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

Table 3 Requests raised by competent authorities and ethics committees

Request type	N. requests from ECs		N. requests from CAs
Request type	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/clarifications^a	4	Cyprus (1)	1	Egypt (1)
Other changes/clarifications^a	4	Italy (3)	1	Egypt (1)

The table shows the number of requests from 8 Ethics Committees and from 2 Competent Authorities as classified by type and country
n.a. not applicable: no request on that specific issue raised
^aStudy procedures, treatment after the study; non-profit declaration; financial contribution; sample exportation

ISSN: 1472-6939