ICR Documents

Document Date Uploaded
SSA National ALS Registry clean 20161103.docx 11/08/2016

Document Date Uploaded
SSB National ALS Registry clean 20161103.docx 11/08/2016

Title Document Document Type Date Uploaded
Authorizing Legislation Attach_1-Public Health Law 110-373.doc Supplementary Document 06/22/2016
60 day FRN Attach_2-60-day-FRN.pdf Supplementary Document 06/22/2016
Summary of Changes Attach_3-Summary of Changes to ICR.docx Supplementary Document 06/22/2016
Privacy Statement Attach_7-Privacy Statement.doc Supplementary Document 06/22/2016
ALS Registry Consent Attach_8A-National ALS Registry Consent Form final.docx Supplementary Document 06/22/2016
ALS Biorepository Consent Attach_8B-National ALS Biorepository (Biospecimen) Consent Form clean 20161024.docx Supplementary Document 11/08/2016
ALS Biorepository Consent - Postmortem Attach_8C-National ALS Biorepository (Postmortem) Consent Form final.docx Supplementary Document 06/22/2016
ALS Biorepository Consent - Postmortem Skin Collection Attach_8D-National ALS Biorepository Consent Form Addendum (PM Skin) final.docx Supplementary Document 06/22/2016
IRB Approval Attach_9A-Current IRB Approval memo.docx Supplementary Document 06/22/2016
IRB Amendment Attach_9B-IRB Approval to add biorepository.docx Supplementary Document 06/22/2016
Privacy Impact Assessment Attach_10-Privacy Impact Assessment V2.pdf Supplementary Document 06/22/2016
ALS Registry Research Application Attach_11A-ALS Registry Research Application Form clean 20161103.docx Supplementary Document 11/08/2016
Biorepository Study Report Attachment_14- Bioorepository Pilot Study Report 20161024.pdf Supplementary Document 11/08/2016
ALS Biorepository Consent - Saliva Attach_8E-National ALS Biorepository (Saliva) Consent Form 20161024.docx Supplementary Document 11/08/2016
Non-Substantive Change Request Justification 0923-0041 Change Request Justification 20180905 V2.docx Justification for No Material/Nonsubstantive Change 09/07/2018

Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received