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SAS CLINICAL TRAILS ONLINE TRAINING IN HYDERABAD , INDIA


Course name : SAS CLINICAL TRAILS Online Training

24*7 technical support

Duration : 30 hours

faculty : Realtime experience


About online training expert trainers

Online trainings expert prides itself on ensuring that our online trainers are real time experts.only the online training company deliver online training programs to our valued candidates.

As part of online trainings expert continuous improvement in online trainings. Each trainer is regularly assessed to candidates given the best quality of training every time.

All our trainers are skilled trainers and addition have the real time experience with proven track record in online trainings. This experience qualifies them as a specialist in their online training delivery in their course.

SAS Clinical Trails Course Content


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

Student Enquiry

Our OTE Highlights

  1. Depth course Material with real time Knowledge .
  2. We are providing online classes with highly qualifyed professional trainers.
  3. We will provide online classes and online demo session at student flexible timings.
  4. In training case studies and real time scenarios covered.
  5. We will give 24*7 technical supports.
  6. We are providing normal track,weekend online trainings,fast track online classes.
  7. We will provide every recorded sessions.
  8. We will give full support while attending the interviews and contact me any time after completion of the course.

Address

Hyderabad,Andhra Pradesh
India - 500060 .

Phone : +91-9441233734
Email : onlinestrainingexpert@gmail.com

Skype ID : onlinetrainingsexpert

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