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Protocol Development

The below documents describe the processes and parties involved in the lifecycle of a protocol, the DAIDS-defined study statuses and milestones, and processes for implementing protocol changes and Letters of Amendment (LOAs).

Doc_Icon_PDF Protocol Development Lifecycle
January 2017
Doc_Icon_PDF DAIDS Study Statuses
September 2015
Doc_Icon_Word DAIDS Guidance for Implementing Protocol Changes
June 2012
Doc_Icon_Word LOA Flowchart
July 2013
Flash DAIDS Collaborators – Roles in the DAIDS Clinical Trial Lifecycle
Interactive visualizations (DAIDS Clinical Trials Collaborators and DAIDS Clinical Trials Lifecycle) and a print-friendly document (DAIDS Collaborators Guide) that were designed to provide information on DAIDS collaborators, points-of-contact, and responsible parties at each step of the clinical trial lifecycle. Click on different topic areas in the visualizations to reveal more information, and click again to hide information. Click on red arrows in the visualizations for hyperlinks to applicable websites for further information.
Content in Adobe Flash format. (Download Adobe Flash Player)

For DAIDS SOPs and Policies, visit the DAIDS Clinical Research Policies page

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Copyright © DAIDS RSC. All rights reserved.
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201700014C, entitled NIAID DAIDS Regulatory Support Center (RSC).

HomeWebsite User Feedback | Accessibility | Privacy Policy | Disclaimer
Copyright © DAIDS RSC. All rights reserved.
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201700014C, entitled NIAID DAIDS Regulatory Support Center (RSC).