DF_SSvisitmap
DF_SSvisitmap — List visit scheduling specifications for a study
Synopsis
DF_SSvisitmap
{study}
[-b]
[-i
{
[
[vmap]
| [visits]
]
[
[vptbl]
| [pvtbl]
]
[
[vdates]
| [etp]
| [cterm]
| [cplate]
| [cvisit]
| [ccycle]
...]
}
]
Description
This report lists the subject scheduling specifications for a study:
Visit Map. The visit map defines all cycles and visits, due dates and overdue allowance, and the CRF plates for each visit (see DFsetup Study Setup User Guide, Subject Visit Scheduling).
Visit Dates. Data fields defined with the VisitDate attribute identify those database fields used to record the date on which a subject assessment occurred (see DFsetup Study Setup User Guide, Visit Dates).
Early Termination Plates. These plates correspond to CRF forms used by the clinical sites to report the early termination of a visit map cycle for a subject. They must be registered in the Plate map as described in DFsetup Study Setup User Guide, PlatesPlates.
Conditional Termination Map. These specifications identify database conditions that trigger early termination of a visit map cycle, or termination of all cycles (see DFsetup Study Setup User Guide, Conditional Tests).
Conditional Plate Map. These specifications identify database conditions that modify the requirements for specified CRF plates at specified visits (see DFsetup Study Setup User Guide, Conditional Tests).
Conditional Visit Map. These specifications identify database conditions that modify the requirements for the visits defined in the visit map (see DFsetup Study Setup User Guide, Conditional Tests).
Conditional Cycle Map. These specifications identify database conditions that modify the requirements for the cycles defined in the visit map (see DFsetup Study Setup User Guide, Conditional Tests).
Options
When DF_SSvisitmap is run with no options, all of the above specifications are included in a report which is printed as one long list of specifications.
-b | Start each section of the report on a new page. | |||
-i vmap visits vptbl pvtbl vdates etp cterm cplate cvisit ccycle | Select any combination of the subject scheduling specifications to be included in the report. The output created by each keyword is illustrated in the examples.
|
![[Note]](../../imagedata/note.png)
Examples
Example 2.108. -i vmap option
DF_SSvisitmap: Visit Map Specifications. DFstudy 253. Mar 18,2018 10:54
Cycle 0: SCREENING - Screening
91: X 0( 0) Screening Visit #1 (VisitDate 1.13)
Req:1 Opt:102 MVP:none
92: X 4( 2) Screening Visit #2 (VisitDate 1.13)
Req:1 Opt:102 MVP:12
93: X 8( 0) Screening Visit #3 (VisitDate 1.13)
Req:1 Opt:102 MVP:12
Cycle 1: IN-STUDY VISITS - Required
starts on day 2( 0) from termination of previous cycle
0: B 0( 0) Baseline (VisitDate 2.9)
Req:2-4 Opt:102 MVP:none
21: S 30( 3) 1 Month Follow-up (VisitDate 5.9)
Req:5 Opt:15,102 MVP:12
22: S 60( 5) 2 Month Follow-up (VisitDate 5.9)
Req:5 Opt:15,102 MVP:12
23: S 90( 5) 3 Month Follow-up (VisitDate 5.9)
Req:5 Opt:15,102 MVP:12
24: S 120( 5) 4 Month Follow-up (VisitDate 5.9)
Req:5 Opt:15,102 MVP:12
30: T 120( 5) Study Termination (VisitDate 7.9)
Req:7-8 Opt:15-18 MVP:12
END OF ALL CYCLES
40: A Death Report (VisitDate 10.9)
Req:10 Opt:none MVP:none
101-199: O AE Report #%{S.2.2}
Req:44 Opt:45 MVP:noneThis option provides a complete listing of the specifications for all cycles and visits defined in the study visit map. If cycle definition records exist in the visit map the visits within each cycle will be listed below a cycle description showing the: cycle number (a sequential number starting at 0 for screening and 1 for the first in-study cycle), cycle label (a descriptive label used on reports like this one), cycle type (Screening, or for in-study cycles: Required, Optional or Conditional), and cycle scheduling (start day and overdue allowance, if the cycle has a scheduling method). The description of each visit begins with the visit number followed by a single letter visit type acronym (one of XPBSTWFEARrO), visit due day (the number of days following the cycle baseline visit), overdue allowance (after which the visit will be classified as overdue if not received), visit label (as it will appear on Quality Control reports to identify overdue visits), database field that contains the visit date (shown as VisitDate plate#.field#), and a list of required plates (Req), optional plates (Opt) and the missed visit plate (MVP).
Example 2.109. -i visits option
DF_SSvisitmap: Visit Map Specifications. DFstudy 253. Mar 18,2018 10:56
Cycle 0: SCREENING - Screening
91: X 0( 0) Screening Visit #1
92: X 4( 2) Screening Visit #2
93: X 8( 0) Screening Visit #3
Cycle 1: IN-STUDY VISITS - Required
starts on day 2( 0) from termination of previous cycle
0: B 0( 0) Baseline
21: S 30( 3) 1 Month Follow-up
22: S 60( 5) 2 Month Follow-up
23: S 90( 5) 3 Month Follow-up
24: S 120( 5) 4 Month Follow-up
30: T 120( 5) Study Termination
END OF ALL CYCLES
40: A Death Report
101-199: O AE Report #%{S.2.2}This option displays the visit map without the VisitDate and plate specifications, and is useful if you want to focus on visit scheduling alone.
Example 2.110. -i vptbl option
DF_SSvisitmap: Visit Map Specifications. DFstudy 253. Mar 18,2018 10:57
Visit Map Table of Visits (rows) by Plates (columns)
1 2 3 4 5 7 8 10 15 16 17 18 44 45 102
91: X . . . . . . . . . . . . . O
92: X . . . . . . . . . . . . . O
93: X . . . . . . . . . . . . . O
0: . X X X . . . . . . . . . . O
21: . . . . X . . . O . . . . . O
22: . . . . X . . . O . . . . . O
23: . . . . X . . . O . . . . . O
24: . . . . X . . . O . . . . . O
30: . . . . . X X . O O O O . . .
40: . . . . . . . X . . . . . . .
101: . . . . . . . . . . . . X O .In visit by plate tables required plates are indicated by the letter 'X' and optional plates are indicated by the letter 'O'. Any visit lists defined in the visit map are represented by the first visit in the list. This is the case for the adverse event reports in our example, which have visit numbers 101-199. This option does not attempt to break or wrap tables into printable chunks and thus may produce results which are best viewed on screen.
Example 2.111. -i pvtbl option
DF_SSvisitmap: Visit Map Specifications. DFstudy 253. Mar 18,2018 10:58
Visit Map Table of Plates (rows) by Visits (columns)
91 92 93 0 21 22 23 24 30 40 101
1: X X X . . . . . . . .
2: . . . X . . . . . . .
3: . . . X . . . . . . .
4: . . . X . . . . . . .
5: . . . . X X X X . . .
7: . . . . . . . . X . .
8: . . . . . . . . X . .
10: . . . . . . . . . X .
15: . . . . O O O O O . .
16: . . . . . . . . O . .
17: . . . . . . . . O . .
18: . . . . . . . . O . .
44: . . . . . . . . . . X
45: . . . . . . . . . . O
102: O O O O O O O O . . .This option displays the same information as the previous example, but with columns and rows reversed.
Example 2.112. -i vdates option
DF_SSvisitmap: Visit Map Specifications. DFstudy 253. Mar 18,2018 10:59
All VisitDates Defined In The Study Schema:
001 13. S1DATE Screen 1 Date
date VisitDate F=dd/mm/yy L=01/01/01-today
Pivot= 1940 Imputation= none
002 9. EDATE Entry Date
date VisitDate F=dd/mm/yy L=01/01/01-today
Pivot= 1940 Imputation= none
005 9. FDATE Visit Date
date VisitDate F=dd/mm/yy L=01/01/01-today
Pivot= 1940 Imputation= none
007 9. TDATE Final Visit Date
date VisitDate F=dd/mm/yy L=01/01/01-today
Pivot= 1940 Imputation= none
010 9. DDATE Date of Death
date VisitDate F=dd/mm/yy L=01/01/01-today
Pivot= 1940 Imputation= none
102 9. ETPtermdate Termination Visit Date
date VisitDate F=dd/mm/yy L=01/01/01-today
Pivot= 1940 Imputation= noneThis option shows the location of all database fields defined using the VisitDate attribute. Each field is identified by plate number followed by field number, name and label on the first line. The second line shows that these are date fields using the VisitDate attribute and identifies the format and legal value specifications. The 3rd line shows the pivot year and imputation method for partial dates. For an explanation of date specifications see Visit Dates in subject scheduling chapter of the study planning guide.
Example 2.113. -i etp option
DF_SSvisitmap: Visit Map Specifications. DFstudy 253. Mar 18,2018 10:59
Plates Which Signal Early Termination of the Current Cycle:
Plate 102 Early Termination ReportEarly termination plates are listed by plate number and plate label. In this example the study has a single form which is used to indicate that the current cycle terminated early.
Example 2.114. -i cterm option
DF_SSvisitmap: Visit Map Specifications. DFstudy 253. Mar 18,2018 10:59
Conditional Termination Map:
1. IF Visit 0 Plate 4 Field 15 equals 1
AND Visit 0 Plate 4 Field 17 is less than 3
the cycle terminates at visit 0
2. IF Visit 91 Plate 102 Field 34 equals 5
all follow-up terminates at visit 91This example illustrates the 2 possible types of conditional termination. The first specification terminates the cycle in which visit 0 is defined when both of the specified database conditions are met. In our example this is cycle 1. The second specification shows a condition which aborts all cycles based on a condition at visit 91, which in our example is the first visit of the screening cycle. As a result all follow-up will end at visit 91, and neither the remaining visits of cycle 0 nor cycle 1 will not be expected for any subject that meets this condition.
Example 2.115. -i cplate option
DF_SSvisitmap: Visit Map Specifications. DFstudy 253. Mar 18,2018 11:00
Conditional Plate Map:
1. IF Visit 30 Plate 7 Field 18 equals 2
at visit 30 required plates: 15-18
2. IF at any Visit Plate 44 Field 32 equals 3,5,6,9
at visits meeting this condition required plates: 45
3. IF at any Visit Plate 44 Field 32 does not equal 3,5,6,9
at visits meeting this condition excluded plates: 45This example shows 3 specifications. If the first condition is met, plates 15-18, which are defined as optional for visit 30 in the visit map (see example 1 above), become required at visit 30. The 2nd and 3rd conditions are related. Plate 44 is required for adverse event reports and plate 45 (defined as optional in the visit map) becomes either required or excluded (i.e. unexpected) depending on the values recorded in field 32 of plate 44 for each and every adverse event report.
Example 2.116. -i cvisit option
DF_SSvisitmap: Visit Map Specifications. DFstudy 253. Mar 18,2018 11:00
Conditional Visit Map:
1. IF Visit 91 Plate 1 Field 12 is less than 80
excluded visits: 92
2. IF at any of Visits 102-199 Plate 44 Field 6 is greater than 0
required visits: 101-value (value = IF condition data field value)In this example the first specification indicates that screening visit 92 is not expected if field 12 is less than 80 at screening visit 91. The second example shows a condition that checks for all adverse events having a lower report number, on the assumption that adverse event report numbers are assigned sequentially, and appear as assessment numbers 101 to 199.
Example 2.117. -i ccycle option
DF_SSvisitmap: Visit Map Specifications. DFstudy 253. Mar 18,2018 11:01
Conditional Cycle Map:
1. IF Visit 0 Plate 2 Field 25 equals 1,3,4
excluded cycles: 0
2. IF Visit 93 Plate 1 Field 33 equals 2
excluded cycles: 1In this example the first specification indicates that cycle 0 (the screening cycle) is not expected if a data value collected at the baseline visit of cycle 1 is equal to 1, 3 or 4. The 2nd specification indicates that cycle 1 is unexpected if a condition is met at visit 93, the last visit of the screening cycle.