SEARCH


UPCOMING LIVE SEMINARS
 






Introduction to Clinical Data Management

Upcoming Courses

Course #: SIMB0614
June 12-13, 2014
Metro Meeting Centers - Boston
Boston, MA
Take advantage of our $1,595.00 price by registering early!
* After May 12, costs are $1,795.00.

Course Description 

This course provides an excellent introduction to clinical data management in the pharmaceutical industry. Its focus on processes and their rationale renders it ideal for the new data manager and to other individuals who wish to learn basic clinical data management skills and the function of clinical data management in the medical product development process. 

Learning Objectives 

  • Understand the medical product and study development process and the regulations that govern the clinical research process 
  • Identify the roles and responsibilities of the clinical research team 
  • Discuss the protocol design and development process 
  • Review the CDM Start-up activities/documentation 
  • Analyze case report form design, data tracking and collection, data entry and capture 
  • Discuss data review, validation, and queries 
  • Comprehend the rationale of the MedDRA dictionary 
  • Identify the role that CDISC and CDASH play in the standardization of data collection and reporting 
  • Understand quality control and quality assurance 
  • Discuss database lock and release 
  • Understand adverse event reporting and reconciliation 
  • Identify the changing CDM role towards project management and the issues associated with managing mega-trials and CROs 
Who Should Attend

  • Staff of Pharmaceutical Companies, Contract or Independent Research Organizations whose function is to review, correct, enter, or manage data, with less than one year of experience in that function 
  • Individuals who desire a basic understanding of the function of clinical data management in the medical product development process 
Instructor

The course will be led by one of the following instructors: 

Denise G. Redkar-Brown, MT 

Click here for complete trainer biographies 

Course Outline 

Day 1: 8:30 a.m. – 5:00 p.m. 

  • Introduction to Medical Product Development: Good clinical practice – purpose and history; roles and responsibilities of the FDA/ICH; phases of medical development research and development 
  • Overview of Clinical Data Management: Data management core processes and data flow; roles and responsibilities within clinical data  management; interfaces with other disciplines within clinical research and development 
  • Protocol and Design: Good clinical study; steps in protocol development; designing a clinical trial; protocol elements and modifications 
  • Study Start-Up – A Clinical Data Management Perspective: Study documentation; data handling manual; annotated case report form and database design; remote data management 
  • Case Report Form Design and Development: Standard and study specific case report form modules; organization of a case report form; CRF design guidelines; data collection methods; CRF tracking; data capture, flow and entry; remote data capture 

Day 2: 8:30 a.m. – 5:00 p.m. 

  • Data Review and Validation: Data errors; frequently encountered problems; identifying and developing data checks; data queries 
  • Coding: Purpose of coding; common coding dictionaries; computerized coding (autoencoding); coding philosophies 
  • Quality Control and Quality Assurance: Roles of quality control and quality assurance; audits and documentation 
  • Database Release and Lock: Study close-out and database release; lock and unlock 
  • Adverse Event (AE) Reporting: Definitions; describing and documenting AEs; collecting AE data 

Interactive Activities 

  • Core Definitions and Concepts 
  • To “Split” or Not to Split 
  • Identifying Data Checks 

 

Registration Fees

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day. 

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings. 

Click here for our seminar cancellation policy 

Accreditation Information

ACPE LogoBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-13-034-L01-P. Released: 10/13. 

Hold this course at your company! 

For more information, contact Naila Ganatra at (215) 413-2471. 

FOLLOW US ON: 

LinkedIn twitter Facebook 


On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.


GCP for Investigators
 

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

For more details on this scenario-based eGCP program for investigators please click here. 


BARNETT CATALOG The Barnett Catalogue is your comprehensive guide to the myriad live, web, and custom training opportunities offered throughout the year. 

Jan - July 2014 Edition

Winter CatalogDownload Today!  

Blended Curriculum Path for the CRA, CRC, and Project Manager

BCP Cover

Download Today! 

 

 

 


 

DVD IconWEB SEMINAR ARCHIVE 

 View Catalog of Offerings   

New Titles added every month! 
Course Alumni Save 50% 


Live SeminarLIVE SEMINARS

Monitoring Clinical Drug Studies: Intermediate 

Informed Consent Content & Process Requirements for Biobanking Studies 

Auditing Techniques for Clinical Research Professionals 


Web SeminarWEB SEMINARS

10-Week CRA & CRC Beginner Program  

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

Use of Notes to File in Clinical Trial Essential Documentation 

10-Week Clinical Research Associate (CRA) On-Boarding Program  


PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)