Table 2 Documents required for DEEP-2 submission compared to the EC Guidance [5, 6]¹

For EC approval

Cover letter, protocol, CTA form, information on countries and sites involved, synopsis in the national language, I.B./SmPC, insurance

x

x

x

x

x

x

x

Receipt of confirmation of EudraCT number, agreement between sponsor and site

x

x

x

x

List of involved Competent Authorities

x

x

x⁵

x

PIP opinion/link to the specific documentation⁴

x

x⁵

x

IMPD, NIMPD (including GMP compliance)

x

x⁵

x

x

x

x

Examples of the label in the national language

x

x^5;6

x

x

x

x

Outline of all active trials with the same IMP

x³

Information documents for parents/legal representative, consent form, any other material used for the recruitment

x

x

x

x

x

x

x

Information material for children, assent form

x

x

x

CVs of Investigators, Investigator disclosure of conflict of interest

x

x

x

x

x

x

Quality of facilities for the trial

x

x

x

x

For CA authorisation

Cover letter, protocol, CTA form, contents of the labelling, I.B. /SmPC

x

x

x³

x

x

x

x

IMPD, NIMPD (including GMP compliance)

x

x

x

x

x

x

Insurance

x

x

x

x

x

x

EC opinion (where available)

x

x

x

x

x

PIP opinion/link

x

x

x

Proof of payment

x

x

n.a

x

x

Agreement between sponsor and site

x

x