1. How long does IRB keep records for? 3 Years 21 CFR 50.24 (c)
2. How long does site keep records for? 2 Years Sub Part D 312.62
3. When would you require an amendment? A sponsor shall submit a pro-
tocol amendment describing any
change in a Phase 1 protocol that
significantly attects the safety of
subjects or any change in a Phase
2 or 3 protocol that significantly
attects the safety of subjects
Examples: Dose change, cohort
additions, new test or procedure
4. Which countries are included in the ICH GCP? European Union, Japan, United
States, Canada and Switzerland
5. True or False: False; human subject only
GCP applies to research in human subjects and
animals.
6. Who is responsible for maintaining the close out Sponsor
report?
7. If a patient fills out questionnaire on sponsor EDC
system, what is the source document?
8. Who is making sure there are enough devices at
the site if patient is using ePRO (electronic Patient
Reported Outcomes) - electronic device capturing
questionnaires?
9. Who is responsible for device accountability? Sponsor and Investigator
1/7
, 10. According to ICH E6, an inspection is defined as: An oflcial review of documents, fa-
cilities, records, and any other re-
sources related to a clinical trial.
11. According to ICH guidelines UAE needs to be re-
ported by investigator within how many days?
12. If site is working on a phase II trial, then they
started phase III, how long is the site required to
keep their records?
13. What is the monitor not responsible for?
A) Patient information
B) Sponsor SOP
C) Protocol/ICF
D) Reporting to IRB
14. What is included in the investigator brochure?
15. An investigator wants to use cardiac device
for another indication (off-label). What applica-
tions/approvals does he need to start?
16. A patient received an initial dose and had no 444mg^3/m
initial reaction. The protocol says the patient
needs to increase it by 20%. The initial dose was
370mg^3/m; what is the next treatment?
17. Study is to last 3.5 years and wants to enroll 400
patients. What is the average recruitment per
month?
18.
2/7
2. How long does site keep records for? 2 Years Sub Part D 312.62
3. When would you require an amendment? A sponsor shall submit a pro-
tocol amendment describing any
change in a Phase 1 protocol that
significantly attects the safety of
subjects or any change in a Phase
2 or 3 protocol that significantly
attects the safety of subjects
Examples: Dose change, cohort
additions, new test or procedure
4. Which countries are included in the ICH GCP? European Union, Japan, United
States, Canada and Switzerland
5. True or False: False; human subject only
GCP applies to research in human subjects and
animals.
6. Who is responsible for maintaining the close out Sponsor
report?
7. If a patient fills out questionnaire on sponsor EDC
system, what is the source document?
8. Who is making sure there are enough devices at
the site if patient is using ePRO (electronic Patient
Reported Outcomes) - electronic device capturing
questionnaires?
9. Who is responsible for device accountability? Sponsor and Investigator
1/7
, 10. According to ICH E6, an inspection is defined as: An oflcial review of documents, fa-
cilities, records, and any other re-
sources related to a clinical trial.
11. According to ICH guidelines UAE needs to be re-
ported by investigator within how many days?
12. If site is working on a phase II trial, then they
started phase III, how long is the site required to
keep their records?
13. What is the monitor not responsible for?
A) Patient information
B) Sponsor SOP
C) Protocol/ICF
D) Reporting to IRB
14. What is included in the investigator brochure?
15. An investigator wants to use cardiac device
for another indication (off-label). What applica-
tions/approvals does he need to start?
16. A patient received an initial dose and had no 444mg^3/m
initial reaction. The protocol says the patient
needs to increase it by 20%. The initial dose was
370mg^3/m; what is the next treatment?
17. Study is to last 3.5 years and wants to enroll 400
patients. What is the average recruitment per
month?
18.
2/7
