Listed below are the
Kaiser Permanente Southern California Institutional Review Board
Applications, Forms, and Reports.
These documents are available by contact the
Kaiser Permanente Southern California Institutional
Review Board.
|
|
New Research - IRB
Applications
|
�
KPSC Full Research Application
|
�
Interregional
Research Application
|
|
�
KPSC Exempt Request Form
|
� Humanitarian Use Device (HUD) Application
|
|
�
KPSC Exempt Request Form
|
� HMORN Research Application Cover Sheet
|
|
New Research - IRB
Forms
|
Ø
Principal Investigator Attestation and Risk Assessment (RAMP)
|
|
Ø
KPSC Conflict of Interest Policy Statement
|
Ø
KPSC Policies
and Regulations Agreement
|
|
�
HIPAA Questionnaire Application
|
�
Research Use Of Internet Questionnaire
|
|
�
Federal Project Budget Template
|
�
Internal Project Budget Template
|
|
�
Industry Project Budget Template
|
�
Biographical Sketch Template
|
|
Research Reporting
Forms
|
�
Modification Request Form
|
�
Protocol Deviations, Violations, and Exemptions Summary
|
|
�
Continuing Review Form
|
�
KPSC Humanitarian Use Device (HUD) Progress Report and Continuing Review Form
|
|
|
�
IRB Authorization Agreement - KPSC Ceding
|
�
IRB Authorization Agreement -KPSC Reviewing to Research
|
|
|
�
Unaffiliated Investigator Agreement
|
�
Single Patient Use IND Application
|
|
|
Principal Investigator Reportable Events and Incidents
|
Ø
Internal Unanticipated Serious Adverse Event Report
|
Ø
External Unanticipated Serious Adverse Event Repor
|
|
Ø
Unanticipated Adverse Device Effect Report
|
Ø
Emergent Modification 5 Day Report and Request
|
|
|
Ø
Unanticipated Problem Report
|
|
|
|
Other Forms
|
Ø
45 CFR 46.118 Destination
|
Ø
Intention to Use PHI Prepatory to Research (RAPTOR)
|
|
Ø
Human Subjects Research Assessment
|
Ø
Determination of KPSC's Engagement in Research |
|
|
�
Local Context Form
|
Ø
Research Versus Non Research Determination Form |