SOPs and GCPs Backend

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 Document Maintenance and 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
ADM 27	Management of StrokeNet Trials with International Sites	Final - September 2024

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 Per Subject Payment	Final - Reviewed July 2026
GCP 12	Regulatory and Clinical Data Maintenance	Final - Reviewed August 2023
GCP 13	Remote Informed Consent Process- Local Management	Final - Reviewed July 2023