The NeuroNEXT Network has developed a set of Standard Operating Procedures (SOPs) to govern how studies are run in the Network:
- General Administration
GA 101: Development and Maintenance of SOPs- GA 102: SOP Training
- GA 103: Document Development and Change Control
- GA 104: Conflict of Interest and Financial Disclosure Requirements
- GA 105: Vendor Selection and Agreements
- GA 106: Publication Policy Development
- GA 107: Data Sharing
- GA 108: Network Coordinating Center Capacity
- GA 109: Sharing Data with Industry Collaborators
- Regulatory Administration
- RA 201: Regulatory Authority Submissions and Contact
- RA 202: Trial Master File Maintenance
- RA 203: Site Regulatory Binder Maintenance
- RA 204: Informed Consent Form Preparation
- RA 205: Adverse Events: Sponsor Responsibilities
- RA 206: Medical Monitoring and Safety Monitoring
- RA 207: Investigational Brochure Development and Approval
- RA 208: Document Translation
- Protocol Development
- Site Selection and Management
- Project Management
- Subject Management
- Computer Systems
- Quality Assurance
- Biostatistics
- BIO 901: Working with an External Biostatistician
- BIO 902: Statistical Analysis Plan Development
- BIO 903: Creating, Verifying, Implementing, and Archiving a Randomization Sequence or Algorithm
- BIO 904: Generation and Validation of Analysis Data Sets
- BIO 905: Validating Statistical Programs and Deliverables
- BIO 906: Presenting Statistical Results for a Final Study Report
- Data Management
- DM 1001: Clinical Data Management
- DM 1002: Data Management Plan Development
- DM 1003: Case Report Form Development
- DM 1004: Specifications Development, Testing Plans, and Validation Documentation
- DM 1005: Data Collection and Data Handling
- DM 1006: Adverse Even Coding
- DM 1007: Concomitant Medications Coding