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Training
Courses are normally conducted in the evenings after working hours and will run for 5 days with a duration of 90 minutes every day. Registration would be expected one month before the course begins. Courses start on first Monday of last month of each quarter. Class size would be a maximum of eight. Specific Details of courses are as follows:
SAS Programming :
Guiding SAS Programmers/Analysts involved with submissions, periodic reporting for DSMB and other regulatory agencies enable them to take certification exams by SAS Institute. Provides insights into CDISC standards, ICH E3 guidelines for reporting, data extraction, transformation and Loading, data sanitation, creating value added datasets and analysis datasets, coding standards and QC/QA of data and reports.
Clinical Data Management :
Enables Clinical Research Assistants (off-site staff) and Clinical Research Coordinators (on-site staff) to effectively perform the activities like data acquisition, cleaning and management, AE/SAE reconciliation, design CRFs/eCRFs, manage queries, understand dictionary coding, protocol documents, SAPs and monitoring guidelines, prepare for DSMBs and submissions, and conduct trials more effectively. Course also covers understanding SOPs, EIC, eDiaries and Random Codes.
Systems Validation :
Helpful to validation staff involved with Systems Validation. Compliance and Testing enable you to understand regulatory requirements and Systems Design Life Cycle Process. Elements of clinical trials design, SOPs and submissions are also covered.
Statistical Analysis :
Helpful to Statisticians involved with Clinical Trials. Enables you to create sample size, understand study design, create random codes and prepare Statistical Analysis Plans, Review study materials (e.g. CRF, CSR) to ensure conformity with protocol content. Essentials of performing interim analysis and final analysis are also covered.