DAIDS Regulatory Support Center (RSC)

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.

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
Content last reviewed on November 17, 2017