SOCRA Certification Exam Questions And Correct Answers
2022/2023
1. 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)
2. Does the FDA consider electronic records that meet requirements to
be equivalent to handwritten records ?: Yes
3. 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)
4. Closed system (FDA term): Environment in which SYSTEM ACCESS is
con- trolled by the same people responsible for the content of the
system (I.E. I control the Robotic Database access AND its contents)
5. 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
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
6. What are some FDA standards to meet when using an Open System?: All
those mentioned for the closed system.
1. Document encryption as appropriate
7. What information should a handwritten SIGNATURE block contain?: 1.
Print- ed name of signer
2. Date and Time when signature was executed
3.The MEANING associated with the signature (approval?
responsibility? author- ship?)
8. Signature and record linking ?: Signatures must be linked to their
respective electronic records to make sure they cannot be copied,
falsified, transferred etc.
9. Do researchers need to request permission from the FDA to use
electronic signatures in place of regular signatures?: Yes
10.What controls should an E-SIGNATURE contain?: Employ at least 2
identifi- cation components - such as an identification code AND a
password.
, 11.Name some CONTROLS for the identification components (i.e. identifica-
tion 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
12.Can an informed consent contain exculpatory language?: NO! Cannot
say things like "you are waiving your right to damages" etc
13.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
-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..)
14.When is it okay to skip informed consent and perform ((EMERGENCY
RE- SEARCH))?: 1. Human subjects are in life threatening danger,
2022/2023
1. 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)
2. Does the FDA consider electronic records that meet requirements to
be equivalent to handwritten records ?: Yes
3. 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)
4. Closed system (FDA term): Environment in which SYSTEM ACCESS is
con- trolled by the same people responsible for the content of the
system (I.E. I control the Robotic Database access AND its contents)
5. 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
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
6. What are some FDA standards to meet when using an Open System?: All
those mentioned for the closed system.
1. Document encryption as appropriate
7. What information should a handwritten SIGNATURE block contain?: 1.
Print- ed name of signer
2. Date and Time when signature was executed
3.The MEANING associated with the signature (approval?
responsibility? author- ship?)
8. Signature and record linking ?: Signatures must be linked to their
respective electronic records to make sure they cannot be copied,
falsified, transferred etc.
9. Do researchers need to request permission from the FDA to use
electronic signatures in place of regular signatures?: Yes
10.What controls should an E-SIGNATURE contain?: Employ at least 2
identifi- cation components - such as an identification code AND a
password.
, 11.Name some CONTROLS for the identification components (i.e. identifica-
tion 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
12.Can an informed consent contain exculpatory language?: NO! Cannot
say things like "you are waiving your right to damages" etc
13.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
-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..)
14.When is it okay to skip informed consent and perform ((EMERGENCY
RE- SEARCH))?: 1. Human subjects are in life threatening danger,
