SOCRA Certification Exam Questions
and Answers 100% Guaranteed Success
Does the FDA consider electronic signatures to be as trustworthy and reliable as
handwritten paper signatures? - ✔✔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 ? - ✔✔Yes
Open system (FDA term) - ✔✔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) - ✔✔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?
- ✔✔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
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©KERRYMARTIN 2025/2026. YEAR PUBLISHED 2025.
,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? - ✔✔All
those mentioned for the closed system.
1. Document encryption as appropriate
What information should a handwritten SIGNATURE block contain? - ✔✔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 ? - ✔✔Signatures must be linked to their respective
electronic records to make sure they cannot be copied, falsified, transferred etc.
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, Do researchers need to request permission from the FDA to use electronic
signatures in place of regular signatures? - ✔✔Yes
What controls should an E-SIGNATURE contain? - ✔✔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? - ✔✔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? - ✔✔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)) - ✔✔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
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©KERRYMARTIN 2025/2026. YEAR PUBLISHED 2025.
and Answers 100% Guaranteed Success
Does the FDA consider electronic signatures to be as trustworthy and reliable as
handwritten paper signatures? - ✔✔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 ? - ✔✔Yes
Open system (FDA term) - ✔✔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) - ✔✔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?
- ✔✔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
1|Page
©KERRYMARTIN 2025/2026. YEAR PUBLISHED 2025.
,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? - ✔✔All
those mentioned for the closed system.
1. Document encryption as appropriate
What information should a handwritten SIGNATURE block contain? - ✔✔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 ? - ✔✔Signatures must be linked to their respective
electronic records to make sure they cannot be copied, falsified, transferred etc.
2|Page
©KERRYMARTIN 2025/2026. YEAR PUBLISHED 2025.
, Do researchers need to request permission from the FDA to use electronic
signatures in place of regular signatures? - ✔✔Yes
What controls should an E-SIGNATURE contain? - ✔✔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? - ✔✔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? - ✔✔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)) - ✔✔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
3|Page
©KERRYMARTIN 2025/2026. YEAR PUBLISHED 2025.
