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

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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
4. Assessment of Risk and Benefits
5. 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.

What is a drug as defined by the FDA? - ✔✔A drug is an product that is intended for use in the diagnosis, cure mitigation, treatment, or prevention of disease; and that is intended to affect the structure or any function of the body. What is Phase 1 of a clinical trial? - ✔✔ 20 - 80: Typical number of healthy volunteers used in Phase 1: this phase emphasizes SAFETY. What is Phase 2 of a clinical trial? - ✔✔100s: Typical number of patients used in Phase 2; this phase emphasizes EFFECTIVENESS What is Phase 3 of a clinical trial? - ✔✔1000's :Typical number of patients used in 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. What is Phase 4 of a clinical trial? - ✔✔Post Marketing: Because it's not possible to predict all of a drug's effects during clinical trials, monitoring 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 - ✔✔Protection of Human Subjects Subpart D of 21 CFR 50 lists the - ✔✔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 - ✔✔a. true X (21 CFR 56. Subpart D)

b. false A Phase ___ protocol is more flexible and less detailed than the others. - ✔✔Phase 1 A source document is any document found that is associated with a clinical trial. - ✔✔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: - ✔✔- IRB approved protocol, IRB approved informed consent form, IRB approval letter, IRB approved recruitment materials

• Signed and completed 1572, CV's and financial disclosures from everyone listed on 1572
• Current lab certifications and normal ranges Certification of absence of financial interest would also be known as: - ✔✔Form 3454 What is the minimum number of IRB members? - ✔✔ 5 The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new dosage would be? - ✔✔ 77 The responsibility for ensuring that the investigator understands a clinical trial lies with - ✔✔the sponsor 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. 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

_____ is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. - ✔✔Direct Access What is 21 CFR 50.53 Subpart D? - ✔✔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? - ✔✔The Sponsor What is 21 CFR 56.110 Subpart C? - ✔✔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? - ✔✔The Declaration of Helsinki What is 45CFR46? - ✔✔HHS - Protection of Human Health Subjects What is 45 CFR 46 Subpart B? - ✔✔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 - ✔✔a. true b. false X

• the witness must sign BOTH the short form and the summary.

The Code of Federal Regulations that applies to Electronic Records; Electronic Signatures is.. - ✔✔21 CFR 11 Which of the following are necessary to satisfy 21 CFR 50.23 Subpart B? - ✔✔- There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject

• The human subject is confronted by a life-threatening situation necessitating the use of the test article
• Informed consent cannot be obtained from the subject because of an inability to communicate with or obtain legally effective consent from, the subject
• Time is not sufficient to obtain consent from the subject's legal representative. What is 21 CFR 50.24 subpart B? - ✔✔Exception from Informed Consent Requirements for Emergency Research That is the minimum number of IRB members? - ✔✔ 5 What is the federal department responsible for helping people of Canada maintain and improve their health? - ✔✔Health Canada The object of GCP is part of the ICH mission statement - ✔✔a. true X b. false A (n) _____ is a printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject - ✔✔Case Report Form, CRF

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

Which of the following are necessary to satisfy 21 CFR 50.24 subpart B? - ✔✔- Participation in the research holds out the prospect of direct benefit to the subjects - as described in 21 CFR 50.24 (a)

• Obtaining informed consent not feasible - as described in 21 CFR 50.24 (a)
• The clinical investigation could not practicably be carried out without the waiver.
• The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness particular interventions.
• The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator, has committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent. What is the FDA form 482 for? - ✔✔Notice of Inspection This form is used for the mandatory reporting of serious adverse events - ✔✔3500A, FDA form 3500A A significant risk device - ✔✔- Is intended as an implant and presents a potential for serious risk to health, safety or the well-fare of the subject.
• 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.
• For use of the substantial importance of diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health and presents potential risk to health, safety or well-fare of the subject.

What is FDA form 3455? - ✔✔ What is 21 CFR 50.23 Subpart B? - ✔✔Exception from General Requirements What is 21 CFR50.55 Subpart D? - ✔✔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? - ✔✔- A description of any benefits to the subject or to others which may reasonably be expected from the research

• An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights and whom to contact in the event of research-related injury to the subject.
• A statement describing the extent if any to which confidentiality of records identifying the subject will be maintained that notes the possibility that the FDA may inspect the records.
• A description of any reasonably foreseeable risks or discomforts to the subject.
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
• A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled.
• For Research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and if so what they consist of or where further information may be obtained.
• A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed and identification of any procedures which are experimental.

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. What is 21 CFR 50.27 Subpart B? - ✔✔Documentation of informed consent