ANSWERS|LATEST UPDATE!!!!!!2026|GUARANTEED
CORRECT = 100
100
INCORRECT=0
STUDY MATERIALS.......DESIGNED TO HELP YOU SUCCEED
SPOTLIGHT 1
1
, DETAILED ANSWERS|LATEST
UPDATE!!!!!!2026|GUARANTEED PASS|GRADED
Electronic Records - ANSWER Use of electronic records must have procedures to
ensure the authenticity, integrity and confidentiality of records. Also, the procedures must
ensure the signer cannot readily repudiate the signed records a snot genuine
Electronic Records - Audit Trail - ANSWER Electronic records must use secure,
computer generated, time-stamped audit trails to independently record the date and time of
entries and actions that create, modify or delete records.
Electronic Records - Changes - ANSWER Record changes must not obscure
previously recorded information
Electronic Records - Audit Trail Retention - ANSWER Audit trail documentation must
be retained for a period at least as long as that required for the subject electronic records
and must be available for agency (FDA) review and copying.
Electronic records - Controls over systems documentation - ANSWER 1. Controls
over the distribution of, access to, and use of documentation for system operation and
maintenance
2. Revision and change control procedures to maintain an audit trail that documents time-
sequenced development and modification of systems documentation
Electronic records - Open system - ANSWER Procedures and controls must be used
to ensure the authenticity, integrity and confidentiality of electronic records from the point
of creation to the point of receipt.
2
,Examples: Encryption, Use of digital signatures
Signed Electronic Records - ANSWER Must contain information associated with the
signing that 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
Electronic Signature Verification - ANSWER Before any organization establishes,
assigns, certifies or otherwise sanctions an individual's electronic signature, the identity of
the individual must be verified
Electronic Signature Certification - ANSWER Prior to using their electronic signature,
one must certify 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 certification or testimony that a specific
electronic signature is the legally binding equivalent of the handwritten signature
Electronic Signatures not based on biometrics - ANSWER 1. Employ at least 2
distinct identification components such as identification code and password
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
3
, Electronic Signatures based on biometrics - ANSWER Designed to ensure that they
cannot be used by anyone other that their genuine owners
Security and Integrity of identification codes/passwords - ANSWER 1. Maintain
uniqueness of each combined ID code and password (No 2 people have same combo)
2. ID code and password are periodically checked, recalled, revised (Prevent PW aging)
3. Loss management procedures to deauthorize lost, stolen, missing or otherwise
compromised devices that generate ID code or PW information and issue replacements
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
General Requirements for informed consent - ANSWER Must obtain legally effective
informed consent
Must allow for sufficient opportunity to consider whether or not to participate
Minimize possibility of coercion or undue influence
Must use language understandable by participant
Informed consent - Language may not - ANSWER Language may not include
exculpatory language in which the subject is made to waive or appear to waive their legal
rights or releases or appears to release the investigator, the sponsor or its agents from
liability or negligence
Exception- Obtaining informed consent - ANSWER Obtaining informed consent is
deemed feasible unless both the investigator and a physician who is not not participating in
clinical investigation certify in writing all of the following:
1. Subject is confronted by life-threatening situation necessitating 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 subject's legal representative
4
CORRECT = 100
100
INCORRECT=0
STUDY MATERIALS.......DESIGNED TO HELP YOU SUCCEED
SPOTLIGHT 1
1
, DETAILED ANSWERS|LATEST
UPDATE!!!!!!2026|GUARANTEED PASS|GRADED
Electronic Records - ANSWER Use of electronic records must have procedures to
ensure the authenticity, integrity and confidentiality of records. Also, the procedures must
ensure the signer cannot readily repudiate the signed records a snot genuine
Electronic Records - Audit Trail - ANSWER Electronic records must use secure,
computer generated, time-stamped audit trails to independently record the date and time of
entries and actions that create, modify or delete records.
Electronic Records - Changes - ANSWER Record changes must not obscure
previously recorded information
Electronic Records - Audit Trail Retention - ANSWER Audit trail documentation must
be retained for a period at least as long as that required for the subject electronic records
and must be available for agency (FDA) review and copying.
Electronic records - Controls over systems documentation - ANSWER 1. Controls
over the distribution of, access to, and use of documentation for system operation and
maintenance
2. Revision and change control procedures to maintain an audit trail that documents time-
sequenced development and modification of systems documentation
Electronic records - Open system - ANSWER Procedures and controls must be used
to ensure the authenticity, integrity and confidentiality of electronic records from the point
of creation to the point of receipt.
2
,Examples: Encryption, Use of digital signatures
Signed Electronic Records - ANSWER Must contain information associated with the
signing that 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
Electronic Signature Verification - ANSWER Before any organization establishes,
assigns, certifies or otherwise sanctions an individual's electronic signature, the identity of
the individual must be verified
Electronic Signature Certification - ANSWER Prior to using their electronic signature,
one must certify 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 certification or testimony that a specific
electronic signature is the legally binding equivalent of the handwritten signature
Electronic Signatures not based on biometrics - ANSWER 1. Employ at least 2
distinct identification components such as identification code and password
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
3
, Electronic Signatures based on biometrics - ANSWER Designed to ensure that they
cannot be used by anyone other that their genuine owners
Security and Integrity of identification codes/passwords - ANSWER 1. Maintain
uniqueness of each combined ID code and password (No 2 people have same combo)
2. ID code and password are periodically checked, recalled, revised (Prevent PW aging)
3. Loss management procedures to deauthorize lost, stolen, missing or otherwise
compromised devices that generate ID code or PW information and issue replacements
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
General Requirements for informed consent - ANSWER Must obtain legally effective
informed consent
Must allow for sufficient opportunity to consider whether or not to participate
Minimize possibility of coercion or undue influence
Must use language understandable by participant
Informed consent - Language may not - ANSWER Language may not include
exculpatory language in which the subject is made to waive or appear to waive their legal
rights or releases or appears to release the investigator, the sponsor or its agents from
liability or negligence
Exception- Obtaining informed consent - ANSWER Obtaining informed consent is
deemed feasible unless both the investigator and a physician who is not not participating in
clinical investigation certify in writing all of the following:
1. Subject is confronted by life-threatening situation necessitating 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 subject's legal representative
4
