SOCRA CCRP EXAM ACTUAL EXAM QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE, Exams of Nursing

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SOCRA CCRP EXAM ACTUAL EXAM

QUESTIONS AND CORRECT DETAILED

ANSWERS WITH RATIONALES

|AGRADE

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? Correct Answer 444mg^3/m Which countries are included in the ICH GCP? Correct Answer European Union, Japan, United States, Canada and Switzerland What is the monitor not responsible for? A) Patient information B) Sponsor SOP C) Protocol/ICF D) Reporting to IRB Correct Answer According to ICH E6, an inspection is defined as: Correct Answer An official review of documents, facilities, records, and any other resources related to a clinical trial. An investigator shall submit a final report to the sponsor and the reviewing IRB within. Correct Answer 3 months after termination or completion of the investigation or the investigator's part of the investigation. 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 Correct Answer C) Sponsor Records inspection Correct Answer A 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. Entry and Inspection Correct Answer A 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). Who is responsible for maintaining the close out report? Correct Answer Sponsor Records identifying subjects. Correct Answer An 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. If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the reviewing IRB within Correct Answer 5 working days. What FDA document must all investigators signed prior to participating in a drug clinical trial? Correct Answer 1572

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 Correct Answer (D) ALl of the above 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 Correct Answer 5 working days. Sponsor must report to FDA and all investigators in an IND safety report of potential serious risks no later than Correct Answer As soon as possible but no later than 15 calendar days Device: Withdrawal of IRB approval Correct Answer 5 working days The FDA form 483 is used for Correct Answer Inspectional Observations What is the federal department responsible for helping people of Canada maintain and improve their health? Correct Answer Health Canada . Who monitors the progress of all clinical trial investigations being conducted under its IND? Correct Answer The 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. Correct Answer Case Report Form- CRF

________________ is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Correct Answer Direct Access The form _____________ is used for investigational new drugs (or IND). Correct Answer 1571 Under 21CFR312, this form is the statement of the investigator of a clinical trial. Correct Answer 1572 What is the FDA form 3455? Correct Answer Disclosure statement for financial disclosure of clinical investigators who have disclosable interests The Code of Federal Regulations that applies to Investigational New Drug Applications is 21CFR_____ Correct Answer 312 A sponsor my transfer responsibility for any of all of the obligations to a _______. Correct Answer CRO, Contract research organization 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. Correct Answer one year. . The contract research organization shall select a monitor that is _______. Correct Answer Qualified by experience. Qualified by training. Before the investigation begins, the sponsor shall give each participation clinical investigator a/an _____. Correct Answer IB, investigator's brochure

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 Correct Answer D. A and C 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 Correct Answer C. A. The dose at which no side effects are reported. 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 Correct Answer A. Double Blinded True or False? When a short form is used for informed consent, the witness must sign both the short form and the summary? Correct Answer True An investigator shall submit a final report to the sponsor and the reviewing IRB within Correct Answer 3 months after termination or completion of the investigation or the investigator's part of the investigation.

Who is responsible for maintaining the close out report? Correct Answer Sponsor A sponsor shall notify all reviewing IRB's and participating investigators of any withdrawal of FDA approval of the investigation within Correct Answer 5 working days after receipt of notice of the withdrawal of approval. The sponsor must also notify FDA of any unexpected fatal or life- threatening suspected adverse reaction... Correct Answer As soon as possible but no later than 7 calendar days Responsibility for investigational product(s) accountability at the trial site(s) rests with the Correct Answer the investigator/institution. 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 Correct Answer - 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 investigational product(s) should be stored.. Correct Answer as specified by the sponsor 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 Correct Answer D) 5 working days 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) Correct Answer B) GCP The Code of Federal Regulations that applies to Institutional Review Boards is: A) 45CFR B) 21CFR C) 21CFR D) 21CFR56 Correct Answer D) 21 CFR 56 _____________ monitors the progress of all clinical trial investigations being conducted under its IND. Correct Answer The Sponsor Center for Biologics Evaluation and Research Correct Answer CBER 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 Correct Answer D) All of the above 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. Correct Answer D) Approved informed consent. 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 Correct Answer C. Oversight of the regulation adherence in clinical trials. "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 Correct Answer B. Life threatening adverse drug experience 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. Correct Answer A. 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: 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 Correct Answer C. "Caution: New Drug-- Limited by Federal (or United States) law to investigational use." 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: Correct Answer a) 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). 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. Correct Answer True 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. Correct Answer True What phase of a drug trial usually includes hundreds to thousands of volunteers? Correct Answer Phase III 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. Correct Answer True 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. Correct Answer A) I True or False? A source document is any document found that is associated with a clinical trial. Correct Answer False- A source document is any document where the data are FIRST recorded. 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 Correct Answer E. 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 Correct Answer D. all of the above The financial aspects of the trial should be documented in an agreement between Correct Answer The sponsor and the investigator The sponsor should determine, for the investigational product(s) Correct Answer acceptable storage temperatures storage conditions (e.g., protection from light), storage times. reconstitution fluids and procedures. and devices for product infusion. _______________is responsible for supplying the investigator(s)/institution(s) with the investigational product? Correct Answer The Sponsor The sponsor should: Correct Answer (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 _______________is responsible for the ongoing safety evaluation of the investigational product(s) Correct Answer The sponsor

True or False? A statement regarding the confidentiality of the subject study records must be included in all informed consent documents. Correct Answer True The essential basic elements of consent include: Correct Answer

• 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 An investigator is planning to submit a grant to a federal agency. Such applications Correct Answer Need not be reviewed by the IRB An electronic IRB Correct Answer May not vote The purposes of trial monitoring are to verify that: Correct Answer (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). Monitors should be thoroughly familiar with: Correct Answer the 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). The FDA has the authority to audit: Correct Answer The IRB, sponsors and clinical investigators A quorum for an IRB meeting must contain Correct Answer A non-scientific member A waiver of informed consent is indicated if Correct Answer The research involves no more than minimal risk 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 Correct Answer The principal investigator The sponsor must report a serious adverse event in an IND safety report to the FDA if the event is Correct Answer Serious, unanticipated and possibly related to the drug For an adverse event to be characterized as unexpected OHRP guidance advises that the event should be in nature, severity or frequency be? Correct Answer Not listed in the research protocol, not listed in the informed consent, and not a characteristic of the study population Annual Report: A sponsor submits a brief report of the progress of the investigation within? Correct Answer 60 days of the anniversary date that the IND went into effect

Fatal or Life-Threatening Unexpected ADRs Correct Answer ASAP, no later than 7 calendar days, full report within 8 calendar days All Other Serious, Unexpected ADRs Correct Answer ASAP, no later than 15 calendar days All SAEs should be reported... Correct Answer immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. Submit final report from sponsor to FDA Correct Answer 6 months after trial ends Sponsor to notify FDA of study completion? Correct Answer 30 days Withdrawal of IRB approval Correct Answer 5 working days In a clinical trial under an IND a death or life-threatening event should be reported to the FDA within Correct Answer 7 days In a clinical trial serious adverse event should be reported by the investigator to the sponsor within Correct Answer one day 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 Correct Answer Adverse event that does not represent an unanticipated problem and does not need to be reported. 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 Correct Answer Protocol deviation. 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? Correct Answer protocol deviation and unanticipated event of risk to self or others a decision to stop a phase 2 or phase 3 trial at all sites is the responsibility of Correct Answer DSMB The Nuremberg code was formulated by Correct Answer The Nazi war crimes tribunal Payments to research subjects should be based on Correct Answer Time and inconvenience According to FDA guidance the payments to research subject should be Correct Answer Should be prorated in accordance with the research related visits According to the FDA guidance on recruitment for studies under an IND, the following information needs to be reviewed by the IRB Correct Answer Protocol, consent forms, recruiting scripts, investigators brochure According to the FDA, if the subject withdraws from a clinical trial Correct Answer All data collected up to the time of withdrawal must remain in the trial database in order for the study to be scientifically valid The_________ should ensure that the trials are adequately monitored. The __________ should determine the appropriate extent and nature of monitoring. T Correct Answer sponsor, sponsor.

IRB Records Correct Answer The 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 Charging in a clinical trial-A sponsor who wishes to charge for its investigational drug, including investigational use of its approved drug, must: Correct Answer (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). 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. Correct Answer True