SOCRA CERTIFICATION UPDATED ACTUAL LATEST
QUESTIONS AND ANSWERS SURE A+
✔✔Sponsor Responsibilities - ✔✔1. Maintain an effective IND or IDE
2. Ensure studies are conducted according to the general investigative plan and
protocols in IND/IDE
3. Promptly report adverse events
4. Select qualified Investigators
5. Provide information such as: investigative brochure
6. Ensure proper monitoring (medical monitor, DSMB, on-site monitoring)
7. Manufacture and label drug/device
✔✔What must the Sponsor obtain from the Investigator prior to start of study? -
✔✔Signed Investigator Statement (Form FDA 1572)
CVs
Phase 1: Clinical protocol
Phase 2/3: Protocol outline w/approx number of subjects to get tx & number to be used
as controls (sex, age, and condition)
Financial Disclosure
✔✔Equity interest in publicly traded company greater than $______ should be
reported? - ✔✔$50,000
✔✔How long is the reporting period for equity interest and significant payments? -
✔✔Study period plus 1 year.
✔✔How long is the reporting period for proprietary interest, equity interest or based on
study outcome? - ✔✔At any time.
✔✔Significant payments of other sorts that greater than $______ must be reported. -
✔✔$20,000
, ✔✔What are the Monitor's responsibilities? - ✔✔1) Verify that the rights and well being
of Subjects are protected
2) Verify that the reported trial data are accurate, complete and verifiable
3) Verify that study is being conducted in accordance with GCP and protocol
✔✔What should drug accountability records include? - ✔✔-Inventory of product/drug
-Dispensation records
-Batch information/expiration dates, etc
✔✔What year was The Nuremburg Code established? - ✔✔1949
✔✔What year was the Declaration of Helsinki established? - ✔✔1964
✔✔What year was the Belmont Report established? - ✔✔1979
✔✔What year was the National Research Act passed by Congress? - ✔✔1974
✔✔What are the 3 Principles of Belmont Report? - ✔✔-Respect for Persons
-Beneficence
-Justice
✔✔Respect for Persons - ✔✔-Individuals to be treated as automous agents &
acknowledged as such
-Persons w/diminished autonomy are entitled to & need protection
✔✔Beneficience - ✔✔-Do not harm
-Maximize possible benefits while minimizing possible harms
✔✔Justice - ✔✔-"Fairness of distribution" or "What is Deserved"
-To each person an equal share (Fair procedures/outcomes in the selection of subjects)
✔✔Short form written consent - ✔✔-Can be used with IRB approval and is most often
used for Subjects who cannot read.
-Needs an impartial witness to consent process
-Study consent form should be read and explained to subject
-Needs oral consent
-Witness signature
-Person obtaining consent signs
✔✔Required signatures for consent - ✔✔-CFR requires only the subject to sign
-ICH requires the subject + person obtaining consent to sign
✔✔Exceptions to informed consent - ✔✔-Subject is unable to consent (unable to
communicate)
QUESTIONS AND ANSWERS SURE A+
✔✔Sponsor Responsibilities - ✔✔1. Maintain an effective IND or IDE
2. Ensure studies are conducted according to the general investigative plan and
protocols in IND/IDE
3. Promptly report adverse events
4. Select qualified Investigators
5. Provide information such as: investigative brochure
6. Ensure proper monitoring (medical monitor, DSMB, on-site monitoring)
7. Manufacture and label drug/device
✔✔What must the Sponsor obtain from the Investigator prior to start of study? -
✔✔Signed Investigator Statement (Form FDA 1572)
CVs
Phase 1: Clinical protocol
Phase 2/3: Protocol outline w/approx number of subjects to get tx & number to be used
as controls (sex, age, and condition)
Financial Disclosure
✔✔Equity interest in publicly traded company greater than $______ should be
reported? - ✔✔$50,000
✔✔How long is the reporting period for equity interest and significant payments? -
✔✔Study period plus 1 year.
✔✔How long is the reporting period for proprietary interest, equity interest or based on
study outcome? - ✔✔At any time.
✔✔Significant payments of other sorts that greater than $______ must be reported. -
✔✔$20,000
, ✔✔What are the Monitor's responsibilities? - ✔✔1) Verify that the rights and well being
of Subjects are protected
2) Verify that the reported trial data are accurate, complete and verifiable
3) Verify that study is being conducted in accordance with GCP and protocol
✔✔What should drug accountability records include? - ✔✔-Inventory of product/drug
-Dispensation records
-Batch information/expiration dates, etc
✔✔What year was The Nuremburg Code established? - ✔✔1949
✔✔What year was the Declaration of Helsinki established? - ✔✔1964
✔✔What year was the Belmont Report established? - ✔✔1979
✔✔What year was the National Research Act passed by Congress? - ✔✔1974
✔✔What are the 3 Principles of Belmont Report? - ✔✔-Respect for Persons
-Beneficence
-Justice
✔✔Respect for Persons - ✔✔-Individuals to be treated as automous agents &
acknowledged as such
-Persons w/diminished autonomy are entitled to & need protection
✔✔Beneficience - ✔✔-Do not harm
-Maximize possible benefits while minimizing possible harms
✔✔Justice - ✔✔-"Fairness of distribution" or "What is Deserved"
-To each person an equal share (Fair procedures/outcomes in the selection of subjects)
✔✔Short form written consent - ✔✔-Can be used with IRB approval and is most often
used for Subjects who cannot read.
-Needs an impartial witness to consent process
-Study consent form should be read and explained to subject
-Needs oral consent
-Witness signature
-Person obtaining consent signs
✔✔Required signatures for consent - ✔✔-CFR requires only the subject to sign
-ICH requires the subject + person obtaining consent to sign
✔✔Exceptions to informed consent - ✔✔-Subject is unable to consent (unable to
communicate)
