ORC Sponsor-Investigator IDE Checklist
A sponsor-investigator assumes BOTH investigator and sponsor responsibilities as outlined in the FDA
Code of Federal Regulations 21 CFR 318. This means that such investigators have additional
responsibilities. Use this checklist to verify sponsor and investigator responsibilities and best practices
at the onset and during the course of your study.
Note: It is the investigator’s responsibility to review and familiarize themselves with FDA regulations outlined in
21CFR312 (as additional responsibilities are listed), Good Clinical Practice (GCP) Guidelines ICH E6, and any other
regulations and policies that may apply. Additionally, if the device is made in your lab, you have to ensure Good
Manufacturing Practice (GMP) compliance.
See GCP ICH E6: Consolidated Guidance for additional information on conducting and maintaining records in clinical
investigation, and Good Manufacturing Practice guidelines on www.fda.gov.
Principal Investigator:
IRB#:
IRB Approval Date:
Protocol Title:
IDE#:
Significant Risk (SR) Device OR
Non-Significant Risk (NSR) Device (follows abbreviated IDE requirements)
Date of Site Initiation Visit with the Office of Research Compliance (ORC):
SPONSOR RESPONSIBILITIES
Sponsors are responsible for:
1. Selecting qualified investigators
For each site investigator obtain:
 Signed Investigator Agreement
 CV or other statement of qualifications such as a professional license
 Written disclosure of any financial conflicts of interest
2. Ensuring proper monitoring of the investigation
 SR devices: select a monitor qualified by training and experience to monitor the study
conducted under its IDE
Monitor: PI CRO Other:
All sites must have a monitoring log and maintain correspondence with the monitor
See FDA Guideline for the Monitoring of Clinical Investigations
 Have a documented and adequate monitoring plan
 Secure compliance from all participating investigators with the signed agreement,
investigational plan, applicable FDA regulations, or with condition of IRB or FDA approval
 In cases of continuing investigator non-compliance discontinue shipment of device, end
investigator’s participation in the investigation, and notify FDA
3. Promptly informing and reporting to FDA, IRB, and participating investigators
 SR devices:
 Submitting the IDE application to the FDA
 Obtaining FDA & IRB approval for the application or supplemental application before
beginning an investigation or part of an investigation
 Submit to the FDA, at 6 month intervals, a current list of the names and addresses of all
investigators participating in the investigation
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ORC Sponsor-Investigator IDE Checklist
 NSR devices:
 Obtaining IRB approval of the investigation as a non-significant risk device study and
maintaining such approval
 Provide the FDA, investigator, and IRB with the investigational plan and report of prior
investigations of the device
 Notify FDA and all reviewing IRBs and participating investigators of any withdrawal of
approval of an investigation or a part of an investigation by a reviewing IRB within 5
working days after receipt of the withdrawal of approval.
 Notify all reviewing IRBs and participating investigators of any withdrawal of FDA
approval of the investigation within 5 working days after receipt of notice.
 Conduct an evaluation of any unanticipated adverse device effect(s) and submit to FDA, all
reviewing IRBs, and participating investigators with a report with the results from any
evaluations conducted for an unanticipated adverse device effect within 10 working days
after the sponsor is first notified
 Terminate all or parts of the investigation immediately if the device presents unreasonable
and significant risk to subjects (within 5 working days after sponsor makes risk
determination, and within 15 days after sponsor is first notified of device effect)
 SR devices: may not resume investigation without IRB and FDA approval
 NSR devices: may not resume investigation without IRB approval. If termination was for
unanticipated adverse device effects, FDA approval must also be sought
 Submit to FDA a copy of any report by an investigator who uses a device without obtaining
informed consent within 5 working days of receipt of notice.
 Submit annual progress reports to all reviewing IRBs, and for SR devices, to the FDA.
 Submit a final report to all reviewing IRBs, and for SR devices, to the FDA and
participating investigators
4. Ensuring control and representation of the investigational device
 Ship devices only to qualified investigators participating in the investigation
 Maintain adequate records of shipment and disposition of devices.
 SR devices: records must include name and address of the consignee, type and quantity of

device, date of shipment, and batch number or code mark. Records of disposition shall describe
the batch number or code marks of any devices returned to the sponsor, repaired, or disposed of
in other ways by the investigator or another person, and the reasons for and method of disposal.
NSR devices: the name and intended use of the device and the objectives of the investigation; a
brief explanation of why the device is a NSR device; the name and address of each investigator
and the IRB that has reviewed the investigation; and a statement of the extent to which the good
manufacturing practice regulation in part 820 will be followed in manufacturing the device
 Ensure the investigational device bears a label with the following:
 Name and place of business of the manufacturer, packer or distributor in accordance
with 21 CFR 801.1 General Labeling Provisions
 Quantity of contents, if appropriate
 The statement: Caution: Investigational device. Limited by Federal (or United States)
law to investigational use
 A description of all relevant contraindications, adverse effect, hazards, interfering
substances or devices, warnings and precautions
 Must not include any statements that may be false or misleading, and should not
represent the device as safe or effective for the purposes for which it is under
investigation
 Notify FDA and all reviewing IRBs of any request that an investigator return, repair, or
otherwise dispose of any units of a device within 30 days of request.
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ORC Sponsor-Investigator IDE Checklist
 Current Good Manufacturing Practices (cGMPs): Ensure the minimum current good
manufacturing practice of devices in compliance with 21 CFR 820, Quality System
Regulation
Other Requirements:
 Maintaining records concerning adverse device effects (whether anticipated or
unanticipated) and complaints
 Maintaining all regulatory documentation including original IDE application, required
reports, and any other correspondence with another sponsor, monitor, investigator, IRB, or
FDA
 Allowing the FDA, at reasonable times, to enter and inspect any establishment where
devices are held (including any establishment where devices are manufactured, processed,
packed, installed, used, or implanted or where records or results from use of devices are
kept), and inspect and copy all records relating to an investigation.
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ORC Sponsor-Investigator IDE Checklist
PRINCIPAL INVESTIGATOR RESPONSIBILITIES
Each participating investigator is responsible for:
1. Conducting the study according to the signed investigator agreement, the investigational plan and
applicable FDA regulations including:
 Only allowing subjects to participate after obtaining IRB and FDA approval
 Disclosing financial information to the sponsor
 Submitting progress reports, safety reports, final report to the sponsor and IRB
 Maintaining the protocol with documents showing dates of and reasons for each protocol
deviation
 Only making changes in a protocol after notifying the sponsor and obtaining IRB approval,
except when necessary to eliminate immediate hazards to human subjects
 Reporting protocol violations/deviations and unanticipated problems to the IRB and
sponsor
 Reporting withdrawal of IRB approval to the sponsor
2. Protecting the rights, safety, and welfare of subjects under the investigator’s care including:
 Personally conducting or supervising the described investigation(s)
 Obtaining informed consent from all human subjects receiving investigational device
(unless exception requirements are met) and documenting this
 Reporting to the sponsor and reviewing IRB if a device was used without obtaining
informed consent within 5 working days after the use occurs
 Promptly reporting to the sponsor and IRB of any unanticipated adverse device effect
occurring during an investigation as soon as possible and within 10 days of learning of the
effect.
See FDA Guideline for Investigator Responsibilities - Protecting the Rights, Safety, and
Welfare of Study Subjects
3. Controlling devices under investigation including:
 Permitting a device to be used only with subjects under the investigator’s supervision
 Maintaining adequate records of receipt, use or disposition of a device, including:
 Type and quantity , dates of its receipt, and batch number or code mark
 Names of all subjects who received, used, or disposed of each device
 Why and how many units of the device have been returned to the sponsor, repaired, or
otherwise disposed of
 Return any remaining supply of the device to the sponsor or dispose of the device as
instructed by sponsor
4. Preparing and maintaining accurate case histories or records and exposure to device for each subject
including:
 Case Report Forms (CRFs) and supporting data (source documents)
 Signed and dated consent forms - For any use of a device by the investigator without
informed consent, any written concurrence of a licensed physician and a brief description
of the circumstances justifying the failure to obtain consent.
 Medical records (e.g. physicians’/nurses’ progress notes, individual hospital chart)
 SR devices:
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ORC Sponsor-Investigator IDE Checklist

Relevant observations including records concerning adverse device effects (whether
anticipated or unanticipated), information and data on the condition of each subject upon
entering, and during the course of the investigation, including information about relevant
previous medical history and the results of all diagnostic tests.
 A record of the exposure of each subject to the investigational device, including the date
and time of each use, and any other therapy.
Other Requirements:
 Maintaining all regulatory documentation including required reports and correspondence
with another investigator, an IRB, the sponsor, a monitor, or FDA.
 Allowing the FDA, at reasonable times, to enter and inspect any establishment where
devices are held (including any establishment where devices are manufactured, processed,
packed, installed, used, or implanted or where records or results from use of devices are
kept), and inspect and copy all records relating to an investigation.
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