SAS Base & Advanced, CDISC, SAS Clinical, SAS Finance
Experience The New Learning Process
cdisc
The CDISC Vision is “informing patient care and safety through higher quality medical research”. The CDISC suite of standards supports medical research of any type from protocol through analysis and reporting of results. They have been shown to decrease resources needed by 60% overall and 70–90% in the start-up stages when they are implemented at the beginning of the research process.
Why this course?
The Clinical Data Interchange Standards Consortium (CDISC) is an open, multidisciplinary, neutral, non-profit standards developing organization (SDO) that has been working through productive, consensus-based collaborative teams, since its formation in 1997, to develop global standards and innovations to streamline medical research and ensure a link with healthcare. The CDISC mission is “to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare”.
Scheduled batches
Course Features
Instructor Live Sessions
There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
Real time case studies
Live project based on any of the selected use cases on the above selected Domain.
Assignments
Each class will be followed by practical assignments which can be completed before the next class.
24 x 7 expert support
We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.
Free job support
After joining to new Job we will provide free Job support untill you feel settled in Job.
Course curriculum
CDISC SDTM ADaM TLFs Content
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
f. Introduction of CDISC
g. Why CDISC and DATA standards
h. What are the versions of CDISC
i. Impact of CDISC Standards on Clinical Activities
j. CDISC Models
k. Study Data Tabulation Model (SDTM)
l. Analysis Dataset Models (ADaM)
m. 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
g. Assumptions for Domain Models
h. General Assumptions for all Domains
Models for Special Purpose Domains
i. DM, CO, SE and SV
Domain Models Based on the General Observation Classes
1. Interventions
a. CM, EX and SU
2. Events
a. AE, DS, MH, DV and CE
3. Findings
a. LB, EG, VS, PE, IE and QS etc..
4. Trial Design Domains
a. TA, TE, TS, TI and TV
Supplemental Qualifies
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
k. ADSL, ADAE, ADEX, ADMH, ADLB, ADVS etc..
Part 4: TLFs
a. Introduction to Clinical Trail
b. Summary Reports (Tables Listings and Figg)
c. Introduction about the ICH E6,E9 and E3
d. Protocol
e. CRF/eCRF
f. SAP
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
o. Real time Project on Phase II Clinical Trial Studies (Diabetics therapeutic area)
Part 5: Define.xml
Introduction to define.xml
Introduction to open cdisc
Projects
Two Real time Clinical SAS Projects on SDTM,ADaM, TLF’s.
faq 's
Yes, you can always attend our demo classes before you decide to enroll for the course.
If you miss a class, we provide you with the recorded video of the missed class and you can attend the missed session in another batch of the same session.
Yes, we do provide full 100% assistance for placements/Jobs.
We offer the following services at SUDARSHAN SAS CLASS sessions:
- Online sessions with corporate trainers
- Full -detailed and well-structured course material
- Real-time projects are presented by the experts in the industry
- Regular practical assessments and tasks are assigned
Full assistance is given for resume preparation to get selected for a good job.
- Doubt clarification sessions to help you prepare to get a job.
- We give full assistance to create a powerful effective resume.
- We assist you by taking mock interviews to prepare you for the real interview.
- We offer full assistance for placements.
certification
1. Once you are successfully through the course you will be ready of Base & Advance SAS cerification exam.
2. Free Certification Related Books & materials will be provided as part of training .
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