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.


  • 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


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


20 Delegates
5 Exhibitors Estimated Count

Category & Type

Medical & Pharma
Education & Training


01-02 Aug 2019 Interested

Frequency Bi-annual

Official Links

Website Contacts

Report Error
Claim this event


Logo Send Stall Book Request

ComplianceOnline USA

Top Rated 320 events listed
+ Add me as user

User Community [Users who have shown interest for this Event]



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


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

Venue Map & Directions


Venue to be announced

Irvine, USA

Get Directions Add Venue

Featured Hotels in Irvine

More Hotels