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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 January 2023
ADM 2 Reporting Conflict of Interest and Financial Disclosures
  		Final - Reviewed February 2023
ADM 3 StrokeNet Publications Committee and Policy
 		 Final - Reviewed July 2022
ADM 4 Network Data Sharing Policy
 		 Final - Reviewed January 2023
ADM 5 Network Process for Solicitation, Review and Development of Clinical Trials RETIRED
ADM 6 Essential Financial and Compliance Documentation
 Final - Reviewed June 2023
ADM 7 Per Subject Payments and Development of Clinical Trial Budgets
 Final - Reviewed June 2023
ADM 8 Network Process for RCC Performance
Final - Reviewed June 2023
ADM 9 RCC Management of Satellites and Performance Sites
 		 Final - Reviewed June 2023
ADM 10 Inclusion of New Satellite Sites and Performance Sites
 Final - Reviewed June 2023
ADM 11 CIRB Reliance and Approvals
 Final - Reviewed January 2023
ADM 12 Central Institutional Review Board (CIRB) Reporting
 Final - Reviewed October 2023
ADM 13 Safety Monitoring and Reporting
 		 Final - Reviewed February 2023
ADM 14 Development of Study Materials and Investigational Site Training
 Final - Reviewed May 2023
ADM 15 Network Communications
 Final - Reviewed August 2023
ADM 16 Network Process for Trial Master and Site Regulatory File Management
 Final - Reviewed February 2023
ADM 17 NIH StrokeNet Organization and Governance
 Final - Reviewed August 2023
ADM 18 NIH StrokeNet and Conduct of Shared Trials
 Final - Reviewed May 2023
ADM 19 Data Monitoring

 Final - Reviewed March 2023
 ADM 20
 Data Quality Assurance and Control
 		 Final - Reviewed April 2023
 ADM 21
 Regulatory Clinical Data Maintenance Storage
 Final - Reviewed August 2023
 ADM 22
 NIH StrokeNet Ancillary Study Approval Process
 		 Final - Reviewed May 2023
 ADM 23
 NIH StrokeNet and VA Central IRB Collaboration
 RETIRED
 ADM 24
 Central Electronic Informed Consent Process
 Final - Reviewed February 2024
 ADM 25
 CIRB and DSMB Joint Operating Procedure
 Final - Reviewed April 2023
ADM 26 Consenting Non-English Speaking or Literacy-Challenged Participants
 Final - Reviewed August, 2023

 
Section Two: Network GCPs

GCP SOP Number GCP SOP title Status
GCP 1 Human Subject Protection
 Final - Reviewed May 2023
GCP 2 Qualified Investigative Personnel and Sites
 Final - Reviewed June 2023
GCP 3 Informed Consent and Stroke Trials
 Final - Reviewed June 2023
GCP 4 Safety Reporting
 Final - Reviewed October 2023
GCP 5 Maintaining Confidentiality
 Final - Reviewed June 2023
GCP 6 Handling Investigational Product
 Final - Reviewed February 13, 2023
GCP 7 Maintaining Data Quality RETIRED
GCP 8 Laboratory-Radiology Competency and Reliability
 Final - Reviewed June 2023
GCP 9 Site Performance Monitoring, Audits and Inspections
 Final - Reviewed August 2023
GCP 10 Trial Recruitment
 Final - Reviewed February 17, 2023
GCP 11 Management of the Per Patient Payment
 Final - Reviewed June 2023
GCP 12 Regulatory and Clinical Data Maintenance
Final - Reviewed August 2023
 GCP 13
 Remote Informed Consent Process- Local Management  Final - Reviewed July 2023