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 Scenarios under consideration

This is the high level list developed by the Architecture Sub Group

Use CasePriorityNotes
1.       Submission of study data (such as HCT trials from trial sites) to a central repository
  Discuss at January WGM
2.       Clinical trial participant registration, and submission of the registration data to ClinicalTrials.gov and other international registries2

 6-Aug-2019 CKD>> 

Need to get clear scope / boundary

Proposed first phase = CT.gov, EudraCT, WHO

https://clinicaltrials.gov/

https://www.clinicaltrialsregister.eu/

https://www.who.int/rpc/research_ethics/format_rp/en/


See mapping spreadsheet under Projects: 

ResearchStudy



3.       Submitting data to research repositories, such as oncology data for the SEER Registry
Discuss this with CIC during January 2018 WGM at the joint meeting
4.       Submit subject lab data to CRO and/or sponsor

TCB Use case 3


Update 6-Aug-2019 CKD>>

Lab IG prepared for balloting in September 2019

http://hl7.org/fhir/uv/cdisc-lab/2019Sep/

Build URL:

http://build.fhir.org/ig/HL7/cdisc-lab/index.html

5.       Study setup, management, and site network management1
6.       Sharing protocol and CRF metadata and subject data among trial stakeholders

7.       Adverse Event reporting3

May duplicate the ongoing FHIR AE resource development by the Patient Care

TCB use case


Update 6-Aug-2019 CKD>>

Mapping in progress as of January 2019.  TCB has identified 6 gaps:

1. Additional values for seriousness (resulting-in-cancer; resulting-from-overdose) – rejected; cannot reflect outcome or cause https://gforge.hl7.org/gf/project/fhir/tracker/?action=TrackerItemEdit&tracker_item_id=23023

2. Definitions for severity (mild-moderate-severe) – rejected; attribute removed from AE resource https://gforge.hl7.org/gf/project/fhir/tracker/?action=TrackerItemEdit&tracker_item_id=23025

3. Suggested definitions for AdverseEvent.outcome (resolved/recovering/ongoing…) – not reviewed https://gforge.hl7.org/gf/project/fhir/tracker/?action=TrackerItemEdit&tracker_item_id=23022

4. Modify Condition.abatement definition (remove “never resolved”) – not reviewed https://gforge.hl7.org/gf/project/fhir/tracker/?action=TrackerItemEdit&tracker_item_id=23020

5. Add Conditon attribute to capture continuity of condition (continuous/intermittent/single event) – not reviewed https://gforge.hl7.org/gf/project/fhir/tracker/?action=TrackerItemEdit&tracker_item_id=23021

6. Track reason for study discontinuation on ResearchSubject - not reviewed https://gforge.hl7.org/gf/project/fhir/tracker/?action=TrackerItemEdit&tracker_item_id=23028



Use Cases Wayne Kubick is Promoting


1

Feasibility,  Investigator & Subject Searches


2

Monitoring Protocol Execution

5

3

Pre-populating EDC CRFs

6

Collect Patient-Originated Data


5

Apply Data Corrections simultaneously to EHR & EDC


6

Drive pragmatic trials and precision medicine


7

Drilldown analysis of source data by regulatory reviewers


8

Bulk transfer of clinical data for analytics

1

January Connectathon Use Cases

#Use CasePriorityNotes
1EMR to EDC

2Real World Evidence Scenario

3Lab Data Import










 Architecture Sub Group  Use Case Detail

1.       Submission of study data (such as HCT trials from trial sites) to a central repository


2.       Clinical trial participant registration, and submission of the registration data to ClinicalTrials.gov and other international registries


Notes

o   Jose: If there is a FHIR implementation, there might be pressure on the registries to all use the same thing. Right now, there is different implementation for each registry.

o   Discuss at January WGM

 

3.       Submitting data to research repositories, such as oncology data for the SEER Registry

Notes

a.       Amy: HL7 CIC working on CDEs for registries primarily for EHR and then secondarily for research (Common Registry Framework). Thinks this will move very quickly. We should collaborate with this group.

b.      Discuss this with CIC during January 2018 WGM at the joint meeting


4.       Submit subject lab data to CRO and/or sponsor (similar to TCB Use case 3)

Notes

a.       May help support the FDA / NIH/ CDISC LOINC effort

                                                               i.      Is this being done to compliment the CDASH/SDTM effort?  Ask Boris

b.      Amy talked about lab tests resulted within EHR vs resulted by 3rd party

c.       Amy suggested collaborating with others on this

Priority

d.      This may be a lower priority relative to other scenarios


5.       Study setup, management, and site network management (12/07/2017 – worked on this scenario at high level)

a.       Several use cases here (the current world, not the future world):

b.      Next Level Use Cases:

                                                               i.      Identify Project/Study Milestones > When was the first subject treated on this study at a site  (This could be executed at Coordinating site level also – provide all the subjects that were treated on this study at every site)

1.       Use Case:  Milestones within project: As site manager, might want to know when the first patient has been treated with study drug at site, country, study. (need to flesh out further)

2.       Actors:  Site Coordinator/Site Manager; CTMS

3.       Data Elements in the Query: Study Id,  Site id

4.       Data Elements Returned in the Query:  Study Id, Study Drug Name, Drug Administration date, Site Name, Site Address, will need to identify additional data elements to complete this query result

5.       Current Candidate FHIR Resources:

6.       Additional Resources or Extending current resources (profiles):

c.       Additional notes from 12/14/2017

                                                               i.      Amy may be interested in this from EHR point of view

                                                             ii.      There will be many milestones associated to this use case – identify the various milestones. Hugh/Parexel building out this scenario in their platform – identifying the milestone and timing

a.       Study Start

b.      First site recruited for a study

c.       First patient recruited at site

d.      First dose

e.      Data lock

f.        Study end [Closing the study, last intervention, etc.] May need standardization of what “Study End” means.  Overall would be good to get standardization for all Study milestones

2.       Need between EHR (events/interactions are being documented) and CRMS (milestone being documented)

3.       Look into Consent Resource [being developed O&O]

                                                            iii.      Visit schedule part of Study Design: Visit schedule is important.

                                                           iv.      Study description as part of Study Design: Need to describe the study with potential sites.

                                                             v.      Management of individual investigators in terms of recruiting

Notes

                                                           vi.      Hugo L --- The Plan Definition Resource appears to define the Protocol structure and then the ResearchStudy Resource defines the Study, but there appears to be a gap in identifying a set of FHIR resources that would be needed for building the study and conducting the study, for example, Encounter resource could be leveraged, but not sure if it has the all the pieces needed from Clinical Research scenarios.

                                                          vii.      Research Subject resource:  Hugo will add the de-identification comment/question to the HL7 FHIR GForge tracker.

Priority

                                                        viii.      Amy puts this at the top of the list, registries second, AE third





6.       Sharing protocol and CRF metadata and subject data among trial stakeholders

Notes

a.       Amy: It would be beneficial to enter data in only one system and not both the EHR and CRMS.

b.      The Plan Definition Resource would be of interest in this scenario.  We would need to identify the work flow of the clinical trial when we get into this. 

c.       Hugo is part of FHIR implementation team in Australia. National Clinical Terminology Service (NCTS) part of Digital Health Agency in Australia --- looking at FHIR resources – SNOMET CT, LOINC, etc.  Focused on terminology aspect of FHIR.  He is interested in Clinical Research resources for Clinical Trial Management System (CTMS).


7.       Adverse Event reporting

Notes

a.       May duplicate the ongoing FHIR AE resource development by the Patient Care

b.      Amy: very interesting use case – connecting to AE systems.

c.       Amy: Interfacing EIRB, CRMS, and EHR systems – one update to all 3 at the same time


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