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