SDTM Conversions ,Validation and Migration Techniques

MAZIWORLD > SDTM Conversions ,Validation and Migration Techniques

SDTM CONVERSIONS ,VALIDATION AND MIGRATION TECHNIQUES


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

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Description

SDTM-Conversions-,Validation-and-Migration-Techniques

Today, SDTM is the general framework for organizing clinical trial information that is submitted to the FDA. SDTM can be developed at different stages in the clinical data management process. SGS Biostatisticians have converted legacy data into SDTM for more than 230 trials on behalf of multiple clients.

What is Sdtm mapping?

SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).

What is Sdtm in clinical data management?

SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. … SDTM is also used in non-clinical data (SEND), medical devices and pharmacogenomics/genetics studies.

Curriculum

Events:

In this SDTM Conversions you will be learning in-depth Professional syllabus.

In this course you will be working on these domains

Special Purpose Domains:

1. Demographic – DM
2. Subject Element – SE
3. Subject Visit – SV

Interventions:

1. Exposure – EX
2. Concomitant Medication – CM

Events:

1. Adverse Events –AE
2. Disposition – DS

Findings:

1. Vital signs- VS
2. Laboratory –LB
3. Electro Cardiogram –EG
4. Questionnaire – QS
5. Cardiovascular –CV

Oncology Domains : will be explained with RECIST Document and with definition based Formula’s.

1. Tumor Identification –TU
2. Tumor Result – TR
2. Tumor Result – TR
3. Disease Response – RS

Findings About : working with FA Domain and RELREC

1. Findings About — [FA]
2. Relationship Records – REL-REC

Supplementary Qualifiers:

1. Supp domain

Custom Domain:

1. Working with Custom Domain .

II. Validation Techniques:

1. Self-Validation / Double check validation
2. QC Validation
3. Sr. Validation
4. Overall Validation.

II. Validation Techniques:

1.Running the code in the Unix
2.Executing the Batch files.
3.Migrating to Production server.

Iv. Submission

1.Submission using Pinnacle 21.

Demo Videos

ADaM Conversions and Extra Variables and Business Logics

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