SOCRA CCRP (2024-2025) EXAM QUESTIONS WITH
ANSWERS
The primary goal of the IRB - <<<Answers>>>to protect the
right and safety of human subjects
Composition of IRB - <<<Answers>>>5 or more members
with different backgrounds including 1 scientific, 1
nonscientific, and 1 not affiliated
Role, Responsibilities, and Obligations of the Sponsor -
<<<Answers>>>- selecting qualified investigators
- providing information and training needed
- monitoring the trial conduct
- ensuring protocol is followed
- maintaining effective IND
- proper reporting of significant AE or risks
What is a sponsor's main responsibility? -
<<<Answers>>>overall clinical trial conduct is in compliance
of regulations
Sponsors should qualify investigators based on what? -
<<<Answers>>>training and experience
Info needed from investigator prior to trial participation -
<<<Answers>>>- 1572
- CV
, SOCRA CCRP (2024-2025) EXAM QUESTIONS WITH
ANSWERS
- Signed protocol
- FDF
Sponsor must choose who to oversee the trial? -
<<<Answers>>>a qualified monitor
Other sponsor responsibilties - <<<Answers>>>- monitor the
progress
- secure compliance or discontinue shipment of IP
- review safety and efficacy data and report safety issues to
FDA
- submit annual reports to FDA
- discontinue use of IP that cause significant risk, notify FDA
5 working days, destroy IP, and submit full report to FDA of
study closure
How long does a sponsor have to submit IND safety report? -
<<<Answers>>>within 15 calendar days after knowing
How many days does sponsor have to submit additional
information to FDA? - <<<Answers>>>within 15 calendar
days after receiving request
How long does sponsor have to notify FDA of unexpected
fatal or life-threatening suspected adverse reaction? -
ANSWERS
The primary goal of the IRB - <<<Answers>>>to protect the
right and safety of human subjects
Composition of IRB - <<<Answers>>>5 or more members
with different backgrounds including 1 scientific, 1
nonscientific, and 1 not affiliated
Role, Responsibilities, and Obligations of the Sponsor -
<<<Answers>>>- selecting qualified investigators
- providing information and training needed
- monitoring the trial conduct
- ensuring protocol is followed
- maintaining effective IND
- proper reporting of significant AE or risks
What is a sponsor's main responsibility? -
<<<Answers>>>overall clinical trial conduct is in compliance
of regulations
Sponsors should qualify investigators based on what? -
<<<Answers>>>training and experience
Info needed from investigator prior to trial participation -
<<<Answers>>>- 1572
- CV
, SOCRA CCRP (2024-2025) EXAM QUESTIONS WITH
ANSWERS
- Signed protocol
- FDF
Sponsor must choose who to oversee the trial? -
<<<Answers>>>a qualified monitor
Other sponsor responsibilties - <<<Answers>>>- monitor the
progress
- secure compliance or discontinue shipment of IP
- review safety and efficacy data and report safety issues to
FDA
- submit annual reports to FDA
- discontinue use of IP that cause significant risk, notify FDA
5 working days, destroy IP, and submit full report to FDA of
study closure
How long does a sponsor have to submit IND safety report? -
<<<Answers>>>within 15 calendar days after knowing
How many days does sponsor have to submit additional
information to FDA? - <<<Answers>>>within 15 calendar
days after receiving request
How long does sponsor have to notify FDA of unexpected
fatal or life-threatening suspected adverse reaction? -
