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Clinical Trials Online Training

Intorduction

Overview Of Data Management

Data Acquisition

Case Report Form

  • CRF designing and development
  • Electronic data capture
  • Standard operating procedure
  • Data privacy
  • Physical and electronic data security
  • Electronic data capture principles
  • Preparation and preservation of crf completion guidelines
  • CDM presentation at investigator meetings

Data Storage

  • Physical Storage

Data Archival

  • Database validation ,programming and standards
  • Data entry and data processing
  • Data Cleaning
  • Data transmission

Data Management

  • Dictonary selection
  • Auto-encoder

Safety Data Management And Reporting

  • Serious adverse event data reconciliation
  • Procedures
  • Assuring data quality
  • Database closure
  • Recommende standard oerating procedures
  • Clinical data archiving
  • Vendor evaluation
  • Vendor management

Metrics For Clinical Trials

  • Data management metrics
  • Cost
  • Time
  • Quality
  • Audit of clinical trails

Choosing An Auditor

  • Conducting the audit
  • Audit checklist
  • Chronology lists
  • Areas to review
  • Regulatory documentation
  • Clinical documentation
  • CRF and sourse documentation consistency
    CRF correlations
  • Ade documentationand reporting
    Investigational device accountability records
  • Special challenges for auditors
  • Using the findings
  • The audit report

Global Issues

  • Introduction
  • Principles
  • Operational benefits of data interchange standards
  • Scientific benefits of data interchange standards
  • CDISC Standards
  • ODM –Operational Data Model
  • SDTM
  • ADaM–Analysis Dataset Model
  • Lab –Clinical Laboratory Data Model
  • Case Report Tabulation Data Definition Specificatio
  • Protocol Representation Standard
  • CDISC standards integration

Clinical trials

  • Responsibilities of Sponsor
  • Post marketing surveillance
  • 21 CFR PART 11
  • Introduction
  • Electronic Records
  • Electronic Signatures

 

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Testimonials

The course content was appropriate and useful. The online trainers were competent and useful. The best thing about the course was the young learner and learning Vs acquisition section.

The thing that the course needs improvement is the format of the assignment

Keerthi
Hyderabad.

I am Mushtak Shaik from Hyderabad. The course content was appropriate and useful. The online trainers were competent and useful.

The thing that the course needs improvement is the format of the assignment


Mushtak Shaik
Hyderabad.