FDA Regulatory Binder and PI Responsibility Requirements
The following checklist details the investigator responsibilities outlined in the FDA Code of
Federal Regulations 21 CFR 312 (drugs/biologics) and 812 (devices). The purpose of this
checklist is to clarify which documents are needed to provide evidence that the investigator has
fulfilled his or her responsibilities in conducting a clinical investigation. Use this checklist for
setting up the regulatory binder to conduct your study as well as to prepare for an FDA and/or
sponsor inspection.
The checklist is divided into the following sections:
 Investigator responsibilities
 Drug/Device Accountability
 Record Retention
Onsite documents (listed in the middle column) correspond to the regulations written in 21 CFR
312 and 812. Depending on the specific study, additional documents may be needed. The
following table is provided for internal tracking.
Principal Investigator:
IRB #:
Study Title:
IND/IDE Holder:
Date:
INVESTIGATOR RESPONSIBILITIES
FDA Regulations
1. Assure IRB review and approval
(312.66, 812.110, 812.150(a))
2. Maintain adequate and accurate
case histories on each subject’s
participation in the trial (312.62(b),
812.140(a)(3))
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Corresponding On-site Documents
IRB documentation:
Initial review
Continuing review
Amendments
Adverse event reports
Unanticipated events
Protocol deviations
Protocol violations
Current IB/Device Manual
Other IRB correspondence
Informed consent for all subjects
Documentation that informed was
obtained prior to study procedures
Documentation that the subject was
given a copy of the signed and
dated consent form
Subject eligibility documented
Source data
Progress notes
CRFs
Concomitant medications recorded
Signature/date of staff obtaining
data
Comments
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FDA Regulations
3. Conduct study according to signed
investigator statement, protocol, and
applicable regulations (312.60,
812.100)
4. 4. Personally conduct
and supervise the investigation
(312.60, 812.100)
Ensure:
- Appropriate delegation
- Adequate training
- Adequate supervision
5. Protect the rights, safety, and
welfare of study subjects (312.60,
812.100)
6. The Investigator is responsible for
providing Sponsor reports:
-
-
Progress reports
Safety reports
Deviations from investigational
plan
Final Reports
Financial disclosure reports
Corresponding On-site Documents
Report deviations/violations to IRB
Promptly report to IRB any “on-site”
adverse events/unanticipated
problems according to UCLA
requirements
Obtain informed consent in
accordance with provisions in 21
CFR 50
Delegation log
Staff training log
Routine research team meeting to
review trial progress, AEs, protocol
changes
Routine meetings with study
monitor
Procedures for internal review of
data
Adhere to protocol
Provide reasonable medical care for
AEs,
Inform subject when medical care is
needed for conditions unrelated to
research
Investigator is available to subjects
during conduct of the study
Appropriate delegation to COInvestigator if PI is not available
The Investigator has provided
sponsor with pertinent
correspondence (i.e., enrollment
numbers, adverse events, financial
information and any changes in
financial information)
N/A, single center study
Comments
DRUG/DEVICE ACCOUNTABILITY
FDA Regulations
7. The sponsor is responsible for the
record of drug/device disposition:
-
-
- Maintain adequate record of
receipt and shipment of investigational
drug/device
- Assure return of all unused
investigational drugs/devices from
individual investigators participating in
trial or authorize alternative disposition
of unused product
- Maintain written records of any
disposition of the drug/device
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Corresponding On-site Documents
Drug/Device Receipt:
Drug/Device received from Industry
Drug/Device accountability log
includes:
Receipt date
Quantity
Lot #
Return/disposition
Method of disposal
Drug/device manufactured on-site
and dispensed per the UCLA
investigational drug pharmacy policy
Comments
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FDA Regulations
-
-
8. The Investigator is required to
maintain adequate records of the
disposition of the drug/device
(312.62, 812.140(a)(2))
9. The Investigator is responsible to
ensure control of investigational
drug/device (312.61, 812.110(c))
Corresponding On-site Documents
Drug/Device Shipment
Single center study – no
drug/device shipment
Drug/device shipped to multiple
sites
Drug/device accountability log includes:
Date
Destination
Who shipped
Quantity
Lot #
Return/disposition
Method of disposal
Comments
Drug/device dispensing record
including:
Research Pharmacy will manage
drug
Date
Lot #
Device #
Quantity
ID# of subject administered or
implanted
Disposition/record of return
ID of person dispensing
Return of drug/device, count &
reason
Enrollment log/Randomization log
Delegation of Responsibility log
- Drug/device will be
administered only to those subjects
enrolled in the clinical study and
under investigator or designee’s
supervision
RECORDS RETENTION
FDA Regulations
10. Sponsor and Investigator:
Corresponding On Site Documents
Records are on file
Comments
- Retain records for 2
years after marketing or 2 years
after investigational use is
discontinued and FDA notified
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