CDISC

 ADaM Concepts and Implementation

ADaM (Analysis data Model) is one of the required standards for data submission now to regulatory bodies. ADaM specifies the fundamental principles and standards to ensure that there is clear lineage from data collection to analysis. ADaM implementation offers following benefits Standardise: Adherence to ADaM means statistical programs for Analysis dataset generation and reporting are standardised with resultant increase in quality and efficiency Traceability: Traceability between Results and their source data elements is important from regulatory perspective. Implementing ADaM enhances traceability. 

Total Course content has been divided into 5 modules. Participants can register any one module or multiple modules on any of the mentioned dates.  Each one module will be very less theory and more hands on training.

Modules &  Date : 

Module 1 : Overview of ADaM Model Requirements & ADaM Metadata Submission

Date : 19th January,2022;

Module 2 : ADSL Data Structure

Date : 2nd February,2022; 

Module 3 : BDS Data Structure and BDS Implementation

Date : 16th February,2022; 

Module 4 : Occurrence Data Structure & Implementation  

Data:   2nd March,2022; 

Module 5 : Practical Strategy to build BDS dataset for Given Analysis requirements 

Data:  16th March,2022;

Duration of Each Module  : 3 hours

Time : 12 noon to 3pm IST (8.30am to 11.30am CET / 5.30pm to 8.30pm Sydney Time / 3.30pm to 6.30pm Tokyo time)

Mode of training : Virtual LIVE using Zoom

Course Fee : 4,000 INR per person per module for participants registering from India

                       100 USD per person per module for participants registering from outside India

Fees include complete training material and certificate.

Trainer's Profile :  

Trainer is a CDISC tabulate certified consultant. He has extensive  knowledge in CDISC for over a decade. He has imparted practical training to more than 1000 participants on SDTM, ADaM, CDASH standards at various corporate and public training courses in the last 10 years. He was previously associated with Novartis as statistical reporting group head, and later as Vice President, Clinical Technology of SIRO Clinpharm.

Please send your name, choice of modules with dates, company designation, contact number  to admin@scientiabio.com to register and call us at +91 804169 2453 / +91 9945318216 for any query or registration help.