 48 hours C) 3 WD D) 5 WD B) 5 working days True or False: A Short Form informed consent is a written summary of the ICF that is not to exceed one page. False Explanation: 21 CFR 50.
Per 21 CFR Part 312, the sponsor must notify FDA and all participating investigators in an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting. True Explanation: 21 CFR 312.32(c)(1) During the clinical trial, regulations require that a subject be given the right to: A) Travel B) Withdraw at any time C) Get financial compensation D) Speak to a sponsors attorney B) Withdraw at any time Which signatures are required by FDA regulation to be on the consent form? A) The investigator B) The subject C) The investigator and the subject D) The subject and a witness B) The subject Explanation: 21 CFR 50. According to 21 CFR 312.56, if a sponsor finds an investigator is non-compliant with a clinical protocol or approved investigational plan, the sponsor must:
A) Report the investigator to the IRB once it becomes aware B) Bring the investigator into compliance C) Immediately close that investigators site D) None of the above B) Bring the investigator into compliance True or False: Minimal risk is defined as "the magnitude of harm that a subject would encounter is not exceeded by those ordinarily encountered in daily life". True In accordance with regulations, before implementation, the informed consent document must be approved by the: A) Sponsor B) Investigator C) IRB or IEC D) A, B & C E) B & C only C) IRB or IEC Proper preparations should be made and adequate facilities provided to protect the experimental subject against even the remotest possibility of:
A request to export an investigational drug from the U.S. must include: A) The quantity of drug to be shipped per shipment and the frequency of expected shipments. B) Adequate information about the drug to satisfy the FDA that the drug is appropriate for the proposed investigational use in animals. C) A statement that the drug will be used for investigational purposes only and that the drug may be legally used by that consignee in the importing country for the proposed use. D) All of the above E) A & C only E) A & C only A) The quantity of drug to be shipped per shipment and the frequency of expected shipments. C) A statement that the drug will be used for investigational purposes only and that the drug may be legally used by that consignee in the importing country for the proposed use. True or False: FDA may waive any of the requirements contained in the regulations, including the requirements for IRB review. True Explanation: 21 CFR 56.105 (Waiver of IRB Requirement)
True or False: The Code of Federal Regulations part 50, 56 and 312 (among others) are designed to ensure the safety of clinical testing and the safety of products following a marketing approval. True Explanation: 21 CFR 312. The Food and Drug Administration (FDA) conducts drug risk assessment by considering which of the following? A) There are a sufficient number of people needing the drug. B) The benefits of the drug outweigh the known and potential risk of the drug C) The side-effects of the drug is measurable D) The sponsor is able to financially support the research B) The benefits of the drug outweigh the known and potential risk of the drug An investigational drug can be exported from the U.S., if: A) Permission is granted by Congress B) The intended recipient is a US pharmacy C) The importer is a foreign pharmacy inspected and approved by the FDA D) Approval is granted after a written request is submitted to the FDAs International Affairs Staff Associate Commissioner.
- Explanation: Allows for emergency use; 21 CFR 312.
