Basic of Clinical Data Management

Unlock the Secrets of Clinical Data Management with Surabhi Jain! 🧑‍⚕️🚀

Course Title: Mastering the Basics of Clinical Data Management 📚

Headline: Transform Your Career with Expertise in Clinical Data Management ✨

Course Description: Dive into the world of Clinical Data Management with our comprehensive online course designed to equip you with the fundamental knowledge and skills required to thrive in the dynamic fields of Contract Research Organizations (CROs) and Pharmaceuticals. Surabhi Jain, an industry expert, will guide you through 10 insightful modules that cover everything from the basics to complex data management processes.

📌 Key Takeaways:

• A step-by-step understanding of Clinical Data Management principles and practices.
• Detailed insights into each clinical trial phase and its relevance to data management.
• Hands-on knowledge on completing Case Report Forms (CRFs) accurately and efficiently.
• Mastery over Clinical Data Management Systems and their operational nuances.
• Practical experience in data entry, cleaning, and handling external data sources.
• A thorough understanding of Medical Coding and its significance in clinical studies.
• Techniques for SAE (Serious Adverse Event) reconciliation and database lock procedures.

Course Modules:

1. Introduction to CDM: Get acquainted with the fundamental concepts of Clinical Data Management and understand its critical role in clinical research. 🎓

   • Overview of Clinical Data Management
   • Importance in the drug development process

2. Clinical Trial Phases in Clinical Data Management: Learn how data management evolves across different trial phases, from Phase I to Phase IV. 🕒

   • Understanding each clinical trial phase
   • Data management considerations for each phase

3. Case Report Form (CRF): Gain proficiency in designing and completing CRFs, which are the backbone of clinical data collection. 📊

   • Structure and function of a CRF
   • Best practices for CRF completion

4. Clinical Data Management System (CDMS/CDISC): Explore the leading systems used in the industry, including CDISC standards. 💻

   • Setting up and using a CDMS
   • Compliance with CDISC standards

5. Data Entry: Master the art of precise and error-free data entry within a clinical study environment. ✍️

   • Techniques for accurate data logging
   • Common pitfalls to avoid in data entry

6. Data Cleaning: Learn the intricacies of cleaning data, ensuring reliability and integrity for analysis. 🧪

   • Data validation processes
   • Identifying and resolving inconsistencies

7. Medical Coding: Understand how medical coding simplifies data collection and facilitates research analysis. 🔍

   • Medical terminology and its coding representation
   • Importance of accurate coding in clinical trials

8. Data Cleaning External Data: Develop skills to manage and clean external data sources, which are often complex and multifaceted. 🌍

   • Integrating external datasets into your study
   • Strategies for external data quality control

9. SAE Reconciliation: Learn the critical process of identifying, reconciling, and tracking SAEs throughout a clinical trial. 🚨

   • Steps in SAE reconciliation
   • Ensuring regulatory compliance in adverse event reporting

10. Database Lock: Understand how to prepare for and execute a database lock, an essential step before data analysis. 🗝️

    • Preparing for the final database lock
    • Ensuring data integrity and security during this crucial phase

By completing this course, you will be well-prepared to handle clinical data with confidence and precision, making you an invaluable asset to any CRO or Pharma company. 🌟

Enroll now and start your journey into the fascinating field of Clinical Data Management with Surabhi Jain – your gateway to a successful career in clinical research! 🎓✨