R34/U01 Clinical Trials Deliverables Project Management

Appendix B: R34/U01 Clinical Trials Deliverables- Project Management

There is an illustration of a building shape with pillars. At the top of the building share is a triangle shaped roof with UM1 Submission in text. The next layer has the words "Regulatory Authority Submission Management."

There are nine pillars holding the roof in place and the read from left to right: Data Management Plan (CRF); Statistical Plan; HSP- Informed Consent (transitions); Drug Supply/Accountability; Monitoring Plan; Enrollment, Randomization & Subject Tracking; Central Laboratory & Sample Repository; Data Safety and Monitoring Plan; Training and Site Initiation Plan.

Below these nine pillars are four levels of flooring, which include form the top to the bottom: Sites/Subcontracts/budgets, Clinical Operations Management and Manual of Procedures, Study team, and lastly, Protocol and Investigator Brochure.