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ACRP CP EXAM 2024 | ACCURATE 2 CURRENTLY TESTING EXAMS, Exams of Nursing

ACRP CP EXAM 2024 | ACCURATE 2 CURRENTLY TESTING EXAMS WITH A STUDY GUIDE AND KNOWLEDGE CHECK FLASHCARDS WITH SUMMARIZED INSTRUCTOR NOTES AT THE END FOR A GUARANTED PASS ACRP CP EXAM 2024 | ACCURATE 2 CURRENTLY TESTING EXAMS WITH A STUDY GUIDE AND KNOWLEDGE CHECK FLASHCARDS WITH SUMMARIZED INSTRUCTOR NOTES AT THE END FOR A GUARANTED PASS

Typology: Exams

2023/2024

Available from 09/09/2024

Registered_Nurse
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558 documents

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ACRP CP EXAM 2024 | ACCURATE 2 CURRENTLY TESTING

EXAMS WITH A STUDY GUIDE AND KNOWLEDGE CHECK

FLASHCARDS WITH SUMMARIZED INSTRUCTOR NOTES

AT THE END FOR A GUARANTED PASS

Who is ultimately responsible for Source Data Verification (SDV)? A. The coordinator b. The subject c. The monitor d. The investigator

C

Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. A. True b. False

A

The Declaration of Helsinki was developed by: a. The Nuremberg tribunal b. The World Medical Association c. The government of Finland d. The American Medical Association

B

This phase determines therapeutic benefit and is usually done in a larger, specific population. A. Phase 1 b. Phase 2 c. Phase 3 d. Phase 4

C

This phase begins after drug approval and explores therapeutic use: a. Phase 1 b. Phase 2 c. Phase 3 d. Phase 4

D

This is the most typical study. Investigates human pharmacology. It is the initial administration or an investigational new drug into humans. It is most commonly done in healthy subjects.

A. Phase 1 b. Phase 2 c. Phase 3 d. Phase 4

A

Providing a unified standard for Europe US, and Japan to facilitate the acceptance of clinical trials is the... A. Mission statement of the ICH b. Mission statement of the Declaration of Helsinki c. Mission statement of the GCP Guidelines d. Mission statement of Canada Health

A

An investigator can be defined as... (Select all that apply) a. A person responsible for the conduct of the clinical trial with the sponsor b. A person responsible for writing the trial protocol c. The responsible leader of the clinical research team at the site and may be called the principal investigator d. A person responsible for the conduct of the clinical trial at that site

C, d

A sub-investigator can be defined as... A. The clinical research coordinator (CRC) or clinical trial nurse b. Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions c. Any individual member of the clinical trial team supervised by the investigator at a trial site to perform trial-related procedures d. Any individual member of the clinical trial team that performs trial related duties

B

A sponsor can be defined as... A. An individual who both initiates and conducts, alone or with others, a clinical trial b. An individual who participates in a clinical trial c. An individual or juridical or other body authorized under applicable law to consent to the subject's participation in the clinical trial d. An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing a clinical trial

D

What is the purpose of ICH-GCP? A. To standardize the design, conduct, recording, and reporting of clinical trials b. To instruct clinicians as to how to conduct preclinical toxicology tests c. To ensure that subjects are treated with the best available therapy d. To increase the number of abbreviations used in clinical practice

A

What is the purpose of the IRB/IEC? A. To help ensure that trials are conducted according to the protocol b. To monitor clinical trials c. To design trial protocols d. To protect subject safety

D

According to ICH, the abbreviation 'LAR' stands for 'Legally authorized Representative'. A. True b. False

B

What is the minimum number of members on an IRB/IEC? A. 3 b. 5 c. 7 d. 8

B

Who is responsible for providing the trial protocol? A. The sponsor b. The investigator c. The IRB/IEC d. The Institution

A

What does 'DSMB' stand for? A. Data Record Monitoring Board b. Drug Statistics Measurement Bureau c. Drug Safety Monitoring Board d. Data and Safety Monitoring Board

D

In any trial, what should be the main concern of the physician? A. The welfare of the subjects b. Ensuring that the allotted quota of subjects enrolled c. The esteem that will be gained from a successful trial outcome d. The scientific outcome of the trial

A

The World Medical Association (WMA) ethical principles for medical research involving human subjects is called: a. The International Research Act b. The Belmont Report c. The National Research Act d. The Declaration of Helsinki

D

The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial is known as: a. Intent to treat b. Legally authorized agreement c. Informed consent of trial subjects d. IRB/IEC approval

C

One of the primary purposes of a Phase I study is to: a. Demonstrate long term safety and efficacy b. Determine he metabolic and pharmacologic action of the drug in humans c. Demonstrate efficacy within the established safe dose range d. Gather information on additional indications for the drug

B

What is the purpose of the 'Data and Safety Monitoring Board (DSMB)'? A. To approve the trial protocol b. To ensure that the monitor is performing his/her duties correctly c. To assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints d. To ensure the accuracy of data and to carry out data analysis

C

. What does the IRB/IEC evaluate? (select all that apply) a. The subject-selection procedure

b. The rights, safety, and well-being of the subjects participating in the trial c. The scientific tenability of the trial d. The contract between the sponsor and investigator

A, b, c

Which of the following documents is the investigator obliged to comply with during the trial? (select all that apply) a. The sponsor's desire to present the investigational product in the best possible light b. All applicable laws and regulations c. ICH-GCP d. The trial protocol

B, c, d

What is the purpose of the initiation visit? (Select all that apply) a. To carry out source documentation verification b. To review standard procedures c. To review the blank Case Report Forms (crfs) d. To review the protocol

B, c, d

According to the principles of ICH GCP... (Select all that apply) a. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only of the anticipated benefits justify the risks. B. Clinical trials should be scientifically sound, and described in a clear, detailed protocol. C. Clinical trials should be conducted in accordance with the ethical principles that have origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirements). D. The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.

A, b, c, d

Source data are... A. Original documents, data, and records like hospital record and laboratory notes b. Detailed, written instructions to achieve uniformity of the performance of a specific function c. A written description of a change to or formal clarification of a protocol d. All information in original records and certified copies of original records of the critical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.

D

  1. A potential investigator usually only receives a protocol and Investigator's Brochure to review from a sponsor: a. After the protocol has been through initial IRB/IEC review b. After an initial telephone conversation c. After signing of a confidentiality agreement d. After an initial visit has been made

C

  1. Which of the following is NOT one of the required elements of an informed consent form? A. A listing of all site personnel who will be involved in the research b. The purpose of the research c. A description of benefits that may be reasonable expected from the research d. A contact person for questions about the research

A

  1. Which of the following should the investigator do if a Serious Adverse Event (SAE) occurs? (Select all that apply) a. Inform the IRB/IEC, if required by local regulations b. Discontinue the subject from the study c. Report it to the monitor during the next study visit d. Inform the sponsor immediately

A, d

  1. After a Serious Adverse Event (SAE) has occurred, how should a subject identification occur on the immediate and follow-up reports? A. By their subject identification number b. By their address c. By their name d. By a unique code for serious Adverse Event (AE) reporting

A

  1. In the event of a subject's death, what additional information should be supplied to the sponsor? (Select all that apply) a. Terminal medical reports, if available b. The address of the next of kin so that the sponsor can write a letter of condolence c. An autopsy report, if available d. The name and address of the subject's general practitioner (GP)

A, c

  1. What documentation should be supplied to the sponsor before the study? (Select all that apply) a. The cvs of all investigators and other study personnel who are significantly involved in trial related duties b. The signed contract between sponsor and investigator c. The completed subject informed consent forms d. The completed Case Report Form (CRF)

A, b

  1. Who must sign the Informed Consent Form (ICF)? (Select all that apply) a. The subject with the subject's legal representative (as applicable) b. The monitor c. A member of the IRB/IEC d. The person who conducted the informed consent interview

A, d

  1. Which of the following documents are required by the IRB/IEC before approval? (Select all that apply) a. Telephone script for patient recruitment b. Clinical Trial Budget c. Subject information leaflet d. Study protocol

A, c, d

  1. What details need to be documented in the subject notes when an Adverse Event (AE) occurs? (Select all that apply) a. What the subject thinks caused the event b. No documentation is necessary c. The severity of the event d. When the event occurred

C, d

  1. Who is responsible for the appropriate monitoring of clinical trials? A. The Sponsor b. The Principal Investigator c. The Contract Research d. The IRB/IEC

A

  1. During the trial, who is responsible for communicating with the IRB/IEC? A. The pharmacist

b. The sponsor c. The monitor d. The investigator

D

  1. Which of the following individuals could be members of an IRB/IEC? (Select all that apply) a. The sponsor b. Lay people c. Trial Subjects d. Medical professionals

B, d

  1. In what format should approval be received from the IRB/IEC? A. Electronic b. Verbal c. Personal d. Written

D

  1. How can an Adverse Drug Reaction (ADR) be defined? A. As an investigational drug that requires a second drug to be taken in order for the first one to be effective b. As a noxious and unintended response to the investigational drug c. As a positive response to the investigational drug d. As an investigational drug that prevents any other drug from being effective

B

  1. Which of the following would be most appropriate for Adverse Event (AE) reporting? A. Telling subjects to only report Serious Adverse Events (saes) b. Documenting and reporting all Adverse Events (aes). However trivial they may appear to be c. Only documenting Adverse Events (aes) if more than one subject reports the event d. Only informing subjects about the Serious Adverse Events (saes) that are likely to occur

B

  1. Which of the following criteria is described in ICH-GCP as necessary for classifying an Adverse Event (AE) as an Adverse Drug Reaction (ADR)? A. That a causal relationship is at least a reasonable possibility b. That a causal relationship is a definite possibility c. That a causal relationship is a strong possibility d. That a causal relationship is a very strong possibility

A

  1. What information needs to be included in the subject's medical records? (Select all that apply) a. Medical history b. Occurrence of AE's c. Randomization number d. Name of the monitor

A, b, c

  1. Which groups of potential subjects are mentioned in ICH-GCP as being 'vulnerable subjects'? (Select all that apply) a. Junior members of the medical profession b. People with heart conditions c. Employees of the pharmaceutical industry d. Members of the armed forces

A, c, d

  1. Who conducts clinical research Quality Control (QC) activities? A. Investigator b. Inspector c. Monitor d. Site staff

C

  1. According to the Declaration of Helsinki, physicians may use an unproven intervention. A. True b. False

A

  1. What is the minimum amount of time after formal discontinuation of the clinical development of an investigational product that essential documents should be retained according to ICH-GCP? A. 16 years after the last marketing application approval in an ICH-GCP region b. 4 years after the last marketing application approval in an ICH-GCP region c. 2 years after the last marketing application approval in an ICH-GCP region d. 8 years after the last marketing application approval in an ICH-GCP region

C

  1. Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and it cannot be carried out in a non-vulnerable group. In addition,

this group should stand to benefit from the knowledge, practices or interventions that result from the research. A. True b. False

A

  1. A candidate presents him/herself for a monitor position. What qualifications should the potential monitor be able to provide proof of to be considered for the position? A. Have the clinical knowledge needed to monitor a trial b. Have the scientific knowledge needed to monitor a trial c. Be familiar with GCP d. A bachelor degree

A, b, c

  1. A monitor is tasked to select investigators for a new upcoming oncology trial. What evidence of qualifications should the potential investigator be able to provide to be considered for the conduct of the trial? (Select all that apply) a. A university degree b. A log of training records of all trial specific training the investigator ever took c. An up to date CV, showing evidence of adequate education, training and experience d. Evidence of awareness of and compliance with GCP and the regulatory requirements

C, d

  1. A subject visits the investigator at the scheduled visit window in her office as an outpatient and reports he suffers from a fever after being treated by the Investigational Product (IP) for a week. Is this occurrence an Adverse Event (AE) or a Serious Adverse Event (SAE)? A. This is an SAE because the fever could be life-threatening, could result in death, could require inpatient hospitalization or prolongation of hospitalization in case the subject was hospitalized, could result in persistent significant disability/incapacity or is a congenital anomaly/birth defect. B. This is an SAE because the fever could be related to the intake of the IP and could result in hospitalization. C. This is an AE because it can be classified as an untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. D. This is an AE because th

C

  1. An experienced research coordinator was asked to train a new junior clinical trial team member on safety reporting. What should she train on? (Select all that apply). A. Report Unexpected Serious Adverse Drug Reactions (SUSARS) as per the applicable regulatory requirements. B. Supply the IRB/IEC with a summary of all Adverse Events (aes) and Serious Adverse Events (saes) on a monthly basis c. All subjects should be identified by unique code numbers rather than by the subject's name. D. Supply the sponsor and the IRB/IEC with any additional requested information for any reported deaths.

A, c, d

  1. When an Adverse Event (AE) occurs, why is it important for the investigator to have a list of drugs that may or may not be permitted during the conduct of the trial? A. To inform subjects b. To avoid using contraindicated medication to treat the Adverse Event (AE) c. As background information d. To make sure the Adverse Event (AE) is not treated unintentionally

B

  1. Which of the following documents can only be found in the sponsor's files? A. Master randomization list b. Investigator's brochure c. Insurance statement d. Signed agreement between the investigator and the sponsor

A

  1. Data and Safety Monitoring Boards (dsmbs) have the power to recommend which of the following? (Select all that apply) a. That sponsor should stop the trial b. That the sponsor should modify the trial c. That the sponsor should continue the trial d. That the sponsor should start a new trial

A, b, c

  1. How can expected Adverse Events (aes) be described? A. Those that are can be seen in every day practice b. Those that have been reported in previous clinical or preclinical trials

c. Those that are consistent with the applicable product information d. Those that aren't serious

B, c

  1. Who is permitted to enter data into the case report form? (Select all that apply) a. The investigator b. The subject c. The sponsor d. Any person delegated by the investigator to carry out this task, as documented

A, d

  1. Which of the following documents is only filed in the investigator's files? A. Serious Adverse Event (SAE) forms b. IRB/IEC approval c. The investigator's (IB) brochure d. Signed informed consent forms

D

  1. When is verbal consent prior to participation in a research study permitted? A. When the subject is illiterate b. When the subject has a Legally Acceptable Representative (LAR) c. When the study has minimal risk d. When the study has more than minimal risk

A

  1. What will be reviewed during an audit? (Select all that apply) a. Procedures for reporting Serious Adverse Events (saes) b. Informed consent procedures c. The accounts of the hospital/research unit d. Adherence to protocol

A, b, d

  1. In which of the following instances is it necessary to contact the IRB/IEC? A. When a subject is found to be noncompliant with the trial medication b. When a Serious, Unexpected Adverse Drug Reaction (sadrs) occurs c. Each time a new subject is enrolled d. If the investigator does not complete enrollment

B

  1. Which signatures are required by ICH Guidelines to be on the Informed Consent Form (ICF)? A. The investigator b. The person who conducted the informed consent discussion c. The investigator and the subject d. The subject

B, d

  1. Whose responsibility is it to safeguard the rights and safety of subjects in clinical trials? (Select all that apply) a. The investigator b. The sponsor c. The IRB/IEC d. The subjects' general practitioner(GP)

A, b, c

  1. Which hospital personnel are normally directly involved in a clinical trial? (Select all that apply) a. Research nurses b. The sponsor c. Pharmacists d. Hospital orderlies

A, c

  1. Who does the investigator need to inform if he/she deviates from the protocol? (Select all that apply) a. The sponsor b. The regulatory authorities c. The office staff d. The IRB/IEC

A, b, d

  1. Who should have access to the trial files? (Select all that apply) a. The subject b. The monitor c. The investigator d. The pharmacist

B, c

  1. An Adverse Event (AE) that is severe in intensity: a. Is always classified as serious b. Is never classified as serious c. May not meet the definition of serious d. Should be submitted to the sponsor within 24 hours

C

  1. Which of the following is always true? A. Adverse Drug Reactions (adrs) are evidence that the drug is working b. An Adverse Drug Reaction (ADR) is an Adverse Event (AE) c. An Adverse Event (AE) is an Adverse Drug Reaction (ADR) d. Adverse Events (aes) are less frequently observed in placebo arms.

B

  1. Which of the following tasks is the investigator responsible for? (Select all that apply) a. Treating the subject if an Adverse Event (AE) occurs in the case the investigator is a qualified physician or dentist b. Make reasonable efforts to ascertain the reasons for a subject's premature withdrawal from the trial c. Encouraging subjects to report all Adverse Events (aes) d. Upon permission of the subject, inform primary physician of subject's participation in the trial

A, b, c, d

  1. Why is it a good idea to develop standard procedures? (Select all that apply) a. To assign responsibility b. To promote compliance c. To ensure that the trial is run consistently d. To practice logical thinking skills

A, b, c

  1. What topics are discussed during the pre-trial visit? (Select all that apply) a. Laboratory requirements b. Availability of subjects c. Competing studies d. Sponsor expectations

A, b, c, d

  1. How should any leftover investigational product be disposed? A. It should always be returned to the sponsor company b. It should always be incinerated at the hospital c. It should always be disposed of by the monitor, as this is one of his/her key responsibilities

d. It should be disposed of according to an agreed-to-procedure arranged before the start of the study

D

  1. During a monitoring visit, it was discovered that a new clinical research coordinator had been hired and assigned to an ongoing study. What actions must be taken by the monitor? (Select all that apply) a. Ensure that the coordinator's name is on the delegation of duties log b. Conduct a background check c. Train the coordinator in GCP and protocol d. Verify coordinator's training and qualifications

A, d

  1. Design in which subjects are randomized to one of two or more arms, each arm being allocated a different treatment. These treatments will include their investigational product at one or more doses, and one or more control treatments, such as placebo and/or an active comparator. A. Crossover design b. Adaptive design c. Parallel design d. Randomized design

C

  1. The clinical trial design in which each subject is randomized to a sequence of two or more treatments and hence acts as his own control for treatment comparisons. A. Crossover design b. Adaptive design c. Parallel design d. Randomized design

A

  1. A subject in its third trial week in an oncology trial at a hospital site asks the investigator during a follow-up visit for some clarifications on the Investigational Product (IP) dosage used. The investigator refers the subject to the pharmacist for more information as (s)he claims not to know the details of

how to use the IP. Is this answer in compliance with the GCP E6 guideline? A. Yes. The pharmacist is responsible for all IP related duties and questions if this task was delegated to the pharmacist and the delegation of duties form was completed by the investigator at the start of the trial. B. Yes. The responsibility for the IP handling is automatically handed over from the investigator to the pharmacist when a trial is conducted at a site that is situated in a hospital that has its own internal pharmacy. The pharmacist should instruct the subject and check periodically for understanding/compliance c. No.

D

  1. A monitor has discovered that an investigational product was stored in a room affected by a power outage over a weekend. The temperature log reflects tht the room temperature dropped to 45of/7oc on Sunday. All investigational products must be stored at temperatures between 59 and 77of ( and 25oc). What action should the monitor take? (Select all that apply) a. Record the temperature excursion in the morning report. No further action would be needed since the room did not reach freezing temperature. B. Contact the sponsor to report the excursion and determine the next course of action regarding the use of investigational products at the site. C. Return all investigational products stored in that room to the sponsor and request a new shipment. D. Document the temperature excursion in the monitoring report and assist the site with a corrective and preventative action.

B, d

  1. An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual's legal representative. Which of the following describes the best course of action for the investigator? A. Sign the consent form on behalf of the subject and use the test article b. Enroll the subject per required measures described in the protocol, with documented approval/favorable opinion by the IRB/IEC. The subject's legally acceptable representative should

be informed as soon as possible to continue consent. C. Do not use the test article until either the subject or the subject's legally acceptable representative can give consent. D. Call the IRB/IEC and ask for an exemption.

B

  1. A subject, who has been 100% compliant this far, has forgotten to bring her medication back to the clinic for her regular visit. She reports that she has not missed any doses and has been fully compliant with the protocol. What is the most appropriate action for the investigator/clinical research coordinator to take? A. Contact the sponsor to report the protocol deviation b. Document that the subject has forgotten to return her medication in the source document and ask her to bring the medication back to the clinic as soon as possible or at her next visit. C. Record nothing in the source document or in the product accountability log. D. Record no missed doses in the source document and in the investigational product accountability log.

B

  1. If the investigator becomes ill during the trial, what will happen to the study? A. The monitor will take over the running of the study until the investigator returns. B. A "second-in-command" (appointed before the start of the study) will take over the running of the study until the investigator returns. C. The study will be put on hold until the investigator is sufficiently well to return to work. D. This study will be postponed for one month (or a period prearranged with the sponsor). After this period, if the investigator is still ill, a fellow member of the team will be appointed investigator.

B

  1. The subject arrives for the informed consent interview, but the investigator has no more informed consent forms. What should the investigator do? (Select all that apply) a. Write the details on a blank piece of paper b. Ask the subject to come back c. Have already made sure that there were enough forms before the interview d. Photocopy another subject's form and use correction fluid to remove the details

B, c

  1. What action should be taken if the protocol is altered during the trial? (Select all that apply) a. The trial must begin again. B. The subject should be asked to re-consent if alterations to the protocol could affect their willingness to participate. C. The sponsor must dismiss the investigator. D. The IRB/IEC should be informed and approve the changes if the trial is to continue.

B, d

  1. A site has been notified it will be inspected. What is the best way to ensure that the site is adequately prepared? A. Complete any incomplete forms with any relevant information the investigator can remember. B. Comply with ICH-GCP guidelines and protocol requirements throughout the study. C. Ensure that everything is tidy. D. Cover up any shortcomings where the investigator thinks inspectors will reveal serious findings.

B

  1. A site is being renovated and no longer has adequate storage space to hold all of the past studies it has conducted. Some studies are older than 20 years. Some Investigational Products (ips) are now marketed. How can the site determine which files it still needs to store? A. Contact the sponsor for each trial to ask for a letter outlining instructions for disposition of records. B. Dispose of studies who products are now marketed in the U.S. for at least 2 years. C. Contact the sponsor for the files the site no longer can store and ask them to store the records. D. Dispose of any studies older than 20 years since patent has expired.

A

  1. A non-English speaking subject has responded to a recruitment ad to participate in a trial for treatment of her diabetes. She arrives at the site with her daughter who is fluent in English. The informed consent forms are only available in English. What actions are compliant with GCP? A. Find a member of the clinic staff who speaks the same language as the subject to serve as the interpreter. B. Contact the IRB/IEC and ask for an exemption to screen subject. C. Call the sponsor to request a translation of the informed consent. D. Ask the subject's daughter to serve as interpreter and read the consent form to the subject.

C

  1. The investigator at a big research center asked the monitor to complete the drug accountability forms as the site staff was not able to complete this on time before the Quality Control (QC) visit of the

monitor. How should the monitor respond best? A. The monitor should not respond and ask advice from their manager on how to act. B. The monitor should refuse kindly and ask the site staff to complete the drug accountability forms. C. The monitor should do as the investigator asks because the investigator is the leader of the trial. D. The monitor should suggest to collaborate with the site staff and complete the drug accountability forms together at the occasion of the site visit.

B

  1. An investigator is willing to lead the conduct of a clinical trial if the sponsor allows deviations from the protocol to accommodate the trial subjects. How should the sponsor react to this request? A. The sponsor should refuse this request as no protocol changes are ever allowed. B. The sponsor should state that each request would need to be considered for a possible amendment prior to allowing any deviations. C. The sponsor should ask the local regulatory bodies for advice. D. The sponsor should allow this as the investigator is responsible for trial conduct.

B

  1. During a routine monitoring visit the monitor finds out the Informed Consent Form (ICF) of one of the subjects enrolled in the trial was NOT personally dated by the subject. What is the BEST corrective action to be taken by the monitor? A. The monitor should leave as is and make a note of it in the monitoring visit report. B. The monitor should ask the site staff to inform the IRB/IEC of the error. C. The monitor should ask the site staff to discuss the issue with the subject and document the discussion in the source documents. D. The monitor should ask the site staff to take action and have the subject date personally and provide an explanation of the change on the original ICF.

D

  1. A Clinical Research Coordinator (CRC) adjusted the dose of the Investigational Product (IP) for subject as the subject was suffering from Adverse Events (aes) like headaches and vomiting. When is a CRC allowed to do this task? A. Only when the CRC is a qualified physician b. Only under the supervision of another site staff member who is named on the signature and delegation log

c. Never d. Always; patient safety comes first

A

  1. A monitor is making corrections on the Case Report Form (CRF) during a monitoring visit and asks the site staff (as identified on the signature and delegation log) to sign and date these corrections. This is an accepted way of working because: a. Anybody can complete the CRF b. The sponsor is ultimately responsible for the quality of the trial data and the investigator only needs to document the corrections. C. It does not matter who makes the corrections on the CRF (sponsor representatives or ite staff identified on the signature and delegation log) as long as they are made when necessary, endorsed by the investigator, and documented. D. The monitor is best suited to make those changes because he/she is considered the experts on the protocol.

C

  1. In general, unused investigational drugs: a. Can be kept for the next study b. Can be destroyed by the investigator or pharmacy c. Can be re-dispensed by the pharmacy d. Must be returned to the sponsor

D

  1. How long is the follow up period for subjects after Adverse Events (aes)? A. One year b. It is specified in the protocol c. Two years d. Six months

B

  1. Which of the following statements would be unacceptable in a consent form? A. In the event of any injury related to this research, you will be given medical treatment. B. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. C. Your participation in this research is voluntary. If you choose not to participate but change your mind later, your decision will not affect your relationship with your doctor. D. The investigator may stop you from participating in this research without your consent if you experience side effects that make your condition worse.

B

  1. What should be done in case of inability to provide the relevant data for a requested piece of information on the Case Report Form (CRF)? A. Enter 'N/A' (Not Applicable) b. Take the average of the previous two readings c. Document why the information cannot be provided d. Nothing

C

  1. Who should provide for the cost of treatment of trial subjects in the event of trial-related injuries? A. The sponsor b. The clinician c. The subject d. The pharmacist

A

  1. If a piece of equipment required for use during the trial is out of order, what should the investigator do? A. Wait for the instrument to be repaired. B. Have already-made contingency plans for back-up equipment before the trial started. C. Inform the monitor and ask him/her to find another instrument that will perform the same task. D. Exclude any tests performed using this equipment from that point onwards.

B

  1. Before the trial begins, what tasks should be undertaken with the pharmacist with regard to trial medication? (Select all that apply) a. The investigator should inform the pharmacist as to how to package and label materials. B. The pharmacist should remove any medication that could be confused with the trial medication from the pharmacy. C. The pharmacist should be informed as to when medication will arrive and how it will need to be stored. D. The investigator should show the pharmacist all the drug accountability documentation that will be used in trial.

A, c, d

  1. What type of document is the Case Report Form (CRF)? A. A source document b. A superfluous document c. A non-essential document d. An essential document that can also be a source document

D

  1. Failing to meet recruitment expectations can lead to problems in which of the following areas? (Select all that apply) a. Statistical analysis b. Delays in the product reaching patients c. Source Data Verification (SDV) d. Subject compliance

A, b

  1. During the conduct of a trial an investigator receives updated Investigator's Brochures (IB's) from the sponsor. The investigator never forwards a copy to the IRB/IEC as (s)he claims this is not needed because the IB was sent to the IRB/IEC and the trial was approved in writing by the IRB/IEC before the trial started. Is this a correct statement? A. Yes. Sending an updated IB to the IRB/IEC is not a GCP requirement. B. Yes. The updates to the IB are mostly administrative in nature so patient safety is safeguarded. C. No. The investigator can decide on a case per case basis to supply the IRB/IEC with a copy of the IB or not. In the event of a safety issue, the investigator must provide the IRB/IEC with a copy. D. No. The investigator should supply a copy of the updated IB to the IRB/IEC.

D

Belmont Report (1979) - CORRECT ANSWER ethical principles and guidelines for the protection of human subjects of research.

respect for persons - CORRECT ANSWER individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection

An autonomous person - CORRECT ANSWER A person capable of deliberation about personal goals and of acting under the direction of such deliberation

Beneficence - CORRECT ANSWER Do not harm and maximize possible benefits and minimize possible harms

Justice - CORRECT ANSWER 1) to each person an equal share 2) to each person according to individual need 3) to each person according to individual effort 4) to each person according to societal contributions 5) to each person according to merit

Justice - CORRECT ANSWER · The selection of research subjects needs to be scrutinized in order to determine whether some classes are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.

Justice - CORRECT ANSWER · Whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.

Three elements of the consent process - CORRECT ANSWER information, comprehension, voluntariness

What is an example of how the principle of beneficence can be applied to a study employing human subjects - CORRECT ANSWER Determining the study has a maximization of benefits and a minimization of risks

What are the three principles discussed in the Belmont Report? - CORRECT ANSWER Respect for persons, beneficence, justice

The Belmont Report's principle of respect for persons incorporates at least 2 ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - CORRECT ANSWER Persons with diminished autonomy are entitled to protection

Nuremberg Code (1947) - CORRECT ANSWER 1) a requirements for voluntary consent 2) the research must have scientific merit 3) The benefits of the research must outweigh the risks 4) Subjects have the ability to terminate participation in the research at any time

National Research Act (1974) - CORRECT ANSWER 1) Authorized the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was charged with developing an ethical code and guidelines for researchers 2) Required the establishment of IRBs at organizations receiving PHS support for human subject's research

The National Commission (1975-1978 - CORRECT ANSWER Issued a series of reports on vulnerable populations (such as fetuses, children, prisoners, and the "mentally infirm") psychosurgery, IRBs, and other topics that included recommendations for regulating human subjects' research. These recommendations had significant influence on the development of the federal regulations governing human subject research.

45 CFR 46 - CORRECT ANSWER Also known as the Common Rule, this legislation established the role of institutional review boards (IRBs) for research on human rights.

Additional protection for these individuals in research - CORRECT ANSWER 1) pregnant women, human fetuses, and neonates 2) children 3) prisoners

21 CFR 50 - CORRECT ANSWER Informed Consent

21 CFR 56 - CORRECT ANSWER IRB

21 CFR 812 - CORRECT ANSWER Investigational Medical Devices

21 CFR 312 - CORRECT ANSWER Investigational Drugs and Biologics

Declaration of Helsinki (1964) - CORRECT ANSWER Recommendations guiding medical doctors in biomedical research involving human subjects

WHO Guidelines (1996) Standards and Operational Guidance for Ethics Review of Health- related Research with Human Participants" - CORRECT ANSWER Documents designed to serve as international guidelines for the review and conduct of research involving human subjects

ICH E6 - CORRECT ANSWER Guideline for Good Clinical Practice

The use of prisoners in research is a concern under the Belmont principle for Justice because: - CORRECT ANSWER Prisoners may not be used to conduct research that only benefits the larger society

What was the result of the Beecher article? - CORRECT ANSWER Realization that ethical abuses are not limited to the Nazi regime

Issued in 1974, 45 CFR 46 raised to regulatory status: - CORRECT ANSWER US Public Health Service Policy

What is included in the Nuremberg Code? - CORRECT ANSWER Informed consent

Informed consent is considered an application of which Belmont principle? - CORRECT ANSWER Respect for persons

IRB (Institutional Review Board) - CORRECT ANSWER A review committee established to help protect the rights and welfare of human research subjects

Regulations require: - CORRECT ANSWER IRB review and approval for research involving human subjects if it is conducted, supported, or regulated by US federal departments and agencies

Federal regulations stipulate that an IRB can: - CORRECT ANSWER Approve research, require modifications, disapprove research, conduct continuing reviews, verify no material changes occurred since previous review, observe, suspend/terminate approval