CDISC (Clinical Data Interchange Standards Consortium) 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.

Course Outline
SDTM stands for Standard Data Tabulation Model defined by Clinical Data Interchange Standards Consortium (CDISC). SDTM defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted to a regulatory authority like FDA as part of a product application. SDTM standard is widely used in the industry, such requirements were standardized and are broadly shared. SDTM should be followed by Data Manager while designing eCRF. SDTM bridges the gap between data manager and statistician by eliminating the dependancy of stastistical programmer. Particular requirements of statisticians and modeling scientists for data formats are known and understood by SDTM. SDTM increase the efficiency of the drug development process. SDTM gives a more consistent and robust CDM approach compared to collecting the clinical data in CDISC standard.

ADaM stands for Analysis Data Model defined by Clinical Data Interchange Standards Consortium (CDISC). ADaM defines a standard for Analysis Dataset’s to be submitted to the regulatory authority like FDA. This provides a clear content, source, and quality of the datasets submitted in support of the statistical analysis performed by the sponsor. The principle of clear and unambiguous communication, relies on clear AD's (Analysis datasets) documentation. ADaM helps to statndardise this documentation.

The training programs provided by Clinnovo are suitable for Life science Graduates, Doctors, Medical Professionals, Pharmacists etc.

Anyone of the following minimum qualification is mandatory to eligible.

  • B.Sc / M.Sc in Biotechnology

  • B.Sc / M.Sc in Microbiology

  • B.Sc / M.Sc in Genetics

  • B.Sc / M.Sc in Biochemistry

  • B.Sc / M.Sc in Life Sciences

  • M.B.B.S / B.D.S / B.A.M.S / B.H.M.S

  • B.Pharmacy / M.Pharmacy

  • Pharm.D

  • Graduates or Post Graduates in Nursing

  • B.E (BT) / B.Tech (BT)

  • Ph.D in Life Sciences / Biomedical Science

Course modules:

  • Understanding of SDTM Implementation Guide

  • Basic of SDTM Domains

  • CDISC Variable types and their importance

  • Fundamentals of CDISC SDTM

  • Special Purpose Domains

  • Creating Custom SDTM Domains

  • Timing variables in SDTM

  • CDISC SDTM core variables

  • Supplemental Qualifiers

  • Dealing with Non standard data.

  • Controlled terminology and different types in it.

  • SDTM Assumptions

  • Special Purpose Domains (DM,CO,SE,SV)

  • Interventions(CM,SU,EX,PR)

  • Events(AE,CE,DS,DV,HO,MH)

  • Findings(DA,PE,VS,LAB,IE,QS,RP,SS,ECG)

  • Annotation of Annotated CRF as per SDTM

  • Creation of Mapping/Metadata Specification as per SDTM Guidelines

  • Creation of different SDTM Datasets(DM,AE etc)

  • Creation of Trial Design Domain datasets.

  • Programming of Various Standard SDTM Macros like study day,empty dataset etc.

  • SDTM datasets validation and resolution

  • FDA Submission standards of SDTM


  • ADSL Subject level information basics

  • BDS basics

  • ADaM Implementation Rules

  • Creation of ADaM Metadata Specification

  • Creation of ADAM datasets (ADSL and BDS dataset)

  • ADaM datasets validation and resolution

  • Creation of ADaM Define.XML

  • Creation of Analysis Data Reviewers Guide.

  • FDA Submission standards of ADAM datasets


  • Creation of Safety tables

  • Creation of Efficacy tables

  • Calculation of treatment variables, study day etc.

During the training period thefollowing modules will be covered as a part of Student career Improvement Program.

  • Communication and Soft skill development

  • Just A Minute Sessions

  • Seminars

  • Case studies

  • Mock interviews

  • Guest lectures

  • Student improvement program

  • Professional career building

  • Organizing Resume

  • Knowledge Sharing on new techniques

For more information please contact at 9912868928
Can I attend a demo session before enrollment?
What Features do you provide?

Class Room & Online Live sessions
Ongoing projects
Expert faculty 
Mock Interviews 
Aptitude Test 
Guest Lectures 
Lab facilities
Resume preparation
Placement assistance
Software installation
Clarification Q&A sessions

Do I receive a certificate for training ?

Once you are successfully through the course you will be awarded with Clinnovo Training certificate.


(5 Ratings)

Provide Your Rating

Gabriele Accetta

Statistical Lead

In this online course, Clinnovo gives me the opportunity to explore CDISC beyond the traditional textbook or guideline. The 1-to-1 online course CDISC SDTM ADaM TLF is well-structured and the course schedule is very flexible. Exercise and examples are a great study Guide resources making me get started in looking in CDISC details. Highly recommended!


SAS-SDTM-Mapping Programmer

Clinnovo provided an excellent and effective Online training in CDISC SDTM in Hitech City. The courses were well designed and well taught out with the right level of challenge for new comers like me. I have found this courses very beneficial and feel the techniques learned will enable me to secure a good job in the future.


SDTM SAS Programmer

Its been great being with u people for 3 months of time learning about the course in CDISC - SDTM - ADaM, Hyderabad. Your faculty has been very friendly and helpful whenever needed with out any hesitation and made me understand the subject better. Thank you for providing me such a good training.