Difference between revisions of "Process"
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** [[Review Process|Approve & Publish Public Comment Draft]] | ** [[Review Process|Approve & Publish Public Comment Draft]] | ||
− | * Publicly Reviewed | + | * Consensus Stage (Publicly Reviewed) |
− | ** [[Public Comment Process|Collect | + | ** [[Public Comment Process|Collect & Collate Comments]] |
*** [[Work Product for Review]] | *** [[Work Product for Review]] | ||
− | ** [[Review Process|Approve | + | ** Reach Consensus on resolution for all comments |
+ | ** [[Review Process|Review & Approve Consensus Profile]] | ||
+ | ** [[Publication Process|Publish Consensus Profile]] | ||
* Technical Confirmation Stage | * Technical Confirmation Stage | ||
− | ** [[Confirmation Process| | + | ** [[Confirmation Process|Plan & Coordinate Technical Confirmation]] |
*** [[QIBA Protocol/Profile Implementation Feedback Process]] | *** [[QIBA Protocol/Profile Implementation Feedback Process]] | ||
** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | ** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | ||
− | ** [[Review Process|Approve & Publish | + | ** [[Review Process|Review & Approve Technically Confirmed Profile]] |
+ | ** [[Publication Process|Publish Technically Confirmed Profile]] | ||
+ | |||
+ | * Claim Confirmation Stage | ||
+ | ** [[Confirmation Process|Plan & Coordinate Claim Confirmation]] | ||
+ | ** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | ||
+ | ** [[Review Process|Review & Approve Claim Confirmed Profile]] | ||
+ | ** [[Publication Process|Publish Claim Confirmed Profile]] | ||
* Clinical Confirmation Stage | * Clinical Confirmation Stage | ||
− | ** [[Confirmation Process| | + | ** [[Confirmation Process|Plan & Coordinate Clinical Confirmation]] |
** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | ** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | ||
− | ** [[Review Process|Approve | + | ** [[Review Process|Review & Approve Clinically Confirmed Profile]] |
+ | ** [[Publication Process|Publish Clinically Confirmed Profile]] | ||
* Maintenance | * Maintenance |
Revision as of 22:59, 20 May 2016
Overview
QIBA attempts to industrialize biomarkers by selecting candidate biomarkers, investigating underlying sources of variance and other practical impediments to their use, and drafting specification documents ("Profiles") to help vendors and healthcare providers overcome those impediments and sources of variance.
The details of how those steps are carried out is described here. The Process Coordinating Committee manages this content.
Procedures and Conventions
- QIBA Profile Template
- Change Tracking and File Naming
- Profile Editions
- Profile Conformance
- Publication Process
QIBA Profiling Process
- Drafting and Public Comment Stage
- Consensus Stage (Publicly Reviewed)
- Collect & Collate Comments
- Reach Consensus on resolution for all comments
- Review & Approve Consensus Profile
- Publish Consensus Profile
- Technical Confirmation Stage
- Claim Confirmation Stage
- Clinical Confirmation Stage
- Maintenance
- Retirement
Groundwork Projects and Funding
Groundwork and Profiling - a model for linking research, validation, standardization, product implementation and deployment.
- Groundwork Process
- Funding Submission Process
- Evaluation and Selection Process
- Publication of Results - discuss where, how, level of detail, embargo period (6 months from completion of project?), extension requests, completion=submission of report, actual posting/publication can be later
See Also
- Profile Development Process Comparison - Considering analogs between DICOM, IHE, UPICT and QIBA
- Orphan Documents
- How to Write a Profile