Skip to main content

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

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

Documents required by the EC Guidance   EU Non-EU
CY GR IT2 UK AL EG TU
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 x5;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
  1. n.a.: not applicable for DEEP-2 trial given the non-profit nature of the trial; IMPD: Investigational Medicinal Product Dossier; NIMPD: Not-Investigational Medicinal Product Dossier
  2. 1Scientific Advice, Indemnity/compensation for participants and rewards to investigators, unjustified/unexpected impurities, viral safety information, GMOs, radiopharmaceuticals, TSE certificate required by EC Guidance on ECs submission [5] not foreseen in DEEP-2 trial. Scientific Advice, Indemnity/compensation for participants and rewards to investigators required by EC Guidance on CAs submission [6] not foreseen in DEEP-2 trial
  3. 212 CAs addressed in Italy
  4. 3, 62 out of 12 sites in Italy
  5. 4 The PIP not mentioned in the Guidance [5], being issued after the Paediatric Regulation [17], but required by the EC
  6. 5 Only the EC issuing the single opinion