myCSG © |Area: SDTM| Concept: TI : Trial Inclusion/Exclusion Criteria | Lesson: LCSG801 : TI domain for an example study CSG801 |

 

Background
  • In every clinical trial, each patient will be enrolled into the study only if they meet prespecified conditions mentioned in the study protocol
  • These 'prespecified conditions' are called 'Inclusion criteria' and 'Exclusion criteria'
  • Subject should meet all inclusion criteria to be eligible for enrollment
  • Subject should NOT meet any exclusion criteria 
  • SDTM standard has a standard domain for capturing all the inclusion/exclusion criteria - "Trial Inclusion/Exclusion Criteria (TI)"
  • TI dataset has an expected record structure of 'One record per I/E criterion'

What type of information is typically collected or presented?
  • Study identifier
  • Domain name
  • Incl/Excl Criterion Short Name
  • Inclusion/Exclusion Criterion
  • Inclusion/Exclusion Category
  • Protocol criteria versions

Eligibility criteria from protocol

Inclusion Criteria

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

1.       Male and female patients 18-70 (inclusive) years of age.

2.       Active ulcerative colitis confirmed by colonoscopy.

3.       The patient is able and willing to comply with the requirements of this trial protocol.

 

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

1.       Pregnant or breastfeeding women. 

2.       Contraindication to colonoscopy

3.       Allergies to any component of CSG801.

 
 
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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