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Table 3 Requests raised by competent authorities and ethics committees

From: Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project

Request type N. requests from ECs N. requests from CAs
Tot Details Tot Details
Changes/clarifications to/on material for patients/parents 87 Cyprus (1) n.a n.a
Greece (1)
Italy (4)
UK (1)
Changes/clarifications to/on protocol 3 Cyprus (1) 1 UK (1)
Italy (1)
UK (1)
Changes to/clarifications on insurance 3 Cyprus (1) n.a n.a
Greece (1)
Italy (1)
Other changes/clarificationsa 4 Cyprus (1) 1 Egypt (1)
Italy (3)
  1. The table shows the number of requests from 8 Ethics Committees and from 2 Competent Authorities as classified by type and country
  2. n.a. not applicable: no request on that specific issue raised
  3. aStudy procedures, treatment after the study; non-profit declaration; financial contribution; sample exportation