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Filtering by: Creator Fleming, Emily K Keyword ClinicalTrials.gov Discipline Health Sciences

Data for Evaluating Individual Participant Data Plans for ICMJE Compliance: A Case Study at University of Michigan

Creator:

Samuel, Sara M, Wilson, Diane L, and Fleming, Emily K

Description:

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.

Keyword:

research data sharing, research data policy, research data, clinical trials, ClinicalTrials.gov, individual participant data, IPD, data sharing plan, and compliance

Citation to related publication:

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

Discipline:

Health Sciences, Social Sciences, and General Information Sources