SOCRA Certification Exam With
100% Correct Answers 2025
,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)
Does the FDA consider electronic records that meet requirements to be equivalent to handwritten
records ? - Correct Answer-Yes
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)
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)
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
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
8. Use device checks to validate data input
9. Make sure those authorized to use system have appropriate training, education, experience
10. Have written policies that deter data falsification
11. Audit and control the maintenance of the actual system
What are some FDA standards to meet when using an Open System? - Correct Answer-All
those mentioned for the closed system.
1. Document encryption as appropriate
What information should a handwritten SIGNATURE block contain? - Correct Answer-1. Printed name of
signer
2. Date and Time when signature was executed
3. The MEANING associated with the signature (approval? responsibility? authorship?)
, Signature and record linking ? - Correct Answer-Signatures must be linked to their respective
electronic records to make sure they cannot be copied, falsified, transferred etc.
Do researchers need to request permission from the FDA to use electronic signatures in place of regular
signatures? - Correct Answer-Yes
What controls should an E-SIGNATURE contain? - Correct Answer-Employ at least 2 identification
components - such as an identification code AND a password.
Name some CONTROLS for the identification components (i.e. identification code and password) for
e-signature? - Correct Answer-1. no 2 people should have the same identification controls (password...
code)
2. Identification codes and passwords should be periodically checked, revised, etc.
3. Deauthorize lost, stolen, missing codes and passwords
4. Periodically test your devices that generate these codes
Can an informed consent contain exculpatory language? - Correct Answer-NO! Cannot say things like
"you are waiving your right to damages" etc
When may an experimental drug or device be used on a patient WITHOUT informed consent?
((EMERGENCY USE)) - Correct Answer-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 physician
-documentation must be submitted to the IRB within 5 working days
-the president can authorize use on the military (lots of information on this military stuff..)
When is it okay to skip informed consent and perform ((EMERGENCY RESEARCH))? - Correct
Answer-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
-risks are reasonable
4. could not practicably be carried out without waiver of consent
5. OTHER protective measures are in place (counseling, disclosure, disclosure to public, data
monitoring committee ETC
100% Correct Answers 2025
,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)
Does the FDA consider electronic records that meet requirements to be equivalent to handwritten
records ? - Correct Answer-Yes
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)
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)
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
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
8. Use device checks to validate data input
9. Make sure those authorized to use system have appropriate training, education, experience
10. Have written policies that deter data falsification
11. Audit and control the maintenance of the actual system
What are some FDA standards to meet when using an Open System? - Correct Answer-All
those mentioned for the closed system.
1. Document encryption as appropriate
What information should a handwritten SIGNATURE block contain? - Correct Answer-1. Printed name of
signer
2. Date and Time when signature was executed
3. The MEANING associated with the signature (approval? responsibility? authorship?)
, Signature and record linking ? - Correct Answer-Signatures must be linked to their respective
electronic records to make sure they cannot be copied, falsified, transferred etc.
Do researchers need to request permission from the FDA to use electronic signatures in place of regular
signatures? - Correct Answer-Yes
What controls should an E-SIGNATURE contain? - Correct Answer-Employ at least 2 identification
components - such as an identification code AND a password.
Name some CONTROLS for the identification components (i.e. identification code and password) for
e-signature? - Correct Answer-1. no 2 people should have the same identification controls (password...
code)
2. Identification codes and passwords should be periodically checked, revised, etc.
3. Deauthorize lost, stolen, missing codes and passwords
4. Periodically test your devices that generate these codes
Can an informed consent contain exculpatory language? - Correct Answer-NO! Cannot say things like
"you are waiving your right to damages" etc
When may an experimental drug or device be used on a patient WITHOUT informed consent?
((EMERGENCY USE)) - Correct Answer-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 physician
-documentation must be submitted to the IRB within 5 working days
-the president can authorize use on the military (lots of information on this military stuff..)
When is it okay to skip informed consent and perform ((EMERGENCY RESEARCH))? - Correct
Answer-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
-risks are reasonable
4. could not practicably be carried out without waiver of consent
5. OTHER protective measures are in place (counseling, disclosure, disclosure to public, data
monitoring committee ETC
