Chapters Documents TMF ISF filed Comment Master randomisation list, signed (in x sealed envelope) Randomisation Decoding procedure for blinded trials x x 9 Treatment allocation and decoding x Decoding documentation Other, specify: Investigator brochure (IB), IMP/MD Dossier or other information on IMP/MD, x x incl. any update Instructions for handling of IMP/MD x x Investigational Certificate(s) of analysis x medicinal Sample of label(s) x 10 product (IMP) / Shipping records x x Medical device Accountability documentation (site (MD) x/C x/O specific and patient specific) Temperature log x x Documentation of IMP/IMD destruction x x Other, specify: Normal values/ranges, incl. any update x x Certification or accreditation, incl. any x (x) update 11 Laboratory Other validation (as required) x (Central) lab manual x x Other, specify: Site authorisation and delegation log x/C x/O CVs of PI and investigators, signed x x GCP training evidence of PI and x x investigators CVs of other site personnel, signed (if x x required) 12 Site information GCP training evidence of other site x x personnel (if required) Financial disclosure forms, FDA 1572 (if x x required) Site personnel training documentation (x) x Other, specify: Relevant communication (emails, letters, 13 Correspondence meeting minutes, contact reports, x x newsletters) if not filed in other sections – Confidentiality agreement x x Signed contract/agreement, incl. x x 14 Contracts list Contract amendment, update of x x list Insurance 15 Insurance statement, incl. any renewal x x documents 16 Finances Financial aspects of the trial x x Study clinicaltrials.gov, KOFAM and / or other 17 x registration registration information 18 Website Information on website x Study acronym and / or number: Chapters Documents TMF ISF filed Comment
Chapters Documents TMF ISF filed Comment 9 Randomisation Decoding Master randomisation list, signed (in sealed envelope) x Decoding procedure for blinded trials x x Treatment allocation and decoding documentation x Other, specify: 10 Investigational medicinal product (IMP) / Medical device (MD) Investigator brochure (IB), IMP/MD Dossier or other information on IMP/MD, incl. any update x x Instructions for handling of IMP/MD x x Certificate(s) of analysis x Sample of label(s) x Shipping records x x Accountability documentation (site specific and patient specific) x/C x/O Temperature log x x Documentation of IMP/IMD destruction x x Other, specify: 11 Laboratory Normal values/ranges, incl. any update x x Certification or accreditation, incl. any update x (x) Other validation (as required) x (Central) lab manual x x Other, specify: 12 Site information Site authorisation and delegation log x/C x/O CVs of PI and investigators, signed x x GCP training evidence of PI and investigators x x CVs of other site personnel, signed (if required) x x GCP training evidence of other site personnel (if required) x x Financial disclosure forms, FDA 1572 (if required) x x Site personnel training documentation (x) x Other, specify: 13 Correspondence Relevant communication (emails, letters, meeting minutes, contact reports, newsletters) – if not filed in other sections x x 14 Contracts Confidentiality agreement x x Signed contract/agreement, incl. list x x Contract amendment, update of list x x 15 Insurance documents Insurance statement, incl. any renewal x x 16 Finances Financial aspects of the trial x x 17 Study registration clinicaltrials.gov, KOFAM and / or other registration information x 18 Website Information on website x Study acronym and / or number: Chapters Documents TMF ISF filed Comment
01_TableOfContents_TMF_ISF_v05_eng.docx