BCO Pilot Project
Introduction
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.
BioCompute Objects (BCOs)
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.
Pilot Project
Description
Documentation and Reporting
Standard Operating Procedures (SOPs)
Documentation Guidelines
Reporting Results
Compliance and Standards
Regulatory Compliance
Standards and Best Practices
Collaboration and Communication
Stakeholders
Communication Plan
Collaboration Tools
Challenges and Solutions
Common Challenges
Solutions and Mitigations
Future Directions
Next Steps