SAS CDM Training
SAS Clinical data management is a tool practiced in clinical research to handle data coming from various clinical sources. It gathered data from various clinical sources at the investigator site in the form of case reports and stored in the CDMS. It completely reduces the probability of occurring errors due to human intervention, the system employs various ways to standardize the data. It Creates, handles and standardizes clinical research metadata and data. It provides agility and ability by automating repeatable clinical data integration tasks.
|Instructor – Led Live Online Training||Connect Live|
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|Course Name||SAS CDM Online Training|
|Contents||Fundamentals and Concepts of Clinical Data Management|
|Duration||30 Hours with Flexible timings|
|Delivery||Instructor Led-Live Online Training|
|Ideal For||Aspiring job seekers in the field of SAS Data Management|
|Availability||Regular/Weekend Batches. 24×7 teaching assistance and support.|
What you’ll learn in SAS CDM Training Course?
- Understand the complete Clinical Data Management process.
- Understanding of key enterprise clinical data management tools.
- Understanding the management of clinical data used in projects and clinical trials.
- Learn and create up a comprehensive plan for a sample project.
- Understand the techniques used for analysis of the data from various sources.
What are the pre-requisites to learn SAS CDM Course?
Experience of Working in the Health or Pharmaceutical Sector, Knowledge in Clinical Database Maintenance
MODULE 1: CLINICAL DATA MANAGEMENT INTRODUCTION
TOPICS: Crf Design for Clinical Trial, Data – Definition & Types, Query Resolution, 21cfr Part 11 Compliance, Edc System, Database Locking, Drug Safety, And Database Update, Data Management in Epidemiology, Data Privacy, Data Management in Pharmacoeconomics
MODULE 2: PROJECT MANAGEMENT
TOPICS: Project Management for the Clinical Data Manager, Data Management Plan, Data Management Standards in Clinical Research, Vendor Selection, and Management, Edit Check Design Principles, Design and Development of Data Collection
MODULE 3: ELECTRONIC DATA CAPTURE AND CASE REPORT FORMS
TOPICS: CRF Completion Guidelines, Electronic Data Capture- Conduct & Close Out, Concepts and Study Start-Up
MODULE 4: VALIDATION
TOPICS: External Data Transfer, Standards, Programming, And Data Validation, CDM Presentation at Investigator Meetings, Patient- Reported Outcomes, Systems Software Validation Issues
MODULE 5: DATA QUALITY & INTEGRITY
TOPICS: Assuring Data Quality, Data Quality and Data Integrity, Data Storage, Measuring Data Quality, Safety Data Management, and Reporting, Data Entry Process, Serious Adverse Event Data Reconciliation, Database Closure, Medical Coding Dictionary Maintenance, and Management, Clinical Data Archiving
MODULE 6: METRICS FOR ELECTRONIC CLINICAL TRIALS
TOPICS: Clinical Trials Metrics Collection, Objectives & Introduction, Re-Engineering the Clinical Data Management Process
MODULE 7: QUALITY AUDITS
TOPICS: Audit Standards, Audit – Definition, Types & Procedures, Audit Plan, Audit Trail & its Role in Authenticity of Data, Logistics, GDP and GMP, Audit by Regulatory Authorities, What Makes a Good Audit, Preparing and Delivering Audit Reports, New Product Development & GXP Regulations
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