SDSP 2 April 2015 Meeting Minutes

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2015-04-02

Agenda


  • Welcome new team members
  • PhUSE – a recap of the discussion around this plan
  • PhUSE Wiki site for this plan
  • Section 3 of the plan (please read it on the Wiki if you have time)
  • Section 4 of the plan if time permits (1 new column added)


Attendees

  • Cathy Bezek
  • Michael Brennan
  • Tony Chang
  • Kate Dwyer
  • John Franchino
  • Jiaan Illidge
  • Kristin Kelly
  • Maggie Lo
  • Janet Low
  • Jane Lozano
  • Nick Naro
  • Anne Russotto


Meeting Discussion

  • Welcome new team members!
  • A synopsis of the PhUSE conference last month was provided. Ron Fitzmartin (FDA) indicated that this document doesn't have to be complicated. Keep it simple. Also, it is important to have discussions with FDA early regarding data standards. There doesn't need to be a separate meeting but should be done early in the development of a compound. A submission could be rejected due to non-compliance with the standards in the Data Standards Catalog. One other learning was that the Technical Conformance Guide is non-binding but sponsors are highly encouraged to follow it. Also, the Data Specifications Guide can still be used as there are gaps in the Technical Conformance Guide.
  • The test unit plan team was supposed to provide a template to Jane by March 30th. This has not been done yet.
  • Jane showed the team the Wiki site for the SDSP and also displayed the 2 spreadsheets that were added. One is to document decisions made to the deliverables in order to avoid discussing an item more than once. The second one is to document scenarios to be considered when creating the Completion Guidelines document and Example document. Please send your scenarios to Jane and she will update the spreadsheet and post on the Wiki.
  • At the PhUSE conference, the team focused on clinical studies. It is important to get feedback from the non-clinical team. Peggy will coordinate with the SEND team which meets every other week on a Wednesday from 10:00 - 11:30 am.
  • Team members are encouraged to share the template with colleagues and get their feedback.
  • The team discussed the importance to have a document for sponsors regarding process. The regulatory representatives from a sponsor aren't responsible for the SDSP but will be part of conversations with FDA in which standards are discussed. A new document will be created to discuss the target audience for the SDSP, the role within a sponsor that should be responsible for the SDSP, and other information to assist the sponsor in ensuring that this plan is created and discussed with FDA at the right time.
  • It was suggested that a document (or within the SDSP) be created to document when the SDSP was discussed and decisions made during discussions with FDA so that everyone is in alignment/agreement with the content of the SDSP.
  • There are going to be subgroups formed that will be expected to meet between SDSP project meetings and provide updates to the project team. The subgroups are: 1) Completion Guidelines 2) Example Document 3) Regulatory Communications 4) Points to Consider or ReadMe Document.
  • Section 2.2 of the SDSP will be finalized at the next meeting. Please be ready to discuss.
  • At the next meeting (April 14), the team will define reasonable timelines for the completion of deliverables, including the template and the subgroup deliverables.


Action Items

  • [Jane] Add name column to the scenarios spreadsheet so that we know who made the comment.
  • [Jane] Summarize data elements that are not in Section 2 of the template in order to document prior decisions.
  • [Team] Let Jane know which area you are interested in participating: Completion Guidelines/Example Document/Regulatory Communications/Points to Consider or ReadMe Document.
  • [Peggy] Send email to the SEND team. This has been done. Thank you!!
  • [Team] Provide scenarios to Jane and she will update the spreadsheet and post to the Wiki.
  • [Jane] Follow up with Matt Bryant regarding the test unit plan.