myCSG © |Area: SDTM| Concept: TV : Trial Visits | Lesson: LCSG801 : TV domain for an example study CSG801 - parallel, 3 arms |

 

Background
  • In most clinical trials, subjects are expected to visit the investigator at predetermined timepoints
  • SDTM calls these visits of the subjects as 'clinical encounters'
  • Clinical trial protocol will list all the planned visits that has to occur over the course of the trial and the timing of each visit
  • SDTM has a domain named "Trial Visits (TV)" to capture these planned visits of the study
  • In most studies, the planned visits and the order of visits remain same across different arms of the study but in some cases, these can be different
  • If the visits are same across arm, we can present the visits in TV domain leaving ARMCD and ARM variables null
  • If the visits or visit order is different across arms, then we should represent the planned visits within each ARM

What type of information is typically collected or presented?
  • Study identifier
  • Domain name
  • Visit number
  • Visit name
  • Planned study day of the visit
  • Planned arm code
  • Description of the planned arm
  • Visit start rule
  • Visit end rule
 

Schedule of assessments

 

 

Screening

Treatment

Follow-up

Week

 

0

2

4

6

8

10

12

15

Day (s)

-28 to -1

1

15

29

43

57

71

85

106

Allowed window for visit (days)

 

 

±1

±1

±2

±2

±2

±2

±2

Visits

Visit 1 Screening

Visit 2 Baseline

Visit 3

Visit 4

Visit 5

Visit 6

Visit 7

Visit 8

Visit 9

Informed consent

x

 

 

 

 

 

 

 

 

Randomization

 

x

 

 

 

 

 

 

 

Demographics

x

 

 

 

 

 

 

 

 

Alcohol and tobacco usage

x

 

 

 

 

 

 

 

 

Medical history

x

 

 

 

 

 

 

 

 

Surgical history

x

 

 

 

 

 

 

 

 

Efficacy evaluation

 

x

x

x

x

x

x

x

 

Clinical laboratory tests

 

x

x

x

x

x

x

x

x

ECG

 

x

 

x

 

x

 

x

x

Concomitant medications

x

x

x

x

x

x

x

x

x

Adverse Events

x

x

x

x

x

x

x

x

x
 
VARIABLE_NAMEVARIABLE_LABELDERIVATION
General General notes There will be no formal specification for Trial design domains.
We need to create it based on the protocol.
See the lesson description for the study design.
Complete SAS code to generate the output is available for registered users!

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