Combined AE-SAE Tracking Log Template
Combined AE-SAE Tracking Log (per subject) Form Template
Updated 11/27/2019
File: Combined-AE-SAE-Log-Tracking-Log-Per-Subject-Form-Template-_2019.10.22.docxDOCX
Team Member Agreement Form Template for IND IDE
Team Member Agreement Form Template for IND IDE
Updated 11/22/2019
File: Team-Member-Agreement-Form-Template-for-IND_IDE_2019_11_8.docxPrincipal Investigator Agreement Template for IDE
Principal Investigator Agreement Template for IDE
Updated 11/22/2019
File: Principal-Investigator-Agreement-Template-for-IDE_2019.11.8.docxDelegation of Authority Guidance
Delegation of Authority Guidance (docx)
Updated 11/19/2019
File: Delegation-of-Authority-Guidance.docxStudy Startup Procedures Guidance
Study Startup Procedures Guidance
Updated 11/19/2019
File: Study-Startup-Procedures-Guidance.docxIRB Submission Guidance
IRB Submission Guidance
Updated 11/19/2019
File: IRB-Submission-Guidance.docxProtocol Deviations SOP
Protocol Deviations Standard Operating Procedure (SOP)
Updated 11/19/2019
File: Protocol-Deviations-SOP.docxInformed Consent Process SOP
Informed Consent Process Standard Operating Procedure (SOP)
Updated 11/19/2019
File: Informed-Consent-Process-SOP.docxMaintaining a Regulatory File SOP
Maintaining a Regulatory File Standard Operating Procedure (SOP)
File: Maintaining-a-Regulatory-File-SOP.docxData Collection Form SOP
Data Collection Form Standard Operating Procedure (SOP)
Updated 11/19/2019
File: Data-Collection-Form-SOP.docx