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Handbooks and Help

AE Reporting - What to report, and how
Created Date:  2/10/2009 2:54 PM
Type: PDF (.pdf file)
 
Amendment Application Guide - Jan 2016
Created Date:  9/7/2006 8:59 AM
Type: PDF (.pdf file)
 
Best Practices for Investigator Initiated Trials
Created Date:  5/25/2016 4:26 PM
Type: PDF (.pdf file)
 
Case Studies
Created Date:  7/30/2012 2:52 PM
Type: PDF (.pdf file)
 
Chart Review Studies & Confidentiality
Created Date:  9/10/2015 4:45 PM
Type: PDF (.pdf file)
 
CITI Course Instructions_v5-2016.pdf
Created Date:  10/3/2007 9:35 AM
Type: PDF (.pdf file)
 
CITI Guidance_Adding Second Affliation_v11-2009
Created Date:  10/20/2009 12:09 PM
Type: PDF (.pdf file)
 
Clinical Trails.Gov Checklist
Created Date:  7/3/2017 3:19 PM
Type: PDF (.pdf file)
 
Clinical Trials.Gov Guidance.docx
Created Date:  7/15/2016 3:50 PM
Type: Word (.docx file)
 
Confidentiality and OMIS Access Agreement-2016 - LOCKED fillable only.dotx
Created Date:  2/22/2017 9:16 AM
Type: Resource (.dotx file)
 
Consent Waiver Requests for FDA Regulated Studies.pdf
Created Date:  7/20/2017 3:21 PM
Type: PDF (.pdf file)
 
Continuing Review Application Guide
Created Date:  9/7/2006 8:55 AM
Type: PDF (.pdf file)
 
Conversion Guide: Paper to ERSA
Created Date:  1/6/2006 2:23 PM
Type: PDF (.pdf file)
 
Data Sets not Requiring IRB Review.pdf
Created Date:  5/1/2017 12:19 PM
Type: PDF (.pdf file)
 
Device Determination Decision Tree
Created Date:  1/20/2012 2:46 PM
Type: PDF (.pdf file)
 
DSMB's
Created Date:  7/18/2016 2:07 PM
Type: PDF (.pdf file)
 
Electronic Informed Consent Guidance
Created Date:  12/5/2016 3:36 PM
Type: PDF (.pdf file)
 
ERSA Department Approval Process.docx
Created Date:  7/18/2005 12:07 PM
Type: Word (.docx file)
 
External Access for Sponsor Monitor Guidance
Created Date:  2/22/2017 9:16 AM
Type: Word (.docx file)
 
External Data Access Request Form
Created Date:  3/2/2017 5:12 PM
Type: Word (.doc file)
 
Financial Disclosure Guidance
Created Date:  12/2/2008 3:37 PM
Type: PDF (.pdf file)
 
Glossary of Application States (Status)
Created Date:  6/16/2008 8:24 AM
Type: PDF (.pdf file)
 
Glossary of ERSA Roles
Created Date:  11/9/2009 9:31 AM
Type: PDF (.pdf file)
 
Initial Application Guide
Created Date:  3/3/2006 1:44 PM
Type: PDF (.pdf file)
 
Investigator Brochures
Created Date:  7/2/2015 12:02 PM
Type: PDF (.pdf file)
 
 
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Training Presentations

SAE Reporting_2008.01.17
Created Date:  1/17/2008 9:01 AM
Type: Resource (.pps file)