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# System prepended metadata

title: nf-core regulatory special interest group meeting notes
tags: [meetings, regulatory, meeting notes, special-interest-groups]

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# Regulatory Special Interest Group Meeting Minutes

## September 09, 2024

* Focus: Write _something_ and iterate on this.
    * Have box at the top inviting alternative viewpoints
* Collaborative session working with regulatory experts?
    * Talk to validation leads, sit down with them and write notes -> turn into guidelines document
    * Moritz - if move Nextflow into clinical settings could help here. But early days.
    * R organisation: https://www.r-project.org/certification.html
        * Could we take this as a template?
        * Could send this to someone to see how useful it is before we put a lot of work into it?
        * https://www.pharmar.org/
* Decision guideline framework

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* What tests are needed for accreditation?
    * `-profile test` is likely not enough
    * Official cell line samples best
    * [Moritz] Probably can't do full validation centrally. So question is how far can we support people to do their own internal validation.
    * A universal validation is probably not possible but we could provide guidelines on how to do this properly.
        * Provide guidelines
        * Share reports / data?
    * What's already done?
        * sarek: Genome in a bottle?
        * rnafusion: 
        * rnaseq: GM12878 (SciLifeLab ages ago)
        * `-profile test_full`
    * Can we have standardised comparison scripts?
        * Would be great to automate `test_full` comparisons
        * Lower ambition: could we encourage folks to share validation / comparison scripts on Figshare? List on #regulatory SIG webpages.
            * Many existing reports likely exist. Share reports or if private data then could share scripts?
            * Google docs / PDF / webpage / figshare - bunch of links
            * Prefer markdown if possible, figshare if data
    * Can we version the test datasets and config?
* Oncoanalyser - clinical use pipeline
    * Stable release process - mentioned in release notes
    * 

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* [PHUSE consortia meeting](https://phuse.global/)
    * [PHUSE EU Connect 2024](https://www.cdisc.org/events/education/external-events/2024/11/phuse-eu-connect-2024)
    * Novo going to meeting and will present, may be able to include one slide about our work
    * Good group of people to network with for feedback
    * Has some workstreams with R Validation hub teams
        * Partner project: https://www.pharmar.org/

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* Suggestions for invited speakers
    * [BioCompute](https://www.biocomputeobject.org/)
        * Jonathon Keeney
        * Topic: Pipeline provenance
    * [FDA Omics workshop](https://www.fda.gov/science-research/scientific-meetings-conferences-and-workshops/fda-omics-days-2024-precision-practice-regulatory-science-best-practices-and-future-directions-omics) this week
        * Vivek to share learnings back to the group


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* Meeting schedule
    * Alex to send out future dates
    * Aim for monthly - mid October next.

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* TODO for next time
    * _[**All**]_ Share all accrediation results / scripts possible
    * [Alex] Get feedback from BI accrediation folks on usefulness of R guidelines
    * [Alex] Ask what accrediation folks would like in a accredited pipeline
    * [Vivek] Look into asking for guideance on process, key info needed
    * [Famke] Look into information about central guideance for university clinical analysis
    * [Ken + Susanna] Start a _very_ rough google doc with a handful of bullet points to share with validation teams for feedback

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