Simplicity without Compromise

Oncology
Legacy Data => SDTM

mathiesen & mathiesen

AG fr informatik

Simplicity without Compromise

List of Content
1.! Therapeutic Area ONCOLOGY = CDISC-Tumor Domains 2.! Main Challenges / Oncology Challenges 3.! Metadata Repository Drives the Process. 4.! Legacy Data Structure <-> SDTM Structure 5.! Challenges in Detail 6.! Conversion Step by Step 7.! Questions

Simplicity without Compromise

1.! CDISC-Tumor Domains

Simplicity without Compromise

TU Tumor Identification
LINKID

Identifier used to link identified tumors to the assessment results.

TR Tumor Results
LINKID

RS Response

Simplicity without Compromise

List of Content
1.! Therapeutic Area ONCOLOGY = CDISC-Tumor Domains 2.! Main Challenges / Oncology Challenges 3.! Metadata Repository Drives the Process. 4.! Legacy Data Structure <-> SDTM Structure 5.! Challenges in Detail 6.! Conversion Step by Step 7.! Questions

Simplicity without Compromise

Main / Oncology Challenges

1. ONE SAS file converted to THREE Domains 2. Identify LINKID 3. Response Domain (RS): 4. Dates and Visits: 5. Date/Time Format:
Differentiated in Target Response and Overall Response All unscheduled visits has to be in Visit number order Legacy date format -> ISO Standard. Any time informations to be combined into ISO date standard.

Simplicity without Compromise

List of Content
1.! Therapeutic Area ONCOLOGY = CDISC-Tumor Domains 2.! Main Challenges / Oncology Challenges 3.! Metadata Repository Drives the Process. 4.! Legacy Data Structure <-> SDTM Structure 5.! Challenges in Detail 6.! Conversion Step by Step 7.! Questions

CDISC

Legacy

?
SDTM Dene.XML Result.XLS

CDISC

Legacy

Drag and Drop for SDTM Structure

Fill-in and save with F2

D S r o f Click

e t a r e n e g M T

SDTM Dene.XML Result.XLS

Clinical Trials:

Protocol Writing Study Build

Meta Data Repository

Data Capture

Tabulations

Source: Dave Iberson-Hurst,

Analysis Datasets

Raw Data

Two times

washed

SDTM

CDISC

Metadata driven Legacy Metadata

SDTM CDASH Import I

Standards Library (SHARE)

Study Metadata Repository

Import II

SDTM Dene.XML Result.XLS

CDISC

Metadata driven Study Build / SDTM

Metadata
Standards Library (SHARE) SDTM CDASH

Study Metadata Repository

tr

eCRF Blank.CRF

SDTM Dene.XML Result.XLS

Simplicity without Compromise

List of Content
1.! Therapeutic Area ONCOLOGY = CDISC-Tumor Domains 2.! Main Challenges / Oncology Challenges 3.! Metadata Repository Drives the Process. 4.! Legacy Data Structure <-> SDTM Structure 5.! Challenges in Detail 6.! Conversion Step by Step 7.! Questions

Simplicity without Compromise

SAS File
TUM.xpt

TU Tumor Identification TR Tumor Results RS Response

Simplicity without Compromise

CRF
TYM Part

TU Tumor Identification TR Tumor Results RS Response

Simplicity without Compromise

CRF

Simplicity without Compromise

CRF

Simplicity without Compromise

CRF

Simplicity without Compromise

SDTM Files

TU

TR

RS

SDTM Result TU Tumor Identification

TR RS

Simplicity without Compromise

List of Content
1.! Therapeutic Area ONCOLOGY = CDISC-Tumor Domains 2.! Main Challenges / Oncology Challenges 3.! Metadata Repository Drives the Process. 4.! Legacy Data Structure <-> SDTM Structure 5.! Challenges in Detail 6.! Conversion Step by Step 7.! Questions

Simplicity without Compromise

5. Challenges in Detail
5.1 THREE Domains

TYM

TU Tumor Identification TR Tumor Results RS Response

Simplicity without Compromise

5. Challenges in Detail
5.2 TULINKID; TRLINKID; RSLINKID A. Identify the Legacy Data parameter for Link
(Lesion No LES1N = LINKID)

Simplicity without Compromise

5. Challenges in Detail
5.3 Response Domain (RS): 5.3.1 Target Response with "LINKID" 5.3.2 Overall Response without "LINKID"

Simplicity without Compromise

5. Challenges in Detail
5.4 Dates and Visits:

! All Records in the TYM.xpt le are reported as Unscheduled observations.

! SDTM request a VISITNUM acording to the reported observation date. ! Date/Time according to the ISO standard.

Simplicity without Compromise

List of Content
1.! Therapeutic Area ONCOLOGY = CDISC-Tumor Domains 2.! Main Challenges / Oncology Challenges 3.! Metadata Repository Drives the Process. 4.! Legacy Data Structure <-> SDTM Structure 5.! Challenges in Detail 6.! Conversion Step by Step 7.! Questions

n
Simplicity without Compromise

Step by Step

Upload and Two Times Washed

1. 2.

3. 1. 2.

Upload Import I
Cli load p u r ck fo

Dene Study and Visit's

Simplicity without Compromise

n
Step by Step

(Harmonise with Legacy Data)

n
Simplicity without Compromise

Step by Step

Prepare Visit's
Visit Number; Ready for calculation Visit Number X.1 etc

6. Conversion
Simplicity without Compromise

Date Conversion to SDTM Standard

Legacy Data TYM use two parameters for Date informations Legacy Data has no time informations RSDTC Is the generated Date/ Time in SDTM format RSDTC is the Date Parameter for all three Domains

Simplicity without Compromise

6. Conversion
Step by Step

Metadata Ready
A. CDISC Data - Ready for Use - SHARE imported
CDASH, SDTM

B. Use in Current Oncology Project

Copy from A) CDISC Data Copy from B) Previous Project Drag and Drop

6. Conversion
Simplicity without Compromise

Copy Metadata from SHARE Repository

Copy Domain: TU - TR - RS from SHARE

Click for METADATA Repository copy

6. Conversion
Simplicity without Compromise

Conrm SDTM Domain Structure

Drag and Drop

Simplicity without Compromise

6. Conversion

Conrm Parameter Entrance for Conversion

Fill-in

and s ave w

ith F2

Simplicity without Compromise

6. Conversion
Generate SDTM

Simplicity without Compromise

6. Conversion
SDTM on your Drive

! SDTM in SAS Export Format; The

three Oncology domains among the total domains from the converted study.

! Dene.xml ! Open CDISC Validation ! Report.xls le ! Plus SDTM in XML and CSV

6. Conversion
Simplicity without Compromise

SDTM Examples

TU

TR

6. Conversion
Simplicity without Compromise

SDTM Examples

RS

Simplicity without Compromise

"Overnight"
Conversion to

SDTM Datasets
mathiesen & mathiesen
AG fr informatik

Simplicity without Compromise

Questions and Contact

mathiesen & mathiesen
AG fr informatik

St. Jakobs-Strasse 54 4002 Basel

+41 61 271 69 42

niels.mathiesen@m-m.ag www.clivax.com