Become An Expert in SDTM Domains & Device Domains


Duration: 30 Days
Level: Advanced
Prerequisite: SDTM
Fast-Track: Available
Fast-Track Duration: 15 Days

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Become-An-Expert-in-SDTM-Domains-&-Device-Domains

In this domain you be experiencing with SDTM 3.3 IG Guide. The main purpose of this topic is to get a keen knowledge on each and every domain and its assumptions.

In this course you will be learning in-depth techniques how to assign the variables, calculations, derivations, computations, time-point calculations, hardcoding, validation techniques and business logics in a professional way.

The main advantage of learning these domains is

  1. You can able to create blank annotated CRF to SDTM aCRF
  2. You can understand the SDTM specs
  3. You can identify the issues and able to track and communicate with spec writer.
  4. Interaction can be done easily between production programmer and QC Validator.

Part 1 : SDTM Domain Contents

Special-Purpose Domains

1.DM: Demographics
2.CO : Comments
3.SE : Subject Elements
4.SV : Subject visits

Interventions General Observation Class

1.CM : Concomitant Medications

2.EC : Exposure as Collected

3.EX: Exposure
4.SU : Substance Use

5.PR : Procedure

Events General Observation Class

1.AE: Adverse Events

2.CE: Clinical Events

3.DS: Disposition

4.DV : Protocol Deviation

5.HO: Healthcare Encounters

6.MH : Medical History

Findings General Observation Class

1.DA : Drug Accountability
2.DD : Death Details
3.EG : ECG Test Results

4.IE : Inclusion Criterion Not Met

5.LB : Laboratory Test Results
6.MO: Morphology
7.PC : PK Plasma concentration
8.LB : Laboratory Test Results
9.PE: Physical Examination
10.QS : Questionnaire

11.SU : Subject Characteristics

12.SS : Subject Status

13.VS : Vital Signs

Oncology Domains – Findings Class

1.TU: Tumor Identification
2.TR : Tumor Results
3.DS : Disease Response

Findings About:

1. Findings About — [FA]
2.SR : Skin Response

Relationship Data-sets

2.RELREC : Related Records
1.SUPP—Datasets —-Supplementary Qualifiers

Part 2: Device Domains

7.Device-Subject Relationship (DR
6.Device Exposure (DX)
5.Device Tracking and Disposition (DT)
4.Device Events (DE)
3.Device In-Use (DU)
2.Device Properties (DO)
1.Device Identifiers (DI)

SCHEME OF MAPPING DEVICE-SPECIFIC DATA

4. Overall Validation.

Device-related data fit to data models from the main SDTMIG and were linked to device domains using RELREC :

II. Validation Techniques:

ADaM Conversions and Extra Variables and Business Logics

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