The Division of AIDS Enterprise System (DAIDS-ES) Protocol Management module within NCRMS is a repository of key protocol information for Network and non-Network protocols supported by DAIDS. The Protocol Management module has approximately 250 fields available for the abstraction of data regarding the protocol and attributes of the study (statuses, accrual, projections, etc.). The Clinical Study Information Office (CSIO) at the DAIDS Regulatory Support Center (RSC) receives and abstracts protocols and related documents [concept sheets/proposals, protocols, amendments, clarification memos, informed consents, summary of changes, and Letters of Amendment (LOAs)], as well as protocol attributes into the Protocol Management module of the DAIDS-ES.
Submitting a Protocol
- Submit a protocol for DAIDS review.
- Once received, protocol documents are assigned DAIDS-ES ID numbers to begin tracking protocol development information and DAIDS review processes.
Submitting Protocol Status and Milestone Updates
Protocol status and milestone updates are tracked in the DAIDS-ES Protocol Management module throughout the protocol lifecycle.
Protocol Development Lifecycle
For a complete listing of DAIDS study statuses, milestone names, milestone definitions, status and milestone responsible parties, and clarifying information, refer to:
DAIDS Study Statuses
Protocol status and milestone updates may be sent directly to the DAIDS-ES through web services, if they are available to your Network or Team. For further information on web services, please contact CRMSSupport@niaid.nih.gov.
If your Network or Team does not have web services, protocol status and milestone updates can be submitted to CSIO@tech-res.com.