Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial.

ABSTRACT:

Background

In 2019, investigators from China, South Korea and the United States of America initiated a coordinated multinational trial. The trial included three parallel randomized studies with a planned pooled analysis of individual patient data, to test the effectiveness of acupuncture on hot flash-related symptoms in hormone receptor-positive breast cancer patients prescribed adjuvant endocrine therapy. Given the study's approach, there was no central coordinating center or data monitoring committee for the study, so a site performance self-monitoring toolkit was developed and implemented to support study teams in collecting and maintaining high-quality regulatory information, and consistent review of study data and documentation.

Methods

The site performance self-monitor

SUBMITTER: Baedorf Kassis S 

PROVIDER: S-EPMC9204361 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature