Restructuring the NIAID Clinical Trials Networks

Resources for Applicants

General Information about NIAID

• NIAID Division of AIDS (DAIDS)
• NIAID Division of Microbiology and Infectious Diseases (DMID)
• NIAID Research Agenda on Antimicrobial Resistance
• NIAID Antimicrobial (Drug) Resistance Website
• NIAID HIV/AIDS Website
• DMID Clinical Research Programs
• NIAID Leadership Group for a Clinical Research Network on Antibacterial Resistance—New Funding Opportunity
• HIV/AIDS Network Coordination Office (HANC)
• HIV/AIDS Strategic Working Group (SWG)
• HIV/AIDS Community Partners (CP)
• NIAID Data and Safety Monitoring Boards (DSMBs)

Grant Policies and Guidance

• NIH Grants Policy Statement
• NIH Guidance on Multiple Principal Investigators
• NIH Financial Conflict of Interest Policy
• FDA Conflict of Interest Regulation (21CFR54)

Clinical Policies and Procedures

• DAIDS Clinical Research Policies and Procedures
• DAIDS Clinical Research Policies and Standard Procedures Documents
• DAIDS Clinical Research Policies and Standard Procedures Related Q&A 
• DMID Clinical Research Policies and Templates

Laboratory Information and Standards

• College of American Pathologists (CAP) accreditation program
• Good Clinical Laboratory Practice (PDF)
• Guidance for Industry: Q2(R1) Validation of Analytical Procedures
• ICH Guidelines, Validation of Analytical Procedures: Text and Methodology, Q2(R1) document that includes the original Q2A and Q2B documents
• ISO 15189:2207 standards
• U.S. FDA Guidance, Compliance and Regulatory Information (Drugs)
• U.S. Food and Drug Administration, Guidance for industry: Bioanalytical Methods Validation (PDF)

Data Standards

• Clinical Data Interchange Standards Consortium (C-DSIC)
• Compliance with ClinicalTrials.gov and the Food and Drug Administration Amendments Act (FDAAA) of 2007