How do I update contact information for site personnel in the DAIDS-ES?
Contact information for site personnel, such as office/mailing/shipping address, e-mail, phone and fax number, can be reviewed and updated by the site coordinator using the DAIDS-ES. Information regarding staff can be found on the CRS profile report, available in the DPRS and CSM modules. Updates can be made using the person tab in the Adverse Experience Reporting module. For detailed Instructions for accessing information and submitting updates can be found in How to Update Site Personnel in the DAIDS-ES.
What is the DAIDS RSC CSIO?
The DAIDS RSC CSIO is the DAIDS Regulatory Support Center (RSC) Clinical Study Information Office (CSIO). The primary responsibility of the DAIDS RSC CSIO is to abstract and update protocol and contact information.
The DAIDS RSC CSIO updates contact information on organizations (sites, networks, pharmaceutical corporations, collaborators and contractors) and key personnel who are involved in the conduct of DAIDS clinical trials. The DAIDS RSC CSIO is also responsible for abstracting information from DAIDS sponsored protocols to enter into the DAIDS-ES. Accuracy of this information is critical for the successful support of the DAIDS clinical trials which are tracked using the DAIDS-ES.
What protocol statuses are needed and who is responsible for providing that information?
Information for updating protocol statuses is available under the "help" tab located in the upper right corner of the home page for the Protocol Management module in the DAIDS-ES. Responsible parties associated with each status/milestone are identified in the document. For a complete listing of study statuses, milestone names, milestone definitions, status and milestone responsible parties, and clarifying information, refer to Study Statuses and-Milestones Definitions.
What site functions/people roles require prior authorization and from whom?
Organizations including Clinical Research Sites (CRS), Clinical Trial Units (CTU) and site-associated pharmacies require approval by the appropriate DAIDS Project/Program Officer in the Office of Clinical Site Oversight (OCSO) or Westat ( for NICHD sites) prior to being entered or updated in the DAIDS-ES Master Contact module. Individuals including the CRS Leader, CRS Coordinator, CTU Principal Investigator, CTU Coordinator and the Pharmacist(s) are considered key personnel who require prior approval from the DAIDS OCSO Project/Program Officer or Westat (for NICHD sites), before being entered or updated in the DAIDS-ES. Contact the appropriate DAIDS Project/Program Officer or Westat point of contact for your organization to obtain authorization prior to submitting the request. The CSIO cannot process any requests without the appropriate approvals. For detailed instructions please see the Clinical Research Site Personnel Qualifications, Training and Responsibilities Section of the DAIDS SCORE Manual.