For study protocols-specific activities, the Network has developed policies and guidelines:

• Network Manual (version 2.0, May 2009)
• Consent guideline for incapacitated adults
• Consent guideline for children
• Informed Consent Regulations
• Publication Policy
• Draft Concept Protocol Submission Form

Site Self-reliance Program

• Site Development Road Map
• Site Proficiency Skills (rev Feb 24)
• SOP for Site Self-reliance Visit (March 13)
• Site Assessment Worksheet (Version 2 March 19)
• CTSS Support
  

Data and Safety (Please go to DSMB for further information)

Laboratory Policy

• SEAICRN Laboratory Quality Assessment Policy
• SAMPLE SEAICRN Laboratory Assessment Checklist
• SAMPLE SEAICRN Laboratory Assessment Report Template

SOP for Site  

• Sample Site SOP for Handling Specimen Transport and Chain of Custody
• Sample Site SOP for Handling Study Drug Chain of Custody
• Sample Site SOP for Informed Consent 
• Sample Site SOP Participant Screening and Enrollment 
• Sample Site SOP Source Documents
• Template for Site SOP 

Site Assessment

• Sample Site Assessment Questionnaire 

Quality Assurance  

• Quality Assurance Template

Template Job Description  

• Sample Study Team Position Descriptions

Network Travel Guidelines  

• Travel Guidelines June 2008
• Travel Request Form