What makes us different?
At Resolve Medicode, we take a unique approach to prepare our professionals career in clinical data management. Our mission is to bridge the gap between academic learning and industry expectations through focused, practical and career-oriented training. Our coaching program is designed to reflect the latest standards in clinical data management. We develop our syllabus based on real world job roles, regulatory requirements and current industry’s demand. Topics ranges from ICH-GCP guidelines to advance data handling, query management and data validation process.
Our skilled instructors who are experienced professionals and also worked on global clinical data management, so they understand what employers are looking for. This means you will get insight knowledge directly from people who been in the field. We provide real world experience by offering hands on training in clinical data management course with key tools. Candidates practice in the stimulated environment to build confidence and gain clinical data management course certification by our institute.
Who can join?
- Life science, Pharmacy, Biotechnology graduates
- Working Professionals in Healthcare
- Students looking for a career in clinical data management
What you’ll learn?
1: Introduction to Clinical Research
Overview of clinical trials and phases (I–IV)
Role of clinical data management in drug development
Key stakeholders: Sponsor, CRO, Investigator, Regulatory Bodies
GCP (Good Clinical Practice) guidelines
2: Fundamentals of Clinical Data Management
Definition and objectives of CDM
CDM life cycle overview
Roles and responsibilities of a CDM professional
Regulatory bodies (FDA, EMA, ICH-GCP) and their impact on CDM
3: Clinical Trial Design and Protocol Review
Clinical trial protocol structure
Case Report Form (CRF) design principles
Data collection strategies (paper vs. electronic)
Importance of protocol adherence
4: Case Report Form (CRF) Design
CRF components and layout
Data fields, validations, and edit checks
CRF annotation and completion guidelines
Tools for CRF design (e.g., InDesign, XML templates)
5: Data Management Plan (DMP)
Purpose and structure of a DMP
Key components: database design, validation rules, timelines
Version control and amendments
Role of DMP in regulatory inspections
6: Electronic Data Capture (EDC) Systems
Overview of EDC systems (e.g., Medidata Rave, Oracle Clinical, REDCap)
User roles and access controls
Data entry and edit checks
Source Data Verification (SDV)
7: Data Validation and Cleaning
Data validation process and edit check development
Queries: raising, tracking, and resolving
Discrepancy management tools
Handling missing and inconsistent data
8: Coding Clinical Data
Introduction to medical coding in CDM
MedDRA (Medical Dictionary for Regulatory Activities)
WHO-DD (World Health Organization Drug Dictionary)
Coding AE/SAEs and concomitant medications
9: SAE Reconciliation and Quality Control
Adverse Event (AE) and Serious Adverse Event (SAE) reporting
Reconciliation of safety and clinical databases
Data quality metrics and audits
Data cleaning reports and tools
10: Database Lock and Archival
Data review meetings and pre-lock activities
Database freeze vs. lock
Final reconciliation and archiving procedures
Regulatory submission readiness
11: Regulatory Guidelines & Compliance
ICH-GCP, 21 CFR Part 11 compliance
CDISC (Clinical Data Interchange Standards Consortium) standards
Audit trail and data traceability
Role of quality assurance in CDM
12: Career Preparation & Certification
Resume building and interview guidance
Mock interviews and case-based discussion
Overview of global CDM certifications (SCDM, CCRP)
Freelance, remote, and global job opportunities in CDM
Key Features:
Industry Relevant Curriculum: Covers complete CDM lifecycle including data collection, validation, cleaning, database lock aligned with global clinical data standards.
Access to study materials: Well-structured study materials and tool manuals for self-spaced revision and practice.
Hands on Training: Practical sessions on widely used CDM tools techniques for our candidates.
Flexible learning options and Duration: Live sessions and recorded sessions for our candidates to choose which will be ideal for them and provide 45 days course duration.
Assessments and Certification: Regularly candidates are assessed and a recognised course completion certificate to validate your learning.
Placement Support: Job referral support to help you transition confidently to workforce.
