Milwaukee,WI
The Society for Clinical Data Management recently published Edit Check Design Principles, a collection of best practices for the creation of edit checks-a key tool for efficiency and data quality.
The chapter is a new addition to SCDM’s Good Clinical Data Management Practices(GCDMP), an award-winning resource for clinical data managers and others involved in medical device, biotechnology, and pharmaceutical trials.
According to SCDM, edit checks are a crucial component of achieving error-free data.
“Trustworthy data are necessary for successful analysis and assessment in clinical research,” said Charlene Dark, CCDM, GCDMP Taskforce leader. “By publishing a set of best practices pertaining to edit check design, SCDM provides a foundation from which Clinical Data Management professionals can create comprehensive data cleaning to meet the highest level of data integrity.”
The new chapter focuses on creating efficient and accurate edit checks, automated review processes used to identify errors in data. It also discusses different types of edit checks and things to consider when working with them.
“The best practices outlined in Edit Check Design Principles are universal and can be applied in any clinical research setting-pharmaceutical, biotech or CRO, U.S.-based or international, paper trials or EDC,” said Melissa Lamb, who serves as a subject matter expert for SCDM’s GCDMP Taskforce. “This chapter is a guide for creating edit checks that result in the common goal of data quality and accuracy.”
The new text is available free to SCDM members, or by purchase to non-members, through the SCDM Web site. A podcast of the chapter is in production and scheduled for release this spring.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.