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

Documentation Guidelines

Regulatory Compliance

Standards and Best Practices

Collaboration and Communication

Stakeholders

Communication Plan & Collaboration Tools

Challenges and Solutions

Common Challenges

Solutions and Mitigations

Future Directions

References and Resources

White Paper