DMP Guide: CONICET for Clinical Medicine & Trials

1. Funder Policy & Open Data Compliance

In alignment with international open-science mandates, Consejo Nacional de Investigaciones Científicas y Técnicas 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 SIGEVA 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 **CONICET** 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 CONICET 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

To secure approval from Consejo Nacional de Investigaciones Científicas y Técnicas, the investigator's data management plan dmp must clearly justify chosen data collection methods and adhere to active data curation standards. Integrating digital dmptool workflows helps automate compliance reporting via the SIGEVA portal. Investigators must outline procedures for post-collection data cleaning, strict audits of data integrity, and programmatic data wrangling to transform raw outputs into clean models. Furthermore, a descriptive data dictionary must be provided to define the database schema. The DMP must justify whether files are catalogued in a structured data warehouse or kept as raw files in a flexible data lake, discussing how a data lake vs data warehouse decision impacts subsequent data analysis and programmatic exploratory data analysis for Clinical Medicine & Trials. Upon completion, data will be submitted to the dryad data repository, published as figshare datasets, or preserved via a zenodo data upload to be registered in the global data citation index and satisfy nsf data management plan guidelines and regional CONICET open-science rules. Researchers are required to publish systematic data versioning protocols through the open science framework osf to facilitate long-term reproducible data sharing in line with fair data principles examples. If data is collected from specialized regions, the plan must comply with the care data principles and respect indigenous data sovereignty care rights to meet Consejo Nacional de Investigaciones Científicas y Técnicas ethical benchmarks. Implementing this storage layout satisfies compliance protocols overseen by the CONICET data audit team.

4. Frequently Asked Questions