SOCRA CERTIFICATION SCRIPT 2026 FULL
QUESTION SET SOLUTIONS
COMPREHENSIVE STUDY GUIDE GRADED
A+
⩥ Application for treatment use of IDE.
Answer: 1. Name, address and phone number of sponsor
2. Intended use of the device, criteria for patient selection and written
protocol describing treatment use
3. Explanation of rationale for use of the device including (as
appropriate) a list of available regiment that ordinarily should be tries
before the investigational device o an explanation of why use of the
investigational device is preferable to the use of marketed treatments
4. Descriptions of clinical procedures, laboratory tests or other measures
used to evaluate effect of device and minimize risk
5. Written procedures for monitoring the treatment use and name/address
of the monitor
6. Instructions for the device and all other labeling
7. Info related to safety and effectiveness of the device
8. Statement of sponsor's committment to meet all applicable
responsibilities and to ensure compliance of all participating
investigators with informed consent requirements
,9. Example agreement to be signed by investigators and certification that
no investigator will be added to treatment IDE before agreement is
signed
10. If device is to be sold, price to be charged and a statement indicating
that the price is based on manufactuirng and handling costs only
⩥ Investigational Device Exemption - Prohibition of promotion and
other practices.
Answer: A sponsor, investigator or any person acting on their behalf may
not:
1. Promote or test market an investigation device until the FDA has
approved the device for commercial distribution
2. Commercialize and investigational device by charging the subjects or
investigators for a device a price larger than that necessary to recover
costs of manufacture, research, development and handling
3. Unduly prolong an investigation - Sponsor must terminate
investigation if they determine device cannot be approved
4. Represent that an investigational device is safe or effective for the
purposes for which it is being investigated
⩥ Existence of IDE.
Answer: FDA will not disclose existence of IDE untill its existence has
previously been publicly disclosed or acknowledged, until the FDA
approves an application for premarket approcal or a notice of completion
of a product development protocol for the device has become effective
,⩥ IDE - Responsibilities of sponsors.
Answer: Selecting qualified investigators and providing them with the
info they need to conduct the investigation properly
Ensuring proper monitoring
Ensuring that IRB review and approval are obtained
Submitting an IDE application to the FDA
Ensuring that any reviewing IRB and FDA are promptly infomred of
significant new info about the investigation
⩥ IDE - Responsibilities of sponsors - Monitoring Investigations.
Answer: Securing compliance - A sponsor who discovers an investigator
is non-compliant shall either promptly secure compliance or discontinue
shipments of the device
Unanticipated adverse device effects - Sponsor must immediately
conduct an evaluation of any unanticipated adverse device effect. If a
device is determined to present an unreasonable risk to subjects, the
sponsor must terminate investigations of parts of investigations
presenting the risk as soon as possible and no later than 5 working after
the determination is made and not later than 15 days after the sponsor
first received notice of the efffect
Resumption of terminated studies - Significant risk device: Must receive
IRB/FDA approval. Not significant risk: must receive IRB approval and
if study was terminated due to unreasonable risk must also receive FDA
approval
, ⩥ Responsibilities of Investigators - IDE.
Answer: Ensuring the investigation is conducted according to the signed
agreement, the investigational plan and applicable FDA regulations for
protecting the rights, safety and welfare of subjects
Control of devices under the investigation
Ensuring informed consent is obtained in accordinace with regulations
⩥ Specific Responsibilities of Investigators - IDE.
Answer: Awaiting approval - Investigator may determine whether
potential subjects would be interested but shall not request informed
consent or allow participation before obtaining IRB and FDA approvl
Compliance with IRB, FDA and sponsor
Supervising device use
Investigator will only permit device to be used by subjects under
investigator's supervision
Financial Disclosure
Disposing od device - Upon completion or termination of a clinical
investigation or the investigator's part of the investigation, or at the
sponsor's request, any remaining supply of the device shall be returned
to to the sponsor or otherwise disposed
⩥ Investigator records- IDE - Must maintain accurate, complete and
current records related to investigation.
QUESTION SET SOLUTIONS
COMPREHENSIVE STUDY GUIDE GRADED
A+
⩥ Application for treatment use of IDE.
Answer: 1. Name, address and phone number of sponsor
2. Intended use of the device, criteria for patient selection and written
protocol describing treatment use
3. Explanation of rationale for use of the device including (as
appropriate) a list of available regiment that ordinarily should be tries
before the investigational device o an explanation of why use of the
investigational device is preferable to the use of marketed treatments
4. Descriptions of clinical procedures, laboratory tests or other measures
used to evaluate effect of device and minimize risk
5. Written procedures for monitoring the treatment use and name/address
of the monitor
6. Instructions for the device and all other labeling
7. Info related to safety and effectiveness of the device
8. Statement of sponsor's committment to meet all applicable
responsibilities and to ensure compliance of all participating
investigators with informed consent requirements
,9. Example agreement to be signed by investigators and certification that
no investigator will be added to treatment IDE before agreement is
signed
10. If device is to be sold, price to be charged and a statement indicating
that the price is based on manufactuirng and handling costs only
⩥ Investigational Device Exemption - Prohibition of promotion and
other practices.
Answer: A sponsor, investigator or any person acting on their behalf may
not:
1. Promote or test market an investigation device until the FDA has
approved the device for commercial distribution
2. Commercialize and investigational device by charging the subjects or
investigators for a device a price larger than that necessary to recover
costs of manufacture, research, development and handling
3. Unduly prolong an investigation - Sponsor must terminate
investigation if they determine device cannot be approved
4. Represent that an investigational device is safe or effective for the
purposes for which it is being investigated
⩥ Existence of IDE.
Answer: FDA will not disclose existence of IDE untill its existence has
previously been publicly disclosed or acknowledged, until the FDA
approves an application for premarket approcal or a notice of completion
of a product development protocol for the device has become effective
,⩥ IDE - Responsibilities of sponsors.
Answer: Selecting qualified investigators and providing them with the
info they need to conduct the investigation properly
Ensuring proper monitoring
Ensuring that IRB review and approval are obtained
Submitting an IDE application to the FDA
Ensuring that any reviewing IRB and FDA are promptly infomred of
significant new info about the investigation
⩥ IDE - Responsibilities of sponsors - Monitoring Investigations.
Answer: Securing compliance - A sponsor who discovers an investigator
is non-compliant shall either promptly secure compliance or discontinue
shipments of the device
Unanticipated adverse device effects - Sponsor must immediately
conduct an evaluation of any unanticipated adverse device effect. If a
device is determined to present an unreasonable risk to subjects, the
sponsor must terminate investigations of parts of investigations
presenting the risk as soon as possible and no later than 5 working after
the determination is made and not later than 15 days after the sponsor
first received notice of the efffect
Resumption of terminated studies - Significant risk device: Must receive
IRB/FDA approval. Not significant risk: must receive IRB approval and
if study was terminated due to unreasonable risk must also receive FDA
approval
, ⩥ Responsibilities of Investigators - IDE.
Answer: Ensuring the investigation is conducted according to the signed
agreement, the investigational plan and applicable FDA regulations for
protecting the rights, safety and welfare of subjects
Control of devices under the investigation
Ensuring informed consent is obtained in accordinace with regulations
⩥ Specific Responsibilities of Investigators - IDE.
Answer: Awaiting approval - Investigator may determine whether
potential subjects would be interested but shall not request informed
consent or allow participation before obtaining IRB and FDA approvl
Compliance with IRB, FDA and sponsor
Supervising device use
Investigator will only permit device to be used by subjects under
investigator's supervision
Financial Disclosure
Disposing od device - Upon completion or termination of a clinical
investigation or the investigator's part of the investigation, or at the
sponsor's request, any remaining supply of the device shall be returned
to to the sponsor or otherwise disposed
⩥ Investigator records- IDE - Must maintain accurate, complete and
current records related to investigation.
