Skip to content

Study Data Model

A Study entry documents key information about research projects, including methodologies, participants, and ethical considerations. Properly maintaining study records ensures that data is compliant with research standards, traceable, and usable across various scientific fields. This section explains how to create and maintain a valid study entry using the required fields, templates, and example data provided.

Why You Should Contribute Study Entries

Contributing study entries ensures that critical research details such as methodology, investigators, and related datasets are documented and accessible. This fosters transparency, collaboration, and reproducibility in research. A well-maintained study entry also helps stakeholders understand the scope, purpose, and outcomes of research efforts, enabling better data integration and analysis across projects.

Who Should Be Contributing Study Entries?

  1. Principal Investigators (PIs) – Provide clear documentation of your studies to enhance visibility and demonstrate research contributions for funding agencies and collaborators.

  2. Research Coordinators and Project Leads – Ensure proper record-keeping of studies under your supervision, supporting compliance, reporting, and resource allocation.

  3. Data Managers – Create study entries to link related datasets, publications, and tools, improving data provenance and facilitating cross-references within research ecosystems.

  4. Consortium Participants – Contribute study information to showcase collaborative research efforts and track joint achievements.

  5. Funding Agencies and Grant Monitors – Monitor study progress by ensuring that all funded research is accurately documented and accessible.

  6. Ethics and Compliance Officers – Maintain study entries to verify that all necessary de-identification methods, IRB protocols, and data use policies are in place.

Download Template

To streamline the process, download the study entry template for standardized data entry.

Example Data Entry

The table below includes sample values to demonstrate proper attribute usage.

Attribute Example Value
Study Biology
Study Name Effects of Diet and Exercise on Obesity
Study Description Analysis of Cardiovascular Response during Exercise
Study Investigator Dr. Jane Doe, PhD in Nutrition Science, University of Texas
Study Reuse Statement Data from this study may be reused under conditions of proper citation and ethical approval.
Study_id STUDY_2024_OBESITY_EXERCISE
Study Number of Participants 5000
Study De-identification Method Type Manual
Study De-identification Method Description Personal identifiers such as names and dates were removed, and randomization techniques were applied.
Study De-identification Method Software Safe Harbor Privacy Software
Study dbGaP Accession Id phs000424.v7.p2
Study License CC BY-NC 4.0
Study Data Use Codes IRB, PUB, HMB

Full Field Reference

Below is the full field reference table with attributes and their descriptions.

Attribute Description Required Validation Rules Examples
Study Studies associated with a grant False None ProjectView_45678
Study Name Name of the study True str Effects of Diet and Exercise on Cancer
Study Description Description of the study, including the types of experimental assays, model systems, types of analysis, etc. True str Analysis of Cancerous Cell Response during Exercise
Study Investigator Investigator(s) associated with the project. Multiple names should be provided as a comma-separated list. True list like Dr. Jane Smith
Study Reuse Statement The funder-, contributor-, patient-, etc., derived content that includes terms, conditions, or statements associated with accessing and reusing the resource(s). False str Data from this study can be used for future research purposes under the conditions that all information is properly cited and referenced.
Study_id A unique primary key that enables record updates using schematic. True unique CA261717-CancerResearch-7-2024
Study Number of Participants The number of participant instances associated with systematic investigation into a subject. True int 5000
Study De-identification Method Type General description of the de-identification method True None Manual
Study De-identification Method Description Description of the process of removing potentially identifying data or data elements to render data into a form that does not identify individuals and where identification is not likely to take place. False str All personal identifiable information such as names, addresses, and identification numbers were removed from the data. The dates were also shifted to a random point in the future to preserve the temporal relationships but without revealing the actual dates. The datasets were further reviewed and verified by a privacy officer to ensure all participants' identity is completely unidentifiable.
Study De-identification Method Software Software that was used to de-identify the images (if used) False str Safe Harbor Method Software
Study dbGaP Accession Id A stable unique alphanumeric identifier assigned to a study and any objects by the database of Genotypes and Phenotypes (dbGaP). Required for controlled access data being submitted to CDS/CRDC. False str phs000424.v7.p2
Study License Official or legal permission to do or own a specified thing. Studies with data that will be submitted to CDS are required to provide a license. False None CC BY-NC 4.0
Study Data Use Codes DUO code - A data item that is used to indicate consent permissions for datasets and/or materials and relates to the purposes for which datasets and/or material might be removed, stored, or used. Available DUO code definitions can be found here: https://mc2-center.github.io/data-models/valid_values/sharingPlans/#attribute-dsp-data-use-codes False list like NCU
Study Index Date The reference event associated with timepoints in this study. One of Diagnosis Date, Enrollment Date, Collection Date, or Birth Date. False None Diagnosis Date