The RSC Public Website, run by the DAIDS Regulatory Support Center (RSC) contractor, has been used in the DAIDS community for over 10 years and is a primary platform to communicate updates to templates, process changes, and other information needed by the RSC research community.
Website resources include: DAIDS policies, manuals and other guidelines and standards; process tutorials; reports and information specific to task areas; and relevant contact information and external links.
More information about this resource is available at DAIDS Regulatory Support Center (RSC)
Main Areas of Focus
- To provide day-to-day support for all regulatory activities related to all DAIDS-supported and/or sponsored network and non-network clinical trials including rules and regulations, DAIDS information sheets, guidelines and standards
- Communicate and improve compliance with DAIDS policies and manuals through access to DAIDS RSC resources, procedures, forms, and checklists
- Offer support and Frequently Asked Questions (FAQ) resource to researchers
Support Services
- Protocol development
- Protocol review
- Protocol registration
- Safety reporting
- CRF document storage
- Access to the NCRMS system
Tools
- Safety reporting resources (trainings, quick reference cards, etc.)
- Protocol registration resources (trainings, quick reference cards, etc.)
- Protocol development rules
- DAIDS collaborators
- Lists of IND/non-IND protocols whose records will not be stored by DAIDS
- IB/PI Tables
- Tools for entering and maintaining Personnel in NCRMS
Standards
- Safety grading table
- Safety EAE reporting manual
- Protocol registration manual and policy
- Protocol template language
- DAIDS Risk Lists
- DAIDS/FDA forms
- Applicable SOPs/policies/guidelines, etc.
Who Can Use This Resource
- Available for public use
How To Get Started
- Available for public use
Contact Information
- Contact information can be found at DAIDS Regulatory Support Center