Clinical Data Management Training

BY
Bangalore Clinical Research Institute

Learn clinical data management, process flow and data design and validation with Clinical Data Management Training by BCRI

Mode

Online

Duration

2 Months

Quick Facts

particular details
Medium of instructions English
Mode of learning Self study, Campus Based/Physical Classroom
Mode of Delivery Video and Text Based

Course overview

The Clinical Data Management Training certification course duration is 2 months. The programme focuses on providing in-depth knowledge of clinical data management, process flow, and CDM systems. The course is designed for the Life Science, Pharmacy, Medical Graduates and Post Graduates (including B.D.S, B.A.M.S, B.H.M.S, B.P.T). 

The course offers a comprehensive curriculum, real-time exposure using practical projects, and potential industry collaborations. The Clinical Data Management Training certification by BCRI provides internship opportunities to the students for two months after pursuing the course to enhance existing theoretical knowledge and improve their skills. It also provides 100% placement support at the end of the course.

The highlights

  • Training Online/Classroom
  • Campus/Free Webinars
  • Real-Time Industry Experts
  • Case Studies/100% Genuine Placement Assistance

Program offerings

  • Robust curriculum
  • Hands-on experience
  • Industry ready support

Course and certificate fees

certificate availability

No

Who it is for

The course is designed and developed for aspiring students, and working professionals to enhance their skills and knowledge. This course is also beneficial for:

Eligibility criteria

Academic Qualifications

The certification programme eligibility criteria are that the students must pursue Life Science, Pharmacy, Medical Graduates and Post Graduates (including B.D.S, B.A.M.S, B.H.M.S, B.P.T).

What you will learn

After completing the Clinical Data Management Training certification syllabus, the students will gain a comprehensive understanding of unique data management techniques, data collection, data validation, and data entry. They will also gain hands-on experience with EDC with the support of industry experts. 

The participants will learn about Tracking CRF Data, Entering data, Approved Protocol, Project Plan, eCRF Specification, DB design, DVS, UAT and IxRS Integration. Upon the completion of the Clinical Data Management Training, the participants will explore database design and 21 CFR part 11. They will be able to apply the learned techniques in real-world scenarios.

The syllabus

Process flow

  • Data management plan
  • Study set up
  • Tracking CRF Data
  • Entering data
  • Managing lab data
  • Identifying and Managing
  • discrepancies
  • Collecting adverse Event Data

Study Set-up

  • Approved Protocol
  • Project Plan
  • eCRF Specification
  • Visit Form Matrix
  • DB design
  • DVS
  • UAT
  • IxRS Integration
  • Final Sign off – Go Live
  • DMP

Clinical Trail Management

  • Fundamentals of clinical trials
  • Basic statistics for clinical trials
  • Clinical trials in practice
  • Reporting and reviewing clinical trials
  • Protocol development
  • Trial designs
  • Project management and research co-ordination
  • Regulatory affairs, good clinical practice and ethics
  • Data management
  • Data monitoring and interim analyses
  • Data reconciliation
  • DCMs and DCIs

CDM Systems

  • Where systems come from?
  • Choosing vendor products
  • Implementing New Systems
  • System Validation
  • Test plans
  • Migrating legacy Data
  • Change control

Creating Standards

  • Creating hierarchies
  • Sops and guidelines
  • Working with CROS
  • CRF Design Consideration
  • Remote Data Entry
  • Data entry in RDC and Discrepancy
  • Management in RDC
  • Auto coder Algorithms

Admission details


Filling the form

The participants must visit the official course page, click on the "Enroll and Pay" button, fill in the application form with the required details, and submit it.

How it helps

The Clinical Data Management Training certification benefits include:

  • The certification programme provides students with the necessary knowledge and skills by offering a comprehensive and industry-focused curriculum. 
  • The programme offers 100% placement assistance to the students who complete the course. 
  • Students will also receive certified and experienced instructor support.

FAQs

How long does the Clinical Data Management Training last?

The certification programme duration is 2 months. The course focuses on providing an extensive curriculum that covers all the aspects of clinical data management training.

How are the classes conducted for the Clinical Data Management Training certification course

Students will be able to attend the classes online and live at their convenience. The course also provides campus training.

Does the Clinical Data Management Training online course provide internship opportunities to the students?

Yes, the students will also get internship opportunities at the end of the course for two months to enhance their skills and knowledge.

What is the career scope of the Clinical Data Management Training certification course?

Students can work within the healthcare and pharmaceutical industries with roles like Clinical Data Manager, Clinical Data Coordinator, Data Entry Specialist, Clinical Data Analyst, Clinical Data Programmer, and Quality Assurance Specialist (Clinical Data).

How is the Clinical Data Management Training online course unique than others?

The course prepares students for the clinical research industry by offering a robust curriculum, and real-time experience through practical projects, and industry collaborations. It focuses on developing advanced skills in the field.

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