For Internal Use Only
STANFORD UNIVERSITY
Research Compliance Office
Human Subjects Research
Sponsor-Investigator Checklist – IDE (Devices)
This checklist is based on the Sponsor and Investigator responsibilities outlined in the FDA Code of Federal Regulations, 21 CFR 812,
Investigational Device Exemptions, Subparts A-G. Documents listed in the column on the right correspond to regulations listed in the left
column.
Additional responsibilities: Dean of Research memo, June 4, 2007
Protocol Director:
Admin Contact:
Coordinator:
Institution/Division/Department:
eProtocol: xxx
e-mail
(408)
Address/ rm #
(650)
Address/ rm #
(650) 725-xxxx
Address/ rm #
CR Date: mm/dd/yyyy (Panel )
Initial IRB Approval Date: mm/dd/yyyy (Panel )
Protocol Title:
Children’s Finding:
Risk Level:
IDE #: xxxxxxx (Approved: mm/dd/yyyy)
Multi-site:
Monitoring Entity:
IDE Description: xxxxxxx [manufacturer]
FDA IDE Annual Report due by:
Send Investigator List to FDA:
IDE holder:
Training Participants:
Review Participants:
Trainer:
Reviewer:
Training Date(s):
Review Date(s): mm/dd/yy
Trainer Recommendations:
Reviewer Recommendations:
Note: This document is for use with significant risk device studies. Not all aspects of this document are appropriate for Treatment Use IDEs;
consult 21 CFR 812.36
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Hyperlinks to additional information are highlighted in yellow.
General hints are highlighted in blue.
Guidance
Documents/Info to include in Regulatory Binder(s)
FDA Regulations - IDE
21CFR 812 Subparts A-G
What is a clinical trial?
1.0 Regulatory Documentation
*SU DoR clinicaltrials.gov-registration-facts
All correspondence with FDA including:
1.1 As the Sponsor, maintain an effective IDE:
 Initial IDE application (812.20) with:
o Investigational Plan (812.25)
 FDA approval of IDE obtained before initiating study. (812.20(a)(2))
and (812.30(a))
 Labeling of Investigational Devices. (812.5)
 Supplemental FDA applications for:
o changes in investigational plan: (812.35(a)(1-4)
o IRB approval for new facilities (812.35(b)
 Maintain Sponsor Records and correspondence (812.140(b))
 Certify that study is registered* on clinicaltrials.gov; send form,
3674, to the FDA (with 3414 form);
 Reports:
o Progress Reports (FDA and all reviewing IRBs, at least annually) (Semiannually for Treatment IDEs); (812.150(b)(5))
o Completion or Termination notice (FDA, within 30 working days);
(812.150(b)(7))
o Final Report (FDA, all reviewing IRBs, and participating investigators,
w/in six (6) months of termination or completion); (812.150(b)(7))
Unanticipated Adverse Device Effect. (Evaluate and report to FDA,
all reviewing IRBs, and participating investigators w/in 10 working
days) (812.150(b)(1))
Unanticipated adverse device effects
A sponsor who conducts an evaluation of an unanticipated adverse
device effect under §812.46(b) shall report the results of such
evaluation to FDA (MedWatch 3500A) and to all reviewing IRB's and
participating investigators within 10 working days after the sponsor
first receives notice of the effect. Thereafter the sponsor shall submit
such additional reports concerning the effect as FDA requests.
(812.150(b)(1))
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Original IDE application (including Form 3514)
Date____________
FDA approval letter: Date___________
Clinical protocol
Device Manual/Description and Manufacturing Information, if
applicable
Copy of device label and labeling practice statement
Amendments (w/ 3514) Dates__________
Unanticipated Adverse Device Effect (w/ 3514 and MedWatch
3200A)
Dates_______________________________
Progress reports (w/ 3514)
Date__________ Period______________
Date__________ Period______________
Date__________ Period______________
All correspondence with:
Another sponsor,
A monitor,
An investigator,
An IRB, or
FDA, including required reports.
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Hyperlinks to additional information are highlighted in yellow.
General hints are highlighted in blue.
FDA Regulations - IDE
21CFR 812 Subparts A-G
Guidance
Documents/Info to include in Regulatory Binder(s)
1.2 As the Investigator, assure IRB review and approval.
IRB documentation (IRB approved protocol, IRB approval letters, and IRB
approved consents):
An investigator shall assure that an IRB complies with the
requirements for the initial and continuing review and approval of
the proposed clinical study. [21CFR 56 (56.115 (5))]
Initial review
Continuing review
Date: __________
The investigator shall also assure that he or she will promptly
report to the IRB:
 All changes in the research activity;
 All unanticipated problems involving risk to human subjects
or others; and
That he or she will not make any changes in the research without
IRB approval, except where necessary to eliminate apparent
immediate hazards to human subjects.
Date: __________
Amendments/Modifications
Date: __________
Date: __________
Unanticipated Adverse Device Effect
Date: __________
Protocol deviations/Non-Compliance
Additional guidance is available on the IRB website:
Human Subjects and IRB Home Page
Other IRB correspondence
IRB Rosters – copies for all years that study is approved by IRB
Submit Documents for IRB Review
(Initial and current updates/amendments) Including, but not limited
to:
Device Manual/Device Description Dates: __________
Clinical protocol
FDA IDE Approval letter.
Other FDA correspondence, e.g., clinical hold and progress
reports and Final Report.
Final Report
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General hints are highlighted in blue.
FDA Regulations - IDE
21CFR 812 Subparts A-G
Guidance
Documents/Info to include in Regulatory Binder(s)
2.0 Qualified Investigators
How to complete financial disclosure forms
2.1 As the Sponsor, maintain records (812.140(b) and select
qualified investigators (812.43)
For Sponsor and each site Investigator;
(a) Select Investigators qualified by training and experience.
(b) Control of Device – ship only to qualified investigators
participating in the study.
(c) Obtain signed agreements for each investigator that includes
**:
(1) Curriculum vitae (CV)
(4)(i) Statement to follow investigational plan
(5) Financial disclosure information (including any changes)
(d) Current Investigator List – Send to FDA at 6-month intervals.
First list required 6 months after FDA approval of IDE.
(812.150(b)(4)
** Collect information before permitting an investigator to
participate in clinical study.
Signed Investigator Statement to follow Investigational Plan
Dates: ______________________________
Current Investigator List (required - every six (6) months from
approval date)
Dates sent to the FDA: ___________________________________
For each clinical investigator:
CV or Biographic Sketch
Medical Licenses (copy of wallet card, valid for all years IDE is
held)
Financial disclosures (FDA 3454/3455 or equivalents):
 Use 3454, if there are NO financial interests or conflicts.
 Use 3455, if there are financial interests or conflicts.
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Hyperlinks to additional information are highlighted in yellow.
General hints are highlighted in blue.
FDA Regulations - IDE
21CFR 812 Subparts A-G
Guidance
Documents/Info to include in Regulatory Binder(s)
2.2 As Investigator, conduct study according to signed
investigator statement, protocol, and applicable regulations: (812
Subpart E)
Events and Information that Require Prompt Reporting to the
IRB
 Disclose accurate financial information to the sponsor to
complete certification of financial disclosure statements.
Review guidelines applicable to study:
 Obtain informed consent in accordance with provisions in 21
CFR 50.
 Protect rights, safety, and welfare of subjects;
 Report violations/deviations to IRB;
Adverse event reporting requirements
IRB
FDA
Informed consent
 Control devices under investigation;
 Supervise device use
 Submit progress reports to the sponsor at regular intervals
(812.150(a)(3))
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Violation/deviation
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Recruitment
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Guidance
Documents/Info to include in Regulatory Binder(s)
FDA Regulations - IDE
21CFR 812 Subparts A-G
Clinical Trial Data Monitoring Committees
3.0 Monitoring
3.1 As the Sponsor, ensure ongoing monitoring investigations:
1. Document the sponsor's written monitoring procedures and the
name and address of any monitor. (812.25)
Guideline for monitoring clinical investigations
Documentation of safety monitoring plan
Documentation of data monitoring plan
Monitor of study:
2. Select monitors qualified by training and experience.
(812.43(d))
Protocol Director
3. Secure Compliance (812.46(a)):
 Secure Investigator compliance with the signed agreement,
investigational plan, etc., or terminate investigator’s
participation and discontinue shipments of the
investigational device to the investigator;
 Require terminated investigator to dispose of or return the
device, unless this action would jeopardize the rights, safety,
or welfare of a subject.
Other: ____________________
All Correspondence with monitor:
Monitoring log
N/A
Who will be reviewing safety data:
4. Immediately conduct an evaluation of any unanticipated
adverse device effect (UADE). (812.46(b)(1))
Protocol Director
5. Discontinue investigation within five (5) working days when
the UADE determination identifies unreasonable risks to
subjects and not later than 15 working days after the sponsor
first received notice of the effect. (812.46(b)(2))
Obtain IRB and FDA approval before resuming terminated
studies. (812.46(c))
Medical Monitor
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DSMB
Other ____________
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General hints are highlighted in blue.
Guidance
Documents/Info to include in Regulatory Binder(s)
FDA Regulations - IDE
21CFR 812 Subparts A-G
4.0 Record Keeping
4.1 As the Investigator, maintain adequate and accurate case
histories on each subject’s participation in the trial. (812.140 (3))
Records of each subject's case history and exposure to the device.
Case histories include the case report forms and supporting data
including, for example, signed and dated consent forms and
medical records including, for example, progress notes of the
physician, the individual's hospital chart(s), and the nurses' notes.
Such records shall include:
 Informed Consent
 Relevant Observations and Adverse Device Effect (anticipated and
unanticipated)
A record of the exposure of each subject to the investigational device,
including the date and time of each use, and any other therapy.
FDA Good Clinical Practice Guidance
(Review sections 8.2 and 8.3:
Before and during the Clinical Trial)
Source data
Progress notes –
Concomitant medications recorded –
Subject eligibility documented
(use Inclusion/Exclusion checklist)
CRFs (Case Report Forms) signed or initialed and dated – See
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Appropriately documented consent forms
Documentation that informed consent was obtained prior to study
procedures
Documentation that subject was given a copy of signed and dated
consent form
Signature/date of staff obtaining data
* Reference specific subject observations
5.0 Device Accountability
5.1 As the Investigator, permit use of investigational device only
Enrollment log (Document chronological enrollment of subjects
with subjects under the investigator's supervision. An investigator by trial number, e.g., study/subject ID)
shall not supply an investigational device to any person not
Screening log
authorized under this part to receive it. (812.110)
(Document identification of subjects who entered pretrial screening)
Randomization log (if applicable)
Delegation of Responsibility log (signed and initialed by each
investigator, with their study participation start/stop dates, etc)
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Hyperlinks to additional information are highlighted in yellow.
General hints are highlighted in blue.
FDA Regulations - IDE
21CFR 812 Subparts A-G
Guidance
Documents/Info to include in Regulatory Binder(s)
5.2 As the Sponsor and/or Investigator, maintain accurate,
complete, and current records relating to the device investigation:
(812.140)(a)(b)
Device Receipt
Device received from Industry
Device accountability log includes:
Receipt date
Type and Quantity
Batch # or code mark
Return/disposition
Method of disposal, return, or repair
a. As the Sponsor,
 Records of shipment and disposition including:
o name and address of the consignee,
o type and quantity of device,
o date of shipment, and
o batch number or code mark.
Device manufactured onsite
 Records of disposition shall describe the batch number or code
marks of any devices:
o returned to the sponsor,
o repaired, or disposed of in other ways by the investigator
or another person, and
o reasons for and method of disposal.
b. As the Investigator, maintain written records of receipt, use or
disposition of a device that relate to:
 The type and quantity of the device,
 Dates of its receipt, and
 Batch number or code mark.
 The names of all persons 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.
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Device Shipment
Single center study – no device shipment
Device shipped to multiple sites
Device accountability log includes:
Name and address of consignee
Date
Destination
Who shipped
Type and Quantity
Batch # or code mark
Return/disposition
Method of disposal or repair
Device use or disposition record including:
Name of person who received or used
Date
Batch # or code mark
Type and Quantity
Disposition/record of return
ID of person supervising device use
Return of device, count & reason
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Hyperlinks to additional information are highlighted in yellow.
General hints are highlighted in blue.
FDA Regulations - IDE
21CFR 812 Subparts A-G
Guidance
Documents/Info to include in Regulatory Binder(s)
5.3 As the Sponsor, inform other investigators about the
investigational product and prohibition of promotion and other
practices.
Plan to distribute updated information to all Investigators about
product, safety information, protocol changes, etc.
A sponsor shall supply all investigators participating in the
investigation with copies of the investigational plan and the
report of prior investigations of the device. (812.45)
A sponsor, investigator, or any person acting for or on behalf of a
sponsor or investigator shall not:
 Promote an investigational device that the FDA has not approved for
commercial distribution.
Current Investigator’s Brochure
Initial and ongoing study education
(Document who, what, and when, e.g., Training Log/Meeting
Minutes)
Single study center
Multi-center study
 Charge subjects or investigators more than necessary to recover
costs.
 Unduly prolong an investigation.
 Represent that an investigational device is safe and effective for the
purposes for which is being investigated. (812.7)
6.0 Inspection
6.1 As the Sponsor or Investigator: Allow inspection of records
and reports by authorized FDA employees. (812.145)
Upon request, permit FDA officer to access, copy and verify any
records or reports made by the investigator
Basic review of FDA inspection procedures
7.0 Communication with Sponsor or Investigator, if applicable
7.1 As the Investigator, provide reports to sponsor and IRB:
(812.150)
a.
b.
c.
d.
Unanticipated Adverse Device Effects (within 10 working days)
Withdrawal of IRB Approval (w/in 5 days)
Progress reports (no less than yearly)
Deviations from the investigational plan (ASAP or w/in 10 days, if
emergency to protect subject)
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All pertinent correspondence between sponsor and investigator
(examples: enrollment numbers, adverse events, financial
information and any changes in financial information)
N/A
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Guidance
Documents/Info to include in Regulatory Binder(s)
FDA Regulations - IDE
21CFR 812 Subparts A-G
e. Final reports (within three months)
f. Financial disclosure reports
g. Changes in financial disclosure
As the Sponsor, collect and maintain Investigator reports for all
sites if:
 Multi-site study, per IDE protocol; or
 Multiple protocols under one IDE.
7.3 As the Sponsor or Investigator, maintain records of
correspondence with sponsor, monitor, and FDA, if applicable.
Sponsor
Monitor
FDA
N/A
8.0 Additional Good Clinical Practice (GCP) documentation
8.1 Laboratory Documentation
Current laboratory certification
Laboratory normal values –
8.2 Documentation of study staff signature/initials.
(Obtain signatures and initials of all persons authorized to make
entries and/or corrections on Case Report Forms- CRFs)
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Staff signature log – often combined with delegation of authority
log
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