SOCRA CCRP Exam 2023-2024: Actual Exam Questions & Correct Answers with Rationales, Exams of Health sciences

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SOCRA CCRP EXAM 2023-2024 ACTUAL

EXAM QUESTIONS & CORRECT ANSWERS

WITH RATIONALES. GRADED A

_____________ monitors the progress of all clinical trial investigations being conducted under its IND. - ANSThe Sponsor ________________ is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. - ANSDirect Access _______________is responsible for supplying the investigator(s)/institution(s) with the investigational product? - ANSThe Sponsor _______________is responsible for the ongoing safety evaluation of the investigational product(s) - ANSThe sponsor . 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. - ANSCase Report Form- CRF . The contract research organization shall select a monitor that is _______. - ANSQualified by experience. Qualified by training. . Who monitors the progress of all clinical trial investigations being conducted under its IND? - ANSThe Sponsor

"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: A. Serious adverse drug experience B. Life threatening adverse drug experience C. None of the above - ANSB. Life threatening adverse drug experience 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. A. Curriculum vitae B. Letter from a fellow investigator C. Statement of qualifications of the investigator D. A and C - ANSD. A and C a decision to stop a phase 2 or phase 3 trial at all sites is the responsibility of - ANSDSMB A drug's safety is determined by which of the following criteria? A. The Food and Drug Administration's (FDA) review of source documentation at a clinical site B. The absence of harmful side effects on the individuals exposed so far. C. The dose at which no side effects are reported. D. All of the above - ANSC. A. The dose at which no side effects are reported. A patient received an initial dose and had no initial reaction. The protocol says the patient needs to increase it by 20%. The initial dose was 370mg^3/m; what is the next treatment? - ANS444mg^3/m A Phase ________ protocol is more flexible and less detailed than the others. A. I B. II C. III D. None of the Phases are flexible. - ANSA) I

A quorum for an IRB meeting must contain - ANSA non-scientific member A research subject enrolled in a clinical trial experiences significant chest pain and is admitted to the emergency department for the possible evaluation of a cardiac event. The event occurs where are the drug administration is still ongoing in the clinical trial. The casualty of the event should be determined by - ANSThe principal investigator 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 - ANSD) All of the above A sponsor my transfer responsibility for any of all of the obligations to a _______. - ANSCRO, Contract research organization A sponsor shall notify all reviewing IRB's and participating investigators of any withdrawal of FDA approval of the investigation within - ANS5 working days after receipt of notice of the withdrawal of approval. A sponsor will not ship a study drug until they have received all of the following documents: A. IRB approved protocol, IRB approved informed consent form, IRB approval letter, IRB approved recruitment materials. B. Signed and completed 1572, CV's and financial disclosures from everyone listed on 1572.

C. Current lab certifications and normal ranges D. A and B E. All of the above - ANSE. All of the above A subject with a psychology study requires sequestration in a small space and develops claustrophobia which is described as one of the risks in the IRB approved protocol. The event is - ANSAdverse event that does not represent an unanticipated problem and does not need to be reported. A waiver of informed consent is indicated if - ANSThe research involves no more than minimal risk According to FDA guidance the payments to research subject should be - ANSShould be prorated in accordance with the research related visits According to ICH E6, an inspection is defined as: - ANSAn official review of documents, facilities, records, and any other resources related to a clinical trial. According to the FDA guidance on recruitment for studies under an IND, the following information needs to be reviewed by the IRB - ANSProtocol, consent forms, recruiting scripts, investigators brochure According to the FDA, if the subject withdraws from a clinical trial - ANSAll data collected up to the time of withdrawal must remain in the trial database in order for the study to be scientifically valid All Other Serious, Unexpected ADRs - ANSASAP, no later than 15 calendar days All SAEs should be reported... - ANSimmediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. An electronic IRB - ANSMay not vote An investigator is planning to submit a grant to a federal agency. Such applications - ANSNeed not be reviewed by the IRB

An investigator shall notify the sponsor and the reviewing IRB of any deviation from the investigational plan to protect the life or physical well- being of a subject in an emergency no later than - ANS5 working days. An investigator shall submit a final report to the sponsor and the reviewing IRB within - ANS3 months after termination or completion of the investigation or the investigator's part of the investigation. An investigator shall submit a final report to the sponsor and the reviewing IRB within. - ANS3 months after termination or completion of the investigation or the investigator's part of the investigation. Annual Report: A sponsor submits a brief report of the progress of the investigation within? - ANS60 days of the anniversary date that the IND went into effect Before the investigation begins, the sponsor shall give each participation clinical investigator a/an _____. - ANSIB, investigator's brochure Center for Biologics Evaluation and Research - ANSCBER Charging in a clinical trial-A sponsor who wishes to charge for its investigational drug, including investigational use of its approved drug, must: - ANS(i) Provide evidence that the drug has a potential clinical benefit that, if demonstrated in the clinical investigations, would provide a significant advantage over available products in the diagnosis, treatment, mitigation, or prevention of a disease or condition. (ii) Demonstrate that the data to be obtained from the clinical trial would be essential to establishing that the drug is effective or safe for the purpose of obtaining initial approval of a drug, or would support a significant change in the labeling of an approved drug (e.g., new indication, inclusion of comparative safety information) (iii) Demonstrate that the clinical trial could not be conducted without charging because the cost of the drug is extraordinary to the sponsor. The cost may be extraordinary due to manufacturing complexity, scarcity of a natural resource, the large quantity of drug needed (e.g., due to the size or

duration of the trial), or some combination of these or other extraordinary circumstances (e.g., resources available to a sponsor). Device: Withdrawal of IRB approval - ANS5 working days During a study under an IND the investigator places the data on a laptop and the laptop is stolen. The date it was not encrypted. The event is? - ANSprotocol deviation and unanticipated event of risk to self or others During the study monitoring visit it was noted that a sample for laboratory analysis were being shipped long after the required shipment date. Many of the samples were deemed non-valuable. The event is - ANSProtocol deviation. Entry and Inspection - ANSA sponsor or an investigator who has authority to grant access shall permit authorized FDA employees, at reasonable times and in a reasonable manner, to enter and inspect any establishment where devices are held (including any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records of results from use of devices are kept). Fatal or Life-Threatening Unexpected ADRs - ANSASAP, no later than 7 calendar days, full report within 8 calendar days For an adverse event to be characterized as unexpected OHRP guidance advises that the event should be in nature, severity or frequency be? - ANSNot listed in the research protocol, not listed in the informed consent, and not a characteristic of the study population If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the reviewing IRB within - ANS5 working days. In a clinical trial serious adverse event should be reported by the investigator to the sponsor within - ANSone day In a clinical trial under an IND a death or life-threatening event should be reported to the FDA within - ANS7 days

Investigational new drug means A. A new drug or biological drug that is used in a clinical investigation, B. The method of labeling bottles of medication with unknown side effects. C. Test marketing new drugs. - ANSA. A new drug or biological drug that is used in a clinical investigation. IRB Records - ANSThe records required by this regulation shall be retained for at least 3 years after completion of the research, and the records shall be accessible for inspection and copying by authorized representatives of the Food and Drug Administration at reasonable times and in a reasonable manner Monitors should be thoroughly familiar with: - ANSthe investigational product(s) the protocol written informed consent form and any other written information to be provided to subjects. the sponsor's SOPs, GCP, and the applicable regulatory requirement(s). 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 - ANSD) 5 working days Payments to research subjects should be based on - ANSTime and inconvenience Records identifying subjects. - ANSAn investigator shall permit authorized FDA employees to inspect and copy records that identify subjects, upon notice that FDA has reason to suspect that adequate informed consent was not obtained, or that reports required to be submitted by the investigator to the sponsor or IRB have not been submitted or are incomplete, inaccurate, false, or misleading.

Records inspection - ANSA sponsor, IRB, or investigator, or any other person acting on behalf of such a person with respect to an investigation, shall permit authorized FDA employees, at reasonable times and in a reasonable manner, to inspect and copy all records relating to an investigation. Responsibility for investigational product(s) accountability at the trial site(s) rests with the - ANSthe investigator/institution. Sponsor must report to FDA and all investigators in an IND safety report of potential serious risks no later than - ANSAs soon as possible but no later than 15 calendar days Sponsor to notify FDA of study completion? - ANS30 days Submit final report from sponsor to FDA - ANS6 months after trial ends 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. - ANSone year. The Code of Federal Regulations that applies to Institutional Review Boards is: A) 45CFR B) 21CFR C) 21CFR D) 21CFR56 - ANSD) 21 CFR 56 The Code of Federal Regulations that applies to Investigational New Drug Applications is 21CFR_____ - ANS The contents of a protocol should generally contain: (A) Trial objectives and purpose (B) Assessment of efficacy (C) Data handling and recordkeeping (D) All of the above - ANS(D) ALl of the above

The contents of a protocol should generally contain: A. Trial objectives and purpose B. assessment of efficacy C. Data handling and recordkeeping D. all of the above - ANSD. all of the above The essential basic elements of consent include: - ANS- A statement that the study involves research and its purpose.

• Description and identification of experimental procedures.
• The duration of the study.
• Statements of the risk benefits
• Alternate procedures
• Any compensation for injury
• Confidentiality of records -contact information regarding subject rights The FDA form 483 is used for - ANSInspectional Observations The FDA has the authority to audit: - ANSThe IRB, sponsors and clinical investigators The financial aspects of the trial should be documented in an agreement between - ANSThe sponsor and the investigator The form _____________ is used for investigational new drugs (or IND). - ANS The immediate package of an investigational new drug intended for human use shall bear a label with the statement: A. "Caution: for FDA research purposes only" B. "Caution: New drug-- limited known side effects" C. "Caution: New Drug-- Limited by Federal (or United States) law to investigational use." D. None of the above - ANSC. "Caution: New Drug-- Limited by Federal (or United States) law to investigational use."

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) - ANSB) GCP The investigational product(s) should be stored.. - ANSas specified by the sponsor The investigator may implement a deviation from, or a change in, the protocol to eliminate an immediate hazard(s) to trial subjects without prior IRB/IEC approval/favorable opinion. As soon as possible, the implemented deviation or change, the reasons for it, and, if appropriate, the proposed protocol amendment(s) should be submitted: - ANSa) To the IRB/IEC for review and approval/favorable opinion; (b) To the sponsor for agreement and, if required; (c) To the regulatory authority(ies). The investigator/institution and/or a pharmacist or other appropriate individual, who Contains Nonbinding Recommendations 18 is designated by the investigator/institution, should maintain records - ANS-the product's delivery to the trial site -the inventory at the site the use by each subject -the return to the sponsor or alternative disposition of unused product The Nuremberg code was formulated by - ANSThe Nazi war crimes tribunal The purposes of trial monitoring are to verify that: - ANS(a) The rights and well-being of human subjects are protected. (b) The reported trial data are accurate, complete, and verifiable from source documents. (c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).

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 - ANSC) Sponsor The sponsor must also notify FDA of any unexpected fatal or life- threatening suspected adverse reaction... - ANSAs soon as possible but no later than 7 calendar days The sponsor must report a serious adverse event in an IND safety report to the FDA if the event is - ANSSerious, unanticipated and possibly related to the drug The sponsor should determine, for the investigational product(s) - ANSacceptable storage temperatures storage conditions (e.g., protection from light), storage times. reconstitution fluids and procedures. and devices for product infusion. The sponsor should: - ANS(a) Ensure timely delivery of investigational product(s) to the investigator(s). (b) Maintain records that document shipment, receipt, disposition, return, and destruction of the investigational product(s) (c) Maintain a system for retrieving investigational products and documenting this retrieval (e.g., for deficient product recall, reclaim after trial completion, expired product reclaim). (d) Maintain a system for the disposition of unused investigational product(s) and for the documentation of this disposition The_________ should ensure that the trials are adequately monitored. The __________ should determine the appropriate extent and nature of monitoring. T - ANSsponsor, sponsor. True or False?

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 subjects. - ANSTrue True or False? A source document is any document found that is associated with a clinical trial. - ANSFalse- A source document is any document where the data are FIRST recorded. True or False? Data reported on the CRF, that are derived from source documents, should be consistent with the source documents or the discrepancies should be explained. - ANSTrue True or False? Essential documents should be retained until at least 2-years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product. - ANSTrue True or False? 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 subjects. - ANSTrue True or False? When a short form is used for informed consent, the witness must sign both the short form and the summary? - ANSTrue True or False? A statement regarding the confidentiality of the subject study records must be included in all informed consent documents. - ANSTrue Under 21CFR312, this form is the statement of the investigator of a clinical trial. - ANS

What FDA document must all investigators signed prior to participating in a drug clinical trial? - ANS What is not listed on the FDA 1571? A. Name, address, phone number of the sponsor B. A commitment not to start the clinical investigation until the IND is in effect. C. Identification of the phase of the trial. D. Approved informed consent document. - ANSD) Approved informed consent. What is the FDA form 3455? - ANSDisclosure statement for financial disclosure of clinical investigators who have disclosable interests What is the federal department responsible for helping people of Canada maintain and improve their health? - ANSHealth Canada What is the monitor not responsible for? A) Patient information B) Sponsor SOP C) Protocol/ICF D) Reporting to IRB - ANS What phase of a drug trial usually includes hundreds to thousands of volunteers? - ANSPhase III Which countries are included in the ICH GCP? - ANSEuropean Union, Japan, United States, Canada and Switzerland Which of the following design methods would best 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? A. Double Blinded B. Interpretive Bias C. Bias Reduction D. Phase 1 - ANSA. Double Blinded

Which of the following responsibilities falls under the jurisdiction of the Food and Drug Administration (FDA)? A. Approval of individual study sites in clinical trials B. Direct management of clinical trials C. Oversight of regulation adherence in clinical trials D. All of the above - ANSC. Oversight of the regulation adherence in clinical trials. Who is responsible for maintaining the close out report? - ANSSponsor Who is responsible for maintaining the close out report? - ANSSponsor Withdrawal of IRB approval - ANS5 working days