GCP TRAINING QUIZ
The Principal Investigator retains ultimate responsibility for the conduct of the study even if specific tasks are delegated to other staff members. A. TRUE B. FALSE
A
The research protocol must be approved by a designated Institutional Review Board: A. Before the research study can begin. B. After the first participant is randomized. C. By the last participant has completed the last follow up visit. D. There is no designated time for approval.
A. Before the research study can begin.
1The sponsor has the ultimate responsibility for implementing and maintaining Quality Assurance systems. A. TRUE B. FALSE
A. TRUE
Choose the definition for Falsification: A. Making up data or results and recording or reporting them. B. Changing the research record so that it does not accurately reflect the research findings. C. Using another person's ideas, processes, results or words without giving credit.
B
The severity of an adverse event (AE) is the same as its seriousness. A. TRUE B. FALSE
B. FALSE
4This is not one of the serious advent event (SAE) criteria. A. Death B. Life threatening C. Pregnancy D. Hospitalization
C. Pregnancy
5The staff at the research site may include: A. Research Assistants. B. Therapists/Counselors. C. Principal Investigator. D. All of the above. E. None of the above.
D
3The primary purpose of the Institutional Review Board (IRB) is to: A. Investigate allegations of research misconduct. B. Administer compensation for participation to study volunteers. C. Protect the rights and welfare of research participants. D. All of the above.
D. All of the above.
2For an IRB review to be required, clinical research must be: A. Federally funded. B. Involve a product regulated by the FDA. C. Fall under local institutional rules requiring IRB approval. D. Any or all of the above A, B or C.
D. Any or all of the above A, B or C.
1The three key principle(s) that underlie the current system of human research protections include which of the following? A. Respect for persons B. Beneficence C. Justice D. Honor E. All of the above. F. A, B, and C
F. A, B, and C
Which of the following safeguards are included as protections for prisoners involved in research? A. The IRB must approve the study as prisoner research. B. The study must present no more than minimal risk to the participants. C. The IRB that reviews and approves the study must not include prisoners or prisoner advocates in its membership. D. The research must involve practices intended to improve the health or well-being of the participants. E. All of the above. F. A, B, and D
F. A, B, and D
A protocol violation is any action that does not adhere to the study description in the protocol. A. TRUE B. FALSE
TRUE
A principal investigator is required to comply with the Institutional Review Board (IRB) for : A. Reporting protocol deviations or changes collectively once the study is closed. B. Beginning a study based on a predetermined timeline by the study team, even if that is prior to IRB approval C. Hiring specific study staff based on social status. D. Obtaining initial and continuing review approval at the start and during the course of a research study.
A
A principal investigator is required to comply with the Institutional Review Board (IRB) for: A. Reporting protocol deviations or changes collectively once the study is closed. B. Beginning a study based on a predetermined timeline by the study team, even if that is prior to IRB approval. C. Hiring specific study staff based on social status. D. Obtaining initial and continuing review approval at the start and during the course of a research study.
A
3How long does the FDA require storage of trial-related records? A. 2 years B. 5 years C. 3 years D. 18 months
A. 2 years
One (1) bottle of study medication containing 100 tablets was supplied to the research center. 55 tablets were ingested and 3 tablets were lost. How much study medication is on hand? A. 42 tablets. B. 45 tablets. C. 97 tablets. D. Amount unknown.
A. 42 tablets.
The consent form is signed by the participant but is missing the participant's initials in several places. Which strategy helps to prevent this from occurring in the future with other participants? A. Conduct consent interviews in a quiet, separate room with no distractions or interruptions. B. The person obtaining the participant's consent must be present when the form is signed. C. Create and use a checklist to ensure that every detail in the informed consent process is completed. D. All of the above.
A. Conduct consent interviews in a quiet, separate room with no distractions or interruptions.
Which section of the research protocol should describe the type and timing of data to be collected for participants who withdraw from the study? A. Data Management B. Selection and Withdrawal of Participants C. Assessment of Safety D. Background Information
A. Data Management
4Based on confidentiality regulations, written records must be: A. Maintained in a secure location, such as a locked file room, cabinet, or safe. B. Stored in an open location, accessible to all staff at the research site. C. Accessible to study participants at all times.
A. Maintained in a secure location, such as a locked file room, cabinet, or safe.
A participant missed several study visits and the research site staff becomes aware of a participant's death searching through public records. What is the most appropriate next course of action? A. Report this as a serious adverse event (SAE). B. Report this as an adverse event (AE). C. No action is required. D. Contact the Study Physician for instructions on next steps
A. Report this as a serious adverse event (SAE).
When research sites collect incorrect data or do not maintain good documentation practices, what can be a consequence? A. Sloppy or incorrect data can lead to misleading conclusions. B. Study investigators will increase credibility when publishing results. C. Results of studies are interpreted correctly. D. All of the above.
A. Sloppy or incorrect data can lead to misleading conclusions.
5Which of the following applies when new information is available to researchers regarding the study medication? A. Study participants will be advised promptly if the researchers find any new information that might affect them. B. Participants are never informed of the new information on study medication. C. Participants do not have to continue taking part in the study. D. Participants will not incur penalties or loss of benefits if they withdraw from the study. E. A, C, and D
A. Study participants will be advised promptly if the researchers find any new information that might affect them.
2Because of being incarcerated, prisoners may not be able to make a voluntary decision about participating in a clinical trial. A. TRUE B. FALSE
A. TRUE
2Federal regulations outline the records requirements and retention schedule for all federally funded research projects. A. TRUE B. FALSE
A. TRUE
2The purpose of an IRB is to safeguard the rights, safety, and well-being of all human research participants. A. TRUE B. FALSE
A. TRUE
2The role of monitoring is to support and assist members of the study team to maintain high quality standards. A. TRUE B. FALSE
A. TRUE
4All serious adverse events (SAEs) must be reported to the research site's Institutional Review Board (IRB). A. TRUE B. FALSE
A. TRUE
4An IRB may perform an expedited review of a protocol or informed consent form change if the change involves no more than minimal risk to study participants. A. TRUE B. FALSE
A. TRUE
4When an original consent form has been lost, the only steps that must be taken are that study staff report the loss immediately to the IRB, the sponsor, and get another signed as soon as possible. A. TRUE B. FALSE
A. TRUE
A person who has a court-appointed legal guardian or who has been determined by a court to be legally incompetent can sign an informed consent form. A. TRUE B. FALSE
A. TRUE
A protocol violation is any action that does not adhere to the study description in the protocol. A. TRUE B. FALSE
A. TRUE
According to regulations, every aspect of a research study must be documented in compliance with GCP guidelines in order to obtain useful data. A. TRUE B. FALSE
A. TRUE
According to the Code of Federal Regulations, there are certain exceptions to confidentiality requirements for alcohol and drug abuse patient records. A. TRUE B. FALSE
A. TRUE
As part of the consent, each participant must be informed that she/he has a right to withdraw only at the beginning of a study. A. TRUE B. FALSE
A. TRUE
Based on Good Clinical Practice (GCP) guidelines, the Sponsor has the primary responsibility for selecting study monitors. A. TRUE B. FALSE
A. TRUE
Certificates of Confidentiality may contribute to increased enrollment in trials due to assurance of participant privacy. A. TRUE B. FALSE
A. TRUE
Medical records, paper based and electronic, are subject to disclosure and confidentiality requirements. A. TRUE B. FALSE
A. TRUE
4If the research participant is a minor (under the age of 18), which of the following must occur before the individual can participate in the research study? A. The parent/legal guardian must give permission for the minor to participate. B. The minor must agree to participate in the research. C. A judge gives permission for the minor to participate in the research. D. A and B E. A, B, and C
A. The parent/legal guardian must give permission for the minor to participate.
2Researchers are not required to account for disclosures of protected health information (PHI) when: A. The participant authorizes disclosure. B. The information is provided as a complete data set. C. The information contains participant identifiers.
A. The participant authorizes disclosure.
Which section of the research protocol should describe the pharmacological treatment and any other interventions included in the study? A. Treatment of Subjects B. Data Management C. Selection and Withdrawal of Participants D. Assessment of Safety
A. Treatment of Subjects
Which section of the research protocol should describe the pharmacological treatment and any other interventions included in the study? A. Treatment of Subjects B. Data Management C. Selection and Withdrawal of Participants D. Assessment of Safety
A. Treatment of Subjects
Protocol Monitor responsibilities are outlined in GCP guidelines, and include which one of the following responsibilities? A. Verifying investigator and research staff qualifications. B. Consenting research participants. C. Performing physical examinations. D. Administering investigational drug to research participants.
A. Verifying investigator and research staff qualifications.
Is the following statement true? All informed consent documents should be written in non-technical language that potential participants would understand; rather, the language should be consistent with the proposed participants educational level, cultural views, and familiarity with research. A. Yes, the statement is true. B. No, the statement is false.
A. Yes, the statement is true.
If the Sponsor transfers all study related duties and functions to a clinical research organization (CRO), the Sponsor is no longer responsible for the conduct of the study. A TRUE B. FALSE
B
Study drug accountability is not as important in research projects and investigators do not need to maintain accurate records of study drug disposition. A. TRUE B. FALSE
B
of the following study roles, which one would be responsible for receiving and dispensing medications?. A. Supervisor B. Pharmacist C. Quality Assurance Monitor D. Regulatory Specialist
B
5Which section of the research protocol should contain a description of the problem the study is addressing, as well as its public health significance? A. Data Management B. Background Information C. Quality Control and Quality Assurance D. Treatment of Subjects
B. Background Information
Which section of the research protocol should contain a description of the problem the study is addressing, as well as its public health significance? A. Data Management B. Background Information C. Quality Control and Quality Assurance D. Treatment of Subjects
B. Background Information
The document that provides protection for the privacy of study participants in alcohol and drug abuse research studies is called: A. Affidavit B. Certificate of Confidentiality C. Disclosure Certificate D. Confidentiality Agreement Form
B. Certificate of Confidentiality
5Which of the following statements is false regarding errors in the informed consent process? A. Errors are considered protocol violations and must be reported to the relevant IRB. B. Errors are very uncommon and always result in suspension of the study. C. Errors must be dealt with openly and honestly. D. Once errors are identified, a description must be provided of the action taken to correct the error and prevent it from occurring again.
B. Errors are very uncommon and always result in suspension of the study.
1A protocol that has been previously reviewed by the full IRB is always eligible for expedited review. A. TRUE B. FALSE
B. FALSE
Based on Good Clinical Practice (GCP) guidelines, the research site investigator has the primary responsibility for selecting study monitors. A. TRUE B. FALSE
B. FALSE
The Informed Consent form can be used to consent research participants before the IRB reviews and approves the language. A. TRUE B. FALSE
B. FALSE
1If an individual agrees to participate in a research study because he or she believes that harm or punishment will result for refusing to participate in the study, the individual's decision to participate was: A. Obtained voluntarily. B. Influenced improperly (coerced). C. Neither.
B. Influenced improperly (coerced).
Which section of the research protocol should describe the type and timing of data to be collected for participants who withdraw from the study? A. Data Management B. Selection and Withdrawal of Participants C. Assessment of Safety D. Background Information
B. Selection and Withdrawal of Participants
5A serious adverse event (SAE) does NOT need to be reported to NIDA or designee within 24 hours in which of the following situation: A. The investigator considers the SAE unrelated to study intervention. B. The SAE is non-fatal and non-life-threatening. C. The SAE occurs in a behavioral study. D. The SAE occurs in a non-Investigational New Drug study. E. The SAE occurs in the post-treatment observation period. F. None of the above.
B. The SAE is non-fatal and non-life-threatening.
3Choose the definition for Plagiarism: A. Making up data or results and recording or reporting them. B. Changing the research record so that it does not accurately reflect the research findings. C. Using another person's ideas, processes, results, or words without giving credit.
C
According to GCP, who is responsible for all study-related medical decisions? A Study Coordinator B. Pharmacist C. Qualified physician D. Phlebotomist
C
An informant is considered: A. a whistleblower. B. one who alleges research misconduct. C. A and B. D. one who does not disclose research misconduct. E. None of the above.
C
Which one is NOT a goal of the regulations for dealing with research misconduct (42 CFR 50 subpart A) A. To define research misconduct. B. To define penalties for research misconduct. C. To establish procedures for reporting and investigating research misconduct. D. To protect both those who report alleged research misconduct. E. To protect those accused of research misconduct.
C
On-site monitoring activities are conducted: A. At study initiation. B. At study closeout. C. Before, during, and after completion of the study. D. On an "as needed" basis.
C. Before, during, and after completion of the study.
3IRB members must: A. All be physicians who can assess subject safety. B. Be affiliated with the institute or study site conducting the study. C. Have the qualifications and experience to review and evaluate the scientific, medical, behavioral, social, legal, ethical, and non-scientific aspects of a proposed study. D. Be investigators on the study
C. Have the qualifications and experience to review and evaluate the scientific, medical, behavioral, social, legal, ethical, and non-scientific aspects of a proposed study.
3Quality data are critical to ensure that the study results are ________. A. Stored in the documentation of research sites during the conduct of a study. B. Available for participants to review easily when a study is blinded. C. Interpreted correctly. D. None of the above.
C. Interpreted correctly.
4An ongoing clinical protocol at your site includes weekly blood draws to assess an exploratory endpoint. Unfortunately, participants are not happy about visiting the clinic weekly, and they are considering dropping out. Therefore, a protocol amendment is being prepared to remove the weekly blood draw. This change can be implemented: A. Immediately, as it is not a safety assessment. B. Once the protocol is finalized and submitted to the FDA. C. Once the protocol and consent form updates are approved by the IRB. D. As soon as the study sponsor advises that their decision is final to remove these blood draws.
C. Once the protocol and consent form updates are approved by the IRB
3Which of the following is NOT an appropriate response to a protocol violation occurrence: A. Document the violation and corrective action. B. Report the violation to the affiliated IRB. C. Reduce the study sample size in order to minimize future protocol violations. D. Immediately address any concerns regarding participant safety related to the violation
C. Reduce the study sample size in order to minimize future protocol violations.
Which of the following is NOT an appropriate response to a protocol violation occurrence : A. Document the violation and corrective action. B. Report the violation to the affiliated IRB. C. Reduce the study sample size in order to minimize future protocol violations.
C. Reduce the study sample size in order to minimize future protocol violations.
Which of the following is NOT an appropriate response to a protocol violation occurrence : A. Document the violation and corrective action. B. Report the violation to the affiliated IRB. • C. Reduce the study sample size in order to minimize future protocol violations. D. Immediately address any concerns regarding participant safety related to the violation.
C. Reduce the study sample size in order to minimize future protocol violations.
Which of the following refers to a document containing nonclinical and clinical data that describe the previous experience with the experimental intervention, often a medication? A. The Research Protocol B. The Operations Manual C. The Investigator's Brochure D. The IRB Membership Roster
C. The Investigator's Brochure
5Which of the following would you NOT expect to find in the Study Design section of the research protocol? A. A description of primary and secondary endpoints. B. A schematic diagram of the study design. C. The methods for recording and analyzing the effectiveness criteria. D. The expected duration of participant participation.
C. The methods for recording and analyzing the effectiveness criteria.
Which of the following would you NOT expect to find in the Study Design section of the research protocol? A. A description of primary and secondary endpoints. B. A schematic diagram of the study design. C. The methods for recording and analyzing the effectiveness criteria. D. The expected duration of participant participation.
C. The methods for recording and analyzing the effectiveness criteria.
What information should be provided to an IRB for review at the initiation of a study? Choose the best response. A. A synopsis of the study and an outline of the advertisement to recruit subjects, including how much they will be paid. B. The informed consent form. C. The study protocol (and amendments), the information to be given to the subject (informed consent, advertisements), the Investigator Brochure (or drug label), any other relevant safety information, and an outline of the qualifications of the lnvestigator. D. The study protocol (and amendments) and the Investigator Brochure.
C. The study protocol (and amendments), the information to be given to the subject (informed consent, advertisements), the Investigator Brochure (or drug label), any other relevant safety information, and an outline of the qualifications of the lnvestigator.
After the IRB reviews and approves your protocol, informed consent, and associated documents, you should receive: A. A phone call telling you the study can now proceed. B. A personal visit from the IRB chair telling you how excited he/she is about your research. C. Written notification of the IRB decision and the approved versions of the protocol and informed consent forms. D. Nothing. If you do not receive a response in 30 days, you can proceed with your study.
C. Written notification of the IRB decision and the approved versions of the protocol and informed consent forms.
3A principal investigator is required to comply with the Institutional Review Board (IRB) for: A. Reporting protocol deviations or changes collectively once the study is closed. B. Beginning a study based on a predetermined timeline by the study team, even if that is prior to IRB approval. C. Hiring specific study staff based on social status. D. Obtaining initial and continuing review approval at the start and during the course of a research study.
D
4Essential documents collected for research projects may be audited or inspected for GCP compliance by which stakeholder? A. Financial audit agencies B. Regulatory authorities C. Quality Assurance monitors D. B and C
D
The Sponsor is responsible for designating qualified individuals to carry out all stages of the study process, including: A. Managing and verifying the study data and planning and conducting the statistical analysis and preparing reports. B. Supervising the overall conduct of the study and monitoring study performance. C. Releasing data on ClinicalTrials.gov with PHI and identifiers to link back to study participants. D. A and B. E. A, B, and C.
D
The Sponsor is responsible for: A. Implementing and maintaining quality assurance and quality control systems. B. Ensuring that the study is conducted and documented in compliance with the protocol and GCP. C. Ensuring that the study is conducted and documented in compliance with regulatory requirements. D. All of the above.
D
The primary responsibility for investigating allegations of research misconduct belongs to: A. Office of Research Integrity (ORI) B. Researcher(s) C. Research institution(s) D. B and C. E. A, B and C.
D
3Behavioral studies have requirements for essential documents in addition to GCP guidelines and may include which of the following: A. Counseling materials and manuals. B. Audio recordings of behavioral intervention. C. Video media files of treatment sessions. D. A, B, and C.
D. A, B, and C.
4The research protocol describes: A. Why the study is being conducted. B. What will be done in the study. C. Who will be involved in the research study D. All of the above
D. All of the above
3A participant reported migraine headache and missed work for a day. Is this an AE? A. Check baseline medical history B. Assess the severity level C. Assess if there is change from baseline. D. All of the above.
D. All of the above.
3A protocol violation is: A. An omission (i.e., failure to do something required in the protocol) B. An addition (i.e., any action that is not required in the protocol). C. A change in any procedure described in the protocol D. All of the above.
D. All of the above.
Certificates of Confidentiality (CoC) do not prevent investigators from releasing personal information without participant consent in which of the following cases: A. Matters such as child abuse or neglect. B. Reportable communicable diseases. C. Threatened violence or harm to self or others. D. All of the above.
D. All of the above.
Informed consent is: A. The process by which a person voluntarily agrees to participate in a research study after being fully informed about the study. B. The legal document that explains the study. C. A document stating that the study information was presented orally to the person. D. All of the above.
D. All of the above.
There are many historical examples of blatant coercion where: A. Participants believed that they would be harmed or punished for refusing to take part in research. B. Relationships existed that involved dependence or unequal power between those carrying out the research and potential participants. C. Research team members designated to explain the study to the participant linked participation to employment or receipt of benefits. D. All of the above.
D. All of the above.
5Which source document may NOT be used to determine whether an adverse event is expected or not in clinical studies in which an investigational new drug is used? A. Investigator Brochure B. Protocol C. Informed Consent Form D. Annual Safety Report E. All of the above may be used.
D. Annual Safety Report
1Essential documents collected for research projects may be audited or inspected for GCP compliance by which stakeholder? A. Financial audit agencies B. Regulatory authorities C. Quality Assurance monitors D. B and C
D. B and C
Of the following factors, which one does not influence the capacity to consent? A. Age B. Cognitive (mental) impairment C. Illness D. Financial factors
D. Financial factors
1A serious adverse event (SAE) should be reported to the local IRB within what period of time after learning of the event? A. 5 days B. 2 weeks C. 24 hours D. Follow the local IRB reporting guidelines.
D. Follow the local IRB reporting guidelines.
Choose the study document that outlines monitoring procedures for a trial, defining when, how many, and the types of visits to occur. A. Study Protocol. B. Monitoring Plan. C. Manual of Procedures. D. Good Clinical Practice (GCP) Guidelines.
D. Good Clinical Practice (GCP) Guidelines.
A participant missed a study visit as he was hospitalized for pneumonia, and then he reported to the study clinic a week later. What is the most appropriate course of action? A. No action is required. B. Report it as an adverse event (AE). C. Remind the participant of the importance of attending study visit as scheduled without exception D. Report it as a serious adverse event (SAE).
D. Report it as a serious adverse event (SAE).
2Which of the following events is considered research misconduct? A. Unintentional errors in data entry. B. Differences of opinion. C. Failure to protect human research subjects. D. Authorship dispute not involving plagiarism. E. None of the above.
E
5Based on GCP, the Sponsor is responsible primarily for study design and management as well as _______________. A. Research site submissions to the IRB. B. Training staff that are not related to or involved in the study. C. Participant safety. D. Interference in the day-to-day operation of research sites. E. Changing the site's institutional policies.
E
Based on GCP, the Sponsor is responsible primarily for study design and management as well as A Research site submissions to the IRB B. Training staff that are not related to or involved in the study. C. Participant safety. D. Interference in the day-to-day operation of research sites. E Changing the site's institutional policies.
E
Which of the following constitutes research misconduct according to federal regulations? A. Fabrication of data. B. Falsification of data. C. Failure to protect human research subjects. D. Plagiarism. E. A, B, and D
E
4Study monitors are ________. A. Familiar with the product under investigation in the study. B. Appropriately trained and have qualifications to monitor clinical studies. C. Not required to have any specific knowledge of the trial or the investigational product. D. All of the above. E. A and B
E. A and B
For participants discontinuing participation in a study because of a serious adverse event (SAE) or pregnancy, which of the following are correct? A. There should be an attempt to follow up the outcome of the pregnancy to term in cases of women discontinuing because of pregnancy. B. There should be an attempt to complete any final evaluations required by the study protocol. C. There should be an attempt to perform other medical evaluations to try to determine the cause of the serious adverse event (SAE) and its possible relationship to the study intervention. D. The serious adverse event (SAE) should be marked as resolved on the date of discontinued participation since the participant may not be evaluated again in the future. E. A, B, and C only F. All of the above are correct.
E. A, B, and C only
Which of the following practices ensure the confidentiality of research participants? A. Properly dispose of all paper documents containing identifiers (SSN, address, DOB, etc.). B. Require passwords to access computerized records. C. Use the participant's SSN instead of the participant's full name. D. Store paper records in a secure place (secure room, locked cabinet, safe, etc.). E. A, B, and D. F. A, B, C, and D.
E. A, B, and D.
3The HIPAA Privacy Rule applies to which of the following identifiable health information for individuals: A. Fingerprints and voice prints B. License and license plate numbers C. Names D. Dates E. All of the above.
E. All of the above.
Common problems identified in audits by the U.S. Food and Drug Administration (FDA) include which of the following: A. Inadequate oversight at the Clinical Coordinating Center. B. Inadequate records that do not support the reported data. C. Inadequate study drug accountability. D. A and B E. B and C
E. B and C
Examples of adverse events (AE) include which of the following? A. Damaged wheelchair. B. Anxiety. C. Decreased blood sodium. D. Enlarged thyroid on physical examination. E. B, C, and D only F. All the above are adverse events (AEs).
E. B, C, and D only
4Protocol Monitors perform which of the following duties during the conduct of a trial: A. Verify the accuracy of reported trial data. B. Verify the financial statements of the research site. C. Verify that the site has the adequate resources to continue the trial. D. Verify that all research site staff has documentation of driver's licensure. E. Verify that participant rights and well-being is being protected. F. A, C, and E G. B, D, and E
F. A, C, and E
2For participants discontinuing participation in a study because of a serious adverse event (SAE) or pregnancy, which of the following are correct? A. There should be an attempt to follow up the outcome of the pregnancy to term in cases of women discontinuing because of pregnancy. B. There should be an attempt to complete any final evaluations required by the study protocol. C. There should be an attempt to perform other medical evaluations to try to determine the cause of the serious adverse event (SAE) and its possible relationship to the study intervention. D. The serious adverse event (SAE) should be marked as resolved on the date of discontinued participation since the participant may not be evaluated again in the future. E. A, B, and C only F. All of the above are correct.
F. All of the above are correct.
1Who can report an adverse event (AE)? A. Participant B. Participant's spouse C. Caregiver D. Participant's family member E. Research Nurse F. All of the above can report an AE
F. All of the above can report an AE
The U.S. Congress passed the Health Insurance Portability and Accountability Act (HIPAA) in 1996, and the HIPAA privacy rule applies to which of the following entities? A. Institutional Review Boards. B. A health plan. C. A health care clearinghouse. D. Scientific Advisory Committees. E. A and D F. B and C
F. B and C
1The person(s) responsible for assuring the safety and rights of study participants include: A. Principal Investigator. B. Sub-Investigator. C. Data and Safety Monitoring Board. D. Research Assistant. E. Study Physician. F. Phlebotomist. G. All of the above.
G. All of the above.