PARTICIPATING SITE INFORMATION FILE (SIF) – Guidance and Template Map - Site Investigator File – Table of Contents Document Filing Guideline

• Any significant correspondence to and from the Site relating to site-specific Feasibility Questionnaire and completed Feasibility Assessment 2.2 Team Communication Documents to be filed in this Section include: - Include meeting minutes, • Copies of meeting minutes, emails to and emails, significant from site correspondence • All other significant correspondence 3.0 Protocol/Protocol Amendments. [...] 12.2 Records of Unblinding Documents to be filed in this Section include: - Local Participants • Copies of all local participant records of unblinding during study conduct and reasons for unblinding 12.3 Related Correspondence Documents to be filed in this Section include: - All significant correspondence relating to participant randomisation and unblinding procedures. [...] 16.7 Related Correspondence Documents to be filed in this Section include: • All significant correspondence to and from the site relating to the storage of Biospecimens/Translational Research aspect of the study, if applicable. [...] 19.0 Finance Documentation 19.1 Invoices/Receipts Documents to be filed in this Section include: • Copies of relevant Site-Specific invoices and receipts pertaining to the study, • Copies of relevant invoices received from participating sites relating to study-related Per Patient Payments (PPP) 19.2 Related Correspondence Documents to be filed in this Section include: MCTC013 Site Investigator Fil. [...] 20.2 Other General Correspondence Documents to be filed in this Section include: • Other significant general correspondence 21.0 Archiving 21.1 Archiving Details Documents to be filed in this Section include: • Investigator Agreement to Archive Trial Documents Form – completed and signed by Site Investigator and Sponsor-Investigator.