About the Course
Oak Tree Technologies based in KPHB Colony, Kukatpally is providing professional training on Live Project training with real time scenarios. The training will mainly focus on CDISC, SDTM, ADaM, TLFs. The trainer is a Real time Technical expert, currently working with CMM Level 5 Company. This training will help you to utilize your SAS knowledge in real time projects.
What Is CDISC?
CDISC is an organization that develops industry standards. The standards support the electronic acquisition, exchange, and archival of clinical trials data and metadata for medical and biopharmaceutical product development. CDISC defines several data models for the interoperability of clinical data exchange.
The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of health care.
What is SDTM?
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). The Submission Data Standards team of Clinical Data Interchange Standards Consortium (CDISC) defines SDTM.
On July 21, 2004, SDTM was selected as the standard specification for submitting tabulation data to the FDA for clinical trials and on July 5, 2011 for nonclinical studies. Eventually, all data submissions will be expected to conform to this format. As a result, clinical and nonclinical Data Managers will need to become proficient in the SDTM to prepare submissions and apply the SDTM structures, where appropriate, for operational data management.
Topics CoveredSAS Clinical Project Content (CDISC SDTM ADaM TLF)
Part 1: INTRODUCTION
a. Introduction about the course
b. Introduction about the each deportments(clinical operations, CDM, Bio-statistics and Medical writing)
c. Detailed information about the Bio-Statistics (statistician, statistical programmers and SAS programmers)
d. Introduction about the Client, Regulatory bodies ,Submission of the study
e. Introduction to specifications
Part 2: CDISC -SDTM
a. Introduction of CDISC
b. Why CDISC and DATA standards
c. What are the versions of CDISC
d. Impact of CDISC Standards on Clinical Activities
e. CDISC Models
f. Study Data Tabulation Model (SDTM)
g. Analysis Dataset Models (ADaM)
h. Operational Data Model (ODM)
Fundamentals of SDTM
a. What is SDTM?
b. Observations and Variables in SDTM
c. Special Purpose Datasets
d. General Observation Classes in SDTM
e. SDTM Standard Domain Models
f. Creating New Domain
Submitting Data in Standard Format
a. Assumptions for Domain Models
b. General Assumptions for all Domains
Models for Special Purpose Domains
a. DM, CO, SE and SV
Domain Models Based on the General Observation Classes
a. CM, EX and SU
a. AE, DS, MH, DV and CE
a. LB, EG, VS, PE, IE and QS etc..
4. Trial Design Domains
a. TA, TE, TS, TI and TV
SDTM Mapping Programming Using SAs
SDTM Annotation on CRF
SDTM Mapping Specifications
Real time Project on SDTM
a. SDTM Mapping programming using SAS
b. SDTM Mapping Specifications
Part 3: CDISC -ADaM:
a. Introduction to ADaM
b. Why ADaM
c. Key Concepts
d. ADaM naming conventions
e. ADaM Implementation
f. Fundamentals of the ADaM Standards
g. Variables in General
h. ADSL variables
i. BDS Variables
j. Real time Project on ADAM
Part 4: TLFs
a. Introduction to Clinical Trail
b. Summary Reports (Tables Listings and Figg)
c. Introduction about the ICH E6,E9 and E3
g. Mock shells
h. Introduction about the statistical reports
i. Introduction about the clinical study report
j. SAS programs development, and validation (QC)
k. MeDRA Guidelines
l. Generating Summary Reports
m. Generating Listings
n. Generating Graphs
Real time Project on Phase II Clinical Trial Studies (Diabetics therapeutic area)
Who should attendCandidates must have completed base & advance SAS training or currently working on SAS to take up this training.
Pre-requisitesShould have basic knowledge of SAS.
What you need to bringA laptop if possible."