Partnering for Success: Clinical Research Collaborations for Data Quality

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

Overview
The focus of this webinar is the importance of cross-functional collaboration among clinical research professionals during the clinical trial process to assure data quality. Each participant in the process of data collection in a clinical trial brings their unique perspective to the project based on their role. Sites focus on recording accurate medical information in source documents, clinical monitors verify that data against the case report form, data managers review that data for completeness and logic and then hand that off to statisticians who summarize it for presentation to regulatory authorities. Strategies will be discussed for effective collaboration aimed at avoiding re-work or project delays.

Presenters
Jonathan Andrus, CCDM, manages data and study operations for BioClinica, Inc. In this role, he is responsible for overseeing the design, development, implementation and management of all clinical studies. Andrus previously served as chair of the SCDM Board of Trustees.

Ellen Coull, CCDM, is senior project manager and a member of the e-clinical team at PRA with responsibility for the development and delivery of training content for clinical, site and sponsor users of several EDC and supporting review tools. Coull is a member of the SCDM Education Webinar Taskforce.

Objectives
At the conclusion of the program you will be able to:

• Collaborate effectively with Clinical Research Professionals so that your study is as successful as possible and avoids costly rework during the study.
• Implement steps to improve study design through cross-functional collaboration.
• Determine data cleaning methods in conjunction with the CRA to avoid toe stepping.
• Embrace integrated study closeout methods for successful and timely lock.

Level
Intermediate

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.

Continuing Education Credit Opportunity
Attendees are eligible for CEUs upon attendance and successful completion of assessment questions. Each part of this 2 part webinar carries 0.2 CEUs.
SCDM is authorized by IACET to offer .2 CEUs for this program.