1. Which document contains a standardized set of rules for conducting clinical trials?
A) Declaration of Helsinki
B) Belmont Report
C) Good Clinical Practice guidelines
D) Standard operating procedures
2. Which organization establishes regulations and guidance for Good Clinical Practices?
A) ICH
B) FDA
C) WHO
D) EMA
3. In Good Clinical Practice guidelines, what is meant by “compensation”?
A) Money paid to investigators
B) Handling requests for medical treatment
C) Subject reimbursement for participation
D) Compensation for injury during a clinical trial
4. Which best defines the responsibilities of a clinical investigator according to GCP?
A) Conducting research, recruiting subjects, oversight of study team
B) Analyzing data and publishing results
C) Managing financial aspects and budgeting
D) Obtaining ethics approval and regulatory authorization
5. According to Good Clinical Practice regulations, who should obtain informed consent?
A) Sponsor or designee
B) Principal investigator
C) Regulatory authority
D) Subject’s legal representative
6. What is required for informed consent documentation according to GCP?
A) Subject’s dated signature and date of signature
B) Signature of at least one witness
C) Language that is easily understood by subjects
D) All of the above
7. According to Good Clinical Practice guidelines, when is Essential Documents collection required?
A) Throughout the clinical trial
B) Only during the subject enrollment period
C) Only for the duration of the monitoring visit
D) Only at trial completion
8. Which statement about trial monitoring according to GCP is TRUE?
A) Not required for low risk clinical trials
B) Only required after trial initiation
C) May be conducted remotely in some instances
D) Only by regulatory authorities and sponsor personnel
9. Which document describes the protocol according to ICH-GCP?
A) Clinical trial agreement
B) Monitoring plan
C) Informed consent form
D) Investigator’s brochure
10. Which best describes source data requirements according to GCP?
A) Data reported in the CRF reconciled with other records
B) Supporting documentation for all data points
C) Only data entered into electronic systems
D) Only data mandated for reporting by protocol
11. According to GCP guidelines, who resolves conflicts of interest?
A) Principal investigator
B) Sponsor
C) Regulatory authorities
D) Institutional review board
12. What document describes methods for recording, processing and reporting trial data according to ICH-GCP?
A) Data management plan
B) Clinical trial agreement
C) Monitoring plan
D) Statistical analysis plan
13. What qualification is required for a clinical investigator according to Good Clinical Practice?
A) Medical degree
B) Clinical trials training certification
C) Affiliation with academic medical center
D) All of the above
14. What organization ensures investigators have current necessary medical expertise and oversight according to ICH-GCP?
A) Sponsor
B) Principal investigator
C) Institutional review board
D) Regulatory authorities
15. What requirement ensures confidentiality of participant medical information during and after the clinical trial according to GCP?
A) Informed consent
B) Data protection plan
C) Clinical trial agreement
D) Health Insurance Portability and Accountability Act
16. In Good Clinical Practice guidelines, what document defines the quality management system?
A) Standard operating procedures
B) Quality assurance program
C) Quality control procedures
D) All of the above
17. What person is responsible for clinical quality assurance according to ICH-GCP?
A) Sponsor
B) Regulatory authorities
C) Institutional review board
D) Clinical quality manager
18. Which best defines the role of an Independent Data Monitoring Committee according to ICH-GCP?
A) Ensure safety of clinical trial subjects
B) Provide regulatory oversight
C) Conduct statistical analyses
D) Recommend early trial termination if needed
19. According to GCP, when should a deviation from the Investigational Plan be documented?
A) During routine monitoring visits
B) Immediately after the deviation occurs
C) At the study close-out visit
D) Only if it impacts subject safety
20. Which statement about records retention according to GCP regulations is FALSE?
A) May be shortened to meet local requirements
B) Must comply with ICH-GCP guidelines
C) 3 years after last marketing approval of study product
D) 2 years after last market authorization for study product
21. In Good Clinical Practice guidelines, which document governs the overall trial?
A) Clinical trial agreement
B) Informed consent form
C) Study protocol
D) Quality management system
22. According to ICH-GCP, which roles require delegation of responsibilities in writing?
A) Investigator and clinical research associate
B) Sponsor designee and regulatory authorities
C) Institutional review board and study statistician
D) Principal investigator and sub-investigators
23. What should periodic safety reports summarize according to Good Clinical Practice?
A) Enrollment status and data quality
B) Adverse events and safety issues identified
C) Protocol amendments and consent process
D) Monitoring activities and deviation reporting
24. Which process ensures unbiased selection of participants according to ICH-GCP?
A) Informed consent
B) Enrollment log
C) Randomization
D) Stratification
25. Who is responsible for quality control in clinical trial analysis according to ICH-GCP?
A) Sponsor and CRO
B) Independent statistician
C) Principal investigator
D) Regulatory authorities
26. According to GCP guidelines, what level of training should clinical research associates receive?
A) ICH-GCP certificate
B) Standard operating procedures
C) Trial-specific training
D) Both B and C
27. Which best defines “investigator’s brochure” according to GCP guidance?
A) Comprehensive document about investigational product
B) Informed consent training records
C) Clinical trial agreement
D) Quality management manual
28. What management role according to GCP oversees the overall trial conduct?
A) Principal investigator
B) Study coordinator
C) Clinical monitor
D) Clinical research associate
29. Which best defines the purpose of the clinical protocol according to ICH-GCP?
A) Obtain ethics approval and study authorization
B) Describe research design, conduct and analysis
C) Provide instructions to clinical investigators
D) Define endpoint adjudication criteria
30. What document should describe provisions for medical care and compensation according to ICH-GCP?
A) Informed consent form
B) Clinical trial agreement
C) Standard operating procedures
D) Quality management plan
31. According to GCP, which role has ultimate responsibility for the quality and integrity of trial data?
A) Principal investigator
B) Sponsor
C) Clinical monitor
D) Independent statistician
32. In GCP guidelines, what document defines authorization of investigator site initiation?
A) Protocol
B) Clinical trial agreement
C) Informed consent form
D) Monitoring plan
33. Which best describes the role of a Clinical Research Associate according to ICH-GCP?
A) Recruit and enroll participants
B) Ensure sites follow regulations and guidelines
C) Analyze and interpret trial data
D) Provide medical care to participants
34. Good Clinical Practice regulations state the principal investigator must:
A) Personally conduct all study visits
B) Provide oversight of delegated trial tasks
C) Be qualified to evaluate efficacy
D) Be affiliation with sponsor organization
35. According to ICH-GCP, which party assumes responsibility for archiving trial master files?
A) Principal investigator at each site
B) Independent auditor
C) Sponsor
D) Regulatory authorities
36. What is the intended use of a clinical trial agreement in Good Clinical Practice?
A) Ensure ethical and regulatory approvals are obtained
B) Define ownership of raw data and intellectual property
C) Specify prohibited practices for investigators
D) Standardize informed consent processes
37. Which medical professional is responsible for the safety of clinical trial subjects according to ICH-GCP?
A) Institutional review board chair
B) Independent safety monitor
C) Principal investigator
D) Sponsor medical monitor
38. Which document defines the management structure for a clinical trial in Good Clinical Practice?
A) Protocol
B) Study organization chart
C) Clinical trial agreement
D) Quality management manual
39. According to ICH-GCP, when must investigator documentation of informed consent be obtained?
A) Before any trial-related activities
B) Within 3 days of screening
C) Prior to randomization or treatment
D) At the first study visit
40. What process ensures separation of responsibilities for clinical trial data entry and analyses according to GCP?
A) Monitoring
B) Blinding
C) Training certifications
D) Independent verification
41. According to Good Clinical Practice, where should Essential Documents be stored?
A) Archived at sponsor location only
B) Maintained at investigator site only
C) Both at site and sponsor locations
D) Destroyed after trial completion
43. According to GCP, which role is responsible for timely reporting of adverse events?
A) Sponsor medical monitor
B) Principal investigator
C) Safety oversight committee
D) Clinical monitor
44. Which organization oversees standards of biomedical research involving human subjects?
A) WHO
B) ICH
C) CIOMS
D) Nuremberg Code
45. What best defines protocol deviations according to GCP guidance?
A) Consent process errors
B) Changes to assessments or evaluations
C) Non-compliance with study procedures
D) All of the above
46. Which document defines trial conduct roles and responsibilities according to ICH-GCP?
A) Job descriptions
B) Protocol
C) Standard operating procedures
D) Clinical trial agreement
47. Which process verifies interim and final clinical trial data according to GCP guidelines?
A) Line listings
B) Data validation
C) Statistical analysis
D) Source data verification
48. According to Good Clinical Practice, the informed consent process must ensure participant:
A) Voluntary participation
B) Understanding of risks and procedures
C) Ability to contact investigators
D) All of the above
49. In addition to IRB/IEC approval, what regulatory body authorization is required by GCP guidelines?
A) Health authority
B) Sponsor
C) Publication committee
D) Safety oversight committee
50. What is the primary purpose of a risk management plan according to Good Clinical Practice?
A) Identify, evaluate and minimize risks to trial integrity
B) Ensure subject safety is not compromised
C) Satisfy regulatory requirements for monitoring and oversight
D) Prevent data quality and biostatistical issues
51. According to ICH-GCP, the clinical monitor should review which essential document?
A) Authorization letters
B) Source documents
C) Investigator site files
D) Delegation of authority logs
52. Which guidance describes standards for EC/IRB composition, procedures and review according to ICH-GCP?
A) Declaration of Helsinki
B) Belmont Report
C) OPRR report
D) CIOMS guidelines
53. According to Good Clinical Practice guidelines, who maintains authority over protocol amendments?
A) Sponsor and regulatory authorities
B) Investigators and IRB/IEC
C) Data monitoring committee
D) Safety oversight committee
54. What qualification should investigators have to obtain informed consent according to GCP?
A) Medical degree
B) ICH-GCP certificate
C) Consent training certification
D) Both A and C
55. Which document serves as the key reference for all essential trial documents according to GCP?
A) File index
B) Trial master file table of contents
C) Archiving spreadsheet
D) Essential documents log
56. According to ICH-GCP, case report forms should be designed to collect data for which objectives?
A) Efficacy and safety analyses
B) Source data verification
C) Adverse event reporting
D) All of the above
57. Good Clinical Practice guidance states medical records and informed consent forms must document which element of the consent discussion?
A) Voluntary nature of participation
B) Participant willingness to participate
C) Description of all study procedures
D) All interactions with study physicians
58. Which ICH guideline recommends standards for safety data and privacy protection?
A) E2A
B) E3
C) E6(R2)
D) E8
59. Which body oversees clinical trial transparency reporting according to Good Clinical Practice standards?
A) Regulatory authority in country of trial
B) International Committee of Medical Journal Editors
C) World Health Organization Trial Registration Data Set
D) Clinical Trial Transparency Initiative
60. According to ICH-GCP, which document should define roles of contract research organizations?
A) Protocol
B) Job descriptions
C) Clinical trial agreement
D) Quality management plan
61. What individual or group ensures medical care of participants according to ICH-GCP?
A) Data safety monitoring board
B) Safety oversight committee
C) Sponsor medical monitor
D) Principal investigator
62. Which person or group reviews monitor reports to ensure GCP compliance according to ICH?
A) Safety monitor
B) Medical writer
C) Sponsor study manager
D) Institutional review board
63. Good Clinical Practice guidelines state the clinical protocol must be approved by which entity?
A) Sponsor
B) Regulatory authorities
C) Independent ethics committee/IRB
D) Investigators
64. According to ICH-GCP, what personnel require documented delegation of trial-related duties from the principal investigator?
A) Medical monitor
B) Clinical research associate
C) Study coordinator
D) Safety monitor
65. What individual’s responsibilities include verification of informed consent according to Good Clinical Practice?
A) Sponsor medical monitor
B) Independent safety reviewer
C) Study monitor
D) Principal investigator
66. Which document specifies critical trial conduct activities and timelines in GCP guidance?
A) Study schedule
B) Monitoring plan
C) Statistical analysis plan
D) Clinical trial agreement
67. What qualification do sub-investigators require according to the ICH-GCP guidelines?
A) Medical degree
B) Active clinical license
C) GCP training certificate
D) Both B and C
68. Which documentation must verify resolution of clinical queries according to Good Clinical Practice?
A) Source documents
B) Correspondence records
C) Data clarification forms
D) Query tracking logs
69. In addition to the sponsor, who verifies trial data integrity according to ICH-GCP guidelines?
A) Independent auditor
B) Regulatory inspectors
C) Principal investigator
D) Both A and B
70. According to GCP guidance, what approval bodies must authorize protocol amendments?
A) Sponsor and IRB/IEC only
B) Sponsor, IRB/IEC and regulatory authorities
C) Regulatory authorities only
D) Sponsor only
71. Which team role is responsible for adherence to ICH-GCP guidelines according to the standards?
A) Data monitoring committee
B) Safety oversight committee
C) Sponsor management team
D) Clinical operations group
72. What is the minimum training required for clinical research associates performing monitoring visits according to GCP?
A) Trial-specific
B) Sponsor SOPs
C) ICH-GCP course
D) Both B and C
73. Good Clinical Practice guidance requires which document to define roles in medical care of trial participants?
A) Consent form
B) Care plan
C) Protocol
D) Clinical trial agreement
74. What document should contain delegation of authority according to ICH-GCP?
A) Job descriptions
B) Curriculum vitae
C) Signature logs
D) Authorization letters
75. According to GCP guidance, how must records of IRB review and approval be maintained?
A) In essential documents
B) Archived separately from investigator site files
C) Available upon request from sponsor or authorities
D) For 5 years after trial completion
76. What guidance describes standards for EC/IRB functions and operations?
A) Declaration of Helsinki
B) Belmont Report
C) ICH-GCP
D) CIOMS
77. Which individual is responsible for clinical trial data quality control according to GCP?
A) Data manager
B) Biostatistician
C) Principal investigator
D) Sponsor medical monitor
78. Which individual should evaluate eligibility criteria and obtain informed consent according to ICH-GCP?
A) Sub-investigators
B) Clinical research associates
C) Principal investigator
D) Safety monitor
79. What guidance directs management and reporting of deviations from GCP?
A) ICH-GCP
B) Standard operating procedures
C) Protocol
D) Monitoring plan
80. Which statement about Good Documentation Practices according to GCP is FALSE?
A) Source documents should be legible and indelible
B) May paraphrase if exact documentation not required
C) Changes must have single line-through, initial and date
D) Errors require complete new entry rather than corrections
81. What term refers to Good Documentation Practices according to the ICH-GCP guidelines?
A) Source data
B) Direct data capture
C) Electronic records
D) Essential documents
82. According to ICH-GCP, when should final study reports be completed and shared?
A) Within 6 months of last subject last visit
B) 1 year after database lock
C) 2 years after last subject enrollment
D) Determined by sponsor and authorities
83. What individual ensures accuracy, completeness and timeliness of data entry according to GCP?
A) Data manager
B) Clinical monitor
C) Principal investigator
D) Safety monitor
84. Which guidance recommends standards for IND/CTA requirements and administrative details?
A) ICH E6
B) ICH E8
C) 21 CFR 312
D) FDA Guidance for Industry
85. What role verifies Case Report Forms according to ICH-GCP?
A) Clinical research associate
B) Data entry staff
C) Principal investigator
D) Medical monitor
87. According to GCP guidance, which role has overall responsibility for clinical quality assurance?
A) Sponsor
B) Clinical quality manager
C) Principal investigator
D) Monitoring team
88. According to GCP, what personnel qualification does a clinical monitor require?
A) Medical degree
B) Clinical research certification
C) Clinical trials training
D) Both B and C
89. How should essential documents be controlled according to GCP guidelines?
A) Version control with document revision histories
B) Restricted access with signature logs
C) Secured onsite storage with backups
D) All of the above
90. Which guidance recommends standards for safety reporting in clinical trials?
A) ICH E2A
B) ICH E6
C) CTCAE
D) MedDRA
91. According to GCP, what role ensures delegation of responsibilities to sub-investigators is documented properly?
A) Principal investigator
B) Institutional review board
C) Sponsor
D) Monitoring team
92. What requirement ensures traceability of amendments according to ICH-GCP?
A) Version histories for protocol and ICF
B) Regulatory approval logs
C) Documentation of communication to sites
D) All of the above
93. Good Clinical Practice guidelines state clinical trial data should be managed according to which principles?
A) Accuracy, completeness, consistency
B) Traceability, reliability, reproducibility
C) Accessibility, security, confidentiality
D) All of the above
94. In addition to monitors, which role may perform source document verification according to GCP?
A) Data manager
B) Independent auditor
C) Safety monitor
D) Medical writer
95. According to GCP, how should the investigator’s responsibilities to trial participants be defined and communicated?
A) In clinical trial agreement
B) Standard operating procedures
C) Consent form
D) All of the above
96. What guidance recommends processes for trialmaster file organization and archiving according to GCP?
A) FDA eCTD
B) ICH E6
C) GCP Directive
D) 21 CFR Part 11
97. Which management role according to GCP oversees day-to-day trial operations?
A) Sponsor study manager
B) Safety monitor
C) Clinical research associate
D) Medical quality officer
98. According to ICH-GCP, what role reviews essential documents for protocol deviations?
A) Clinical monitor
B) Independent auditor
C) Safety monitor
D) Principal investigator
99. What guidance provides regulatory standards for bioanalytical method validation?
A) ICH Q2
B) ICH E6
C) 21 CFR Part 11
D) ICH E9
100. According to GCP guidelines, which role is responsible for investigation of noncompliance issues?
A) Principal investigator
B) Sponsor
C) Independent Data Monitoring Committee
D) Regulatory authorities