Innovative Clinical Trials SOP Quiz V1 30jun12
Employees are required to read, review, and complete a comprehensive quiz on 29 Standard Operating Procedures annually. A passing score of 80% or better is required to pass. This quiz is presented open-book style.
- 1.
The acronym GCP as it relates to clinical research stands for:
- A.
Great Clinical Points
- B.
General Clinic Practice
- C.
Global Carbon Project
- D.
Good Clinical Practice
Correct Answer
D. Good Clinical PracticeExplanation
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. It ensures that the rights, safety, and well-being of trial subjects are protected, and that the data generated is reliable and credible. GCP guidelines provide a framework for researchers, sponsors, and ethics committees to follow when conducting clinical research. It covers various aspects such as trial design, informed consent, data collection, monitoring, and reporting of adverse events. GCP is essential for maintaining the integrity and validity of clinical trial data.Rate this question:
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- 2.
Choose the best answer for the following definition: Any adverse experience, the specificity or severity of which is not consistent with the current investigator brochure; or, if an investigator brochure is not required or available, the specificity or severity of which is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended. [21CFR312.32(a)]
- A.
Adverse Event
- B.
Side Effect
- C.
Unexpected Adverse Event
- D.
Serious Adverse Event
Correct Answer
C. Unexpected Adverse EventExplanation
An unexpected adverse event refers to any adverse experience that does not align with the information provided in the current investigator brochure, or if not available, with the risk information described in the general investigational plan or elsewhere in the current application. This means that the event is not consistent with what was previously known or anticipated, highlighting the unexpected nature of the adverse event.Rate this question:
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- 3.
Standard Operating Procedures may be signed by any of the Principal Investigators.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
Standard Operating Procedures (SOPs) are typically signed by the authorized personnel who are responsible for the specific process or task outlined in the SOP. This ensures accountability and adherence to the established procedures. Principal Investigators may be involved in the development or approval of SOPs, but they are not the ones who typically sign them. Therefore, the statement that SOPs may be signed by any of the Principal Investigators is false.Rate this question:
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- 4.
An Adverse Event that causes death, prolongs hospitalization, causes a birth defect, or causes a life-threatening event is called a:
Correct Answer
Serious Adverse Event
SAEExplanation
An Adverse Event that causes death, prolongs hospitalization, causes a birth defect, or causes a life-threatening event is considered a Serious Adverse Event (SAE). This term is used to categorize severe and potentially dangerous incidents that occur during medical treatments, drug trials, or other healthcare interventions. The designation of SAE helps to differentiate these significant events from less severe adverse events and ensures that they receive appropriate attention and reporting for further analysis and evaluation.Rate this question:
- 5.
The Investigator is responsible for: (check all that apply)
- A.
Maintaining SOPs that meet or exceed FDA regulations and GCP Guidelines
- B.
Maintains all test articles, including investigational product and subject records
- C.
Ensuring all study activites are performed correctly
- D.
Ensuring every staff member has had training on taking blood presssures
- E.
Ensuring that each coordinator has been trained on research SOPs
- F.
Ensuring source documents are signed in a timely manner
Correct Answer(s)
A. Maintaining SOPs that meet or exceed FDA regulations and GCP Guidelines
B. Maintains all test articles, including investigational product and subject records
C. Ensuring all study activites are performed correctly
E. Ensuring that each coordinator has been trained on research SOPs
F. Ensuring source documents are signed in a timely mannerExplanation
The Investigator is responsible for maintaining standard operating procedures (SOPs) that meet or exceed FDA regulations and GCP Guidelines to ensure compliance with regulatory requirements. They also maintain all test articles, including investigational product and subject records, to ensure proper documentation and accountability. Additionally, the Investigator is responsible for ensuring that all study activities are performed correctly, that each coordinator has been trained on research SOPs, and that source documents are signed in a timely manner to maintain data integrity.Rate this question:
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- 6.
The appropriate people who may co-sign a non-licensed coordinator to dispense, maintain, or receive a Controlled Substance Investigational Product (CSIP) can be which of the following:
- A.
Principal Investigator, if he's an MD or DO
- B.
RN
- C.
PharmD
- D.
Principal Investigator, if he's a Doctor of Chiropractic
- E.
LVN
- F.
SubInvestigator, if he's an MD or DO
- G.
UAP (Unlicensed Assistive Personnel)
Correct Answer(s)
A. Principal Investigator, if he's an MD or DO
B. RN
C. pHarmD
E. LVN
F. SubInvestigator, if he's an MD or DOExplanation
The appropriate people who may co-sign a non-licensed coordinator to dispense, maintain, or receive a Controlled Substance Investigational Product (CSIP) include the Principal Investigator, if they are an MD or DO, as well as RNs, PharmDs, LVNs, and SubInvestigators who are MDs or DOs. These individuals have the necessary qualifications and expertise to handle controlled substances and ensure their proper use in clinical trials.Rate this question:
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- 7.
Each visit from a Clinical Research Associate (CRA, or 'Monitor') must be recorded on a Monitor Visit Log and maintained in the Regulatory Files.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
The statement is true because in clinical research, it is important to maintain accurate records of all visits from a Clinical Research Associate (CRA) or Monitor. These visits are recorded on a Monitor Visit Log, which is a document that tracks the activities and findings during each visit. These logs are an essential part of the Regulatory Files, which are maintained to ensure compliance with regulatory requirements and to provide a detailed record of the study conduct.Rate this question:
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- 8.
Who of the following might be ideal to coordinate a study at Innovative Clinical Trials:
- A.
Someone who has been a nurse for 20 years, but no research experience
- B.
Someone who is not a nurse, but has 3 years experience coordinating studies in phase I-IV
- C.
A newly hired recruiter with no coordinating experience
- D.
A medically trained person who says they can coordinate clinical trials
Correct Answer
B. Someone who is not a nurse, but has 3 years experience coordinating studies in pHase I-IVExplanation
The ideal candidate to coordinate a study at Innovative Clinical Trials would be someone who is not a nurse but has 3 years of experience coordinating studies in phase I-IV. This person has relevant experience in coordinating clinical trials and would likely have a good understanding of the processes and requirements involved. While the other options may have some relevant experience or medical training, they do not have the specific experience in coordinating studies that the ideal candidate possesses.Rate this question:
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- 9.
In order to ensure accuracy and quality is at its best, all _____ ______ _____ are complete during the study visit or as soon as possible after the visit. The Clinical Trial Agreement often dictates how much time a site has to complete these after a visit occurs.
Correct Answer
case report forms
crfs
CRF'sExplanation
The correct answer is "case report forms, crfs, CRF's." Case report forms (CRFs) are documents used to collect and record data during a clinical trial. They contain specific fields and questions to capture relevant information about each study participant. Completing the CRFs accurately and promptly is crucial to ensure the accuracy and quality of the data collected. The Clinical Trial Agreement often outlines the timeframe within which the site must complete these forms after a study visit occurs.Rate this question:
- 10.
One element contained within Informed Consent is:
- A.
The subject's responsibilities
- B.
The clinical trial is non-invasive
- C.
A statement of indemnification of the physician investigator
- D.
The guarantee that the subject will receive active drug
Correct Answer
A. The subject's responsibilitiesExplanation
Informed Consent includes the subject's responsibilities because it is important for the subject to understand their role and obligations in the clinical trial. This ensures that they are fully aware of what is expected from them and can make an informed decision about participating. Including the subject's responsibilities in the informed consent process promotes transparency and allows the subject to actively participate in the trial, leading to better compliance and accurate data collection.Rate this question:
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- 11.
Two original copies of a Clinical Trial Agreement (Investigator Agreement) are prepared and signed prior to starting any study procedures.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
Two original copies of a Clinical Trial Agreement (Investigator Agreement) are prepared and signed prior to starting any study procedures. This is because having two original copies ensures that both parties involved, the investigator and the sponsor, have a legally binding agreement that outlines their responsibilities and obligations. It also allows each party to retain a copy for their records. By signing the agreement before starting any study procedures, both parties confirm their commitment to following the terms and conditions outlined in the agreement, ensuring proper conduct and protection of all involved parties.Rate this question:
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- 12.
One of the criteria used to evaluate a site for the appropriateness of a clinical trial is:
- A.
That all site personnel wear navy blue scrubs
- B.
That the site has qualified study personnel without sufficient time, knowledge, and experience to conduct the study
- C.
That the site has access to an adequate number of potential study subjects that would meet study criteria
- D.
That all site personnel have had experience with FDA audits
Correct Answer
C. That the site has access to an adequate number of potential study subjects that would meet study criteriaExplanation
The criteria used to evaluate a site for the appropriateness of a clinical trial is that the site has access to an adequate number of potential study subjects that would meet study criteria. This is important because in order to conduct a successful clinical trial, the site needs to have a sufficient pool of eligible participants who meet the specific criteria of the study. Without a large enough number of potential subjects, it may be difficult to recruit enough participants to generate meaningful and reliable results.Rate this question:
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- 13.
An IRB must have at least 5 members, be composed of men and women, and have at least one member with non-scientific expertise, among other criteria.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
The statement is true because an Institutional Review Board (IRB) is a committee that is responsible for reviewing and approving research involving human subjects. To ensure the protection and ethical treatment of participants, an IRB must have a minimum of 5 members. Additionally, the board must be diverse in terms of gender representation, including both men and women. Furthermore, at least one member of the IRB should possess non-scientific expertise to provide a balanced perspective and ensure that the research is evaluated from various angles. Therefore, the statement accurately reflects the requirements for an IRB.Rate this question:
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- 14.
Before a study can be started, name a document that the site must have:
Correct Answer
Form 1572
signed financial disclosure document
final signed protocol
IRB approval letter
Current CV
CV
1572
financial disclosure
FDA Form 1572
IRB approval
IRB approved ICF
Informed Consent
Informed Consent Document
approved ICF
approved Informed ConsentExplanation
Before a study can be started, the site must have several documents in place. These include Form 1572, which is a form that provides information about the investigator and the study site; a signed financial disclosure document, which ensures that there are no financial conflicts of interest; the final signed protocol, which outlines the study procedures; an IRB approval letter, which indicates that the study has been reviewed and approved by an ethics committee; a current CV, which details the qualifications of the investigator; and an informed consent document, which explains the study to potential participants and obtains their consent to participate.Rate this question:
- 15.
One of the most important things to ensure when reviewing a potential protocol is that the study is safe.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
When reviewing a potential protocol, it is crucial to prioritize the safety of the study. This means evaluating whether the study design, procedures, and interventions have been carefully planned to minimize risks to participants. Safety considerations include assessing the potential harm or discomfort that participants may experience, ensuring that appropriate measures are in place to mitigate these risks, and verifying that the study has been approved by an ethical review board. By prioritizing safety, researchers can protect the well-being and rights of participants and maintain the integrity and validity of the study.Rate this question:
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- 16.
One of the most important things to think about when conducting internal QA/QC of source documents is
- A.
The color of the ink used to record entries
- B.
The presence of the most current ICF, sign appropriately by all required parties
- C.
The date in which the visit was done
- D.
The data written on a sticky note, but attached to a memo-to-file explanation
Correct Answer
B. The presence of the most current ICF, sign appropriately by all required partiesExplanation
When conducting internal QA/QC of source documents, it is crucial to ensure the presence of the most current ICF (Informed Consent Form) that has been signed appropriately by all required parties. This is important because it ensures that all necessary consent has been obtained and documented correctly, reducing the risk of legal and ethical issues. It also ensures that the research or study is being conducted in compliance with regulations and guidelines.Rate this question:
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- 17.
From the following recruitment methods, choose the ones that ARE NOT appropriate for Innovative Clinical Trials staff to do: (choose all that apply)
- A.
Advertisements
- B.
Enticing a reluctant student into participation with promises of 'Big Cash'
- C.
Posters
- D.
Leading a homeless person to the office with offers of 'free medicine'
- E.
Use of EMR for patients who've agreed to be contacted
Correct Answer(s)
B. Enticing a reluctant student into participation with promises of 'Big Cash'
D. Leading a homeless person to the office with offers of 'free medicine'Explanation
The recruitment methods that are not appropriate for Innovative Clinical Trials staff to do are enticing a reluctant student into participation with promises of 'Big Cash' and leading a homeless person to the office with offers of 'free medicine'. These methods involve unethical practices of coercion and exploitation, as they manipulate vulnerable individuals into participating in the trials for personal gain rather than informed consent.Rate this question:
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- 18.
Regulatory Documents, although the PI's responsibiltiy, are often delegated to the Coordinator. The Coordinator knows that ___ _______ relating to clinical studies will be kept in the regulatory binder, and that ___ ________is required before any study activities can commence.
- A.
All medications, monitor documentation
- B.
Lab certification, clia waiver
- C.
Source data, IRB closeout letter
- D.
All documents, IRB approval
Correct Answer
D. All documents, IRB approvalExplanation
The coordinator knows that all documents relating to clinical studies will be kept in the regulatory binder, and that IRB approval is required before any study activities can commence. This means that all necessary documents, including regulatory documents, need to be stored in the binder, and the study must receive approval from the IRB before any activities can begin.Rate this question:
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- 19.
The purpose of sponsor interactions may include which of the following (select all that apply)
- A.
Site initiation visit
- B.
Ongoing study visit
- C.
Close-out visit
- D.
Holiday lunch
- E.
Telephone conversations
Correct Answer(s)
A. Site initiation visit
B. Ongoing study visit
C. Close-out visit
E. TelepHone conversationsExplanation
Sponsor interactions serve various purposes in a research study. Site initiation visits are conducted to establish a new study site, provide training, and ensure that the site is ready to start the study. Ongoing study visits involve regular communication and monitoring of the study progress, addressing any issues, and ensuring compliance. Close-out visits are conducted at the end of the study to review data, ensure proper documentation, and close the site. Telephone conversations are used for regular updates, addressing queries, and resolving any issues. Holiday lunch is not a purpose of sponsor interactions as it is not directly related to the study.Rate this question:
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- 20.
At study close-out, which of the following is not appropriate for the coordinator to do?
- A.
Ensure all CRFs are complete, all source is complete
- B.
Prepare the study closure report for the IRB
- C.
Pack the unused & returned drug for long-term storage with the source documents
- D.
Ensure the safety & data reports are complete with the help of the CRA
Correct Answer
C. Pack the unused & returned drug for long-term storage with the source documentsExplanation
The coordinator should not pack the unused and returned drug for long-term storage with the source documents. This task is typically the responsibility of the pharmacy or another designated team. The coordinator's role is to ensure all CRFs and source documents are complete, prepare the study closure report for the IRB, and ensure the safety and data reports are complete with the help of the CRA.Rate this question:
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- 21.
Patient ABC has consented to have her medical record reviewed for clinical research purposes. This means that any research team member can peruse her chart at any time for any reason.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
False. The statement implies that Patient ABC has given consent for any research team member to access her medical record for any reason at any time. However, this is not accurate. In clinical research, patient consent is obtained for specific research purposes and access to medical records is usually limited to authorized individuals who are directly involved in the research study.Rate this question:
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- 22.
It is not necessary to check the ID of an FDA Auditor when they present themselves to the research office, even if they say they are an FDA Auditor.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
It is necessary to check the ID of an FDA Auditor when they present themselves to the research office, even if they say they are an FDA Auditor. This is important for security and verification purposes to ensure that the person claiming to be an FDA Auditor is indeed authorized and legitimate. Failing to check the ID could potentially lead to unauthorized access or fraudulent activities.Rate this question:
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- 23.
The following are examples of different types of fraud as it relates to clinical trial conduct: (select all that apply)
- A.
Not taking a subject's blood pressure, but writing a blood pressure in the source
- B.
Not taking a subject's blood pressure, but writing a note in the source that it was 'inadvertantly missed'
- C.
Signing someone else's name on a delegation log
- D.
Taking a subject's study drug upon return, but keeping it for oneself and documenting it was taken by the subject
- E.
Retaking an EKG repeatedly until measurements 'fit' the criteria
- F.
Retaking an EKG once to 'verify' the reading, but calling the sponsor for guidance
Correct Answer(s)
A. Not taking a subject's blood pressure, but writing a blood pressure in the source
C. Signing someone else's name on a delegation log
D. Taking a subject's study drug upon return, but keeping it for oneself and documenting it was taken by the subject
E. Retaking an EKG repeatedly until measurements 'fit' the criteriaExplanation
The given answer includes examples of different types of fraud in clinical trial conduct. These examples involve not taking a subject's blood pressure but falsely documenting it, signing someone else's name on a delegation log, taking a subject's study drug for personal use and falsely documenting it, and repeatedly retaking an EKG until the measurements meet the desired criteria. These actions demonstrate fraudulent behavior by intentionally manipulating or falsifying data in the clinical trial process.Rate this question:
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- 24.
The reporter of misconduct on a clinical trial will be protected as a 'Whistle Blower' and no retaliatory actions will be tolerated.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
The statement is true because whistleblowers who report misconduct on a clinical trial are protected by law. Whistleblower protection laws exist to encourage individuals to come forward with information about illegal or unethical activities without fear of retaliation. In the context of a clinical trial, this protection ensures that individuals who witness or suspect misconduct, such as fraudulent data manipulation or unethical practices, can report it without facing any negative consequences. This protection promotes transparency, accountability, and the overall integrity of the clinical trial process.Rate this question:
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- 25.
In case of a nature disaster, who is responsible for ensuring security and recovery of all financial and information technology systems?
- A.
Tim, the IT Guy
- B.
Office Manager
- C.
PI
- D.
Coordinator
Correct Answer
B. Office ManagerExplanation
The Office Manager is responsible for ensuring the security and recovery of all financial and information technology systems in case of a natural disaster. This role typically involves overseeing the overall operations of the office, including managing IT infrastructure and systems. As such, the Office Manager is responsible for implementing measures to protect and recover financial and IT systems in the event of a disaster, ensuring business continuity and minimizing potential losses.Rate this question:
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- 26.
Who may conduct the revised informed consent process?
- A.
PI, CCRC, RN, SUBI, LVN, CCRP
- B.
PI, CCRC, LVN, Recruiter, CCRP
- C.
CCRC, RN, Research Assistant, PI
- D.
CCRC, Subject, LVN, SubI
Correct Answer
A. PI, CCRC, RN, SUBI, LVN, CCRPExplanation
The correct answer is PI, CCRC, RN, SUBI, LVN, CCRP. In the revised informed consent process, it is important to involve multiple individuals who have the necessary knowledge and expertise. The Principal Investigator (PI) is responsible for overseeing the research study and ensuring that the informed consent process is conducted properly. The Clinical Research Coordinator (CCRC) plays a crucial role in obtaining informed consent from participants and ensuring their understanding of the study. The Registered Nurse (RN) may also be involved in the consent process, providing information and answering any questions. The Sub-Investigator (SUBI), Licensed Vocational Nurse (LVN), and Certified Clinical Research Professional (CCRP) may also be involved in different aspects of the consent process, depending on their roles and responsibilities.Rate this question:
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- 27.
To be trained on Innovative Clinical Trials' SOPs, you may read the SOPs individually, or the SOPs may be reviewed as a group during a staff meeting.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
The statement suggests that there are two ways to be trained on Innovative Clinical Trials' SOPs: reading the SOPs individually or reviewing them as a group during a staff meeting. The answer "True" indicates that this statement is correct and both methods can be used for training on the SOPs.Rate this question:
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- 28.
A blinded rater is one who:
- A.
Is blind and has to use one of those red-tipped white canes
- B.
A study personnel who performs study assessments, but is prohibited from seeing other certain study information or performing other certain study assessments
- C.
Is completely blind to who the subject is
- D.
A rater who cannot see the assessments he/she is giving
Correct Answer
B. A study personnel who performs study assessments, but is prohibited from seeing other certain study information or performing other certain study assessmentsExplanation
A blinded rater is a study personnel who performs study assessments but is prohibited from seeing other certain study information or performing other certain study assessments. This means that the rater is only responsible for conducting the assessments and does not have access to additional information or tasks that may bias their judgment. The purpose of blinding the rater is to ensure unbiased and objective assessment of the study subjects.Rate this question:
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- 29.
The usual and customary temperature for an investigational drug storage area is:
- A.
66F-78F
- B.
68F-77F
- C.
65F-80F
- D.
66F-76F
Correct Answer
B. 68F-77FExplanation
The correct answer is 68F-77F. This temperature range is considered to be the usual and customary temperature for an investigational drug storage area. It is important to maintain a consistent temperature within this range to ensure the stability and effectiveness of the drugs. Temperatures outside of this range could potentially degrade the drugs and affect their potency.Rate this question:
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- 30.
The first person who finds a person in a medical emergency does what?
- A.
Calls for help
- B.
Does her nails while the person turns blue
- C.
Transport the person to the roof for medivac pickup
Correct Answer
A. Calls for helpExplanation
In a medical emergency, the first person who finds a person should call for help. This is because calling for help is the most immediate and important action to take in order to ensure that medical professionals or emergency services can be dispatched to provide the necessary assistance and support. It is crucial to seek help as quickly as possible in order to increase the chances of a positive outcome for the person in need.Rate this question:
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- 31.
If a tornado warning is issued by the appropriate officials, the central internal safe room designated for the office is the:
- A.
Research bathroom
- B.
Record room behind the front desk
- C.
The recruiter's office
- D.
Dr. McCarroll's office
Correct Answer
B. Record room behind the front deskExplanation
The correct answer is the record room behind the front desk. In the event of a tornado warning, it is important to seek shelter in a secure location. The record room behind the front desk is likely a reinforced and protected area, making it a suitable safe room. The research bathroom, the recruiter's office, and Dr. McCarroll's office may not have the same level of safety measures in place, making them less suitable for seeking shelter during a tornado.Rate this question:
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- 32.
If a subject pre-qualifies for more than one study at the same time, he or she:
- A.
May decide to participate in both at the same time
- B.
May be persuaded by the PI to do one rather than the other
- C.
Must be given the choice to choose one for him/herself without coercion
- D.
May participate in both, but only if he/she agrees not to take drug on both studies
Correct Answer
C. Must be given the choice to choose one for him/herself without coercionExplanation
If a subject pre-qualifies for more than one study at the same time, they must be given the choice to choose one for themselves without coercion. This means that the subject cannot be forced or influenced by the Principal Investigator (PI) to participate in one study over the other. The subject should have the autonomy to make their own decision and choose the study that they are most interested in or feel is most suitable for them.Rate this question:
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- 33.
BONUS: When the PI assesses Adverse Events, he shouldn't indicate 'CS or NCS', but rather indicate 'related or not-related' to study drug or procedure.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
The explanation for the given correct answer is that when the PI assesses Adverse Events, it is more appropriate to indicate whether they are related or not related to the study drug or procedure, rather than using the terms "CS or NCS." This distinction allows for a clearer understanding of the potential impact of the study intervention on the occurrence of adverse events and helps in determining the overall safety profile of the drug or procedure being studied.Rate this question:
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Current Version
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Mar 21, 2023Quiz Edited by
ProProfs Editorial Team -
Jun 01, 2012Quiz Created by
Ryeatts
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