Within 30 days of filing the proposed Study Plan, the licensee must hold a meeting to take further comments and more importantly, seek to resolve disputes related to choice of studies.1 It may hold further meetings for the same purpose. A participant must file any written comments on the proposed Study Plan within 90 days after the plan filing.2 If the participant disagrees with a choice (or rejection) of a study, the comments must comply with the study criteria discussed above in Section 4.2.5.
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18 C.F.R. § 5.11(e).
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See 18 C.F.R. § 5.12.
 | 4.2.7 Proposed Study Plan | Page 77 of 143 | 4.2.9 Revised Study Plan |  |