CONSIDER Statement: Consolidated Recommendations for Sharing Individual Participant Data from Human Clinical Studies.

ABSTRACT: Many research sponsors require sharing of data from human clinical trials. We created the CONSIDER statement, a set of recommendations to improve data sharing practices and increase the availability and re-usability of individual participant data from clinical trials. We developed the recommendations by reviewing shared individual participant data and study artifacts from a set of completed studies, as well as study data deposited on ClinicalTrials.gov and on several data sharing platforms. The CONSIDER statement is comprised of seven sections including: format, data sharing, study design, case report forms, data dictionary, data de-identification and choice of data sharing platform. We developed several different forms of CONSIDER which includes a brief form (the checklist), a full form (

SUBMITTER: Mayer CS 

PROVIDER: S-EPMC8378623 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature