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1st Edition  Conference

Clinical Data Management (FDA E6 GCP Guidelines)


"CDISC,CDASH&STDM standards"
Clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO).CDM involves all aspects of collecting, processing, and interpreting information. There are many types of computer applications and database systems to support data collection and management. However, there are elements of CDM that apply across the board.Review and approval of drugs or devices by regulatory agencies requires the assumption that the data presented are valid and reliable. Integrity of the data is paramount to ensure confidence in the results and conclusions you will make.This seminar is based on FDA E6 GCP Guidelines which are the basis of effective data quality management. Even if your research is not FDA regulated, the information you learn in this course will help to ensure a robust data collection and management plan.

Highlights

  • Regulatory guidelines for Clinical Data Management,Best practices for data collection
  • Data preparation and quality assurance for accuracy,Maintaining confidentiality of data
  • CDISC/CDASH/STDM standards,Responsibilities of personnel,Case report form criteria
  • Data storage and transferability,Data systems validation,Data monitoring plan criteria
  • Troubleshooting and resolution of deviations from plan,Adverse event reporting and coding criteria

Timings

8:30 AM - 4:30 PM (Aug 01) (General)
8:30 AM - 4:30 PM (Aug 02) (General)

Entry Fees

Paid Ticket Starts from 1499 USD View Details

Participants

20 Delegates
5 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma
Education & Training

Editions

01-02 Aug 2019 Interested


Frequency Bi-annual

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ComplianceOnline USA

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HUSSAIN ALHUSSAIN

HUSSAIN ALHUSSAIN

MD, FRCPC, MMGMT, CPHQ at King Fahad Medical City/ Saudi Commission for Health Specialties Riyadh, Saudi Arabia

Speakers

Speaker
Elaine Eisenbeisz

Elaine Eisenbeisz

Owner & Principal Statistician of Omega Statistics. I assist with...

Visitor Ticket Price Buy Now

1499 USDAttendee Seminar One Registration
33.684000 -117.795000

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Venue to be announced

Irvine, USA

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