India-flagINDIA : +91-8099902123   usa-flagUSA : 201-710-8393
Call Me Back

training courses

SAS clinical trials Training

United Global Soft provides Clinical Trials Online & Classroom Training course by excellent experienced IT professionals. Our trainer has good training experience so that best quality output will be delivered. All our faculty is dedicated so that we can complete your course as per the schedule given. we provide classes through Clinical Trials online by using world class interactive system. We also give interview support & Technical support. We market your profile in USA, UK SINGAPORE, INDIA, and SOUTH AFRICA. We trouble shoot your problems both theoretically & practically during the Online & Classroom Training ,even after the course completion. After completion of your Clinical Trials training we will help you to clear your interviews. We will give you 100% Satisfaction and We provide best quality real time online & Classroom 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

In consultation with the trial statistician, develop specifications for analysis datasets, pooled datasets, and Tables, Listings and Figures (TLFs).
Develop original SAS programs and deliver, according to specifications, analysis datasets, pooled datasets, TLFs for US phase I-IV clinical trials and for pooled analyses with high quality and within milestones.
QC Clinical Research Organization (CRO) delivered programs and TLFs for outsourced clinical trials.
Develop SAS programs to help data managers for checking data quality.
Make certain that documents and specifications are consistent and comply with company standards by providing input into CRFs, data structures, and templates for TLFs for outsourced phase I-IV clinical trials and submission activities.
Maintain records for all assigned projects and archive trial/project programs, analyses and associated documents.
Provide input on process improvement initiatives and participate in non-clinical project activities with support from the Group Head.
Respond to Health Authority/FDA/audit requests pertaining to project-specific programming issues.

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

If you want to know more about Clinical Trails Training do not hesitate to call +91-9393 002 123 or mail us on info@unitedglobalsoft.com