2.1 Basic form, including a summary of the protocol in the national language of the trial site and reasons for the requested categorisation;
2.2 protocol;
2.3 case report form (CRF);
2.4 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements;
2.5 other documents issued to participants;
2.6 information on the type and amount of remuneration for participants;
2.738 for Category B clinical trials of medicinal products: the prescribing information and the Investigator's Brochure (IB), giving details of how the use of the product differs from the dosage/indication specified in the prescribing information;
2.8 for Category C clinical trials of medicinal products: the Investigator's Brochure (IB);
2.9 for Category C clinical trials of medical devices with no assessment of conformity: the documents specified in Annex 4 number 3.4 letter a;
2.10 for Category C clinical trials of medical devices bearing a conformity marking which are not used in accordance with the intended purpose or the instructions: the documents specified in Annex 4 number 3.5 letters a-d;
2.11 the investigator's CV, including evidence of his or her knowledge and experience, and a list of the other persons conducting the clinical trial, indicating their responsibilities and relevant professional knowledge;
2.12 information on the suitability and availability of infrastructure at the trial site;
2.13 information on the secure handling of personal data;
2.14 agreements between the sponsor, or third parties acting on the sponsor's behalf, and the investigator, in particular with regard to the financing of the clinical trial, remuneration of the investigator and publication;
2.15 certificate of insurance or other proof of coverage for possible damage, including agreements on this matter between the sponsor, or a third party acting on the sponsor's behalf, and the investigator;
2.16 for clinical trials of gene therapy: the information specified in Annex 4 number 4;
2.17 any decisions or opinions of ethics committees abroad concerning the clinical trial, including any conditions imposed and the reasons given.