SOCRA Certification Exam Questions
With 100% Pass
/.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
/.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
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.
/.Short Form consent - Answer-✅In the context of human subjects research, a written
document stating that the elements of informed consent required by the Common Rule
have been ORALLY presented to and understood by the subject or the subject's legally
authorized representative
/.When can children participate in clinical trials ? (conditions) - Answer-✅1. No more
than minimal risk
2. Adequate assent of the child
3. Risk is justified by potential benefit
4. Risk is above minimal, but likely to yield knowledge about a disorder or condition. Not
reasonably different from their expected medical course. Assent.
/.Things to consider when soliciting ASSENT - Answer-✅Age, maturity, mental capacity
/.When is ASSENT NOT REQUIRED? - Answer-✅Children cannot be reasonably
consulted in this case. Benefit is so great. Minimal risk. Could not practicably be carried
out without the waiver.
/.When can WARDS be included? - Answer-✅related to their status as wards,
conducted in a setting (school) where most are not wards, advocate has experience to
act in the best interest of the child (cannot be associated with study team)
/.Within how many days can emergency use of a test article be reported to the IRB? -
Answer-✅5
With 100% Pass
/.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
/.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
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.
/.Short Form consent - Answer-✅In the context of human subjects research, a written
document stating that the elements of informed consent required by the Common Rule
have been ORALLY presented to and understood by the subject or the subject's legally
authorized representative
/.When can children participate in clinical trials ? (conditions) - Answer-✅1. No more
than minimal risk
2. Adequate assent of the child
3. Risk is justified by potential benefit
4. Risk is above minimal, but likely to yield knowledge about a disorder or condition. Not
reasonably different from their expected medical course. Assent.
/.Things to consider when soliciting ASSENT - Answer-✅Age, maturity, mental capacity
/.When is ASSENT NOT REQUIRED? - Answer-✅Children cannot be reasonably
consulted in this case. Benefit is so great. Minimal risk. Could not practicably be carried
out without the waiver.
/.When can WARDS be included? - Answer-✅related to their status as wards,
conducted in a setting (school) where most are not wards, advocate has experience to
act in the best interest of the child (cannot be associated with study team)
/.Within how many days can emergency use of a test article be reported to the IRB? -
Answer-✅5
