DMP Guide: ARC for Clinical Medicine & Trials

1. Funder Policy & Open Data Compliance

In alignment with international open-science mandates, Australian Research Council requires all principal investigators to submit a comprehensive Data Management Plan (DMP) with their grant application. A robust DMP details how research data will be collected, processed, documented, stored, shared, and preserved both during and after the project.

For projects in the field of Clinical Medicine & Trials, managing data correctly is essential not only for compliance, but also to support peer-review validation and reproducibility. All DMPs must be submitted through the RMS portal, using standard institutional guidelines.

2. Data Types, Formats, and Metadata Standards

A high-quality DMP must explicitly identify the types of data that will be generated and specify open, non-proprietary file formats to ensure long-term usability. For Clinical Medicine & Trials, datasets typically range from raw observational measurements to curated computational models.

Biological data streams for **Clinical Medicine & Trials** focus on cellular imaging and experimental protocols. The DMP specifies long-term archival plans, structured indexing mapped to the **Therapeutics Category** terminology, and secure patient anonymisation to satisfy **ARC** auditors.

To guarantee discoverability, datasets should be documented using standardised metadata schemas that map to the Therapeutics Category branch of scholarly vocabularies. This ensures indexers and crawlers can crawl and identify research outputs accurately.

3. Step-by-Step DMP Construction Protocol

When preparing your DMP for a ARC proposal, structure your document around these core sections:

1. Data Collection and Generation:
   Describe the methodology, instrumentation, or software used to collect or generate new data. Detail quality assurance and quality control measures implemented at your facility.
2. Documentation and Metadata:
   Explain how the data will be documented, including accompanying read-me files, data dictionaries, and laboratory notebooks. Specify the metadata standards to be utilized (using CDISC ODM, Dublin Core, ClinicalTrials.gov schema as standard).
3. Ethics, Intellectual Property, and Consent:
   Address how sensitive or confidential datasets will be handled. Detail anonymisation processes, access controls, and compliance with institutional ethics boards.
4. Storage, Backups, and Security:
   State where data will be stored during active research. Detail automated backup schedules, server redundancies, and access authorisation protocols.
5. Long-Term Preservation and Archiving:
   Select the digital repository for post-project archiving (such as ClinicalTrials.gov, Zenodo, Dryad, Vivli, and directory servers mapped in PubMed, Embase & ClinicalTrials.gov). Confirm that the repository supports persistent identifiers (handles/DOIs) and provides secure preservation.

Open Science Workflows, Data Curation & Repositories

Establishing a robust data management plan dmp for Clinical Medicine & Trials requires outlining rigorous data collection methods alongside established data curation standards from day one. PIs can leverage structured dmptool workflows to coordinate these data frameworks for review by Australian Research Council. Our project methodology mandates systematic data cleaning and continuous verification of data integrity to support reproducible data wrangling pipelines. To aid secondary usage, a comprehensive data dictionary will accompany every published record. For active storage, the proposal compares a relational data warehouse schema against an unstructured data lake model, reviewing the functional benefits of a data lake vs data warehouse environment for general data analysis and initial exploratory data analysis of study outputs. Open-access guidelines require teams to push finalised files to the dryad data repository, configure shared figshare datasets, or initiate a zenodo data upload, securing a permanent slot in the data citation index that aligns with nsf data management plan directives. To support replication, we will establish strict data versioning protocols on the open science framework osf to guide reproducible data sharing that follows fair data principles examples. When working with sensitive community records, the project will strictly observe the care data principles and indigenous data sovereignty care guidelines to guarantee ethical data stewardship in accordance with ARC rules. Aligning the archiving schedule directly with ARC open-access metrics protects the project's funding cycles.

4. Frequently Asked Questions