Difference between revisions of "Process"
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− | QIBA | + | QIBA ''' ''industrializes'' biomarkers''' by selecting biomarkers ready for industrialization, investigating underlying sources of variance and 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. Comments are welcome. [mailto:qiba@rsna.org Email QIBA] |
==Committee Procedures== | ==Committee Procedures== | ||
* [[Committee Procedures]] | * [[Committee Procedures]] | ||
− | |||
− | |||
− | |||
** [[Voting Privileges]] | ** [[Voting Privileges]] | ||
+ | * [[Review Process]] | ||
+ | * [[Publication Process]] | ||
+ | * [[Public Comment Process]] | ||
+ | * [[Committee Organization]] | ||
+ | ** [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]] | ||
− | == | + | ==Profile Creation Process== |
Understand [[QIBA Profile Stages]] & [[QIBA Concepts]] | Understand [[QIBA Profile Stages]] & [[QIBA Concepts]] | ||
− | + | ||
:* [[Selection Process|Submit Proposals]] | :* [[Selection Process|Submit Proposals]] | ||
:* [[Selection Process|Evaluate and Approve Proposals]] | :* [[Selection Process|Evaluate and Approve Proposals]] | ||
− | '''Stage 1: Public Comment | + | '''Getting to Stage 1: Public Comment''' |
:* Start Drafting the Profile | :* Start Drafting the Profile | ||
:** See [[How to Write a Profile]] | :** See [[How to Write a Profile]] | ||
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:* [[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 | ||
− | |||
:* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]] | :* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]] | ||
− | '''Stage 2: Consensus | + | '''Getting to Stage 2: Consensus''' |
:* [[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 | ||
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:* You have reached Stage 2 | :* You have reached Stage 2 | ||
− | '''Stage 3: | + | '''Getting to Stage 3: Technically Confirmed''' |
:* [[Technical Confirmation Process#Planning|Plan & Coordinate Technical Confirmation]] | :* [[Technical Confirmation Process#Planning|Plan & Coordinate Technical Confirmation]] | ||
:** See [[QIBA Protocol/Profile Implementation Feedback Process]] | :** See [[QIBA Protocol/Profile Implementation Feedback Process]] | ||
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:* You have reached Stage 3 | :* You have reached Stage 3 | ||
− | '''Stage 4: Claim | + | '''Getting to Stage 4: Claim Confirmed''' |
:* [[Claim Confirmation_Process#Planning|Plan & Coordinate Claim Confirmation]] | :* [[Claim Confirmation_Process#Planning|Plan & Coordinate Claim Confirmation]] | ||
:* [[Claim Confirmation_Process#Soliciting Feedback|Collect and Resolve Feedback]] | :* [[Claim Confirmation_Process#Soliciting Feedback|Collect and Resolve Feedback]] | ||
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:* You have reached Stage 4 | :* You have reached Stage 4 | ||
− | '''Stage 5: | + | '''Getting to Stage 5: Clinically Confirmed''' |
:* [[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]] | ||
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* [[Review Process]] | * [[Review Process]] | ||
* [[Publication Process]] | * [[Publication Process]] | ||
+ | * [[Clinical Trial Planning]] | ||
* [[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 21:11, 15 October 2018
QIBA industrializes biomarkers by selecting biomarkers ready for industrialization, investigating underlying sources of variance and 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. Comments are welcome. Email QIBA
Committee Procedures
- Committee Procedures
- Review Process
- Publication Process
- Public Comment Process
- Committee Organization
Profile Creation Process
Understand QIBA Profile Stages & QIBA Concepts
Getting to Stage 1: Public Comment
- Start Drafting the Profile
- Initiate/Conduct Groundwork
- Review & Approve then Publish Public Comment Draft
- You have reached Stage 1
Getting to Stage 2: Consensus
- Collect & Collate Public Comments
- Reach Consensus on resolution for all comments
- Review & Approve then Publish Consensus Profile
- You have reached Stage 2
Getting to Stage 3: Technically Confirmed
- Plan & Coordinate Technical Confirmation
- Collect and Resolve Feedback
- Review & Approve then Publish Technically Confirmed Profile
- You have reached Stage 3
Getting to Stage 4: Claim Confirmed
- Plan & Coordinate Claim Confirmation
- Collect and Resolve Feedback
- Review & Approve then Publish Claim Confirmed Profile
- You have reached Stage 4
Getting to Stage 5: Clinically Confirmed
- Plan & Coordinate Clinical Confirmation
- Collect and Resolve Feedback
- Review & Approve then Publish Clinically Confirmed Profile
- You have reached 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
- Clinical Trial Planning
- Orphan Documents
- Profile Development Process Comparison - Considering analogs between DICOM, IHE, UPICT and QIBA