Work Description

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

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Methodology
  • The raw data for this study was retrieved from ClinicalTrials.gov via API, using a Study Field Query. See ClinicalTrials.gov API URLs ( https://clinicaltrials.gov/api/gui/ref/api_urls) for more information. Using the administrator portal PRS (Protocol Registration and Results System) for ClinicalTrials.gov, a list of NCT numbers was retrieved for all U-M registered clinical trials, with a start date of 1 January 2019 through those that were registered by 31 March 2021. The list of NCT numbers was then used to download clinical trial registration data through the ClinicalTrials.gov API. Data was pulled on 23 April 2021. The original data pull included 243 trials. The last trial in the list was not a U-M registered trial but included a reference to one of the NCT numbers in the list. After removing this trial, 242 remained in the data set. Studies that were Observational, as opposed to Interventional, were removed (31), as the ICMJE policy does not currently apply to that study type. Also, there were 13 “Withdrawn” trials that had “0” entered for their enrollment which were also removed from the data set. The final data set consisted of 198 analyzable trials. In order to sort and analyze the free text responses from the various data fields, the study team created a data collection form using Qualtrics. With this form, the team captured information about each trial and grouped them together according to the characteristics of interest. More information about the data collection can be found in the files below.
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.
Creator
Depositor
  • henrysm@umich.edu
Contact information
Discipline
Keyword
Citations to related material
  • 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
Resource type
Curation notes
  • 2023-03-02 Updated record with final publication citation.
Last modified
  • 03/03/2024
Published
  • 04/03/2023
Language
DOI
  • https://doi.org/10.7302/72tg-ap24
License
To Cite this Work:
Samuel, S. M., Wilson, D. L., Fleming, E. K. (2023). Data for Evaluating Individual Participant Data Plans for ICMJE Compliance: A Case Study at University of Michigan [Data set], University of Michigan - Deep Blue Data. https://doi.org/10.7302/72tg-ap24

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Files (Count: 4; Size: 72.1 KB)

Thumbnailthumbnail-column Title Original Upload Last Modified File Size Access Actions
Readme_file_for_Data_for_Evaluat...e.txt 2023-03-24 2023-04-03 644 Bytes Open Access
RawDataRetrieval_IPDProject.pdf 2023-03-24 2023-03-24 28.5 KB Open Access
IPDPlans_AnalyzableData_20220210...e.csv 2023-03-24 2023-03-24 39.7 KB Open Access
IPDPlans_AnalyzableData_FormInfo...e.csv 2023-03-24 2023-04-03 3.22 KB Open Access

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

RawDataRetrieval_IPDProject.pdf
This PDF file provides a description of how the raw data for this project were acquired.

IPDPlans_AnalyzableData_20220210_Share.csv
This CSV file is the data that were used to produce the final tables and charts for the associated publication.
Blank cells within this file indicate that no information was available for further evaluation - the relevant fields were empty, so there was no additional analysis performed.

IPDPlans_AnalyzableData_FormInfo_20220210_Share.csv
This CSV file lists the fields that were used to analyze the raw data, as well as mapping them to the column names in the data file (IPDPlans_AnalyzableData_20220210_Share.csv).

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