Difference between revisions of "Process"
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QIBA attempts to ''' ''industrialize'' biomarkers''' by selecting biomarkers ready for industrialization, 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. | QIBA attempts to ''' ''industrialize'' biomarkers''' by selecting biomarkers ready for industrialization, 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. | The details of how those steps are carried out is described here. The '''[[Process Coordinating Committee]]''' manages this content. | ||
| − | ==Procedures | + | ==Committee Procedures== |
* [[Committee Procedures]] | * [[Committee Procedures]] | ||
| Line 12: | Line 11: | ||
** [[Voting Process]] | ** [[Voting Process]] | ||
** [[Voting Privileges]] | ** [[Voting Privileges]] | ||
| − | |||
| − | |||
| − | |||
| − | == | + | ==Profiling Process== |
| − | [[QIBA Profile Stages]] & [[QIBA Concepts]] | + | Understand [[QIBA Profile Stages]] & [[QIBA Concepts]] |
| − | '''Selection''' | + | '''Stage 0: Selection''' |
:* [[Selection Process|Submit Proposals]] | :* [[Selection Process|Submit Proposals]] | ||
:* [[Selection Process|Evaluate and Approve Proposals]] | :* [[Selection Process|Evaluate and Approve Proposals]] | ||
| − | ''' | + | '''Stage 1: Public Comment Stage''' |
| − | :* [[QIBA Profile Drafting Process| | + | :* [[QIBA Profile Drafting Process|Start Drafting QIBA Profile]] |
| − | :** [[How to Write a Profile]] | + | :** See [[How to Write a Profile]] |
| − | :** [[QIBA Profile Template]] and [[Claim Guidance]] and [[Assessment Procedure Guidance]] | + | :** See [[QIBA Profile Template]] and [[Claim Guidance]] and [[Assessment Procedure Guidance]] |
:* [[Groundwork Process|Initiate/Conduct Groundwork]] | :* [[Groundwork Process|Initiate/Conduct Groundwork]] | ||
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft | ||
| − | :** [[Work Product for Review]] | + | :** See [[Work Product for Review]] |
| + | :* You have completed [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]] | ||
| − | '''Consensus Stage (Publicly Reviewed)''' | + | '''Stage 2: Consensus Stage (Publicly Reviewed)''' |
:* [[Public Comment Process|Collect & Collate Public Comments]] | :* [[Public Comment Process|Collect & Collate Public Comments]] | ||
:* Reach Consensus on resolution for all comments | :* Reach Consensus on resolution for all comments | ||
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile | ||
| + | :* You have completed Stage 2 | ||
| − | '''Technical Confirmation Stage''' | + | '''Stage 3: Technical Confirmation Stage''' |
:* [[Confirmation Process|Plan & Coordinate Technical Confirmation]] | :* [[Confirmation Process|Plan & Coordinate Technical Confirmation]] | ||
| − | :** [[QIBA Protocol/Profile Implementation Feedback Process]] | + | :** See [[QIBA Protocol/Profile Implementation Feedback Process]] |
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | :* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | ||
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile | ||
| + | :* You have completed Stage 3 | ||
| − | '''Claim Confirmation Stage''' | + | '''Stage 4: Claim Confirmation Stage''' |
:* [[Confirmation Process|Plan & Coordinate Claim Confirmation]] | :* [[Confirmation Process|Plan & Coordinate Claim Confirmation]] | ||
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | :* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | ||
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile | ||
| + | :* You have completed Stage 4 | ||
| − | '''Clinical Confirmation Stage''' | + | '''Stage 5: Clinical Confirmation Stage''' |
:* [[Confirmation Process|Plan & Coordinate Clinical Confirmation]] | :* [[Confirmation Process|Plan & Coordinate Clinical Confirmation]] | ||
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | :* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | ||
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile | ||
| + | :* You have completed Stage 5 | ||
'''Profile Maintenance''' | '''Profile Maintenance''' | ||
| Line 78: | Line 79: | ||
* [[:Category:Templates|Wiki Page Templates]] | * [[:Category:Templates|Wiki Page Templates]] | ||
* '''[[How To's]]''' for this Wiki | * '''[[How To's]]''' for this Wiki | ||
| − | + | * [[Public Comment Process]] | |
| + | * [[Review Process]] | ||
| + | * [[Publication Process]] | ||
* [[Orphan Documents]] | * [[Orphan Documents]] | ||
* [https://docs.google.com/document/edit?id=1TG5bHj9yTsYpHuMRt8R9T12Ml_08Ah599oxgOsiXyrg&hl=en&authkey=CJbfqekH Profile Development Process Comparison] - Considering analogs between DICOM, IHE, UPICT and QIBA | * [https://docs.google.com/document/edit?id=1TG5bHj9yTsYpHuMRt8R9T12Ml_08Ah599oxgOsiXyrg&hl=en&authkey=CJbfqekH Profile Development Process Comparison] - Considering analogs between DICOM, IHE, UPICT and QIBA | ||
Revision as of 01:02, 18 February 2017
QIBA attempts to industrialize biomarkers by selecting biomarkers ready for industrialization, 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.
Committee Procedures
Profiling Process
Understand QIBA Profile Stages & QIBA Concepts
Stage 0: Selection
Stage 1: Public Comment Stage
- Start Drafting QIBA Profile
- Initiate/Conduct Groundwork
- Review & Approve then Publish Public Comment Draft
- You have completed Stage 1
Stage 2: Consensus Stage (Publicly Reviewed)
- Collect & Collate Public Comments
- Reach Consensus on resolution for all comments
- Review & Approve then Publish Consensus Profile
- You have completed Stage 2
Stage 3: Technical Confirmation Stage
- Plan & Coordinate Technical Confirmation
- Collect and Resolve Feedback
- Review & Approve then Publish Technically Confirmed Profile
- You have completed Stage 3
Stage 4: Claim Confirmation Stage
- Plan & Coordinate Claim Confirmation
- Collect and Resolve Feedback
- Review & Approve then Publish Claim Confirmed Profile
- You have completed Stage 4
Stage 5: Clinical Confirmation Stage
- Plan & Coordinate Clinical Confirmation
- Collect and Resolve Feedback
- Review & Approve then Publish Clinically Confirmed Profile
- You have completed Stage 5
Profile Maintenance
Profile 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
Conformance
See Also
- Profile Editions
- Change Tracking and File Naming
- Wiki Page Templates
- How To's for this Wiki
- Public Comment Process
- Review Process
- Publication Process
- Orphan Documents
- Profile Development Process Comparison - Considering analogs between DICOM, IHE, UPICT and QIBA