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DataCapture
5.
6.
7.
secuTrial® 4.7
4.10 Patient file.................................................................................................................................. 41
Barcode print for pseudonyms...............................................................................................42
4.11 Adverse events.......................................................................................................................... 42
4.12 Image families........................................................................................................................... 43
4.13 Filling out or editing forms.......................................................................................................... 44
Notes on filling out forms:...................................................................................................... 44
Plausibility checks................................................................................................................. 45
Summary: steps for entering data into forms.........................................................................46
Form Components............................................................................................................................. 47
5.1 Basic form components............................................................................................................. 47
5.2 Combined form components...................................................................................................... 47
5.3 Scores....................................................................................................................................... 48
5.4 Catalogues................................................................................................................................ 49
5.5 Repetition groups ..................................................................................................................... 51
5.6 Uploading images...................................................................................................................... 52
5.7 Uploading DICOM images......................................................................................................... 53
Form functions................................................................................................................................... 56
6.1 Imports...................................................................................................................................... 56
6.2 Entering and viewing comments and queries............................................................................56
Comments............................................................................................................................. 57
Queries.................................................................................................................................. 57
Automatic query answering................................................................................................... 58
6.3 Question-based help function.................................................................................................... 59
6.4 Print........................................................................................................................................... 59
6.5 Review....................................................................................................................................... 59
6.6 Source Data Verification (SDV).................................................................................................60
Changing the SDV status at the form level............................................................................60
Performing an SDV at the form overview level......................................................................61
Automatically resetting the "verified" status...........................................................................62
6.7 Data Entry Complete (DEC)...................................................................................................... 63
RepetitionGroups................................................................................................................... 63
6.8 Revalidation............................................................................................................................... 64
6.9 Centre Specific Project Versioning (CPV).................................................................................65
Status Header........................................................................................................................ 65
Data Entry (Forms, Visits)..................................................................................................... 65
Document History / Audit Trail............................................................................................... 66
Reports and Statistics............................................................................................................ 66
Download Documents........................................................................................................... 66
Form Data Mass Import ........................................................................................................ 67
Discrepancies-Import (DTM)................................................................................................. 67
Change to an Earlier Project Version....................................................................................67
6.10 Audit Trail.................................................................................................................................. 67
6.11 Electronic signature (optional)................................................................................................... 69
6.12 Hide........................................................................................................................................... 69
Appendix............................................................................................................................................ 71
7.1 DTM .......................................................................................................................................... 71
XML format............................................................................................................................ 71
CSV format............................................................................................................................ 72
7.2 Form Data.................................................................................................................................. 73
List format.............................................................................................................................. 73
CSV Format........................................................................................................................... 73
As of 13/10/2014
–3–
© iAS