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SOCRA 2025 > SOCRA_CCRP_Practice_Exam_Questions > Flashcards

SOCRA_CCRP_Practice_Exam_Questions Flashcards

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1
Q

Q1

A
  1. Which of the following is a required element when developing an informed consent document?
    A. Compensation details for research staff
    B. Investigator’s academic background
    C. A statement that participation is voluntary
    D. Description of the investigational product
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2
Q

Q2

A
  1. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data?
    A. Investigator’s Brochure
    B. Financial Disclosure Form
    C. Site Monitoring Plan
    D. Delegation Log
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3
Q

Q3

A
  1. Which of the following is a required element when developing an informed consent document?
    A. Compensation details for research staff
    B. Investigator’s academic background
    C. A statement that participation is voluntary
    D. Description of the investigational product
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4
Q

Q4

A
  1. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data?
    A. Investigator’s Brochure
    B. Financial Disclosure Form
    C. Site Monitoring Plan
    D. Delegation Log
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5
Q

Q5

A
  1. Which of the following is a required element when developing an informed consent document?
    A. Compensation details for research staff
    B. Investigator’s academic background
    C. A statement that participation is voluntary
    D. Description of the investigational product
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6
Q

Q6

A
  1. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data?
    A. Investigator’s Brochure
    B. Financial Disclosure Form
    C. Site Monitoring Plan
    D. Delegation Log
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7
Q

Q7

A
  1. Which of the following is a required element when developing an informed consent document?
    A. Compensation details for research staff
    B. Investigator’s academic background
    C. A statement that participation is voluntary
    D. Description of the investigational product
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8
Q

Q8

A
  1. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data?
    A. Investigator’s Brochure
    B. Financial Disclosure Form
    C. Site Monitoring Plan
    D. Delegation Log
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9
Q

Q9

A
  1. Which of the following is a required element when developing an informed consent document?
    A. Compensation details for research staff
    B. Investigator’s academic background
    C. A statement that participation is voluntary
    D. Description of the investigational product
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10
Q

Q10

A
  1. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data?
    A. Investigator’s Brochure
    B. Financial Disclosure Form
    C. Site Monitoring Plan
    D. Delegation Log
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11
Q

Q11

A
  1. Which of the following is a required element when developing an informed consent document?
    A. Compensation details for research staff
    B. Investigator’s academic background
    C. A statement that participation is voluntary
    D. Description of the investigational product
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12
Q

Q12

A
  1. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data?
    A. Investigator’s Brochure
    B. Financial Disclosure Form
    C. Site Monitoring Plan
    D. Delegation Log
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13
Q

Q13

A
  1. Which of the following is a required element when developing an informed consent document?
    A. Compensation details for research staff
    B. Investigator’s academic background
    C. A statement that participation is voluntary
    D. Description of the investigational product
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14
Q

Q14

A
  1. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data?
    A. Investigator’s Brochure
    B. Financial Disclosure Form
    C. Site Monitoring Plan
    D. Delegation Log
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15
Q

Q15

A
  1. Which of the following is a required element when developing an informed consent document?
    A. Compensation details for research staff
    B. Investigator’s academic background
    C. A statement that participation is voluntary
    D. Description of the investigational product
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16
Q

Q16

A
  1. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data?
    A. Investigator’s Brochure
    B. Financial Disclosure Form
    C. Site Monitoring Plan
    D. Delegation Log
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17
Q

Q17

A
  1. Which of the following is a required element when developing an informed consent document?
    A. Compensation details for research staff
    B. Investigator’s academic background
    C. A statement that participation is voluntary
    D. Description of the investigational product
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18
Q

Q18

A
  1. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data?
    A. Investigator’s Brochure
    B. Financial Disclosure Form
    C. Site Monitoring Plan
    D. Delegation Log
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19
Q

Q19

A
  1. Which of the following is a required element when developing an informed consent document?
    A. Compensation details for research staff
    B. Investigator’s academic background
    C. A statement that participation is voluntary
    D. Description of the investigational product
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20
Q

Q20

A
  1. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data?
    A. Investigator’s Brochure
    B. Financial Disclosure Form
    C. Site Monitoring Plan
    D. Delegation Log
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21
Q

Q21

A
  1. Which of the following is a required element when developing an informed consent document?
    A. Compensation details for research staff
    B. Investigator’s academic background
    C. A statement that participation is voluntary
    D. Description of the investigational product
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22
Q

Q22

A
  1. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data?
    A. Investigator’s Brochure
    B. Financial Disclosure Form
    C. Site Monitoring Plan
    D. Delegation Log
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1
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23
Q

Q23

A
  1. Which of the following is a required element when developing an informed consent document?
    A. Compensation details for research staff
    B. Investigator’s academic background
    C. A statement that participation is voluntary
    D. Description of the investigational product
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24
Q

Q24

A
  1. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data?
    A. Investigator’s Brochure
    B. Financial Disclosure Form
    C. Site Monitoring Plan
    D. Delegation Log
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25
Q25
101. Which of the following is a required element when developing an informed consent document? A. Compensation details for research staff B. Investigator's academic background C. A statement that participation is voluntary D. Description of the investigational product
26
Q26
102. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data? A. Investigator’s Brochure B. Financial Disclosure Form C. Site Monitoring Plan D. Delegation Log
27
Q27
101. Which of the following is a required element when developing an informed consent document? A. Compensation details for research staff B. Investigator's academic background C. A statement that participation is voluntary D. Description of the investigational product
28
Q28
102. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data? A. Investigator’s Brochure B. Financial Disclosure Form C. Site Monitoring Plan D. Delegation Log
29
Q29
101. Which of the following is a required element when developing an informed consent document? A. Compensation details for research staff B. Investigator's academic background C. A statement that participation is voluntary D. Description of the investigational product
30
Q30
102. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data? A. Investigator’s Brochure B. Financial Disclosure Form C. Site Monitoring Plan D. Delegation Log
31
Q31
101. Which of the following is a required element when developing an informed consent document? A. Compensation details for research staff B. Investigator's academic background C. A statement that participation is voluntary D. Description of the investigational product
32
Q32
102. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data? A. Investigator’s Brochure B. Financial Disclosure Form C. Site Monitoring Plan D. Delegation Log
33
Q33
101. Which of the following is a required element when developing an informed consent document? A. Compensation details for research staff B. Investigator's academic background C. A statement that participation is voluntary D. Description of the investigational product
34
Q34
102. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data? A. Investigator’s Brochure B. Financial Disclosure Form C. Site Monitoring Plan D. Delegation Log
35
Q35
101. Which of the following is a required element when developing an informed consent document? A. Compensation details for research staff B. Investigator's academic background C. A statement that participation is voluntary D. Description of the investigational product
36
Q36
102. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data? A. Investigator’s Brochure B. Financial Disclosure Form C. Site Monitoring Plan D. Delegation Log
37
Q37
101. Which of the following is a required element when developing an informed consent document? A. Compensation details for research staff B. Investigator's academic background C. A statement that participation is voluntary D. Description of the investigational product
38
Q38
102. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data? A. Investigator’s Brochure B. Financial Disclosure Form C. Site Monitoring Plan D. Delegation Log
39
Q39
101. Which of the following is a required element when developing an informed consent document? A. Compensation details for research staff B. Investigator's academic background C. A statement that participation is voluntary D. Description of the investigational product
40
Q40
102. When preparing for a research study involving an investigational product, which document provides a summary of relevant clinical and nonclinical data? A. Investigator’s Brochure B. Financial Disclosure Form C. Site Monitoring Plan D. Delegation Log
41
Q41
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
42
Q42
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
43
Q43
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
44
Q44
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
45
Q45
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
46
Q46
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
47
Q47
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
48
Q48
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
49
Q49
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
50
Q50
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
51
Q51
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
52
Q52
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
53
Q53
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
54
Q54
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
55
Q55
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
56
Q56
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
57
Q57
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
58
Q58
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
59
Q59
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
60
Q60
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
61
Q61
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
62
Q62
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
63
Q63
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
64
Q64
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
65
Q65
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
66
Q66
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
67
Q67
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
68
Q68
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
69
Q69
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
70
Q70
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
71
Q71
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
72
Q72
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
73
Q73
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
74
Q74
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
75
Q75
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
76
Q76
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
77
Q77
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
78
Q78
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
79
Q79
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
80
Q80
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
81
Q81
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
82
Q82
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
83
Q83
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
84
Q84
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
85
Q85
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
86
Q86
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
87
Q87
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
88
Q88
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
89
Q89
141. What is the most appropriate action if a protocol deviation occurs during a clinical trial? A. Ignore it if it doesn’t affect the outcome B. Document and report it to the IRB and sponsor C. Only tell the subject D. Immediately terminate the study
90
Q90
142. When documenting adverse events, what is required? A. Sponsor’s approval B. Summary report only C. Source documentation and CRF updates D. IRB minutes
91
Q91
191. What must be verified during a study closeout visit? A. Study staff vacation schedules B. Final study subject payment C. Essential documents are complete and investigational product is accounted for D. New protocol submission to IRB
92
Q92
192. Who should receive the final report after study closure? A. The study monitor B. The principal investigator only C. IRB, sponsor, and applicable regulatory authorities D. Only the clinical trial subjects
93
Q93
191. What must be verified during a study closeout visit? A. Study staff vacation schedules B. Final study subject payment C. Essential documents are complete and investigational product is accounted for D. New protocol submission to IRB
94
Q94
192. Who should receive the final report after study closure? A. The study monitor B. The principal investigator only C. IRB, sponsor, and applicable regulatory authorities D. Only the clinical trial subjects
95
Q95
191. What must be verified during a study closeout visit? A. Study staff vacation schedules B. Final study subject payment C. Essential documents are complete and investigational product is accounted for D. New protocol submission to IRB
96
Q96
192. Who should receive the final report after study closure? A. The study monitor B. The principal investigator only C. IRB, sponsor, and applicable regulatory authorities D. Only the clinical trial subjects
97
Q97
191. What must be verified during a study closeout visit? A. Study staff vacation schedules B. Final study subject payment C. Essential documents are complete and investigational product is accounted for D. New protocol submission to IRB
98
Q98
192. Who should receive the final report after study closure? A. The study monitor B. The principal investigator only C. IRB, sponsor, and applicable regulatory authorities D. Only the clinical trial subjects
99
Q99
191. What must be verified during a study closeout visit? A. Study staff vacation schedules B. Final study subject payment C. Essential documents are complete and investigational product is accounted for D. New protocol submission to IRB
100
Q100
192. Who should receive the final report after study closure? A. The study monitor B. The principal investigator only C. IRB, sponsor, and applicable regulatory authorities D. Only the clinical trial subjects

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