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SOCRA CERTIFIED CLINICAL RESEARCH PROFESSIONAL (CCRP) EXAM PRACTICE QUESTIONS AND 100% CORRECT ANSWERS 2024-2025 UPDATED AND GRADED A+ SOCRA CERTIFIED CLINICAL RESEARCH PROFESSIONAL (CCRP) EXAM PRACTICE QUESTIONS AND 100% CORRECT ANSWERS 2024-2025 UPDATED AND GRADED A+
Typology: Exams
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Which of the following is a disclosure of financial interest’s form? - Solution FDA Form 3455 Which of the following is a certification of financial interest form? - Solution FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - Solution FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - Solution Investigational New Drug Application (1571) In the top right corner, form have OMB number. What does it stand for? - Solution Office of Management and Budget The form, which is submitted to the FDA to report an Adverse Event is - Solution 3500 Medical device adverse events/problems are reported via a form: - Solution 3500A What is FDA form 1571? - Solution Cover-sheet for Investigational New Drug Applications 21 CFR 312 deals with - Solution Investigational New Drug Application Investigational new drug means - Solution 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 - Solution "Caution: New Drug— Limited by Federal (or United States) law to investigational use."
Which of the following is not listed on FDA form 1571: - Solution 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... - Solution Life threatening adverse drug experience What are the three main basic ethical principles of the Belmont Report? - Solution 1. Respect for Persons
safety issues after drugs get on the market is critical. The role of FDA's post-marketing safety system is to detect serious unexpected adverse events and take definitive action when needed. The main concept of 21 CFR 50 is - Solution Protection of Human Subjects Subpart D of 21 CFR 50 lists the - Solution Additional Safeguards for children in Clinical Investigations The FDA may restrict, suspend, or terminate an institution's or IRB's use of the expedited review procedure when necessary to protect the rights or welfare of subject - Solution a. true X (21 CFR 56.110 Subpart D) b. false A Phase ___ protocol is more flexible and less detailed than the others. - Solution Phase 1 A source document is any document found that is associated with a clinical trial. - Solution a. true b. false X (A source document is any document where the date are FIRST recorded) A sponsor will not ship a study drug until they have received all of the following documents: - Solution - IRB approved protocol, IRB approved informed consent form, IRB approval letter, IRB approved recruitment materials
The responsibility for ensuring that the investigator understands a clinical trial lies with - Solution the sponsor Significant risk device is defined as an investigational device that is: - Solution 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. Answer: All the above A purpose of monitoring clinical trials is to verify that: - Solution 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 - Solution Contract Research Organization (CRO) A contract research organization shall be responsible for : - Solution - Control of the Drug
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 - Solution a. true X b. false Before the investigation begins, the sponsor shall give each participation clinical investigator a/an _______. - Solution Investigator Brochure ____ means the party who submits a marketing application to FDA for approval of a drug device or biologic product. - Solution 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. - Solution a. true b. false X
What is 21 CFR 50.27? - Solution 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 - Solution 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 ____ - Solution Adverse drug reactions, ADR _____ is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. - Solution Direct Access What is 21 CFR 50.53 Subpart D? - Solution Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalization knowledge about the subjects' disorder or condition - Children Who monitors the progress of all clinical trial investigations being conducted under its IND? - Solution The Sponsor What is 21 CFR 56.110 Subpart C? - Solution Expedited review procedures for certain kinds of research involving no more than minimal risk for minor changes in approved research The World Medical Association (WMA) ethical principals for medical research involving human subjects is called? - Solution The Declaration of Helsinki What is 45CFR46? - Solution HHS - Protection of Human Health Subjects What is 45 CFR 46 Subpart B? - Solution Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
When a short form is used for Informed Consent, the witness must sign either the short form or the summary - Solution a. true b. false X
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 - Solution a. true X b. false What is 45 CFR 46 subpart A? - Solution Basic HHS policy for Protection of Human Research Subjects This form is used for the voluntary reporting of adverse events and product problems - Solution 3500, FDA 3500 The Code of Federal Regulations that applies to investigational new drug application is: - Solution 21 CFR 312 What does 21 CFR 54 deal with? - Solution Financial Disclosure of clinical investigators A(n) ____ is an investigation or marked product, or placebo, used as a reference in a clinical trial. - Solution Comparator, Product What is the FDA form 3454? - Solution 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? - Solution 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 - Solution Good Clinical Practice (GCP) What is 21 CFR 50/51 subpart D? - Solution Clinical investigations not involving greater than minimal risk- children
What is 21 CFR 50.54 Subpart D? - Solution 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? - Solution Additional Safeguards for Children in Clinical Investigations The Code of Federal regulations that applies to the Protection of Human Subjects is - Solution 45 CFR 46 What are the three fundamental ethical principals for human subjects research - Solution 1. respect for persons
What is 21 CFR50.52 Subpart D? - Solution Clinical investigations involving greater than minimal risk, but presenting the prospect of direct benefit to individual subjects children Which of the following are necessary to satisfy 21 CFR 50.24 subpart B? - Solution - Participation in the research holds out the prospect of direct benefit to the subjects - as described in 21 CFR 50.24 (a)
What is 21 CFR 50.23 Subpart B? - Solution Exception from General Requirements What is 21 CFR50.55 Subpart D? - Solution Requirements for permission by parents or guardians and for assent by children Which of the following are considered BASIC elements of the informed consent under section 21 CFR 50.25 subpart B? - Solution - A description of any benefits to the subject or to others which may reasonably be expected from the research
Under 21 CFR312, this form is the statement of the investigator of a clinical trial - Solution 1572 21 CFR 56.107 subpart B is IRB membership - Solution a. true X b. false The code of federal regulations that applies to Institutional Review boards is - Solution 21 CFR 56 Which of the following is IRB Functions and Regulations - Solution 21 CFR 56.108 Subpart C What is 21 CFR 50.50 subpart D - Solution IRB Duties What is 21 CFR 50.56 subpart D? - Solution Wards What are the three fundamental ethical principals for human subjects research? - Solution Justice Respect for Persons Beneficence 21 CFR 56 is IRB Functions and Operations? - Solution a. true X b. false