SOCRA EXAM CERTIFICATION ACTUAL EXAM 300 EXAM
QUESTIOS AND CORRECT DETAILED ANSWERS (100%
VERIFIED ANSWERS) |ALREADY GRADED A+
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.
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
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. 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
Immediate use of the test article - ANSWER: If immediate use is required, in the
opinion of the investigator, to preserve the life of the subject and time is not
sufficient to obtain independent determination, the determination 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
Documentation for exception in obtaining informed consent - ANSWER:
Documentation required for waiving informed consent must be submitted to the IRB
within 5 working days after the use of the test article
Waiver of consent - President - ANSWER: The president may waive prior consent for
the administration of an investigational new drug to a member of the armed forces
in connection with the member's participation 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
Waiving informed consent for investigation in vitro diagnostic devices used to
identify chemical, biological, radiological or nuclear agents - ANSWER: Before use of
the test article, the investigatory and uninvolved physician must certify in writing:
1. Subject is in life-threatening situation necessitating the use of the product to
identify an agent that would suggest a terrorism event or other public health
emergency
2. Consent cannot be obtained because the person collecting the specimen could not
know there would be a need to use the product on that specimen and time is not
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
Waiving informed consent for investigation in vitro diagnostic devices used to
identify chemical, biological, radiological or nuclear agents - ANSWER: Before use of
the test article, the investigatory and uninvolved physician must certify in writing:
1. Subject is in life-threatening situation necessitating the use of the product to
identify an agent that would suggest a terrorism event or other public health
emergency
2. Consent cannot be obtained because the person collecting the specimen could
know there would be a need to use the product on that specimen and time is not
sufficient 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
Waiving informed consent for use of in-vitro diagnostic device and not sufficient time
to obtain independent determination - ANSWER: Before using the device, the
investigator must make the determination and it must be reviewed within 5 working
days by uninvolved physician
Waiving informed consent for in-vitro diagnostic device - ANSWER: Determination
for waiving consent must be submitted to the IRB for review within 5 working days
Exception from informed consent for emergency research - ANSWER: 1. Subject is in
life-threatening situation, available treatments are unproved or unsatisfactory, and
collection of scientific evidence is necessary to determine safety and effectiveness of
intervention
2. Consent is not feasible because subject cannot consent due to their condition,
intervention must be administered before consent can feasibly be attained, no
reasonable way to prospectively ID eligible participants
3. Participation on the research holds the prospect of a direct benefit to the subject
4. Clinical investigation could not be carried out without waiver of informed consent
5. Potential therapeutic window is defined and efforts are made to contact LAR and
obtain consent
Waiving informed consent for emergency research - Additional protections of the
rights and welfare of subjects - ANSWER: 1. Consultation with representative of the
communities from which subjects will be drawn
2. Public disclosure to the communities where the clinical investigation will take
place prior to study and include risks and benefits. Disclosure will also take place
following conclusion of the study including demographic characteristics and resukts
3. Establish independent data monitoring comittee
Elements of Informed consent - General requirements - ANSWER: 1. A statement
that the study involves research, purpose of the research, expected duration,
description of procedures, ID of an experimental procedures
2. Description of risks or discomforts
3. Description of benefits
4. Disclosure of alternative procedures or courses of treatment
5. Statement describing extent to which confidentiality will be maintained and notes
FDA may inspect records
6. For research involving more than minimal risk, statement explaining whether an
compensation or medical treatments are available if injury occurs
7. Explanation of who to contact for answers to pertinent questions about the
research
8. Statement that participation is voluntary and refusal to participate will involve no
penalty
QUESTIOS AND CORRECT DETAILED ANSWERS (100%
VERIFIED ANSWERS) |ALREADY GRADED A+
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.
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
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. 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
Immediate use of the test article - ANSWER: If immediate use is required, in the
opinion of the investigator, to preserve the life of the subject and time is not
sufficient to obtain independent determination, the determination 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
Documentation for exception in obtaining informed consent - ANSWER:
Documentation required for waiving informed consent must be submitted to the IRB
within 5 working days after the use of the test article
Waiver of consent - President - ANSWER: The president may waive prior consent for
the administration of an investigational new drug to a member of the armed forces
in connection with the member's participation 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
Waiving informed consent for investigation in vitro diagnostic devices used to
identify chemical, biological, radiological or nuclear agents - ANSWER: Before use of
the test article, the investigatory and uninvolved physician must certify in writing:
1. Subject is in life-threatening situation necessitating the use of the product to
identify an agent that would suggest a terrorism event or other public health
emergency
2. Consent cannot be obtained because the person collecting the specimen could not
know there would be a need to use the product on that specimen and time is not
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
Waiving informed consent for investigation in vitro diagnostic devices used to
identify chemical, biological, radiological or nuclear agents - ANSWER: Before use of
the test article, the investigatory and uninvolved physician must certify in writing:
1. Subject is in life-threatening situation necessitating the use of the product to
identify an agent that would suggest a terrorism event or other public health
emergency
2. Consent cannot be obtained because the person collecting the specimen could
know there would be a need to use the product on that specimen and time is not
sufficient 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
Waiving informed consent for use of in-vitro diagnostic device and not sufficient time
to obtain independent determination - ANSWER: Before using the device, the
investigator must make the determination and it must be reviewed within 5 working
days by uninvolved physician
Waiving informed consent for in-vitro diagnostic device - ANSWER: Determination
for waiving consent must be submitted to the IRB for review within 5 working days
Exception from informed consent for emergency research - ANSWER: 1. Subject is in
life-threatening situation, available treatments are unproved or unsatisfactory, and
collection of scientific evidence is necessary to determine safety and effectiveness of
intervention
2. Consent is not feasible because subject cannot consent due to their condition,
intervention must be administered before consent can feasibly be attained, no
reasonable way to prospectively ID eligible participants
3. Participation on the research holds the prospect of a direct benefit to the subject
4. Clinical investigation could not be carried out without waiver of informed consent
5. Potential therapeutic window is defined and efforts are made to contact LAR and
obtain consent
Waiving informed consent for emergency research - Additional protections of the
rights and welfare of subjects - ANSWER: 1. Consultation with representative of the
communities from which subjects will be drawn
2. Public disclosure to the communities where the clinical investigation will take
place prior to study and include risks and benefits. Disclosure will also take place
following conclusion of the study including demographic characteristics and resukts
3. Establish independent data monitoring comittee
Elements of Informed consent - General requirements - ANSWER: 1. A statement
that the study involves research, purpose of the research, expected duration,
description of procedures, ID of an experimental procedures
2. Description of risks or discomforts
3. Description of benefits
4. Disclosure of alternative procedures or courses of treatment
5. Statement describing extent to which confidentiality will be maintained and notes
FDA may inspect records
6. For research involving more than minimal risk, statement explaining whether an
compensation or medical treatments are available if injury occurs
7. Explanation of who to contact for answers to pertinent questions about the
research
8. Statement that participation is voluntary and refusal to participate will involve no
penalty
