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4.3.2 Additional Study Request

A participant may request a modified or new study in response to a Study Report, as follows. Within 15 days of filing the initial Study Report, the licensee will hold a meeting with participants and OEP staff to discuss the study results and any proposed modifications.1 Any participant or the OEP staff may file a disagreement with the meeting summary, which the licensee must prepare within 30 days of that meeting.2 The disagreement may propose a modified or new study. Within 30 days thereafter, the OEP Director will resolve the disagreement and amend the approved Study Plan as appropriate.3 The same procedures for review, disagreement, and resolution apply to the Updated Study Report.4

 

The licensee, participant, or OEP staff who proposes a new or modified study must show good cause. 5 The burden of persuasion is proportional to how much change is proposed in the approved Study Plan, or how much time has passed since the Study Plan Determination.

 

  1. See 18 C.F.R. § 5.15(c). Fifteen days after the meeting, the applicant will file a meeting summary. See id.

  2. See id. The licensee may respond to any such filing within 30 days. See id.

  3. See id.

  4. See id.

  5. See 18 C.F.R. § 5.15(d)-(e).


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