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Guidance

Mar 12, 2012

Study-Specific AE Reporting

Click to review previous steps Step 1 Step 2 Refer to the IRB - approved documents for the specific study that includes a detailed plan for AE reporting . Follow the directions in the plan for reporting to oversight bodies (e.g. DSMB , sponsor, IRB...

Guidance

Oct 17, 2011

Non-Regulated under FDA/OHRP, but Regulated under HIPAA Applications - ARCHIVED

04/23/2021: This page has been archived. Please refer to the more comprehensive pages: Certification Preparatory to Research Decedents De-identified Limited Data Sets

Guidance

Jul 10, 2020

eResearch Cross-Reference Table

These documents provide direction on consistency in application changes for the most common changes to the eResearch (IRB) application and the supporting materials. The "Table" indicates correspondences between all eResearch sections for certain...

Study-Specific AE Reporting

Non-Regulated under FDA/OHRP, but Regulated under HIPAA Applications - ARCHIVED

eResearch Cross-Reference Table

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