FDA Investigator Responsibility Checklist
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 |Corresponding On-site Documents |Comments |
|1. Assure IRB review and approval (312.66, 812.110, |IRB documentation: | |
|812.150(a)) |Initial review | |
| |Continuing review | |
| |Amendments | |
| |Adverse event reports | |
| |Unanticipated events | |
| |Protocol deviations | |
| |Protocol violations | |
| |Current IB/Device Manual | |
| |Other IRB correspondence | |
|2. Maintain adequate and accurate case histories on each | Informed consent for all subjects | |
|subject’s participation in the trial (312.62(b), |Documentation that informed was obtained prior to study | |
|812.140(a)(3)) |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 | |
|FDA Regulations |Corresponding On-site Documents |Comments |
|3. Conduct study according to signed investigator | Report deviations/violations to IRB | |
|statement, protocol, and applicable regulations (312.60, |Promptly report to IRB any “on-site” adverse | |
|812.100) |events/unanticipated problems according to UCLA requirements| |
| |Obtain informed consent in accordance with provisions in 21 | |
| |CFR 50 | |
|4. Personally conduct | Delegation log | |
|and supervise the investigation (312.60, 812.100) |Staff training log | |
|Ensure: |Routine research team meeting to review trial progress, AEs,| |
|Appropriate delegation |protocol changes | |
|Adequate training |Routine meetings with study monitor | |
|Adequate supervision |Procedures for internal review of data | |
|5. Protect the rights, safety, and welfare of study | Adhere to protocol | |
|subjects (312.60, 812.100) |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 CO-Investigator if PI is not | |
| |available | |
|6. The Investigator is responsible for providing Sponsor | The Investigator has provided sponsor with pertinent | |
|reports: |correspondence (i.e., enrollment numbers, adverse events, | |
|Progress reports |financial information and any changes in financial | |
|Safety reports |information) | |
|Deviations from investigational plan |N/A, single center study | |
|Final Reports | | |
|Financial disclosure reports | | |
| |
|DRUG/DEVICE ACCOUNTABILITY |
|FDA Regulations |Corresponding On-site Documents |Comments |
|7. The sponsor is responsible for the record of |Drug/Device Receipt: | |
|drug/device disposition: |Drug/Device received from Industry | |
|Maintain adequate record of |Drug/Device accountability log includes: | |
|receipt and shipment of investigational drug/device |Receipt date | |
|- Assure return of all unused investigational |Quantity | |
|drugs/devices from individual investigators participating|Lot # | |
|in trial or authorize alternative disposition of unused |Return/disposition | |
|product |Method of disposal | |
|- Maintain written records of any disposition of the |Drug/device manufactured on-site and dispensed per the UCLA | |
|drug/device |investigational drug pharmacy policy | |
|FDA Regulations |Corresponding On-site Documents |Comments |
| |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 | |
|8. The Investigator is required to maintain adequate |Drug/device dispensing record including: | |
|records of the disposition of the drug/device (312.62, |Research Pharmacy will manage drug | |
|812.140(a)(2)) |Date | |
| |Lot # | |
| |Device # | |
| |Quantity | |
| |ID# of subject administered or implanted | |
| |Disposition/record of return | |
| |ID of person dispensing | |
| |Return of drug/device, count & reason | |
|9. The Investigator is responsible to ensure control of | Enrollment log/Randomization log | |
|investigational drug/device (312.61, 812.110(c)) |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 |Corresponding On Site Documents |Comments |
|10. Sponsor and Investigator: | Records are on file | |
|Retain records for 2 | | |
|years after marketing or 2 years after investigational | | |
|use is discontinued and FDA notified | | |
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