implementation of oe domain in ophthalmic studies...disclaimer and disclosures •the views and...

Implementation of OE domain in Ophthalmic Studies

Presented by Zhizhuo ZhangSenior Programmer, Data Operation - Ophthalmology, Novartis

20 September 2019

Disclaimer and Disclosures

• The views and opinions expressed in this presentation are those of the author(s) and do not necessarily reflect the official policy or position of CDISC.

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• All data presented in the slides are dummy data, with no connection to any real project or subject

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Implementation of OE domain in Ophthalmic Studies

Presented by Zhizhuo ZhangSenior Programmer, Data Operation - Ophthalmology, Novartis

20 September 2019

Agenda

1. Release of OE Domain in SDTM IG v3.3

2. Variable FOCID in OE Domain

3. Usage of FOCID, OELOC, OELAT and OEDIR

4. Extended Usage of FOCID in Other Classes

Release of OE Domain in SDTM IG v3.3

❑ SDTM IG v3.3 released on 20NOV2018• Introduced morphology/physiology domains to support specific body systems

• OE - Ophthalmic Examinations

• Contains tests that measure ocular health and visual status

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Release of OE Domain in SDTM IG v3.3

• All Ophthalmic findings can be consolidated in one OE domain

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Variable FOCID in OE Domain

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Variable FOCID in OE Domain

❑ FOCID (Focus of Study-Specific Interest)

• Released in SDTM v1.5

• Started to be implemented in clinical trials from SDTM IG v3.3

• Identifier variable in all observation classes

• CDISC CT: OEFOCUS (C119013) for Ophthalmic studies

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Variable FOCID in OE Domain

❑ In ophthalmic studies, the eyes are usually sites of treatment

❑ Exclusively preferred terms used by ophthalmology community

• OD: Oculus Dexter (Right Eye)

• OS: Oculus Sinister (Left Eye)

• OU: Oculus Uterque (Both Eyes)

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Variable FOCID in OE Domain

• Data Structure

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• Baseline Flag derivation

Usage of FOCID, OELOC, OELAT and OEDIR

• FOCID would be included in records in any subject-level domain representing findings, interventions, or events (e.g., AE) related to the eyes.

• Whether or not FOCID is used in a study, --LOC and --LAT should be populated in records related to the eyes

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Usage of FOCID, OELOC, OELAT and OEDIR

❑ FOCID identifies the EYE

❑ OELOC, OELAT, OEDIR can support FOCID to

• Simply describe the eye, OR

• Describe the anatomical location of the eye

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Extended Usage of FOCID in Other Classes

• Identifier variable in all observation classes

• Could be included in records in any subject-level domain representing findings, interventions, or events related to the eyes

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Thank You!