SOCRA EXAM WITH VERIFIED ANSWERS GRADED A+
1. Electronic
Records
2. Electronic
Records - Audit
Trail
3. Electronic
Records -
Changes
4. Electronic
Records - Audit
Trail Retention
5. Electronic
records -
Controls over
systems
documentation
6. Electronic
records - Open
system
7. S...
1. Electronic Use of electronic records must have procedures to ensure
Records the authenticity, integrity and confidentiality of records.
Also, the procedures must ensure the signer cannot read-
ily repudiate the signed records a snot genuine
2. Electronic Electronic records must use secure, computer generated,
Records - Audit time-stamped audit trails to independently record the date
Trail and time of entries and actions that create, modify or
delete records.
3. Electronic Record changes must not obscure previously recorded
Records - information
Changes
4. Electronic Audit trail documentation must be retained for a period at
Records - Audit least as long as that required for the subject electronic
Trail Retention records and must be available for agency (FDA) review
and copying.
5. Electronic 1. Controls over the distribution of, access to, and use of
records - documentation for system operation and maintenance
Controls over 2. Revision and change control procedures to maintain an
systems audit trail that documents time-sequenced development
documentation and modification of systems documentation
6. Electronic Procedures and controls must be used to ensure the au-
records - Open thenticity, integrity and confidentiality of electronic records
system from the point of creation to the point of receipt.
Examples: Encryption, Use of digital signatures
7. Signed Electron- Must contain information associated with the signing that
ic Records clearly indicate all of the following:
1. Printed name of signer
2. Date and time when signature was executed
3. Meaning (such as review, approval, responsibility or
authorship) associated with signature
8. Electronic Signa- Before any organization establishes, assigns, certifies or
ture Verification otherwise sanctions an individual's electronic signature,
the identity of the individual must be verified
, SOCRA EXAM WITH VERIFIED ANSWERS GRADED A+
9. Electronic Signa- Prior to using their electronic signature, one must cer-
ture Certification tify to the agency that the electronic signatures in their
system, used on or after 8/20/97, are intended to be
the legally binding equivalent of traditional handwritten
signatures
1. Certification must be submitted in paper form and
signed with a traditional handwritten signature
2. Upon agency request, must provide additional certifica-
tion or testimony that a specific electronic signature is the
legally binding equivalent of the handwritten signature
10. Electronic Signa- 1. Employ at least 2 distinct identification components
tures not based such as identification code and password
on biometrics a. During a series of signings over a continuous period
of controlled system access, the first signing uses all
electronic signature components while each subsequent
signature uses at least 1 electronic signature component
that is only executable by the individual
2. Be used by the genuine owners
3. Administered and executed to ensure that attempted
use of an electronic signature by anyone other than its
genuine owner requires the collaboration of 2 or more
individuals
11. Electronic Signa- Designed to ensure that they cannot be used by anyone
tures based on other that their genuine owners
biometrics
12. Security and 1. Maintain uniqueness of each combined ID code and
Integrity of password (No 2 people have same combo)
identification 2. ID code and password are periodically checked, re-
codes/pass- called, revised (Prevent PW aging)
words 3. Loss management procedures to deauthorize lost,
stolen, missing or otherwise compromised devices that
generate ID code or PW information and issue replace-
ments
4. Use of safeguards to prevent unauthorized use of PWs
and/or ID codes and to detect and report any attempts at
their unauthorized use
, 5. Initial and periodic testing of devices that generate ID
or PW information to ensure they function properly
13. General Require- Must obtain legally effective informed consent
ments for in- Must allow for sufficient opportunity to consider whether
formed consent or not to participate
Minimize possibility of coercion or undue influence
Must use language understandable by participant
14. Informed con- Language may not include exculpatory language in which
sent - Language the subject is made to waive or appear to waive their legal
may not rights or releases or appears to release the investigator,
the sponsor or its agents from liability or negligence
15. Exception- Ob- Obtaining informed consent is deemed feasible unless
taining informed both the investigator and a physician who is not not par-
consent ticipating in clinical investigation certify in writing all of the
following:
1. Subject is confronted by life-threatening situation ne-
cessitating the use of the test article
2. Informed consent cannot be obtained from the subject
because of an inability to communicate with, or obtain
legally effective consent from, the subject
3. Time is not sufficient to obtain consent from the sub-
ject's legal representative
4. There is now alternative method available or approved
or generally recognized therapy that provides an equal or
greater likelihood of saving the life of the subject
16. Immediate use of If immediate use is required, in the opinion of the inves-
the test article tigator, to preserve the life of the subject and time is not
sufficient to obtain independent determination, the deter-
mination of the investigator shall be made and, within 5
working days of the use of the article, be reviewed and
evaluated in writing by a physician who is not participating
in the clinical investigation
17. Documentation Documentation required for waiving informed consent
for exception in must be submitted to the IRB within 5 working days after
obtaining the use of the test article
, informed
consent
18. Waiver of con- The president may waive prior consent for the adminis-
sent - President tration of an investigational new drug to a member of the
armed forces in connection with the member's participa-
tion in a particular military operation
The president must determine in writing that obtaining
informed consent is not feasible, is contrary to the best
interests of the military member, or is not in the interest
of national security
19. Waiving in- Before use of the test article, the investigatory and unin-
formed consent volved physician must certify in writing:
for investigation 1. Subject is in life-threatening situation necessitating the
in vitro diagnos- use of the product to identify an agent that would suggest
tic devices used a terrorism event or other public health emergency
to identify chem- 2. Consent cannot be obtained because the person col-
ical, biological, lecting the specimen could not know there would be a
radiological or need to use the product on that specimen and time is not
nuclear agents sufficient to obtain consent without risking the subject's
life
3. Time is not sufficient to obtain consent from LAR
4. No available alternative method of diagnosis
20. Waiving in- Before use of the test article, the investigatory and unin-
formed consent volved physician must certify in writing:
for investigation 1. Subject is in life-threatening situation necessitating the
in vitro diagnos- use of the product to identify an agent that would suggest
tic devices used a terrorism event or other public health emergency
to identify chem- 2. Consent cannot be obtained because the person col-
ical, biological, lecting the specimen could know there would be a need to
radiological or use the product on that specimen and time is not sufficient
nuclear agents to botain consent without risking the subject's life
3. Time is not sufficient to obtain consent from LAR
4. No available alternative method of diagnosis
21. Waiving in- Before using the device, the investigator must make the
formed consent determination and it must be reviewed within 5 working
for use of in-vit- days by uninvolved physician
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