Codebook, signed, incl. any update x Data-dictionary, incl. any update x User Acceptance Test (UAT) x documentation Data base user management, incl. any 19 Database x update Data base user manual x x Approval from data protection for the x collection of identifying data in data base Other, specify: Statistical analysis plan, signed x 20 Statistics Statistical analysis report x Other, specify: 21 Final report Final study report/publication x (x) Monitoring plan or quality assurance visit x plan, signed Monitor training documentation x Pre-study visit monitoring report x Site initiation visit report x x Monitoring visit or quality assurance visit Quality x 22 assurance report Close-out visit report x Site visit follow-up letter x x Monitoring visit log x/C x/O Audit certificate x Other, specify: Source documents x Source 23 documents Source data location list (x) x Body Record of retained body fluids/tissue 24 x x fluids/tissue samples Signed, dated and completed CRFs x/O x/C (paper or CD-ROM) 25 Completed CRFs Documentation of CRF corrections (for x/O x/C pCRFs) Background Literature containing information on study 26 (x) literature Documents that do not fit into any other section, specify: 27 Miscellaneous
19 Database Codebook, signed, incl. any update x Data-dictionary, incl. any update x User Acceptance Test (UAT) documentation x Data base user management, incl. any update x Data base user manual x x Approval from data protection for the collection of identifying data in data base x Other, specify: 20 Statistics Statistical analysis plan, signed x Statistical analysis report x Other, specify: 21 Final report Final study report/publication x (x) 22 Quality assurance Monitoring plan or quality assurance visit plan, signed x Monitor training documentation x Pre-study visit monitoring report x Site initiation visit report x x Monitoring visit or quality assurance visit report x Close-out visit report x Site visit follow-up letter x x Monitoring visit log x/C x/O Audit certificate x Other, specify: 23 Source documents Source documents x Source data location list (x) x 24 Body fluids/tissue Record of retained body fluids/tissue samples x x 25 Completed CRFs Signed, dated and completed CRFs (paper or CD-ROM) x/O x/C Documentation of CRF corrections (for pCRFs) x/O x/C 26 Background literature Literature containing information on study (x) 27 Miscellaneous Documents that do not fit into any other section, specify:
01_TableOfContents_TMF_ISF_v05_eng.docx