SOCRA Certification Exam 2025/2026 – Complete Exam Set with Verified Questions & A+ Answers

SOCRA Certification
SOCRA
Exam
Certification Exam
2025| COMPLETE
2025-COMPLETE
EXAM SET
EXAM SET
(questions and v
- converted
SOCRA Certification Exam 2025| COMPLETE EXAM SET
fied answers)frequently most tested questions | already passed!!
Study online at https://quizlet.com/_hfe1zs

Does the FDA consider electronic signatures to be as trust- Yes (although permission to use such e-sigs has to be
worthy and reliable as handwritten paper signatures? approved by the FDA)
Does the FDA consider electronic records that meet re-
Yes
quirements to be equivalent to handwritten records ?
System access is NOT controlled by people who are re-
sponsible for the content of the electronic records in the
Open system (FDA term)
system. (Like me putting data into CHOP - controlled data-
bases)
Environment in which SYSTEM ACCESS is controlled by the
same people responsible for the content of the system
Closed system (FDA term)
(I.E. I control the Robotic Database access AND its con-
tents)
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 Standards to meet when operating a 6. Use operational system checks and restrictions
closed record system? 7. Use authority checks to make sure only authorized indi-
viduals are using the system
8. Use device checks to validate data input
9. Make sure those authorized to use system have appro-
priate 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 All those mentioned for the closed system.
Open System? 1. Document encryption as appropriate

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, SOCRA Certification
SOCRA
Exam
Certification Exam
2025| COMPLETE
2025-COMPLETE
EXAM SET
EXAM SET
(questions and v
- converted
SOCRA Certification Exam 2025| COMPLETE EXAM SET
fied answers)frequently most tested questions | already passed!!
Study online at https://quizlet.com/_hfe1zs
1. Printed name of signer
What information should a handwritten SIGNATURE block 2. Date and Time when signature was executed
contain? 3. The MEANING associated with the signature (approval?
responsibility? authorship?)
Signatures must be linked to their respective electronic
Signature and record linking ? records to make sure they cannot be copied, falsified,
transferred etc.
Do researchers need to request permission from the FDA
Yes
to use electronic signatures in place of regular signatures?
Employ at least 2 identification components - such as an
What controls should an E-SIGNATURE contain?
identification code AND a password.
1. no 2 people should have the same identification con-
trols (password... code)
Name some CONTROLS for the identification components 2. Identification codes and passwords should be periodi-
(i.e. identification code and password) for e-signature? cally checked, revised, etc.
3. Deauthorize lost, stolen, missing codes and passwords
4. Periodically test your devices that generate these codes
NO! Cannot say things like "you are waiving your right to
Can an informed consent contain exculpatory language?
damages" etc
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
When may an experimental drug or device be used on a representation
patient WITHOUT informed consent? ((EMERGENCY USE)) -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
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, SOCRA Certification
SOCRA
Exam
Certification Exam
2025| COMPLETE
2025-COMPLETE
EXAM SET
EXAM SET
(questions and v
- converted
SOCRA Certification Exam 2025| COMPLETE EXAM SET
fied answers)frequently most tested questions | already passed!!
Study online at https://quizlet.com/_hfe1zs
working days
-the president can authorize use on the military (lots of
information on this military stuff..)
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
When is it okay to skip informed consent and perform
3. Participation holds the prospect of direct benefit to
((EMERGENCY RESEARCH))?
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 commit-
tee ETC

1. statement of research. purpose of research. duration of
participation. procedures involved. identification of all that
is experimental.
2. Risks and discomforts
3. Benefits
Name the 8 elements of INFORMED CONSENT
4. Disclosure of alternatives
5. Confidentiality
6. Compensation if injury
7. Who to contact
8. Statement of voluntariness
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