BCO Pilot Project: Difference between revisions

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== BioCompute Objects (BCOs) ==
== Pilot Project ==
A BioCompute Object (BCO) is an instance of the BioCompute standard and is a computational record of a bioinformatics pipeline. A BCO is not an analysis but is a record of which analyses were executed and in exactly which ways. In this way, a BCO acts as an interface for existing standards. A BCO contains all of the necessary information to repeat an entire pipeline from FASTQ to result and includes additional metadata to identify provenance and usage.
BioCompute is shorthand for IEEE 2791-2020, a [https://standards.ieee.org/ieee/2791/7337/ standard for communicating computational workflows]. The standard was developed in response to difficulties in recording and interpreting bioinformatics pipelines. BioCompute is a framework for step by step description of computational workflows. BioCompute defines what content must be included, and what form it should take. It includes data provenance and rich metadata to eliminate ambiguity. The standard also includes an “Execution Domain” for re-executing a pipeline, if desired.


== Pilot Project ==
Three Centers at the FDA [https://www.federalregister.gov/documents/2020/07/22/2020-15771/electronic-submissions-data-standards-support-for-the-international-institute-of-electrical-and have adopted the standard] (see notice in Federal Registry by the Food and Drug Administration on 07/22/2020) for bioinformatics applications. To increase adoption of BioCompute and bring awareness within and outside of FDA we propose a pilot with the BioCompute team, FDA and industry. Because the standard was developed to manage complexity and reduce the organizational burden on FDA reviewers and regulated industry submitting to them, the purpose of this pilot project is to bring both sides in agreement around its usage thereby streamlining and standardizing computational workflow submissions and reviews. Participating sponsors will prepare and submit a computational workflow with a BioCompute Object (BCO) without any additional clarification, and FDA reviewers will review the BCO. Initial planning meetings, gathering project materials, preparing and submitting BCOs, BCO review, and final debrief are expected to take one year.
The BioCompute pilot project aims to increase adoption and awareness of the purpose of BioCompute Objects (BCOs) both within and outside of the FDA. This involves the collaboration among the BioCompute team, FDA and industry. It is significant in fostering mutual agreement on the usage of BCOs thereby streamlining and standardizing computational workflow submissions and reviews.


Participating sponsors will prepare and submit a computational workflow with a BioCompute Object (BCO) without any additional clarification, and FDA reviewers will review the BCO.
== Expected Outcome ==


=== Documentation and Reporting ===
=== Documentation and Reporting ===
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Standards and Best Practices
Standards and Best Practices
=== Collaboration and Communication ===
Stakeholders
Communication Plan & Collaboration Tools


=== Challenges and Solutions ===
=== Challenges and Solutions ===
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Future Directions
Future Directions
== Request ==
=== Collaboration and Communication ===
Stakeholders
Communication Plan & Collaboration Tools


== References and Resources ==
== References and Resources ==
[https://wiki.biocomputeobject.org/White_paper White Paper]
[https://wiki.biocomputeobject.org/White_paper White Paper]
=== Contact ===
For more information or to participate in the pilot, please email Jonathon Keeney, project co-PI at George Washington University: keeneyjg@gwu.edu

Revision as of 15:44, 20 May 2024

Pilot Project

BioCompute is shorthand for IEEE 2791-2020, a standard for communicating computational workflows. The standard was developed in response to difficulties in recording and interpreting bioinformatics pipelines. BioCompute is a framework for step by step description of computational workflows. BioCompute defines what content must be included, and what form it should take. It includes data provenance and rich metadata to eliminate ambiguity. The standard also includes an “Execution Domain” for re-executing a pipeline, if desired.

Three Centers at the FDA have adopted the standard (see notice in Federal Registry by the Food and Drug Administration on 07/22/2020) for bioinformatics applications. To increase adoption of BioCompute and bring awareness within and outside of FDA we propose a pilot with the BioCompute team, FDA and industry. Because the standard was developed to manage complexity and reduce the organizational burden on FDA reviewers and regulated industry submitting to them, the purpose of this pilot project is to bring both sides in agreement around its usage thereby streamlining and standardizing computational workflow submissions and reviews. Participating sponsors will prepare and submit a computational workflow with a BioCompute Object (BCO) without any additional clarification, and FDA reviewers will review the BCO. Initial planning meetings, gathering project materials, preparing and submitting BCOs, BCO review, and final debrief are expected to take one year.

Expected Outcome

Documentation and Reporting

Documentation Guidelines

Regulatory Compliance

Standards and Best Practices

Challenges and Solutions

Common Challenges

Solutions and Mitigations

Future Directions

Request

Collaboration and Communication

Stakeholders

Communication Plan & Collaboration Tools

References and Resources

White Paper

Contact

For more information or to participate in the pilot, please email Jonathon Keeney, project co-PI at George Washington University: keeneyjg@gwu.edu