This packet includes: 1) Application for Initial Review, 2) A list of study documents needed, 3) PI Assurance Form, 4) Research Team Roster, 5) Conflict of Interest Form.
This tool outlines sections needed in a protocol (that has purely descriptive objectives) for retrospective chart reviews. Note that every section may not be necessary, depending on your study. This template should be used when these 3 criteria are met:
Your protocol reflects research involving materials (data, documents, records or specimens) that have been collected solely for non-research purposes (such as medical treatment or diagnosis); AND
Your protocol includes specific dates of data/information etc. that will be used; AND
All data is in existence at the time of IRB submission.
This packet includes information about a case report vs. a case series, HIPAA requirements, and publication guidance in addition to submission materials. On page 9, you will find a submission checklist outlining all components: CVs for all investigators and Research Study Team members, Proof of Good Clinical Practice (GCP) certification for all Research Study Team members, Case Report Determination/Assessment Form, Case Report Team Roster, PI Assurance forms, and Faculty Advisor’s Assurance Form.