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Biostatistics and Clinical Data Management 

The Therapeutics Development Network (TDN) Coordinating Center Biostatistics and Clinical Data Management team has extensive expertise in the support of both controlled clinical trials and observational studies.

We offer full statistical and data management support — from planning to implementation to reporting.

Clinical Data Management 

Our clinical data management team is comprised of seasoned data managers and programmers with CF-specific training who provide quality database setup, data integration, data cleaning and database lock.

Our systems and processes are efficient, user-friendly and designed to ensure the highest-quality data.

Specific data management services include, but are not limited to:

  • Development of study documents, including case report forms, data management plans and data transfer agreements 

  • Design, implementation and maintenance of an electronic data capture system for case report form data collection, edit checks and specimen tracking 

  • Development and execution of a web-based randomization system 

  • Provision of web-based training on electronic data capture and randomization 

  • Implementation of a data quality assurance plan, including ongoing data cleaning and site assistance with online data query resolution 

  • Coordination of external (e.g., core laboratory) data transfers and reconciliation 

  • Performance of medical coding 

  • Programming of interim and final analytic datasets 

  • Preparation of de-identified datasets for data archival

The TDNCC uses an industry-recognized electronic data capture system, and has recently upgraded its global library with standard CF-specific case report forms, edit checks, derivations and custom functions that can be reutilized across studies to maximize efficiency in study startup.

Biostatistics 

Our biostatisticians are accomplished CF researchers with extensive experience in study design, data safety monitoring board (DSMB) support, generation of statistical reports, and manuscript preparation.

Specific statistical services include, but are not limited to:

  • Study design, selection of outcome measures and sample size estimation 

  • Collaboration on writing of the study protocol and other study materials 

  • Analysis of specialized, disease-specific outcome measures 

  • Development and/or review of statistical analysis plans and DSMB charters 

  • Coordination of DSMB teleconferences and in-person meetings 

  • Statistical analyses for interim and final reports 

  • Scientific support for manuscripts and presentations to ensure timely dissemination of study results

Related Information 

For more about other services offered through the TDN Coordinating Center, see the following:

Contact Us 

For more details or to discuss how we can best support your study, please contact us at tdncc@seattlechildrens.org.

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Updated 2/12/13

 

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