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SOCRA CERTIFICATION EXAM 2025
BRAND NEW ACTUAL EXAM WITH
ANSWERS.
1. If a IB lists "kidney problems" as an adverse side effect, and
youre patient develops a specific type of nephritis, would that
be considered Expected? - correct answer -No. If it brings new
light, new SPECIFICS to the table on side effects... it is still
considered unexpected and reporting that problem would be
BENEFICIAL!!!
2. What type of ADR needs to be reported in an EXPEDITED
manner? (2 criteria) - correct answer -SERIOUS AND
UNEXPECTED
3. Are there situations, other than a serious and unexpected ADR,
which require expedited reporting? - correct answer -Yes. For
example, if an expected reaction is happening at a higher-than-
expected rate. A new animal study finding. Lack of efficacy in
patients with life threatening disease.
, Page | 2
4. Describe the timeframe for expedited reporting FATAL or LIFE-
THREATENING and UNEXPECTED ADRs - correct answer -
ASAP, but no later than 7 calendar days by first knowledge of
the sponsor.
5. A COMPLETE report will be required within 8 additional
calendar days
6. Describe the timeframe for expedited reporting- SERIOUS,
UNEXPECTED ADRs (not life-threatening) - correct answer -
ASAP, but no later than 15 calendar days after first knowledge
by the sponsor
7. What form is used to report serious, unexpected ADRs? -
correct answer -CIOMIS-I is widely used, but it doesn't matter
as long as it contains specified information
8. Should you break a blind for a serious, unexpected ADR? -
correct answer -Yes, if a case is serious enough to warrant
EXPEDITED REPORTING. Only for that one patient.
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9. Are there any exceptions to breaking the blind when a serious
adr occurs? - correct answer -If such a serious event is one of
the MAJOR study endpoints.... then it may be useful to find
another way (with proper authority)
10. Are reactions to placebo considered ADRs? - correct answer
-Generally, no. The sponsor can decide when it is appropriate
to report placebo reactions
11. Are post-study events able to qualify for expedited reporting?
- correct answer -Yes.
12. Does the FDA consider electronic signatures to be as
trustworthy and reliable as handwritten paper signatures? -
correct answer -Yes (although permission to use such e-sigs
has to be approved by the FDA)
13. Does the FDA consider electronic records that meet
requirements to be equivalent to handwritten records ? -
correct answer -Yes
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14. Open system (FDA term) - correct answer -System access is
NOT controlled by people who are responsible for the content
of the electronic records in the system. (Like me putting data
into CHOP - controlled databases)
15. Closed system (FDA term) - correct answer -Environment in
which SYSTEM ACCESS is controlled by the same people
responsible for the content of the system (I.E. I control the
Robotic Database access AND its contents)
16. What are some FDA Standards to meet when operating a
closed record system? - correct answer -1. Must be able to tell
if records have been altered or invalid
17. 2. Must be able to copy records for agency review
18. 3. Protect records throughout retention period
19. 4. Limit system to authorized individuals only
20. 5. Use time-stamped audit trails of modification etc
21. 6. Use operational system checks and restrictions
22. 7. Use authority checks to make sure only authorized
individuals are using the system
23. 8. Use device checks to validate data input
24. 9. Make sure those authorized to use system have
appropriate training, education, experience
25. 10. Have written policies that deter data falsification
26. 11. Audit and control the maintenance of the actual system
SOCRA CERTIFICATION EXAM 2025
BRAND NEW ACTUAL EXAM WITH
ANSWERS.
1. If a IB lists "kidney problems" as an adverse side effect, and
youre patient develops a specific type of nephritis, would that
be considered Expected? - correct answer -No. If it brings new
light, new SPECIFICS to the table on side effects... it is still
considered unexpected and reporting that problem would be
BENEFICIAL!!!
2. What type of ADR needs to be reported in an EXPEDITED
manner? (2 criteria) - correct answer -SERIOUS AND
UNEXPECTED
3. Are there situations, other than a serious and unexpected ADR,
which require expedited reporting? - correct answer -Yes. For
example, if an expected reaction is happening at a higher-than-
expected rate. A new animal study finding. Lack of efficacy in
patients with life threatening disease.
, Page | 2
4. Describe the timeframe for expedited reporting FATAL or LIFE-
THREATENING and UNEXPECTED ADRs - correct answer -
ASAP, but no later than 7 calendar days by first knowledge of
the sponsor.
5. A COMPLETE report will be required within 8 additional
calendar days
6. Describe the timeframe for expedited reporting- SERIOUS,
UNEXPECTED ADRs (not life-threatening) - correct answer -
ASAP, but no later than 15 calendar days after first knowledge
by the sponsor
7. What form is used to report serious, unexpected ADRs? -
correct answer -CIOMIS-I is widely used, but it doesn't matter
as long as it contains specified information
8. Should you break a blind for a serious, unexpected ADR? -
correct answer -Yes, if a case is serious enough to warrant
EXPEDITED REPORTING. Only for that one patient.
, Page | 3
9. Are there any exceptions to breaking the blind when a serious
adr occurs? - correct answer -If such a serious event is one of
the MAJOR study endpoints.... then it may be useful to find
another way (with proper authority)
10. Are reactions to placebo considered ADRs? - correct answer
-Generally, no. The sponsor can decide when it is appropriate
to report placebo reactions
11. Are post-study events able to qualify for expedited reporting?
- correct answer -Yes.
12. Does the FDA consider electronic signatures to be as
trustworthy and reliable as handwritten paper signatures? -
correct answer -Yes (although permission to use such e-sigs
has to be approved by the FDA)
13. Does the FDA consider electronic records that meet
requirements to be equivalent to handwritten records ? -
correct answer -Yes
, Page | 4
14. Open system (FDA term) - correct answer -System access is
NOT controlled by people who are responsible for the content
of the electronic records in the system. (Like me putting data
into CHOP - controlled databases)
15. Closed system (FDA term) - correct answer -Environment in
which SYSTEM ACCESS is controlled by the same people
responsible for the content of the system (I.E. I control the
Robotic Database access AND its contents)
16. What are some FDA Standards to meet when operating a
closed record system? - correct answer -1. Must be able to tell
if records have been altered or invalid
17. 2. Must be able to copy records for agency review
18. 3. Protect records throughout retention period
19. 4. Limit system to authorized individuals only
20. 5. Use time-stamped audit trails of modification etc
21. 6. Use operational system checks and restrictions
22. 7. Use authority checks to make sure only authorized
individuals are using the system
23. 8. Use device checks to validate data input
24. 9. Make sure those authorized to use system have
appropriate training, education, experience
25. 10. Have written policies that deter data falsification
26. 11. Audit and control the maintenance of the actual system
