Claim Confirmation Process

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Planning

<TBA> See Process Coordinating Committee

The key purpose in Claim Confirmation is to:

  • to evaluate the validity of the statistical assumptions underlying the Profiles Claims
  • to confirm that the actual performance at a real site is consistent with the performance in the Profile Claims

While it is acceptable to conduct separate studies at two or more sites, it is recommended that a multi-site study be conducted where the data from the sites are pooled and the mean performance is reported. For example, to assess the magnitude of the wCV, a similar number of test-retest cases from two or more sites is collected; the mean wCV from the cases of all sites is estimated, with a 95% CI, and compared with the precision assumption underlying the claims. Note that the sample size for the study should be sufficient such that the 95% CI will provide a tight estimate that rules out values not supportive of the claim.

Soliciting Feedback

<This is just copied from Technical Confirmation. Probably need to re-write>

This step collects feedback on use of the document by implementers and users in the field, including clinical oncologists, imaging scientists, pharma, CRO’s, etc.

Whereas the review and public comment steps prior to this focused on the document itself, this step now seeks feedback on how well it works in practice. As such, comments are solicited specifically from those that have used it and only those that have used it.

A procedure is outlined below listing what is done (by whom).


Period: 30 days

  • Collect list of people that have participated in the field test (Field Test Leader)
  • Finalize comment form that will be used in the survey (Secretariat/Technical Committee)
    • <Q. What's the relationship between this comment form and the standard form linked below?>
  • Announce Call for Feedback to mailing lists (Secretariat), including
  • Email completed Feedback Template to Field Test leader (Commenters)
  • Collate all Feedback comments into a spreadsheet (Secretariat/Field Test Leader)
  • Additionally, summarize feedback into a report (Field Test Leader).
  • Review comments, making changes to the document as needed (Technical Committee)
  • Record comment resolutions in spreadsheet
  • Vote on next step for the document (Technical Committee), either:
    • refer the document to the Modality Committee for Final Text publication
    • conduct another round of field test on revised document
    • place the document into inactive status
  • Post comment spreadsheet, revised document to the Wiki (Field Test Leader/Secretariat)


Solicited Feedback after Publication

The purpose of this process step is to actively seek and periodically respond to feedback on use of published documents. It is important to put this into context with other activities that may seem similar at first: Whereas the review and public comment steps that are part of the Drafting phase focus on the document itself, prior to its use, and the Collect Feedback step as part of the Field Test phase collects feedback on the initial use of the document given that it has been placed into trial implementation, this step is where longer-term, extended use of the document allows for actual assessment of its performance in practice. That is, over the course of time clinical trials may complete that had been designed with this, and/or other results from field usage may become evident either with the user or supplier base. As such, comments are solicited periodically for a wide range of the public that may connect with it in some way.

A procedure is outlined below listing what is done (by whom).


Period: 30 days

  • Periodically, collect list of people that may have used the document and/or professional societies that may have a particular relationship to the document (secretariat)
  • Finalize comment form that will be used in the survey (secretariat with technical committee)
  • Send announcement to mailing lists (secretariat)
  • Email comments to secretariat (Commenters)
    • commenters include full range of users of the document, e.g., vendors/suppliers, clinical oncologists, imaging scientists, pharma, CRO’s, etc. However, only people who have used document are included.
    • please use the provided comment form
  • Collate all comments into a spreadsheet (secretariat)
    • Summarize range of feedback to the questions into a report for review by the technical committee provided by the secretariat.
    • Technical Committee decides what changes to make (if any) to the document and whether to refer it to the Modality Committee for re-publication of an updated version, whether to branch the document leaving the current version in place but spawning a derivative, or to retire the document
  • Record resolution in spreadsheet
    • Regardless of recommended status for this document, ensure that the results are made available to related activities