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. Author manuscript; available in PMC: 2019 Feb 1.
Published in final edited form as: Clin Trials. 2017 Oct 17;15(1):29–35. doi: 10.1177/1740774517737318

Table 1. Docket Review Content Score.

Scoring informed by FDA guidance related to public disclosure and community consultation.

Public Disclosure Community Consultation
Detailed plan 1 Detailed plan 1
Events listed 1 Events listed 1
Material publically disclosed 2 Materials uploaded 1
Results reported 1
Maximum score 4 4