Events

Data Acquisition Webinar

Introduction to Data Collection and Data Management Practices in Cancer Research

Overview

This introductory webinar will cover core topics for new data management staff and those interested in learning about data management supporting cancer clinical trials. Particular focus will be placed on data collection practices.

Attendees will benefit from learning about key elements of data collection specific to cancer trials including toxicity grading scale and criteria for evaluating response to therapy. In addition, clinical trial endpoints for the approval of cancer drugs/biologics will be reviewed incorporating some of the challenges related to data management of these endpoints.

Presenter

Elizabeth Ness, B.S.N., M.S., Director of Staff Development at the National Cancer Institutes' Center for Cancer Research, oversees the training and professional development of staff within the NCI's intramural program.

Target Audience:
Data Managers, Project Managers and other project team members working with cancer research data. This is an introductory webinar for staff new to data management or cancer clinical trials.

Learning Outcomes
At the conclusion of this webinar, participants should be able to:

Recognize best practices in research data collection specific to cancer trials.
Describe key data elements used in cancer clinical trials, such as adverse event grading and response criteria evaluation.
Discuss the challenges associated with data collection for the specific endpoints used in FDA approval of oncology drugs/biologics.

CDM Competencies addressed in the Data Acquisition Webinar

Identifies critical data elements used for analysis and reporting.
Defines the flow of CRFs and DCFs (DM Process).
Outlines all other data flow including external data sources.
Understands the fundamentals of management of local laboratory data including the specification and checking of normal ranges and units and QC of ranges and units against listings from the patient database.
Routinely maintains tracking/inventory and identifies missing CRFs.
Tracks down and retrieves missing CRFs.
Identifies CRF flow issues and initiates steps to resolve.
Resolves issues with data flow in collaboration with the project team.
Relates protocol to CRF design and ensures that design supports data analysis and reporting requirements.
Defines content, structure and procedures for using a library of CRF design modules.

GCDMP Chapters Addressed

Data Acquisition

Continuing Education Units:
SCDM will award continuing education units to participants who attend the entire webinar, successfully pass the five assessment questions (60%) and complete the evaluation forms.
1 contact hour = .1 CEU.