Abbr.
This Health Insurance Portability and Accountability Act was passed in 1996.
What is HIPAA
This person must be notified before an inspection can take place.
What is a (the) PI?
This is where the PI, Study Coordinator, and other personnel should be during the duration of the Inspection
What is on site?
Upon the arrival of the inspector(s) the Inspection Coordinator should ask to see this.
What are the inspectors' credentials?
The Inspection Coordinator receives this at the conclusion of the inspection.
What is a/the Record of Inspection?
PHI
What is Protected Health Information?
Where an unannounced inspector must stay until the PI, IC, or other inspection support personnel can be contacted and an appropriate location be be secured..
What is a public area?
Deficiencies and errors discovered during the review of study documents should be corrected using these guidelines.
What is GCP?
FDA Inspectors should be discouraged from taking these when physically inspecting research facilities.
What are photographs?
A copy of this form is provided to the IRB and the Sponsor after the conclusion of the Inspection
What is FDA 483?
CAPA
This person is selected by the PI to oversee the preparation, conduct, response, and follow-up action items relating to the Inspection.
What is an Inspection Coordinator (IC)?
A process compliant with this will be devised to allow review of EMRs and/or the study database, if requested by the FDA inspector.
What is HIPAA?
The PI and the IC should request this from the Inspector, each day.
What is a Daily Summary Meeting?
These should be tracked and documented as completed, when appropriate.
What are corrective actions?
OHRP
The IRB
The Clinical Trial Sponsor
The Clinical Research Support Office
The Associate Dean for Clinical Research, among others
Who are the parties the PI must notify with notice of an inspection
These study documents are likely to be inspected and will be collected and reviewed for organization and completeness.
Name two.
Regulatory binders, screening and enrollment logs, the DOA, ICFs, CRFs, Participant charts, pharmacy and drug accountability records, device inventory and accountability records, department and cross department SOPs for research conduct.
The FDA inspector must show this to the PI.
What is FDA 482 (Notice of Inspection)?
Acknowledgment of the response that is received from the FDA or the Department of Health and Human Services is reported to the IRB via this.
What is ERICA?
ERICA
What is Electronic Research Integrity Compliance Administration?
Identity of Clinical Trials to be inspected, the scope of the inspection, and the cause of the inspection
Inspection start date, duration, and number of inspectors
Names and contact info of FDA inspectors
Requests for specific personnel or specific documentation
What is the information that should be obtained at the time of notification?
The PI and Study Coordinator should prepare a summary of the clinical trial(s) selected for inspection. This summary should include these.
Name two.
What are:
IRB Status, Enrollment and participant status, description of protocol amendments and IRB approval dates, consent version log, deviations, SAEs/other safety issues.
These can be requested for review by an FDA Inspector
(Name 3)
What are regulatory binders, study participant charts, drug or device accountability records, and other study records?
These should be carefully developed, so that when implemented, they address the root course of a problem and prevent it further.
Timelines and evaluation of components are key.
What is a Corrective and Preventative Action (CAPA) Plan