2/19/25, 5:48 AM SOCRA Certification Exam 2025| COMPLETE EXAM SET (questions and verified answers)frequently most tested questions | …
SOCRA Certification Exam 2025| COMPLETE
EXAM SET (questions and verified
answers)frequently most tested questions |
already passed!!
Save
Terms in this set (154)
Does the FDA consider Yes (although permission to use such e-sigs has to
electronic signatures to be approved by the FDA)
be 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
Open system (FDA term)
records in the system. (Like me putting data into
CHOP - controlled databases)
Environment in which SYSTEM ACCESS is controlled
Closed system (FDA by the same people responsible for the content of
term) the system (I.E. I control the Robotic Database
access AND its contents)
https://quizlet.com/1007769118/socra-certification-exam-2025-complete-exam-set-questions-and-verified-answersfrequently-most-tested-questio… 1/22
,2/19/25, 5:48 AM SOCRA Certification Exam 2025| COMPLETE EXAM SET (questions and verified answers)frequently most tested questions | …
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
operating a closed
authorized individuals are using the system
record 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?
What information should 1. Printed name of signer
a handwritten 2. Date and Time when signature was executed
SIGNATURE block 3. The MEANING associated with the signature
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
E-SIGNATURE contain? as an identification code AND a password.
https://quizlet.com/1007769118/socra-certification-exam-2025-complete-exam-set-questions-and-verified-answersfrequently-most-tested-questio… 2/22
, 2/19/25, 5:48 AM SOCRA Certification Exam 2025| COMPLETE EXAM SET (questions and verified answers)frequently most tested questions | …
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
contain exculpatory right 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
When may an
esubject's legal representation
experimental drug or
-there is no recognized therapy that provides equal
device be used on a
or 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/1007769118/socra-certification-exam-2025-complete-exam-set-questions-and-verified-answersfrequently-most-tested-questio… 3/22
SOCRA Certification Exam 2025| COMPLETE
EXAM SET (questions and verified
answers)frequently most tested questions |
already passed!!
Save
Terms in this set (154)
Does the FDA consider Yes (although permission to use such e-sigs has to
electronic signatures to be approved by the FDA)
be 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
Open system (FDA term)
records in the system. (Like me putting data into
CHOP - controlled databases)
Environment in which SYSTEM ACCESS is controlled
Closed system (FDA by the same people responsible for the content of
term) the system (I.E. I control the Robotic Database
access AND its contents)
https://quizlet.com/1007769118/socra-certification-exam-2025-complete-exam-set-questions-and-verified-answersfrequently-most-tested-questio… 1/22
,2/19/25, 5:48 AM SOCRA Certification Exam 2025| COMPLETE EXAM SET (questions and verified answers)frequently most tested questions | …
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
operating a closed
authorized individuals are using the system
record 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?
What information should 1. Printed name of signer
a handwritten 2. Date and Time when signature was executed
SIGNATURE block 3. The MEANING associated with the signature
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
E-SIGNATURE contain? as an identification code AND a password.
https://quizlet.com/1007769118/socra-certification-exam-2025-complete-exam-set-questions-and-verified-answersfrequently-most-tested-questio… 2/22
, 2/19/25, 5:48 AM SOCRA Certification Exam 2025| COMPLETE EXAM SET (questions and verified answers)frequently most tested questions | …
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
contain exculpatory right 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
When may an
esubject's legal representation
experimental drug or
-there is no recognized therapy that provides equal
device be used on a
or 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/1007769118/socra-certification-exam-2025-complete-exam-set-questions-and-verified-answersfrequently-most-tested-questio… 3/22
