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 Yes (although permission to use
consider such e-sigs has to be approved by
electronic the FDA)
signatures to be
as trustworthy
and reliable as
handwritten
paper
signatures?
,Does the FDA Yes
consider
electronic
records that
meet
requirements to
be equivalent to
handwritten
records ?
System access is NOT controlled by
people who are responsible for the
Open system
content of the electronic records in
(FDA term)
the system. (Like me putting data
into CHOP - controlled databases)
Environment in which SYSTEM
ACCESS is controlled by the same
Closed system people responsible for the content
(FDA term) of the system (I.E. I control the
Robotic Database access AND its
contents)
, 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
What are some modification etc
FDA Standards 6. Use operational system checks
to meet when and restrictions
operating a 7. Use authority checks to make sure
closed record only authorized individuals are using
system? 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 All those mentioned for the closed
FDA standards system.
to meet when 1. Document encryption as
using an Open appropriate
System?
What 1. Printed name of signer
information 2. Date and Time when signature
should a was executed
handwritten 3. The MEANING associated with
SIGNATURE the signature (approval?
block contain? responsibility? authorship?)
Signatures must be linked to their
Signature and respective electronic records to
record linking ? make sure they cannot be copied,
falsified, transferred etc.
Do researchers Yes
need to request
permission from
the FDA to use
electronic
signatures in
place of regular
signatures?
COMPLETE EXAM SET (questions
and verified answers)frequently
most tested questions | already
passed!!
Save
Terms in this set (154)
Does the FDA Yes (although permission to use
consider such e-sigs has to be approved by
electronic the FDA)
signatures to be
as trustworthy
and reliable as
handwritten
paper
signatures?
,Does the FDA Yes
consider
electronic
records that
meet
requirements to
be equivalent to
handwritten
records ?
System access is NOT controlled by
people who are responsible for the
Open system
content of the electronic records in
(FDA term)
the system. (Like me putting data
into CHOP - controlled databases)
Environment in which SYSTEM
ACCESS is controlled by the same
Closed system people responsible for the content
(FDA term) of the system (I.E. I control the
Robotic Database access AND its
contents)
, 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
What are some modification etc
FDA Standards 6. Use operational system checks
to meet when and restrictions
operating a 7. Use authority checks to make sure
closed record only authorized individuals are using
system? 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 All those mentioned for the closed
FDA standards system.
to meet when 1. Document encryption as
using an Open appropriate
System?
What 1. Printed name of signer
information 2. Date and Time when signature
should a was executed
handwritten 3. The MEANING associated with
SIGNATURE the signature (approval?
block contain? responsibility? authorship?)
Signatures must be linked to their
Signature and respective electronic records to
record linking ? make sure they cannot be copied,
falsified, transferred etc.
Do researchers Yes
need to request
permission from
the FDA to use
electronic
signatures in
place of regular
signatures?
