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CR & CDM with Oracle Clinical Database

Clinical research is responsible for ascertaining how safe and effective drugs, devices and diagnostic products.
CDM is the process of collection, cleaning, and management of subject data in compliance with regulatory standards.Many software tools are available for data management, and these are called Clinical Data Management Systems (CDMS).

Why this course ?

There is massive career development in Clinical Research & Clinical data management. Candidates have tremendous career development in CRCDM. There is a great deal of job opportunity in this field, and it has even more economic advantages.

Clinical research is an excellent career to get involved in if you want to develop your role and push yourself.

Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.

Course Features

  • Instructor Live Sessions

    There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
  • Real-time Case Studies

    Live project based on any of the selected use cases on the above selected Domain. 
  • Assignments

    Each class will be followed by practical assignments which can be completed before the next class.
  • 24 x 7 Expert Support

    We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.
  • Certification

    Towards the end of the course, you will be working on a project. Covalent certifies you as an course Expert based on the project.

Course Curriculum

Download
  • CR & CDM with Oracle Clinical Database Course Content

    Clinical Research Theory :

    • Introduction to Clinical Research
    • INDA, NDA, ANDA applications
    • Types, Designs and Phases of Clinical Trials
    • ICH GCP guidelines (ICH E6)
    • Roles and Responsibilities of Investigator and CRA
    • Roles and Responsibilities of Sponsor and CRC
    • Contract Research Organizations-CRO
    • Case Report Form and its Contents with live example
    • Contents of protocol
    • Explanation of Research protocol with live example
    • Informed Consent Form
    • Institutional Review boards(IRB)/IEC
    • Participant safety and Adverse events reporting
    • Safety definitions and reporting requirements
    • Monitoring of Study at participating sites
    • Source Data Verification
    • Investigator's Brochure (IB)
    • Standard operating procedures
    • Essential documents
    • Data Coding using MedDRA and WHODD
    • CRF Design Guidelines
    • SAE/AE Reconciliation

     

    Clinical Data Management Theory :

    • Introduction to Clinical Data Management
    • Clinical Data Management Process and Life cycle
    • Explanation of Study Start Up / Set up
    • Explanation of Study Conduct
    • Explanation of Study Close out
    • Clinical Data Management Plan with Example
    • Case Report Forms, Types of CRFs
    • Designing of CRFs
    • CRF completion Guidelines(CCGs) with Example
    • CRF Annotation
    • Data Capture Methods and EDC
    • Data Entry – First pass and Second Pass Entry
    • Edit Check Specifications
    • Data Validation Procedures
    • Discrepancy Types (Univariate, Multivariate, Manual and Indicator)
    • Discrepancy Management
    • Query Resolution
    • Data Clarification Forms (DCFs)
    • Database Locking and Freezing
    • Pre closure Checks
    • Data Coding and Medical Dictionaries
    • SAE Reconciliation
    • 21 CFR Guidelines

     

    Practical Hands training on Oracle Clinical Database/RDC :

    • Introduction to OC window
    • Subsystems in OC
    • Defining Programs and Projects
    • Defining Organization Units
    • Defining Regions
    • Defining Planned Studies
    • Easy Study Design
    • Creating Intervals
    • Creating Events
    • Creating Investigator, Site Records and Assignments
    • Creating Patient Positions and Assignments
    • CRF Design
    • Creating Questions
    • Creating Question Groups
    • Creating and Maintaining DVG's
    • Creating DCM's, DCI's & DCI Books
    • UAT(User Acceptance Testing )
    • Test a Study
    • Test Data Entry
    • Initial Login
    • Key Changes
    • First Pass Entry
    • Second Pass Entry
    • Comparison Reconciliation
    • Update
    • Browse
    • Patient Enrollment
    • Data Validation(Batch validation)
    • Discrepancy Management
    • Data Clarification Forms (DCFs)
    • Audit Trail
    • Locking and Freezing

     

    RDC (Remote Data Capture):

    • Data entry in RDC
    • Discrepancy Management in RDC
    • CRFs in RDC

     

     

Projects

  • Projects

    We will provide Real Time Projects

FAQ's

  • Can I attend a demo session before enrollment?

    Yes

  • What if I miss a class ?

    If you miss a class we can provide recording video for particular session or we can arrange you the back up session. 

  • Will I get placement Assistance ?

    Yes

  • Do I receive a certificate for training ?

    • Once you are successfully through the course you will be awarded with Covalent's Training certificate.
    • Covalent certification has industry recognition and we are the preferred training partner for many MNCs
  • What support is available after the training?

    Doubts clarification up to getting a job

    Resume preparation

    Mock interviews

    Placement Assistance

  • What Features do you provide?

    Class Room & Online Live sessions
    Real time projects
    Working faculties 
    Lab facilities
    Placement assistance
    Resume preparation
    Doubts clarification

Certifications

  • Course Completion Certificate

    • Once you are successfully through the course you will be awarded with Covalent's Training certificate.
    • Covalent certification has industry recognition and we are the preferred training partner for many MNCs

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