THE FDA IS HERE!

Hi. Im from the FDA.

Ask to see official ID

Ask what the purpose of the visit is
Notify the appropriate staf

Start

Form 482- Notice of Inspection

Opening questions:

How did PI become involved

Responsibilities of each team member
How randomization is done, if applicable
Control and disposition of drug

What do they look for: investigator?

Authority to conduct
Protocol
Informed consent
Sponsor compliance
Records retention
Subjects records

What do they look for: sponsor?

Selection and monitoring of clinical

investigators
AE reporting
Data collection and handling
Record retention
Drug and accountability

The FDA wants to know

Eligibility criteria
Informed consent
Protocol required lab and tests
Con meds
AE reporting
Drug and disposition
Protocol amendments
IRB approvals
CVs of personnel
Monitor visit log
Labs and pharmacy used

End

Form 483- Notice of Observations

Closeout discussion
Review of findings

Most COMMON PI violations

Failure to follow protocol requirements

Discrepancies between source
documents and CRF
Inadequate drug accountability records
Enrolling ineligible patients
Missing IRB approvals
Inadequate ICF
Failed to notify IRB of AEs
Changes made without documentation

Sanctions for PIs

Sanctions are used to protect research

subjects welfare
Examples:

Warning letters
Formal disqualifications
Clinical hold
Voluntary agreements/restriction

Warning letters

Must respond within 15 days

Inform recipient of conditions found
Determines if recipient complies with
regulations
May lead to enforcement action

Disqualification

Warning Letter

Word of Advice

IF ITS NOT WRITTEN

DOWN, IT DIDNT
HAPPEN.
-FDA inspector