Study Development

Below is the flow chart of the study development process. Click on the links in the chart highlighted in yelllow for more information. You can also view our Orientation Handbook and our list of Network terms

After approval of the complete protocol the Coordinating Center will support you in the development of required study start-up documents, such as the Operations documents, Statistical Analysis Plan, Manual of Procedures, and Case Report Forms, using the NIDCR Toolkit templates. For more information and templates, visit the NIDCR Toolkit for Clinical Researchers website.

*NIDCR - National Institute for Dental and Craniofacial Research

**DSMB - Data Safety and Monitoring Board