Handling Laboratory Data

1 part webinar
60-minute presentation followed by 30-minute Q&A

 

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Overview
Laboratory data collected in a clinical trial can represent both safety and efficacy data. Understanding some basic laboratory terminology as it applies to typical lab  testing can facilitate understanding the protocol, designing the CRF and defining data review standards. The terminology is applicable to data collected locally at each site or centrally processed by a single vendor. The accuracy and integrity of lab data is critical to the statistical analysis of trial data.


Outcomes

  • Identify lab requirements detailed within a protocol
  • Describe  the common categories of laboratory testing
  • Assess CRF design requirements for required tests
  • Apply data review standards to Laboratory data


Level
Intermediate/advanced


Presenters

Carolyn Alimecco is lead data manager at PRA International. In this position, she serves as the primary data management contact for the project teams and ensures adherence to client standards, timelines and DM processes. Prior to working in clinical research, Alimecco spent several years in the clinical microbiology laboratory at the University of Virginia Medical Center. Alimecco holds a master’s degree in health evaluation sciences from the University of Virginia and a bachelor’s degree in medical technology from Bloomsburg University in Pennsylvania.


Ed Smith has been functional manager of clinical data management at PRA International since Spring 2008. He previously worked as a lab supervisor in a reference laboratory and as a medical technologist. Smith holds degrees in chemistry and medical technology from South Dakota State University.


Target Audience
CEOs, chief learning officers and trainers, clinical data managers, managers of data groups, quality control and quality assurance statisticians, biostatisticians and project managers working within the clinical trials industry.


CDM Competencies Addressed
Processing Laboratory Data and Maintenance of Lab Normal ranges


GCDMP Chapters Addressed 
Lab Data Handling (new chapter)

Continuing Education Credit Opportunity IACET logo
Attendees are eligible for CEUs upon attendance and successful completion of assessment questions.
SCDM is authorized by IACET to offer .2 CEUs for this program.

 

 

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