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Clinical Data Management Training with OC and Rave EDC

Build practical Clinical Data Management skills through hands-on training with Oracle Clinical, Oracle RDC, Medidata Rave EDC, CRF design, validation, discrepancy management, coding, reconciliation, and database lock workflows.

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Who this is for

Life-sciences, pharmacy, healthcare, and clinical research graduates targeting CDM roles
Candidates preparing for Clinical Data Coordinator, Clinical Data Associate, Clinical Data Analyst, or Clinical Data Manager roles
Professionals who want practical exposure to Oracle Clinical, Oracle RDC, Medidata Rave EDC, and CDM database workflows

Outcomes

Understand the complete CDM lifecycle from study startup to database lock
Create, review, annotate, and manage CRFs and eCRF specifications
Work through edit checks, validation plans, discrepancy management, manual queries, DCFs, and query resolution
Understand coding, SAE reconciliation, external data reconciliation, lab/vendor reconciliation, and database freeze or lock steps
Gain practical exposure to OC, RDC, Rave EDC, Rave Architect, and live project-style database work

Tools and topics

Core concepts and platforms covered through examples, assignments, and interview preparation.

Oracle ClinicalOracle RDCMedidata Rave EDCRave ArchitectCRFeCRFEdit ChecksDCFMedDRAWHODDCDASHSDTM

Course content

Structured modules for practical learning.

Clinical Research and CDM Foundations

Clinical research introduction and clinical trial phases
Trial designs, study types, and clinical study workflow
IND, NDA, and ANDA overview
CRO model and clinical trial team responsibilities
Protocol, Investigator's Brochure, Informed Consent Form, and CRF basics
ICH-GCP, IRB/IEC, 21 CFR Part 11, and SOP overview

Clinical Data Management Lifecycle

CDM overview and importance in clinical trials
Study startup, conduct, and closeout activities
Clinical Data Management Plan with practical examples
CDM team roles, responsibilities, and communication flow
Project milestones, data review cycles, and closeout readiness

CRF, eCRF, and Database Setup

Case Report Form types and design principles
CRF Completion Guidelines and CRF tracking
CRF annotation and eCRF specification preparation
Data capture methods, EDC workflow, and database setup concepts
CCG live example and practical study build discussion

Data Entry, Validation, and Edit Checks

First-pass and second-pass data entry concepts
Edit check specifications and validation rules
Data validation plan and validation procedure
System checks, manual checks, data review, and discrepancy identification
Quality control practices for clean clinical trial data

Discrepancy and Query Management

Discrepancy types and discrepancy lifecycle
Manual queries and Data Clarification Forms
Query generation, routing, response review, and closure
Site communication and follow-up practices
Pre-closure checks before freeze and lock

Coding and Reconciliation

Medical coding and dictionary coding overview
MedDRA and WHO Drug Dictionary concepts
SAE reconciliation process
External data, vendor data, and lab data reconciliation
Coding review, reconciliation issues, and resolution workflow

Database Freeze, Lock, and Unlock

Database freeze and lock concepts
Pre-lock checks, final review, and sign-off workflow
Database unlock scenarios and controlled change handling
Audit trail, compliance, and documentation expectations
End-to-end project closeout practice

Oracle Clinical and Oracle RDC

Oracle Clinical workflow and study setup concepts
Oracle RDC data entry and review workflow
Clinical database navigation and practical data review
Query management in Oracle Clinical and RDC
Hands-on live database project exposure

Medidata Rave EDC and Rave Architect

Rave EDC overview and study navigation
Rave Architect concepts for forms, fields, folders, and edit checks
Data entry, review, discrepancy handling, and query closure in Rave
Rave database workflow and project practice
Practical interview-focused CDM scenarios

Potential recruiters

Training connected to pharma, CRO, healthcare data, and technology roles.

FAQs

Clinical Data Management questions

Quick answers for candidates evaluating this course before applying.

Who is the Clinical Data Management course best for? +

Life-sciences, pharmacy, healthcare, and clinical research graduates targeting CDM roles Candidates preparing for Clinical Data Coordinator, Clinical Data Associate, Clinical Data Analyst, or Clinical Data Manager roles Professionals who want practical exposure to Oracle Clinical, Oracle RDC, Medidata Rave EDC, and CDM database workflows

What will I learn in Clinical Data Management? +

Understand the complete CDM lifecycle from study startup to database lock Create, review, annotate, and manage CRFs and eCRF specifications Work through edit checks, validation plans, discrepancy management, manual queries, DCFs, and query resolution Understand coding, SAE reconciliation, external data reconciliation, lab/vendor reconciliation, and database freeze or lock steps Gain practical exposure to OC, RDC, Rave EDC, Rave Architect, and live project-style database work

Is this course instructor-led? +

Yes. Clini Data Curve courses are positioned as instructor-led live online training with recordings, assignments, assessments, resume preparation, mock interviews, and placement assistance.

How do I apply for this course? +

Use the Apply Now button or enquiry form to share your details and selected course. The team can guide you on batches, fit, and next steps.

Need guidance?

Talk to Clini Data Curve before choosing your course.

Share your background and career goal. The team can help you choose the right CDM, pharmacovigilance, SAS Clinical, CRA, medical coding, or clinical research path.

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