SOCRA EXAMINATION TEST PAPER WITH
COMPLETE SOLUTION AND REVIEW
MATERIAL
●● 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
●● 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
-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
COMPLETE SOLUTION AND REVIEW
MATERIAL
●● 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
●● 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
-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
