SOCRA EXAM CERTIFICATION 2023-2024 ACTUAL EXAM 300 EXAM QUESTIOS AND CORRECT DETAILED
ANSWERS
Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper
signatures? - (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 ? - (answer) Yes
Open system (FDA term) - (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) - (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? - (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? - (answer) All those mentioned
for the closed system.
1. Document encryption as appropriate
,SOCRA EXAM CERTIFICATION 2023-2024 ACTUAL EXAM 300 EXAM QUESTIOS AND CORRECT DETAILED
ANSWERS
What information should a handwritten SIGNATURE block contain? - (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 ? - (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? - (answer) Yes
What controls should an E-SIGNATURE contain? - (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? - (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? - (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)) - (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
, SOCRA EXAM CERTIFICATION 2023-2024 ACTUAL EXAM 300 EXAM QUESTIOS AND CORRECT DETAILED
ANSWERS
-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))? - (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
Name the 8 elements of INFORMED CONSENT - (answer) 1. statement of research. purpose of
research. duration of participation. procedures involved. identification of all that is experimental.
2. Risks and discomforts
3. Benefits
4. Disclosure of alternatives
5. Confidentiality
6. Compensation if injury
7. Who to contact
8. Statement of voluntariness
ADDITIONAL:
Costs, pregnancy, termination of participation, withdrawal consequences, disclosure of findings, number
of subjects in the study.
Clinicaltrials.gov statement.
ANSWERS
Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper
signatures? - (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 ? - (answer) Yes
Open system (FDA term) - (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) - (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? - (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? - (answer) All those mentioned
for the closed system.
1. Document encryption as appropriate
,SOCRA EXAM CERTIFICATION 2023-2024 ACTUAL EXAM 300 EXAM QUESTIOS AND CORRECT DETAILED
ANSWERS
What information should a handwritten SIGNATURE block contain? - (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 ? - (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? - (answer) Yes
What controls should an E-SIGNATURE contain? - (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? - (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? - (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)) - (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
, SOCRA EXAM CERTIFICATION 2023-2024 ACTUAL EXAM 300 EXAM QUESTIOS AND CORRECT DETAILED
ANSWERS
-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))? - (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
Name the 8 elements of INFORMED CONSENT - (answer) 1. statement of research. purpose of
research. duration of participation. procedures involved. identification of all that is experimental.
2. Risks and discomforts
3. Benefits
4. Disclosure of alternatives
5. Confidentiality
6. Compensation if injury
7. Who to contact
8. Statement of voluntariness
ADDITIONAL:
Costs, pregnancy, termination of participation, withdrawal consequences, disclosure of findings, number
of subjects in the study.
Clinicaltrials.gov statement.
