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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 Financial Conflict of Interest and Disclosure
Final - Revised May 2017
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 Assessment Final - Reviewed Dec 2016
ADM 9 RCC Management of Satellite Sites and CPS
Final - Reviewed Dec 2016
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
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
 
Final - Reviewed April 2017

 
Section Two: Network GCPs

GCP SOP Number GCP SOP title Status
GCP 1 Human Subjects Protection
12/17/15
GCP 2 Qualified Investigative Personnel and Sites
12/21/15
GCP 3 Informed Consent and Stroke Trials
12/22/15
GCP 4 Safety Reporting
12/21/15
GCP 5 Maintaining Confidentiality
3/4/16
GCP 6 Handling Investigational Product
6/21/16
GCP 7 Maintaining Data Quality Pending
GCP 8 Laboratory-Radiology Competency and Reliability 7/28/16
GCP 9 Site Monitoring, Audits and Inspections 9/12/16
GCP 10 Trial Recruitment
7/19/2016
GCP 11 Management of Per Subject Payment
12/22/15
GCP 12 Regulatory and Clinical Data Maintenance and Data Storage 12/21/15