Broadcast Memos
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DAIDS RSC Presentations
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Regulatory Information
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Protocol Development Information
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Human Subjects Protection (HSP)
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Protocol Registration
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Safety and Pharmacovigilance
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Case Report Form
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Clinical Study
Information Office |
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⊲ Return to Frequently Asked Questions Subject List.
Clinical Study Information Office (CSIO)
- What is the RSC CSIO?
- What protocol statuses are needed and who is responsible for providing that information?
- What site functions/people roles require prior authorization and from whom?
- How do I update contact information for site personnel?
| 1. |
What is the RSC CSIO? |
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The RSC CSIO is the DAIDS Regulatory Support Center (RSC) Clinical Study Information Office (CSIO). The primary responsibility of the CSIO is to abstract and update protocol and contact information.
The 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 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. |
| 2. |
What protocol statuses are needed and who is responsible for providing that information? |
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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. |
| 3. |
What site functions/people roles require prior authorization and from whom? |
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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. |
| 4. |
How do I update contact information for site personnel? |
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Contact information, such as office/mailing/shipping address, e-mail, phone and fax number, can be updated for personnel at a site by submitting a request to DAIDS-ES support via email at DAIDS-ES-Support@niaid.nih.gov. In order for the update(s) to be completed, you are required to specify the DAIDS ID number for your site, along with the contact information to be updated. If the person(s) being added is new to the DAIDS-ES, please contact your site coordinator to begin the process. Please note that the DAIDS-ES Master Contact database is separate from your network database. |
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