For Internal Use Only
STANFORD UNIVERSITY
Research Compliance Office
Human Subjects Research
Sponsor-Investigator Checklist – IND (Drugs)
This checklist is based on the Sponsor and Investigator responsibilities outlined in the FDA Code of Federal Regulations, 21CFR 312,
Investigational New Drug Application, Subparts A-D. 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
e-mail
Protocol Director:
e-mail
Admin Contact:
e-mail
Coordinator:
Institution/Division/Department:
eProtocol:
Initial IRB Review Date: mm/dd/yyyy (Panel #
(650) 723-xxxx
Address/ rm #
(650) 725-xxxx
Address/ rm #
(650) 725-xxxx
Address/ rm #
)
CR Date: mm/dd/yyyy (Panel # )
Protocol Title:
Children’s Finding:
Risk Level:
IND #: xxx
(Effective date: mm/dd/yyyy)
Multi-site:
Monitoring Entity:
IND Description: xxx
FDA IND Annual Report Due by:
Training Participants:
IND holder:
Review Participants:
Trainer:
Training Date(s): mm/dd/yyyy
Reviewer:
Review Date(s):
Trainer Recommendations:
FDA Treatment IND guidance
Reviewer Recommendations:
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[manufacturer]
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General hints are highlighted in blue.
Guidance
Documents/Info to include in Regulatory Binder(s)
FDA Regulations - IND
21CFR 312 Subparts A-D
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 IND:
 Initial IND submission. (312.23)
 Certify that study is registered* on clinicaltrials.gov; send form,
3674, to the FDA (with 1571 form);
Original IND application (including 1571)
Date____________
Clinical protocol
 Protocol amendments: (312.30)
o New protocol;
o Changes to existing protocol;
o New Investigator;
Investigational Brochure/Product Information
FDA IND Acknowledgement letter
FDA letter of no objection
IND Effective Date____________
Amendments (w/ 1571)
 Information Amendments: (312.31)
o New technical information;
o Discontinuation of clinical investigation;
Dates______________
 IND safety reports (312.32)
o Written reports (e.g., MedWatch 3500A) to FDA and all
participating investigators within required timeframe;
o Follow-up information to a safety report should be submitted
as soon as available;
 Annual Reports (312.33)
o File with FDA within 60 days of the anniversary date that the
IND went into effect
[Required, even if no subjects have been enrolled].
IND Safety reports (w/ 1571)
Dates_______________________________
Evidence of correspondence to other investigators
N/A
Annual reports (w/ 1571)
Date__________ Period______________
Date__________ Period______________
Date__________ Period______________
Other FDA Correspondence
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General hints are highlighted in blue.
FDA Regulations - IND
21CFR 312 Subparts A-D
Guidance
Documents/Info to include in Regulatory Binder(s)
1.2 As the Investigator, assure IRB review and approval. (312.66)
IRB documentation – printed from eProtocol
(IRB approved protocol, IRB approval letters, and IRB approved consents):
An investigator shall assure that an IRB that complies with the
requirements set forth in part 56 will be responsible for the initial
and continuing review and approval of the proposed clinical study.
[21CFR 56 (56.115 (5))]
The investigator shall also assure that he or she will promptly report
to the IRB all changes in the research activity and 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.
Initial review
Continuing review
Date: __________
Date: __________
Amendments/Modifications
Date: __________
Date: __________
Events & Information that require Prompt Reporting to the IRB
Adverse event reports – Date: __________
Additional guidance is available on the IRB website:
Human Subjects and IRB Home Page
Protocol deviations/Non-Compliance
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:
Investigational Brochure/Product Information
Dates: __________
Clinical protocol
FDA IND Acknowledgement and “safe to proceed” letter, if received.
Other FDA correspondence, e.g., clinical hold, release of hold, and
annual reports.
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Guidance
Documents/Info to include in Regulatory Binder(s)
FDA Regulations - IND
21CFR 312 Subparts A-D
2.0 Qualified Investigators
2.1 As the Sponsor, select qualified investigators: (312.50, 53)
a. Select Investigators qualified by training and experience;
Instructions for IND Application
FAQs for completing 1572 Form
How to complete financial disclosure forms
FDA Guidance - Financial Disclosure by Clinical Investigators
For Sponsor and each site Investigator;
Signed FDA form 1572*
b. Report new Investigators to FDA w/in 30 days with signed FDA Dates: ______________________________
form 1572* and CV;
For each clinical investigator:
c. Investigational product will be shipped to only those
investigators participating in the study;
CV or Biographic Sketch
d. Obtain Investigator information from PIs, if multicenter trial;
and
Medical Licenses (copy of wallet card, valid for all years IND is held)
e. Maintain complete and accurate records involving Investigators’
qualifications and financial disclosures (including any changes),
to minimize the potential for study bias. **
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.
** Collect information before permitting an investigator to
participate in clinical study.
*Reminder: Section #4, clinical labs, should also list research labs
and other diagnostic facilities.
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FDA Regulations - IND
21CFR 312 Subparts A-D
Guidance
Documents/Info to include in Regulatory Binder(s)
2.2 As Investigator, conduct study according to signed investigator
statement, protocol, and applicable regulations: (312.50, 66)
Events and Information that Require Prompt Reporting to the IRB
 Report violations/deviations to IRB;
FDA Guidance on Safety Reporting
Review guidelines applicable to study:
 Protect rights, safety, and welfare of subjects;
Violation/deviation
 Promptly report to IRB any “on-site” adverse events in
accordance with institutional requirements; and
Adverse event reporting requirements
IRB
 Obtain informed consent in accordance with provisions in 21 CFR
50.
FDA
Informed consent
Recruitment
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Guidance
Documents/Info to include in Regulatory Binder(s)
FDA Regulations - IND
21CFR 312 Subparts A-D
Clinical Trial Data Monitoring Committees
3.0 Monitoring
3.1 As the Sponsor, ensure ongoing monitoring investigations:
(312.56)
a. Select monitors by training and experience; (312.53 (4)(d))
b. Ensure proper monitoring;
Guideline for monitoring clinical investigations
Documentation of safety monitoring plan
Documentation of data monitoring plan
Monitor of study:
Protocol Director
Other: ____________________
c. Ensure PI compliance or discontinue shipments of the
investigational drug;
All Correspondence with monitor:
d. Review and evaluate drug safety and effectiveness; and
e. Discontinue investigation within five (5) working days when
unreasonable and significant risk to subject are identified.
Monitoring log
N/A
Who will be reviewing safety data:
Protocol Director
DSMB
Medical Monitor
Other ____________
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Guidance
Documents/Info to include in Regulatory Binder(s)
FDA Regulations - IND
21CFR 312 Subparts A-D
FDA Good Clinical Practice Guidance (GCP)
4.0 Record Keeping
(Review GCP sections 8.2 and 8.3:
Before and during the Clinical Trial)
4.1 As the Investigator, maintain adequate and accurate case
Source data
histories on each subject’s participation in the trial. (312.62 (b))
Progress notes –
Concomitant medications recorded –
Case histories include the case report forms and supporting data
Subject eligibility documented
including, for example, signed and dated consent forms and medical
(use Inclusion/Exclusion checklist)
records including, for example, progress notes of the physician, the
CRFs (Case Report Forms) signed or initialed and dated – See Page 10
individual's hospital chart(s), and the nurses' notes.
Appropriately documented consent forms
The case history for each individual shall document that informed
consent was obtained prior to participation in the study.
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 Drug
5.1 As the Investigator, ensure control of investigational drug:
Drug will be administered only to those subjects enrolled in the
clinical study and under investigator or designee’s supervision.
(312.61)
Enrollment log
(Document chronological enrollment of subjects by trial number, e.g.,
study/subject ID)
Screening log (Document subjects who entered pretrial screening - can
be combined with enrollment log)
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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General hints are highlighted in blue.
Guidance
Documents/Info to include in Regulatory Binder(s)
FDA Regulations - IND
21CFR 312 Subparts A-D
5.2 As the Sponsor and/or Investigator, record of drug acquisition Drug Receipt
and disposition:
Drug received from Industry
Drug accountability log includes:
a. As the Sponsor, maintain adequate record of receipt, shipment,
Receipt date
or other disposition of investigational drug; (312.57)
Quantity
Lot #
b. As the Sponsor, assure return of all unused investigational drug
Return/disposition
from individual investigators participating in trial or authorize
Method of disposal
alternative disposition of unused product; and (312.59)
Drug manufactured onsite
c. As the Investigator, maintain written records of any disposition
of the drug, including dates, quantity and use by subjects. (312.59,
62)
Drug Shipment
Single center study – no drug shipment
Drug shipped to multiple sites
Drug accountability log includes:
Date
Destination
Who shipped
Quantity
Lot #
Return/disposition
Method of disposal
Drug dispensing record including:
Research Pharmacy will manage drug
Date
Lot #
Quantity
ID of subject administered
Disposition/record of return
ID of person dispensing
Return of drug, count & reason
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General hints are highlighted in blue.
FDA Regulations - IND
21CFR 312 Subparts A-D
Guidance
Documents/Info to include in Regulatory Binder(s)
5.3 As the Sponsor, inform other investigators about the
investigational product (if applicable).
Plan to distribute updated information to all Investigators about
product, safety information, protocol changes, etc.
All Sponsors will keep each investigator informed of new
observations discovered by or reported to the sponsor on the
investigational product. (312.55)
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
6.0 Inspection
6.1 As the Sponsor or Investigator: Allow inspection of records
and reports. (312.58, 68, and 62)
[See FDA form 1572 Section 9. Commitments]
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 A Sponsor may transfer obligations from the IND holder to a
Contract Research Organization (CRO). (312.52)
Written documentation, describing responsibilities transferred to CRO
N/A
Any such transfer shall be described in writing.
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Hyperlinks to additional information are highlighted in yellow.
General hints are highlighted in blue.
FDA Regulations - IND
21CFR 312 Subparts A-D
Guidance
Documents/Info to include in Regulatory Binder(s)
7.2 As the Investigator, provide reports to the sponsor: (312.64)
a. Progress reports
b. Safety reports
c. Final reports
d. Financial disclosure reports
e. Changes in financial disclosure
All pertinent correspondence between sponsor and investigators
(examples: enrollment numbers, adverse events, financial information and
any changes in financial information)
N/A
As the Sponsor, collect and maintain Investigator reports for all
sites if:

Multi-site study per IND protocol

Multiple protocols under one IND
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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