CCRP SOCRA Exam - Practice Exam #1 Past Questions and Answers Directly from SOCRA.

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 A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct? A) This subject does not need to undergo any of the study procedures since the subject is enrolled on the non-treatment arm B) This subject should undergo all study procedures as outlined in the protocol C) This subject only needs to undergo the study procedures that pertain specifically to the subject D) This subject can undergo the study procedures whenever it is convenient B) This subject should undergo all study procedures as outlined in the protocol A purpose of monitoring clinical trials is to verify that: A) The rights, safety, and well-being of human subjects are protected B) Investigators receive adequate payment for their participation in the clinical trial C) The investigator has received annual reports from the sponsor D) The regulatory agency has received all case history information of subjects enrolled on the clinical trial A) The rights, safety, and well-being of human subjects are protected Which of the following is the proper way to make a correction to a CRF? A) Completely blacken the incorrect entry and then enter the correct information 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 C) HHS - Protection of Children D) HHS - Protection of Research Participants A) HHS - Protection of Human Subjects Explanation: 45 CFR Part 46 covers the HHS (Health and Human Services) standards of protection of human subjects. Also referred to as Public Welfare. True or False: The Code of Federal Regulations that applies to Investigational New Drug Applications is 21CFR812. False INDs are covered in 21 CFR 312 Who monitors the progress of all clinical trial investigations being conducted under an IND? A) Principal Investigator B) IRB C) Sponsor D) CRO C) Sponsor The World Medical Association (WMA) ethical principles for medical research involving human subjects is called: A) The Belmont Report 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) 45CFR46 B) 21CFR312 C) 21CFR50 D) 21CFR56 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