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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 FCOI and Financial Disclosures
 
Final - Reviewed February 2023
ADM 3 Network Publication 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 Federal Compliance
Final - Reviewed September 2016
ADM 7 Per Subject Payments and Development of Clinical Trial Budgets
Final - Reviewed September 2016
ADM 8 Network Process for RCC Performance Final - Reviewed January 2020
ADM 9 RCC Management of Satellites and Performance Sites
 
Final - Reviewed April 2020
ADM 10 Inclusion of New Satellite Sites and CPS
Final - Reviewed December 2016
ADM 11 Central Institutional Review Board Reliance and Approvals
Final - Reviewed January 2023
ADM 12 Central Institutional Review Board (CIRB) Reporting Final - Reviewed July 2021
ADM 13 Safety Monitoring and Reporting
 
Final - Reviewed February 2023
ADM 14 Process for the Development of Study Materials and Training
Final - Reviewed May 2023
ADM 15 Network Communication
Final - Reviewed May 2023
ADM 16 Network Process for Trial Master and Site Regulatory File Management
Final - Reviewed February 2023
ADM 17 StrokeNet Organization and Governance
 
Final - Reviewed February 2023
ADM 18 StrokeNet Conduct of Shared Trials
Final - Reviewed May 2023
ADM 19 Data Monitoring

 
Final - Reviewed December 2016
 ADM 20
Data Quality Assurance and Control
 
Final - Reviewed April 2023
 ADM 21
Regulatory Document Maintenance and Storage
 
Final - Reviewed May 2023
 ADM 22
Ancillary Study Approval Process
 
Final - Reviewed May 2023
 ADM 23
NIH StrokeNet and VA Central IRB Collaboration
RETIRED
 ADM 24
StrokeNet Central Electronic Informed Consent Process
Final - Reviewed February 2023
 ADM 25
CIRB and DSMB Joint Operating Procedure
Final - Reviewed 21 April 2023
ADM 26 Consenting Non-English Speaking or Literacy-Challenged Participants Final - November 17, 2022

 
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 - December 21, 2015
GCP 3 Informed Consent and Stroke Trials
Final - December 22, 2015
GCP 4 Safety Reporting
Final - Reviewed February 2023
GCP 5 Maintaining Confidentiality
Final - March 4, 2016
GCP 6 Handling Investigational Product
Final - Reviewed February 13, 2023
GCP 7 Maintaining Data Quality RETIRED
GCP 8 Laboratory-Radiology Competency and Reliability Final - July 28, 2016
GCP 9 Site Monitoring, Audits and Inspections Final - September 12, 2016
GCP 10 Trial Recruitment
Final - Reviewed February 17, 2023
GCP 11 Management of Per Subject Payment
Final - December 22, 2015
GCP 12 Regulatory and Clinical Data Maintenance Storage
Final - Reviewed May 2023