The International Committee of Medical Journal Editors (ICMJE) requires researchers to post individual participant data (IPD) plans for interventional clinical trials with registration in order to be eligible for publication in its member journals. This study looked at how researchers interpret the ICMJE requirements and the related prompts for information used by ClinicalTrials.gov. This data consists of the analyzed contents of the IPD plans that researchers at the University of Michigan (U-M) submitted with trial registrations for the first 27 months that the 2019 requirement was in effect.
Samuel, S. M. & Wilson, D. L. & Fleming, E., (2023) “Evaluating individual participant data plans for ICMJE compliance: A case study at University of Michigan”, Journal of the Society for Clinical Data Management 3(4). doi: https://doi.org/10.47912/jscdm.257
The data were collected as part of the Stewardship Gap project, an 18-month study to investigate how research data and creative outputs supported by public or non-profit funding in the United States are being stewarded. These data were collected as part of a literature search of sources about research data stewardship and relate most directly to work describing “What We Know About the Stewardship Gap.” In this work, we categorized “gaps” in stewardship identified in the literature, how the gaps were related to one another, and efforts to measure and develop metrics for the gaps.
