9/15/25, 6:08 AM SOCRA Certification EXAM Questions & Answers, Well Elaborated | Already Verified Test |100% Verified solutions | 2025\2026 Late…
SOCRA Certification EXAM Questions & Answers,
Well Elaborated | Already Verified Test |100%
Verified solutions | 2025\2026 Latest!!
Save
Terms in this set (154)
Does the FDA consider Yes (although permission to use such e-sigs has to be
electronic signatures to be approved by the FDA)
as trustworthy and reliable
as handwritten paper
signatures?
Does the FDA consider Yes
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
Open system (FDA term)
in the system. (Like me putting data into CHOP -
controlled databases)
Environment in which SYSTEM ACCESS is controlled
by the same people responsible for the content of the
Closed system (FDA term)
system (I.E. I control the Robotic Database access
AND its contents)
https://quizlet.com/1076463756/socra-certification-exam-questions-answers-well-elaborated-already-verified-test-100-verified-solutions-20252026-lat… 1/23
,9/15/25, 6:08 AM SOCRA Certification EXAM Questions & Answers, Well Elaborated | Already Verified Test |100% Verified solutions | 2025\2026 Late…
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
What are some FDA
6. Use operational system checks and restrictions
Standards to meet when
7. Use authority checks to make sure only authorized
operating a closed record
individuals are using the system
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 All those mentioned for the closed system.
standards to meet when 1. Document encryption as appropriate
using an Open System?
1. Printed name of signer
What information should a
2. Date and Time when signature was executed
handwritten SIGNATURE
3. The MEANING associated with the signature
block contain?
(approval? responsibility? authorship?)
Signatures must be linked to their respective
Signature and record
electronic records to make sure they cannot be
linking ?
copied, falsified, transferred etc.
Do researchers need to Yes
request permission from
the FDA to use electronic
signatures in place of
regular signatures?
What controls should an Employ at least 2 identification components - such as
E-SIGNATURE contain? an identification code AND a password.
https://quizlet.com/1076463756/socra-certification-exam-questions-answers-well-elaborated-already-verified-test-100-verified-solutions-20252026-lat… 2/23
, 9/15/25, 6:08 AM SOCRA Certification EXAM Questions & Answers, Well Elaborated | Already Verified Test |100% Verified solutions | 2025\2026 Late…
1. no 2 people should have the same identification
Name some CONTROLS controls (password... code)
for the identification 2. Identification codes and passwords should be
components (i.e. periodically checked, revised, etc.
identification code and 3. Deauthorize lost, stolen, missing codes and
password) for e- passwords
signature? 4. Periodically test your devices that generate these
codes
Can an informed consent NO! Cannot say things like "you are waiving your right
contain exculpatory to damages" etc
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
When may an
legal representation
experimental drug or
-there is no recognized therapy that provides equal or
device be used on a
greater likelihood of saving life
patient WITHOUT
- within 5 working days this must be evaluated by
informed consent?
another independent physician
((EMERGENCY USE))
-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..)
https://quizlet.com/1076463756/socra-certification-exam-questions-answers-well-elaborated-already-verified-test-100-verified-solutions-20252026-lat… 3/23
SOCRA Certification EXAM Questions & Answers,
Well Elaborated | Already Verified Test |100%
Verified solutions | 2025\2026 Latest!!
Save
Terms in this set (154)
Does the FDA consider Yes (although permission to use such e-sigs has to be
electronic signatures to be approved by the FDA)
as trustworthy and reliable
as handwritten paper
signatures?
Does the FDA consider Yes
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
Open system (FDA term)
in the system. (Like me putting data into CHOP -
controlled databases)
Environment in which SYSTEM ACCESS is controlled
by the same people responsible for the content of the
Closed system (FDA term)
system (I.E. I control the Robotic Database access
AND its contents)
https://quizlet.com/1076463756/socra-certification-exam-questions-answers-well-elaborated-already-verified-test-100-verified-solutions-20252026-lat… 1/23
,9/15/25, 6:08 AM SOCRA Certification EXAM Questions & Answers, Well Elaborated | Already Verified Test |100% Verified solutions | 2025\2026 Late…
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
What are some FDA
6. Use operational system checks and restrictions
Standards to meet when
7. Use authority checks to make sure only authorized
operating a closed record
individuals are using the system
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 All those mentioned for the closed system.
standards to meet when 1. Document encryption as appropriate
using an Open System?
1. Printed name of signer
What information should a
2. Date and Time when signature was executed
handwritten SIGNATURE
3. The MEANING associated with the signature
block contain?
(approval? responsibility? authorship?)
Signatures must be linked to their respective
Signature and record
electronic records to make sure they cannot be
linking ?
copied, falsified, transferred etc.
Do researchers need to Yes
request permission from
the FDA to use electronic
signatures in place of
regular signatures?
What controls should an Employ at least 2 identification components - such as
E-SIGNATURE contain? an identification code AND a password.
https://quizlet.com/1076463756/socra-certification-exam-questions-answers-well-elaborated-already-verified-test-100-verified-solutions-20252026-lat… 2/23
, 9/15/25, 6:08 AM SOCRA Certification EXAM Questions & Answers, Well Elaborated | Already Verified Test |100% Verified solutions | 2025\2026 Late…
1. no 2 people should have the same identification
Name some CONTROLS controls (password... code)
for the identification 2. Identification codes and passwords should be
components (i.e. periodically checked, revised, etc.
identification code and 3. Deauthorize lost, stolen, missing codes and
password) for e- passwords
signature? 4. Periodically test your devices that generate these
codes
Can an informed consent NO! Cannot say things like "you are waiving your right
contain exculpatory to damages" etc
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
When may an
legal representation
experimental drug or
-there is no recognized therapy that provides equal or
device be used on a
greater likelihood of saving life
patient WITHOUT
- within 5 working days this must be evaluated by
informed consent?
another independent physician
((EMERGENCY USE))
-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..)
https://quizlet.com/1076463756/socra-certification-exam-questions-answers-well-elaborated-already-verified-test-100-verified-solutions-20252026-lat… 3/23
