0.0 Table of content

0.1 Delegation- and signature list [10.1]

0.2 Training log [10.3]

0.3 Log for site file documents

1.1 Approval from head of the department

1.2 Trial specific guidelines

1.3 Template for protocol deviations, notes to file [in eCRF]

1.5 Other

2.1 Reports for the Application Evaluation Decision

3.2 Data processing agreements

4.1 Protocols_substantial and non-substantial modifications

4.2 Protocol changes log and domain specific changes log

4.4 Other

5.3 Platform Participation information incl. patient rights

5.4 Domains_ Participant information and consent form

5.12 Other

6.1 Sponsor and investigator (CTA)

6.5 Other

7.1 Copy of all eCRF-versions

7.4 Other

9.1 Source data lists

10.2 Curriculum Vitae and GCP course certificates

10.5 Other

11.1 Summary of product characteristics (SmPC) per domain

14.3 Newsletters

15.1 SAE-SUSAR form

15.5 Annual safety reports, inlcuding SUSAR list per domain

16.1 Documentation of financial agreements

16.2 Documentation of insurance cover