Clinical Research Coordinator Exam
1. ADR: Adverse Drug Reaction _ relationship between IP and AE is at least
reasonably possible life threatening ADR reported to reg agencies within 7
days.
2. Unexpected Adverse drug Reaction: Severity not consistent with IP
information Serious UAE (non life threatening) must be reported to regulators
within 15 days.
3. seriousness vs severity: seriousness is based on outcome usually life threat
Severity is intensity of specific event (severe headache)
4. SAE miniumum info:
Pt Details
IP
Con Meds
SAE details
Reporter name
Sponsor details
5. Audit: systematic examination of a company's accounting system to determine
whether its financial reports reliably represent its operations
6. clinical trials: experiments that study the effectiveness of medical treatments
on
Human Subjects
7. compliance: Adherence to all study related requirements
8. confidentiality: prevent (unauthorized) disclosure of pt info OR sponsor info
9. Coordinating investigator: coordinates investigators at different centers for a
mulit-center trial.
10. Nonclinical Study: Biomedical studies not performed on human subjects.
11. protocol: includes objective, design, methodology, statistical considerations,
and trial organization.
12. Regulatory Authorities: Bodies having the power to regulate. In the ICH
GCP guideline that guidelines the expression Regulatory Authorities includes
the authorities that review submitted clinical data.
13. sponsor: takes responsibility for the initiation, management, and/ or financing
of a clinical trial
14. Sponsor-Investigator: An individual who both initiates and actually conducts,
alone or with others, a clinical investigation, i.e., under whose immediate
direction the test article is administered or dispensed to, or used involving, a
, Clinical Research Coordinator Exam
subject. The term does not include any other person other than an individual,
e.g. corporation or agency. (21 CFR, sec. 50.3)
15. Subinvestigator: Any individual member of the clinical trial team designated
and supervised by the investigator at a trial site to perform critical trial-related
procedures and/or to make important trial-related decisions.
16. Subject Identification Code: A unique identifier assigned by the investigator
to each trial subject to protect the subject's identity and used in lieu of the
subject's name when the investigator reports adverse events and/or other trial
related data.
17. Vulnerable Subjects: Individuals whose willingness to volunteer in a clinical
trial may be unduly influenced by the expectation, whether justified or not, of
benefits associated with participation, or of a retaliatory response from senior
members of a hierarchy in case of refusal to participate. Examples are
members of a group with a hierarchical structure, such as medical, pharmacy,
dental, and nursing students, subordinate hospital and laboratory personnel,
employees of the pharmaceutical industry, members of the armed forces, and
persons kept in detention. Other vulnerable subjects include patients with
incurable diseases, persons in nursing homes, unemployed or impoverished
persons, patients in emergency situations, ethnic minority groups, homeless
persons, nomads, refugees, minors, and those incapable of giving consent.
18. Monitoring Plan: A document that describes the strategy, methods,
responsibilities, and requirements for monitoring the trial.
19. Validation of Computerized Systems: A process of establishing and
documenting that the specified requirements of a computerized system can be
consistently fulfilled from design until decommissioning of the system or
transition to a new system. The approach to validation should be based on a
risk assessment that takes into consideration the intended use of the system
and the potential of the system to affect human subject protection and
reliability of trial results.
20. ICH GCP Principles: 2.1-2.13 Use ethics of Declaration of Helsinki
pt safety, clinically sound, informed consent, documented, confidentiality, IP use
21. ICH IRB responsibilities: 3.1.1-3.1.9 Subjects
documents (ICF, IB , Safety, Payments, PI CV)
Continual review (at least annual)
22. IRB composition: No vested interest in the study or outcomes. At least 5
members (at least 1 scientist, at least 1 non-scientist, at least 1 person not
affiliated with institution)
, Clinical Research Coordinator Exam
23. IRB procedures: rosters scheduling
initial and continuing review
pre approve deviations
Specify that investigator should promptly report- Deviations, increase subj risk,
serious and unexpected ADRs, new info written documents: trial related
decisions, reason for decision, appeal procedure.
24. IRB Records: - Kept for a minimum of 3 years following the completion of the
study
25. Investigator ICH Qualifications: 4.1.1-4.2 Training and edu familiar with IB
Comply with GCP
Permit monitoring
DOA log
adequate resources
26. Investigator - ICH Medical care: qualified physician AE Med care
tell pt PCP if possible
Obtain reason for study
D/C
27. Investigator - ICH Communication with IRB: approval before trial provide IB
Documents
28. Investigator - ICH compliance with protocol: should conduct trial by
protocol pre-approve deviations if possible
document
reporting to IRB
29. Investigator - ICH Investigational Product: on site accountability delegate to
IDS
IP delivery, inventory, distribution, sponsor returns (IP details for these)
IP storage as specified by sponsor
explain IP product use to participants
30. Investigator - ICH Randomization: follow trials randomization procedures,
unblind per protocol, explain premature unblinding.
31. Investigator - ICH informed consent: as per GCP updated as needed/
approved by IRB
no coercion
ICF cannot waive or appear to waive legal
rights use plain language given time to decide/
, Clinical Research Coordinator Exam
address questions impartial witness if unable to
read
decreased ability or children agree to the extent of ability
copy
32. Elements of Informed Consent: Disclosure: Pt has been informed of the
nature of the procedure, risks and benefits, alternatives, no guarantee of
outcome.
Comprehension: Patient can correctly repeat in his or her own words that for
which the patient is giving consent.
Competence: The patient understands information needed to make this decision.
Voluntariness: The patient is voluntarily consenting or refusing.
33. informed consent content: Trial purpose treatments/ procedures subject
responsibilities experimental aspects risks and benefits alternatives to study
payment/ expenses
voluntary
monitors, auditors, IRB... see med
records confidentiality new info contact
info termination reasons duration
# of people in trial
34. emergency research consent: IRB specific approval LAR if possible
consent when appropriate
35. Investigator - ICH Records and reports: Maintain records correction dated
single line retained 2 yrs financial agreement required available to monitor
upon request final reports as needed to IRB
36. source data requirements: ALCOA-C Attributable
legible
contemporaneous
original
accurate
complete
37. Investigator - ICH progress reports: Written at least annually
Prompt reporting where required (significant changes to trial conduct)
38. Investigator - ICH Safety reporting: SAE reported immediately to sponsor
(unless otherwise specified)
AEs identified in protocol as critical
1. ADR: Adverse Drug Reaction _ relationship between IP and AE is at least
reasonably possible life threatening ADR reported to reg agencies within 7
days.
2. Unexpected Adverse drug Reaction: Severity not consistent with IP
information Serious UAE (non life threatening) must be reported to regulators
within 15 days.
3. seriousness vs severity: seriousness is based on outcome usually life threat
Severity is intensity of specific event (severe headache)
4. SAE miniumum info:
Pt Details
IP
Con Meds
SAE details
Reporter name
Sponsor details
5. Audit: systematic examination of a company's accounting system to determine
whether its financial reports reliably represent its operations
6. clinical trials: experiments that study the effectiveness of medical treatments
on
Human Subjects
7. compliance: Adherence to all study related requirements
8. confidentiality: prevent (unauthorized) disclosure of pt info OR sponsor info
9. Coordinating investigator: coordinates investigators at different centers for a
mulit-center trial.
10. Nonclinical Study: Biomedical studies not performed on human subjects.
11. protocol: includes objective, design, methodology, statistical considerations,
and trial organization.
12. Regulatory Authorities: Bodies having the power to regulate. In the ICH
GCP guideline that guidelines the expression Regulatory Authorities includes
the authorities that review submitted clinical data.
13. sponsor: takes responsibility for the initiation, management, and/ or financing
of a clinical trial
14. Sponsor-Investigator: An individual who both initiates and actually conducts,
alone or with others, a clinical investigation, i.e., under whose immediate
direction the test article is administered or dispensed to, or used involving, a
, Clinical Research Coordinator Exam
subject. The term does not include any other person other than an individual,
e.g. corporation or agency. (21 CFR, sec. 50.3)
15. Subinvestigator: Any individual member of the clinical trial team designated
and supervised by the investigator at a trial site to perform critical trial-related
procedures and/or to make important trial-related decisions.
16. Subject Identification Code: A unique identifier assigned by the investigator
to each trial subject to protect the subject's identity and used in lieu of the
subject's name when the investigator reports adverse events and/or other trial
related data.
17. Vulnerable Subjects: Individuals whose willingness to volunteer in a clinical
trial may be unduly influenced by the expectation, whether justified or not, of
benefits associated with participation, or of a retaliatory response from senior
members of a hierarchy in case of refusal to participate. Examples are
members of a group with a hierarchical structure, such as medical, pharmacy,
dental, and nursing students, subordinate hospital and laboratory personnel,
employees of the pharmaceutical industry, members of the armed forces, and
persons kept in detention. Other vulnerable subjects include patients with
incurable diseases, persons in nursing homes, unemployed or impoverished
persons, patients in emergency situations, ethnic minority groups, homeless
persons, nomads, refugees, minors, and those incapable of giving consent.
18. Monitoring Plan: A document that describes the strategy, methods,
responsibilities, and requirements for monitoring the trial.
19. Validation of Computerized Systems: A process of establishing and
documenting that the specified requirements of a computerized system can be
consistently fulfilled from design until decommissioning of the system or
transition to a new system. The approach to validation should be based on a
risk assessment that takes into consideration the intended use of the system
and the potential of the system to affect human subject protection and
reliability of trial results.
20. ICH GCP Principles: 2.1-2.13 Use ethics of Declaration of Helsinki
pt safety, clinically sound, informed consent, documented, confidentiality, IP use
21. ICH IRB responsibilities: 3.1.1-3.1.9 Subjects
documents (ICF, IB , Safety, Payments, PI CV)
Continual review (at least annual)
22. IRB composition: No vested interest in the study or outcomes. At least 5
members (at least 1 scientist, at least 1 non-scientist, at least 1 person not
affiliated with institution)
, Clinical Research Coordinator Exam
23. IRB procedures: rosters scheduling
initial and continuing review
pre approve deviations
Specify that investigator should promptly report- Deviations, increase subj risk,
serious and unexpected ADRs, new info written documents: trial related
decisions, reason for decision, appeal procedure.
24. IRB Records: - Kept for a minimum of 3 years following the completion of the
study
25. Investigator ICH Qualifications: 4.1.1-4.2 Training and edu familiar with IB
Comply with GCP
Permit monitoring
DOA log
adequate resources
26. Investigator - ICH Medical care: qualified physician AE Med care
tell pt PCP if possible
Obtain reason for study
D/C
27. Investigator - ICH Communication with IRB: approval before trial provide IB
Documents
28. Investigator - ICH compliance with protocol: should conduct trial by
protocol pre-approve deviations if possible
document
reporting to IRB
29. Investigator - ICH Investigational Product: on site accountability delegate to
IDS
IP delivery, inventory, distribution, sponsor returns (IP details for these)
IP storage as specified by sponsor
explain IP product use to participants
30. Investigator - ICH Randomization: follow trials randomization procedures,
unblind per protocol, explain premature unblinding.
31. Investigator - ICH informed consent: as per GCP updated as needed/
approved by IRB
no coercion
ICF cannot waive or appear to waive legal
rights use plain language given time to decide/
, Clinical Research Coordinator Exam
address questions impartial witness if unable to
read
decreased ability or children agree to the extent of ability
copy
32. Elements of Informed Consent: Disclosure: Pt has been informed of the
nature of the procedure, risks and benefits, alternatives, no guarantee of
outcome.
Comprehension: Patient can correctly repeat in his or her own words that for
which the patient is giving consent.
Competence: The patient understands information needed to make this decision.
Voluntariness: The patient is voluntarily consenting or refusing.
33. informed consent content: Trial purpose treatments/ procedures subject
responsibilities experimental aspects risks and benefits alternatives to study
payment/ expenses
voluntary
monitors, auditors, IRB... see med
records confidentiality new info contact
info termination reasons duration
# of people in trial
34. emergency research consent: IRB specific approval LAR if possible
consent when appropriate
35. Investigator - ICH Records and reports: Maintain records correction dated
single line retained 2 yrs financial agreement required available to monitor
upon request final reports as needed to IRB
36. source data requirements: ALCOA-C Attributable
legible
contemporaneous
original
accurate
complete
37. Investigator - ICH progress reports: Written at least annually
Prompt reporting where required (significant changes to trial conduct)
38. Investigator - ICH Safety reporting: SAE reported immediately to sponsor
(unless otherwise specified)
AEs identified in protocol as critical
