BCO Pilot Project

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

Throughout the process, we will document anything that is difficult to understand, barriers to working with or reading the BCO, and any other general issues. As a result, a best practices document and security plan have been generated to support the standard and there may be additional training materials, created as needed. These resources are meant to support the standard as a vehicle for more fluid communication, and to enable a group to prepare or read a BCO with minimal training.

In addition, groups that participate in the pilot will have first-hand knowledge of submitting computational analyses and how to do so efficiently. Monthly reports are also submitted to keep...

Request

Collaboration and Communication

Stakeholders

Communication Plan & Collaboration Tools

Challenges and Solutions

Common Challenges

Solutions and Mitigations

Future Directions

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