SOCRA Certification Exam
2025/2026
Exam Prep Material
with
Verified Questions and Answers
A+ Grades Guarantee
, Yes (although permission to use such e-sigs has to be approved by the
Does the FDA consider electronic FDA)
signatures to be as trustworthy and
reliable as handwritten paper
signatures?
Yes
Does the FDA consider electronic
records that meet requirements to be
equivalent to handwritten records ?
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
Open system (FDA term) CHOP - controlled databases)
Environment in which SYSTEM ACCESS is controlled by the same
people responsible for the content of the system (I.E. I control the
Closed system (FDA term) Robotic Database access AND its contents)
1. Must be able to tell if records have been altered or invalid
2. Must be able to copy records for agency review
3. Protect records throughout retention period
4. Limit system to authorized individuals only
5. Use time-stamped audit trails of modification etc
6. Use operational system checks and restrictions
7. Use authority checks to make sure only authorized individuals are
using the system
What are some FDA Standards to 8. Use device checks to validate data input
meet when operating a closed record 9. Make sure those authorized to use system have appropriate training,
system? education, experience
10. Have written policies that deter data falsification
11. Audit and control the maintenance of the actual system
All those mentioned for the closed system.
What are some FDA standards to 1. Document encryption as appropriate
meet when using an Open System?
1. Printed name of signer
What information should a 2. Date and Time when signature was executed
handwritten SIGNATURE block 3. The MEANING associated with the signature (approval?
contain? responsibility? authorship?)
Signatures must be linked to their respective electronic records to make
Signature and record linking ? sure they cannot be copied, falsified, transferred etc.
Yes
Do researchers need to request
permission from the FDA to use
electronic signatures in place of
regular signatures?
What controls should an E- Employ at least 2 identification components - such as an identification
SIGNATURE contain? code AND a password.
, 1. no 2 people should have the same identification controls (password...
code)
Name some CONTROLS for the 2. Identification codes and passwords should be periodically checked,
identification components (i.e. revised, etc.
identification code and password) for 3. Deauthorize lost, stolen, missing codes and passwords
e-signature? 4. Periodically test your devices that generate these codes
Can an informed consent contain NO! Cannot say things like "you are waiving your right to damages" etc
exculpatory language?
1. the investigator and an independent physician agree that the patient is -
life threatening situation
-informed consent cannot be obtained
- there is no time to obtain consent from th esubject's legal representation
-there is no recognized therapy that provides equal or greater likelihood
of saving life
- within 5 working days this must be evaluated by another independent
When may an experimental drug or physician
device be used on a patient -documentation must be submitted to the IRB within 5 working days
WITHOUT informed consent? -the president can authorize use on the military (lots of information on
((EMERGENCY USE)) this military stuff..)
1. Human subjects are in life threatening danger, available treatments are
unproven or unsatisfactory, and collection of valid science is needed
2. Obtaining consent is not feasible
-subjects can't consent due to medical state
-can't feasibly get LAR consent in time
-no reasonable way to identify ahead of time individuals who will be
eligible for participation
3. Participation holds the prospect of direct benefit to subjects
-animal/preclinical studies support it
When is it okay to skip informed -risks are reasonable
consent and perform 4. could not practicably be carried out without waiver of consent
((EMERGENCY RESEARCH))? 5. OTHER protective measures are in place (counseling, disclosure,
disclosure to public, data monitoring committee ETC
2025/2026
Exam Prep Material
with
Verified Questions and Answers
A+ Grades Guarantee
, Yes (although permission to use such e-sigs has to be approved by the
Does the FDA consider electronic FDA)
signatures to be as trustworthy and
reliable as handwritten paper
signatures?
Yes
Does the FDA consider electronic
records that meet requirements to be
equivalent to handwritten records ?
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
Open system (FDA term) CHOP - controlled databases)
Environment in which SYSTEM ACCESS is controlled by the same
people responsible for the content of the system (I.E. I control the
Closed system (FDA term) Robotic Database access AND its contents)
1. Must be able to tell if records have been altered or invalid
2. Must be able to copy records for agency review
3. Protect records throughout retention period
4. Limit system to authorized individuals only
5. Use time-stamped audit trails of modification etc
6. Use operational system checks and restrictions
7. Use authority checks to make sure only authorized individuals are
using the system
What are some FDA Standards to 8. Use device checks to validate data input
meet when operating a closed record 9. Make sure those authorized to use system have appropriate training,
system? education, experience
10. Have written policies that deter data falsification
11. Audit and control the maintenance of the actual system
All those mentioned for the closed system.
What are some FDA standards to 1. Document encryption as appropriate
meet when using an Open System?
1. Printed name of signer
What information should a 2. Date and Time when signature was executed
handwritten SIGNATURE block 3. The MEANING associated with the signature (approval?
contain? responsibility? authorship?)
Signatures must be linked to their respective electronic records to make
Signature and record linking ? sure they cannot be copied, falsified, transferred etc.
Yes
Do researchers need to request
permission from the FDA to use
electronic signatures in place of
regular signatures?
What controls should an E- Employ at least 2 identification components - such as an identification
SIGNATURE contain? code AND a password.
, 1. no 2 people should have the same identification controls (password...
code)
Name some CONTROLS for the 2. Identification codes and passwords should be periodically checked,
identification components (i.e. revised, etc.
identification code and password) for 3. Deauthorize lost, stolen, missing codes and passwords
e-signature? 4. Periodically test your devices that generate these codes
Can an informed consent contain NO! Cannot say things like "you are waiving your right to damages" etc
exculpatory language?
1. the investigator and an independent physician agree that the patient is -
life threatening situation
-informed consent cannot be obtained
- there is no time to obtain consent from th esubject's legal representation
-there is no recognized therapy that provides equal or greater likelihood
of saving life
- within 5 working days this must be evaluated by another independent
When may an experimental drug or physician
device be used on a patient -documentation must be submitted to the IRB within 5 working days
WITHOUT informed consent? -the president can authorize use on the military (lots of information on
((EMERGENCY USE)) this military stuff..)
1. Human subjects are in life threatening danger, available treatments are
unproven or unsatisfactory, and collection of valid science is needed
2. Obtaining consent is not feasible
-subjects can't consent due to medical state
-can't feasibly get LAR consent in time
-no reasonable way to identify ahead of time individuals who will be
eligible for participation
3. Participation holds the prospect of direct benefit to subjects
-animal/preclinical studies support it
When is it okay to skip informed -risks are reasonable
consent and perform 4. could not practicably be carried out without waiver of consent
((EMERGENCY RESEARCH))? 5. OTHER protective measures are in place (counseling, disclosure,
disclosure to public, data monitoring committee ETC
