ࡱ > )! bjbjBrBr 4 8 8 O | t " $ A S| U| U| U| U| U| U| $~ ƀ U| z z z U| 4 j| X% X% X% z ^ S| X% z S| X% X% ?O 0 R P% F oP $ ?| | 0 | P n ! n H R n R ) 0 " X% _ U| U| ,# , | z z z z n : 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 RESPONSIBILITIESFDA RegulationsCorresponding On-site DocumentsComments1. Assure IRB review and approval (312.66, 812.110, 812.150(a))IRB documentation:
FORMCHECKBOX Initial review
FORMCHECKBOX Continuing review
FORMCHECKBOX Amendments
FORMCHECKBOX Adverse event reports
FORMCHECKBOX Unanticipated events
FORMCHECKBOX Protocol deviations
FORMCHECKBOX Protocol violations
FORMCHECKBOX Current IB/Device Manual
FORMCHECKBOX Other IRB correspondence2. Maintain adequate and accurate case histories on each subjects participation in the trial (312.62(b), 812.140(a)(3)) FORMCHECKBOX Informed consent for all subjects
FORMCHECKBOX Documentation that informed was obtained prior to study procedures
FORMCHECKBOX Documentation that the subject was given a copy of the signed and dated consent form
FORMCHECKBOX Subject eligibility documented
FORMCHECKBOX Source data
FORMCHECKBOX Progress notes
FORMCHECKBOX CRFs
FORMCHECKBOX Concomitant medications recorded
FORMCHECKBOX Signature/date of staff obtaining dataFDA RegulationsCorresponding On-site DocumentsComments3. Conduct study according to signed investigator statement, protocol, and applicable regulations (312.60, 812.100) FORMCHECKBOX Report deviations/violations to IRB
FORMCHECKBOX Promptly report to IRB any on-site adverse events/unanticipated problems according to UCLA requirements
FORMCHECKBOX Obtain informed consent in accordance with provisions in 21 CFR 50
4. Personally conduct
and supervise the investigation (312.60, 812.100)
Ensure:
Appropriate delegation
Adequate training
Adequate supervision FORMCHECKBOX Delegation log
FORMCHECKBOX Staff training log
FORMCHECKBOX Routine research team meeting to review trial progress, AEs, protocol changes
FORMCHECKBOX Routine meetings with study monitor
FORMCHECKBOX Procedures for internal review of data5. Protect the rights, safety, and welfare of study subjects (312.60, 812.100) FORMCHECKBOX Adhere to protocol
FORMCHECKBOX Provide reasonable medical care for AEs,
FORMCHECKBOX Inform subject when medical care is needed for conditions unrelated to research
FORMCHECKBOX Investigator is available to subjects during conduct of the study
FORMCHECKBOX Appropriate delegation to CO-Investigator if PI is not available 6. The Investigator is responsible for providing Sponsor reports:
Progress reports
Safety reports
Deviations from investigational plan
Final Reports
Financial disclosure reports FORMCHECKBOX The Investigator has provided sponsor with pertinent correspondence (i.e., enrollment numbers, adverse events, financial information and any changes in financial information)
FORMCHECKBOX N/A, single center studyDRUG/DEVICE ACCOUNTABILITYFDA RegulationsCorresponding On-site DocumentsComments7. 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/deviceDrug/Device Receipt:
FORMCHECKBOX Drug/Device received from Industry
Drug/Device accountability log includes:
FORMCHECKBOX Receipt date
FORMCHECKBOX Quantity
FORMCHECKBOX Lot #
FORMCHECKBOX Return/disposition
FORMCHECKBOX Method of disposal
FORMCHECKBOX Drug/device manufactured on-site and dispensed per the UCLA investigational drug pharmacy policy
FDA RegulationsCorresponding On-site DocumentsComments
Drug/Device Shipment
FORMCHECKBOX Single center study no drug/device shipment
FORMCHECKBOX Drug/device shipped to multiple sites
Drug/device accountability log includes:
FORMCHECKBOX Date
FORMCHECKBOX Destination
FORMCHECKBOX Who shipped
FORMCHECKBOX Quantity
FORMCHECKBOX Lot #
FORMCHECKBOX Return/disposition
FORMCHECKBOX Method of disposal8. The Investigator is required to maintain adequate records of the disposition of the drug/device (312.62, 812.140(a)(2))Drug/device dispensing record including:
FORMCHECKBOX Research Pharmacy will manage drug
FORMCHECKBOX Date
FORMCHECKBOX Lot #
FORMCHECKBOX Device #
FORMCHECKBOX Quantity
FORMCHECKBOX ID# of subject administered or implanted
FORMCHECKBOX Disposition/record of return
FORMCHECKBOX ID of person dispensing
FORMCHECKBOX Return of drug/device, count & reason9. The Investigator is responsible to ensure control of investigational drug/device (312.61, 812.110(c))
Drug/device will be
administered only to those subjects enrolled in the clinical study and under investigator or designees supervision FORMCHECKBOX Enrollment log/Randomization log
FORMCHECKBOX Delegation of Responsibility log
RECORDS RETENTIONFDA RegulationsCorresponding On Site DocumentsComments10. Sponsor and Investigator:
Retain records for 2
years after marketing or 2 years after investigational use is discontinued and FDA notified FORMCHECKBOX Records are on file
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