Clinical Data Management (CDM) and EDC Systems Corporate Training
Learn to run clean, compliant clinical trial data, from EDC study build and eCRF design to query management and database lock.
Edstellar, a corporate training company, delivers this instructor-led program for clinical teams that build and manage EDC systems. Your team will learn to configure studies, validate data, and run audit-ready data reviews in guided labs.
Instructor-led group trainingVirtual / on-site / off-site10 languagesDelivered inEnglish, Spanish, Mandarin, German, Arabic, Portuguese, Hindi, French, Japanese, Italian100+ countriesWe have delivered inUnited States, United Kingdom, India, Canada, Germany, France, Netherlands, UAE, Saudi Arabia, Singapore, Australia, Japan, Brazil, South Africa and 90+ more countries
How we build a audit-ready clinical data team
The Edstellar CLINICAL DATA MANAGEMENT Capability Model
Diagnose CDM capability
Skill checks map your team's EDC fluency, data quality habits, and regulatory baseline.
Standardize data workflows
Common eCRF patterns, edit checks, and query rules bring consistency across studies.
Practice in guided labs
Hands-on labs build EDC studies, validation rules, and discrepancy workflows in test systems.
Measure data quality
Data quality metrics and review checkpoints track accuracy from entry to database lock.
Scale across studies
Reusable study templates and query playbooks extend clean data practice to every trial.
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Program Overview: What is Clinical Data Management (CDM) and EDC Systems?
Clinical Data Management (CDM) & EDC Systems is Edstellar's instructor-led program for clinical data managers, trial coordinators, and biopharma operations teams who own the quality of trial data. Over 24 hours, participants learn trial data foundations and regulatory essentials, EDC study builds, data validation and query management, medical coding, and database lock procedures. The program is built around one standard: data an inspector would accept.
Participants build a study in an EDC environment from scratch, forms, edit checks, visit schedules, then run it: entering data, resolving queries, coding adverse events, and reconciling external data. Instructors with trial experience review validation rules and audit trails the way regulators do. Six practice sessions rehearse each phase before the capstone: a complete end-to-end EDC study build and data review.
Dirty trial data is expensive data: queries pile up, database lock slips, and inspections find what your team missed. Many CDM teams learn EDC systems by clicking around production studies. This program teaches the disciplined alternative, design the database right, validate continuously, manage queries to closure, and lock with an audit trail that tells a clean story.
The capstone has each team build and run a small study end to end, study build, data entry, query resolution, coding, and a mock database lock with inspection-ready documentation. They return ready to run the data side of a trial without the usual firefighting at lock time.
Edstellar delivers this program as hybrid training with live virtual and onsite options, tailored to your EDC environment and study portfolio. Sessions focus on day-to-day work: eCRF design, edit checks, query workflows, coding and reconciliation, and database lock. Teams leave with study templates, query playbooks, and data quality checklists they can apply to active trials immediately.
What's Included in this Workshop for Your Enterprise Teams
- 1
EDC study build
Configure studies, visits, and user roles in a test system.
- 2
eCRF design labs
Design forms, fields, and edit checks for real trial flows.
- 3
Query management practice
Raise, track, and resolve data discrepancies end to end.
- 4
Coding and reconciliation
Code terms and reconcile laboratory and safety data.
- 5
Lock readiness drills
Review audit trails and prepare for database lock.
- 6
Capstone build
Deliver a complete EDC study build with data review.
- Live instructor-led sessions, hybrid, virtual, or onsite
- Test EDC environment for every guided lab
- Study templates, eCRF patterns, and query playbooks
- Data quality metrics and review checklists
- Skill assessment and capstone build review
- Post-training support and rollout guidance
Build your team's skills. Anywhere in the world.
Real-world use cases
from day one
Instructor-led training
for your teams
Delivered globally
in 100+ countries
Enterprise Training Solutions Customized for Your Company
One partner for instructor-led corporate training, delivered the way your teams work.
Request a Training Quote- Customized Training Delivery
- Scale Your Training: Small to Large Teams
- In-person Onsite, Live Virtual or Hybrid Training Modes
- Plan from 2000+ Industry-ready Training Programs
- Hands-On Labs on Live Infrastructure, Led by Industry Experts
Clinical Data Management (CDM) and EDC Systems Course Topics and Program Outline
A tailored 24-hour, six-module workshop: one learning journey from clinical data foundations to a capstone EDC study build. Sessions pair concepts with guided labs on study configuration, validation, query management, and inspection-ready data reviews.
Built by Edstellar with clinical data operations expertise
Built by practitioners who run clinical data management and EDC builds in production, shaped around your stack and use cases.
Skill checks map your team's EDC fluency, data validation habits, and regulatory awareness before training begins.
Instructor-led sessions cover trial data foundations, EDC study build, and validation rules for clinical data teams.
Guided labs in test systems build EDC studies, eCRFs, and query workflows your team will use daily.
A capstone EDC build with data review and lock procedures transfers skills directly to live studies.
From clinical data foundations to a capstone EDC study build, every technique is practiced in guided labs.
Delivered as
Delivered as a hybrid program of live instruction and guided labs, scheduled around your team's calendar in flexible batches.
Walk through a sample EDC study and map its data flow end to end.
learna)Trial phases and the flow of clinical data
b)ICH GCP E6 data integrity principles
c)FDA 21 CFR Part 11 and e-systems compliance
d)Roles across CDM, operations, and biostatistics
Configure a practice study with visits, forms, and user roles in a test system.
learna)Anatomy of a modern EDC platform
b)eCRF design and the data dictionary
c)Field types, visit schedules, and forms
d)User roles, permissions, and site setup
e)Edit checks and configuration basics
Build edit checks, load sample records, and run the query workflow end to end.
practicea)Data validation plans and edit check libraries
b)Query lifecycle: raising, tracking, resolving
c)Manual and automated discrepancy management
d)Data review workflows and source data checks
Code sample terms and reconcile lab and safety datasets with study data.
practicea)Medical coding workflows and dictionaries
b)Laboratory data transfer and reconciliation
c)Serious adverse event data reconciliation
d)Interim data reviews and quality metrics
Review audit trails, complete pre-lock checks, and run a mock lock drill.
applya)Pre-lock data review and cleaning
b)Database lock procedures and sign-offs
c)Audit trail review and ALCOA-C principles
d)Inspection readiness for sponsor and regulator audits
Deliver a complete EDC study build with validated data and a lock-ready review.
applya)Design the study build and eCRFs
b)Configure edit checks and user roles
c)Load sample data and run validation
d)Execute query management and the final data review
Customize this program tailored to your team?
Tell us your training needs: what your team already works with, the level they’re at, and the topics you want them to focus on. We’ll adjust the modules, duration and hands-on labs, and send you a customized outline for your group.
Key Skills and Outcomes Your Team Will Gain
Seven job-ready outcomes your team will demonstrate by the end of the program. Each competency is practiced in guided labs and reviewed in the capstone build.
Set up EDC studies
Configure study builds, visit schedules, and user roles in electronic data capture systems.
Design eCRFs and data dictionaries
Build forms, fields, and dictionaries that capture clean, analysis-ready trial data.
Build validation rules and edit checks
Write edit checks and validation plans that catch discrepancies at entry.
Manage queries and discrepancies
Run the full query lifecycle from raising and tracking to resolution with sites.
Code and reconcile external data
Apply coding standards and reconcile laboratory and safety data with study records.
Run audit-ready data reviews
Review audit trails and quality metrics to keep data inspection-ready throughout.
Execute database lock
Complete pre-lock checks, lock procedures, and sign-offs with confidence.
Teams that Benefit from this Clinical Data Management (CDM) and EDC Systems Group Training
This group training is built for clinical teams running trials with electronic data capture, from study startup to database lock. Content adapts to each cohort's roles, EDC system, and experience, so every batch practices the workflows it owns, from eCRF review to lock readiness.
Keep trial data clean from first patient in
Operations teams run site data entry, monitor visit schedules, and keep studies moving. This program gives them reliable EDC workflows and clear query handling.
Workflow friction
- Slow query turnaround with sites
- Inconsistent data entry standards
- Rework before database lock
How the program helps
- Faster query resolution at sites
- Fewer data discrepancies at entry
- Clean handoffs to data management
Practice use cases
- Site query workflows
- Visit schedule tracking
- Entry quality checks
- Issue escalation paths
Build studies and rules that hold up under audit
Data managers design eCRFs, write edit checks, and own data quality through lock. They practice study builds and validation in guided labs.
Workflow friction
- Late protocol amendments
- Inconsistent coding and queries
- Lock delays from dirty data
How the program helps
- Reusable study build templates
- Stronger edit check coverage
- Audit-ready documentation habits
Practice use cases
- eCRF design
- Edit check configuration
- Query lifecycle management
- Database lock drills
Get analysis-ready datasets on schedule
Biostatistics teams depend on clean, locked datasets. They learn data review routines and quality metrics that protect downstream analysis.
Workflow friction
- Dirty data reaching analysis
- Opaque quality reporting
- Repeated review cycles
How the program helps
- Faster data review cycles
- Clearer data quality signals
- Reliable handoffs to analysis
Practice use cases
- Interim data reviews
- Quality metric dashboards
- Review checkpoint design
- Lock readiness checks
Prove data integrity to inspectors
Quality teams verify ALCOA-C compliance, audit trails, and inspection readiness. They practice review routines that stand up to regulator scrutiny.
Workflow friction
- Gaps in audit trail review
- Inconsistent documentation
- Inspection preparation pressure
How the program helps
- Inspection-ready audit trails
- Consistent integrity checks
- Fewer audit findings
Practice use cases
- ALCOA-C checks
- Audit trail reviews
- Inspection drills
- CAPA documentation
Cohorts train as a cross-functional workforce, with each small group aligned on shared data quality and review standards.
Prerequisites: This program benefits clinical operations, data management, biostatistics, and quality teams working on clinical trials. Basic familiarity with clinical research helps but is not required, and no prior EDC experience is needed. Content adapts to each cohort's EDC environment, study portfolio, and experience level.
Clinical Research Associate to Clinical Data Manager
Move from trial data foundations to advanced EDC configuration and confident database lock execution as modules build toward the capstone.
A program that grows with clinical data careers, from first eCRF review to confident database lock.
Different Teams, Locations, Time Zones, or Languages? We've Got You Covered.
Whether your teams are spread across countries, time zones, languages, or experience levels, we deliver tailored training programs that ensure a consistent learning experience across your global workforce.
Certificate of Training Completion.
On successful completion, employees receive an Edstellar course completion certificate, recognizing their commitment to ongoing learning and professional development. It validates the skills they have built and motivates them to keep growing and contribute to organizational success.
Earned, not attended. Awarded on completion of all hands-on labs and the capstone project.
Training Delivery Modes: Onsite, Virtual and Hybrid
Recordings and lab guides are shared on your LMS so the team can revisit each session after the live training.
Onsite Training
Onsite training brings the instructor to your team, with guided labs in a test EDC environment and your study workflows as examples.
- Dedicated instructor at your location
- Labs tailored to your EDC environment
- Team workshops on your active studies
- Same-day feedback on capstone builds
Live Virtual Training
Live virtual training over Zoom or Teams delivers the same guided labs and instructor support as onsite batches, wherever your team sits.
- Live virtual sessions with screen-sharing labs
- Test EDC access for every participant
- Small batches for personal feedback
- Recordings and guides on your LMS
Hybrid Training
Hybrid delivery blends live virtual instruction with onsite lab days, so teams across sites train together on the same EDC workflows.
- Live sessions led by clinical data practitioners
- Onsite lab days for complex study builds
- Virtual sessions for reviews and query drills
- Flexible scheduling across time zones
Need a customized training format that works for your team?
Our training delivery is customized to your team's schedule, full days, half days, sessions spread across weeks, or modular formats. Share your preferred timeline, and we'll plan the training around it.
Frequently Asked Questions
Share your team size, timelines, and delivery preference, and we will send a detailed per-group quote with batch options.
Yes. Book a discovery call and we will map your EDC environment, study goals, and timelines into a tailored training plan.
Yes. The program runs as live virtual training over Zoom or Teams, with the same guided labs and instructor support as onsite batches.
Yes. Onsite training brings the instructor to your location, with labs in a test EDC environment and your team's workflows as examples.
The program runs 24 hours, typically across four days or in flexible half-day batches to fit your team's calendar.
Question not answered here?
Put it in the request. A training specialist answers it directly, within one business day.
Where this Training Fits in Your Team's learning path.
Clinical data management follows GCP, so your team handles trial data within the rules that protect patients and data integrity. Clean, locked data then supports biostatistical analysis, and the path ends with using AI in clinical trials.
LEARN GCP
Good Clinical Practice (GCP) ICH E6(R3) Training
Learn ICH E6(R3) Good Clinical Practice principles that govern how trial data is handled.
MANAGE TRIAL DATA
Clinical Data Management (CDM) & EDC Systems Training
Build CRFs, manage EDC systems, clean data and prepare databases for lock.
ANALYSE THE TRIAL
Biostatistics for Clinical Research Training
Analyse locked trial data with sound statistical methods to answer the study questions.
ADD AI TO TRIALS
AI in Clinical Trials Corporate Training
Apply AI to trial design, recruitment, monitoring and data review.
Why Choose Edstellar as Your Clinical Data Management (CDM) and EDC Systems Corporate Training Provider
When comparing providers, Edstellar is the training partner teams choose for clinical data expertise and 5+ years of corporate training experience. Our methodology blends concise instruction with guided labs, and we share each trainer profile before booking.
EXPERT TRAINERS
YEARS DELIVERING
ORGANIZATIONS TRAINED
CERTIFIED
Tailored
Content is shaped around your EDC system, study portfolio, and data quality goals, so every lab mirrors real work.
Proven Methodology
Assess, learn, practice, and apply stages move teams from data basics to capstone builds with measurable progress.
Practice-Based Learning
Guided labs in test EDC environments build study configuration, query handling, and review skills through doing.
Expert Trainers
Sessions are led by practitioners with 5+ years in clinical data operations and EDC delivery across trial phases.
Global Scale
Hybrid and virtual delivery support cohorts across sites and time zones with consistent content and standards.
Measurable Outcomes
Skill checks, lab reviews, and data quality metrics show exactly how team capability improves after training.
Develop Clinical Data Management Through Controlled Study Builds and Review Evidence
Edstellar connects clinical data foundations with EDC configuration, validation, reconciliation, and database review. Participants build a practice study and work through queries and coding using sample records. The final study review examines data consistency, traceable corrections, and pre-lock evidence, reinforcing disciplined process rather than assuming inspection or release readiness.
- Step 01
Consult
We explore trial-data responsibilities and EDC familiarity to identify gaps in study configuration, edit checks, query resolution, coding, and pre-lock review.
- Step 02
Plan
We map trial data flows before building study forms and roles, then practice validation, external reconciliation, audit review, and the end-to-end study.
- Step 03
Align
We align clinical data instruction with operations, biostatistics, quality, and data-management roles, adapting exercises to the cohort's EDC environment and experience.
- Step 04
Customize
We tailor practice visits, forms, coded terms, and laboratory records to representative studies while using synthetic data and maintaining traceable review steps.
- Step 05
Execute
Participants configure studies, run queries, reconcile external data, and inspect audit trails, receiving feedback on validation logic, documentation, and unresolved discrepancies.
- Step 06
Evaluate
We assess the study build and pre-lock review for coherent configuration, validated records, traceable query resolution, and complete evidence of outstanding checks.
Also from Edstellar
Talent assessments
Psychometric, behavioral, leadership and 360-degree assessment.
→Training needs analysis
Needs analysis, gap identification, and a training roadmap.
→L&D consulting
Learning strategy, content, technology and ROI measurement.
→OD consulting
Org design, succession planning and cultural change.
→Managed training services
Training outsourcing, vendor management, logistics and administration.
→Coaching solutions
Executive and manager coaching that keeps skills in use.
Start an RFP shaped to your needs.
Answer three quick questions about team size, scope, and how often you need the program run, then send the request from the last step. Everything you choose travels with it, so you only fill this in once.
How many team members need training?
Clinical Data Management (CDM) & EDC Systems Training Packages & Pricing
Where L&D holds an annual budget, license packages price the whole year at once instead of raising a purchase order per workshop. Hours and licenses are pooled across teams, programs and locations, so unused capacity is not stranded in one department.
Starter
120
trainee licenses64 hours of group training
Tailored for SMBs
Growth
320
trainee licenses160 hours of group training
Ideal for growing SMBs
Enterprise
800
trainee licenses400 hours of group training
Designed for large corporations
Custom
Unlimited
trainee licensesDuration set by the rollout
Multi-region and multi-year
Training Packages & Pricing
Choose the training format that works for your team. Pricing is customized based on your requirements, cohort size, and delivery needs.
Request a Quote for Clinical Data Management (CDM) and EDC Systems Training for Your Team
Share your team size, study timelines, EDC environment, and goals to receive a tailored training plan and quote. Book a discovery call to discuss your data management needs; we confirm availability and respond with a per-group proposal.