IDE Investigator Responsibilities - Documentation
Records
The investigator must maintain accurate and complete records relating to the investigation. These records include:
- all correspondence including required reports,
- records of receipt, use, or disposition of the investigational device,
- records of each subject's case history and exposure to the device,
- the protocol and documentation (date and reason) for each deviation from the protocol,
- any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigation or a particular investigation.
See Records for additional information on recordkeeping requirements.
Investigator Reports
The investigator must provide the following reports in a timely manner to the sponsor and/or the IRB.
- Unanticipated Adverse Device Effects
- Withdrawal of IRB Approval
- Progress Reports
- Deviations from the Investigational Plan
- Informed Consent
- Final Report
- Other Reports
Featured Products
ISO 13485 Internal Auditor Checklist
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Price: $95.00
Best Practices for Maintaining an IND and IDE Application with FDA
IND and IDE annual reports - Amending clinical protocols and informed consent – Format, Content, Editing, Submission of Documents
IND and IDE annual reports - Amending clinical protocols and informed consent – Format, Content, Editing, Submission of Documents
IDE (Investigational Device Exemption) for PMA and 510(k) for CDRH and CBER
Meetings with FDA - Sample Size Considerations - Inclusion/Exclusion Criteria - End Points - Case Report Forms - Administrative Plan
Meetings with FDA - Sample Size Considerations - Inclusion/Exclusion Criteria - End Points - Case Report Forms - Administrative Plan
The IDE (Investigational Device Exemption) - It's Purpose and Preparation
The purpose of the IDE – FDA Expectations – preparation – recommended subject headings – content submission - follow up Usage in the clinical trial
The purpose of the IDE – FDA Expectations – preparation – recommended subject headings – content submission - follow up Usage in the clinical trial
Planning for a Successful Pre-IDE Meeting with FDA
Pre-IDE Meeting – Process- Submission preparation - presentation
Pre-IDE Meeting – Process- Submission preparation - presentation