What You Will Learn

• CDM Fundamentals

  Understand the importance and evolution of CDM in clinical research.

• Study Lifecycle Management

  Navigate the study lifecycle, from start-up to close-out, with expertise in CDM processes.

• Project Management

  Apply project management principles in clinical trials, including risk management, audit readiness, and timeline tracking.

• EDC & IWRS/IVRS Systems

  Utilize tools like Electronic Data Capture (EDC), Interactive Web Response System (IWRS), and Interactive Voice Response System (IVRS).

• Study Documents

  Prepare and manage key study documents, such as Case Report Forms (CRFs), Study Design Specifications (SDS), Data Validation Plans (DVP), and Clinical Study Protocols.

• Data Cleaning & Coding

  Implement data cleaning, query management, and coding processes using dictionaries like MedDRA and WHO-DD.

• Quality Control

  Conduct quality checks and interim analysis, ensuring data accuracy, compliance, and integrity.

• Database Lock

  Execute close-out activities, including database soft/hard lock procedures and regulatory documentation.

Why Choose This Course?

• Industry-Relevant Curriculum: Covers all phases of CDM, including start-up, conduct, and close-out, aligned with current clinical research practices.

• Hands-On Learning: Real-world scenarios for eCRF completion, database testing, and data validation.

• Regulatory Insight: Emphasizes ICH GCP guidelines, data privacy, and audit readiness.

• Career Advancement: Equips learners for roles such as Clinical Data Manager, Data Coordinator, or Project Management Support in clinical research.

• Supplementary Resources: Access to mock eCRF and study workflow templates, EDC/IWRS/IVRS tools, MedDRA and WHO-DD coding dictionaries, and templates for Project Health Tracker, Soft Lock/Hard Lock forms, and Audit Preparation.

Career Outcomes

After completion, learners can pursue roles such as:

• Clinical Data Manager

• Data Coordinator

• Project Management Support in Clinical Research

• Clinical Data Associate