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NIH StrokeNet Standard Operating Procedures (SOPs),  Administrative (ADM), and Good Clinical Practice (GCP)

*Note: after reviewing the SOPs please complete the review confirmation form.

Section One: Network Administration SOPs

Administrative SOP Number Adm. SOP Title Status
ADM 1 Developing StrokeNet Standard Operating Procedures Final - Reviewed Sept 2016
ADM 2 Reporting COI and Financial Disclosures
 
Final 
ADM 3 Network Publication Committee and Policy
 
Final - Reviewed Sept 2016
ADM 4 Network Data Sharing Policy
 
Final - Reviewed Sept 2016
ADM 5 Network Process for Solicitation , Review and Development of Clinical Trials RETIRED
ADM 6 Essential Financial and Federal Compliance
Final - Reviewed Sept 2016
ADM 7 Per Subject Payments and Devlopment of Clinical Trial Budgets
Final - Reviewed Sept 2016
ADM 8 Network Process for RCC Performance Final - Revised January 2020
ADM 9 RCC Management aof Satellites and Performance Sites
 
Final - Revised April 2020
ADM 10 Inclusion of New Satellite Sites and CPS
Final - Reviewed Dec 2016
ADM 11 Central Institutional Review Board Reliance
Final - Revised Feb 2017
ADM 12 Central Institutional Review Board Reporting Final - Revised Dec 2019
ADM 13 Safety Monitoring and Reporting
 
Final - Reviewed Dec 2016
ADM 14 Development of Study Materials and Investigational Site Training Final - Reviewed Dec 2016
ADM 15 Network Communications Final - Reviewed Dec 2016
ADM 16 Network Process for Trial “Master” and “Site” Regulatory file Management
Final - Reviewed Dec 2016
ADM 17 StrokeNet Organization and Government
 
Final - Reviewed Dec 2016
ADM 18 NIH StrokeNet Conduct of Shared Trials Final - Reviewed Dec 2016
ADM 19 Data Monitoring

 
Final - Reviewed Dec 2016
 ADM 20
Data Quality Assurance and Control
 
Final - Reviewed Dec 2016 
 ADM 21
Regulatory and Clinical Data Maintenance and Data Storage
 
Final - Reviewed
Dec 2016
 ADM 22
Ancillary Study Approval Process
 
August 12, 2016
 ADM 23

 NIH StrokeNet and VA Central IRB Collaboration

January 16, 2017
 ADM 24

Central Electronic Informed Consent Process
July 23, 2020

 
Section Two: Network GCPs