The Practicalities of Data Standards
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1 The Practicalities of Data Standards Provided by Catherine Carpenter-Clawson, Research Network Manager For EDGE User Conference th March 2014
2 Contents Example 1: Local challenges with study arm data supported by national solution Example 2: Regional collaboration to improve local data consistency Example 3: Benchmarking paediatric oncology research data to support understanding of activity
3 Example 1: Local challenges with study arm data National working to improve data quality regarding patients entering trial arms
4 The Context: Legacy arm data in EDGE v2 required standardisation EDGE v1 allowed local users to add arms to studies Arms merged in EDGE v2 Merged data inconsistent and confusing
5 The Challenge: Requirement to improve national data quality and resolve issues Why are there different variations to arms? Which is the correct version? Who owns the arm data? Who has the authority to update it? How do we manage the arms prospectively? How do we/do we resolve this retrospectively?
6 Proposed Solution: Nationally-led solution inviting effected individuals to support work Group established of interest individuals to tackle this issue nationally Representatives from managers, national coordinating centre and front-line staff Decision to allocate and fund dedicated resource moving forward National EDGE Co-ordinators appointed Collective effort to tackle the issue Involvement from individuals across country to define standard arms Clear processes and procedures outlined moving forward
7 Proposed Solution: the scale of the challenge ~400 studies identified ~23,000 patients might required transferring Additional issues unearthed Studies closed prior to April 2010 Studies where controls listed as arms Studies owned by different organisations Duplication of studies on EDGE adds complexity
8 Proposed Solution: Looking forward and developing this initiative Group established to support this work evolved into NCRN EDGE Collaborative Working Group Membership from EDGE, NCRN core team, managers and front-line staff using EDGE National point of contact for discussing challenges and opportunities within the EDGE system Regular teleconference & discussions NCRN Data Day last October to share developments Opportunity to share good practice and discuss challenges
9 What have we learnt? Local issues can be shared and tackled nationally Collaboration Commitment Clarity Importance of dedicated resource but enthusiasm locally to support Importance of clearly defined processes and escalation points
10 Example 2: Regional Collaboration to Improve Local Data Stakeholder engagement across the West of England Clinical Research Network
11 The Context: Local Clinical Research Networks require some standardisation of data From 1 st April each of the 15 Clinical Research Networks will be required to utilise a local portfolio management system Various documents produced to assist in decision around which systems will meet minimum requirements Within West of England Clinical Research Network existing Trusts and many of the networks currently use EDGE
12 The Challenge: Can we work together across the West of England to improve data? Can we collaborate across the West of England? Can we standardisation data across stakeholders? Who should be involved and lead this collaboration? Who else should be involved? How do we work together? At what level do we collaborate at? What resources do we need to invest? Who is responsible?
13 Proposed Solution: Stakeholders within West of England CRN met to discuss data - Stakeholders asked to define key data items on post-it notes - Data items segregated as either stakeholder specific or of interest to all Study title R&D number Site open to recruit date Chief Investigator Site Initiation Date Lead Nurse Study open to recruit date NHS permission Lay Summary Funding Stream
14 Proposed Solution: Agree key data items will constitute a minimum data set to share across network Data Items Study Type Lay summary from ethics form Sponsor organisation contacts from protocol Portfolio Banding 1, 2, 3 using NIHR Definition Study Target recruitment from contract CTU if applicable who are leading study from protocol Submissions Date NHS permission SIV date Open to recruitment date REC approval dates from lead site MHRA approval dates from lead site Amendment number Recruitment predicted Recruitment screened Recruitment actual Recruitment local Recruitment national Lead Site Trust where CI is based Actual Start Actual End Dates Clarification needed Current RAG Status PI or Local Collaborator Data Items Protocol Number (or not applicable/unknown) (not version actual number) PI Lead Nurse Trial Co-ordinator/Data Contact CI Trial Manager Data Contact Valid Submission Date Study Title (full) Contracts query local NIHR portfolio ID/UKCRN number Sponsor name on protocol CRO Clinical Speciality Group NIHR definition of the 30 groups Site Initiation Visit final site initiation visit Funding Stream commercial/non commercial Funder- alphabetical field Portfolio status adopted/non-adopted 70 Day Bench Mark (yes/no) Study Short Title/acronym Contracts
15 Proposed solution: Data Items defined as study wide items (green) or Trust-specific data (red) - Splitting items as study wide to escalate for national clarification or as Trust specific to discuss locally within the working group Study title Site open to recruit date Chief Investigator Site Initiation Date Lead Nurse Study open to recruit date NHS permission Lay Summary Funding Stream
16 Proposed Solution: Next steps to define our minimum data set and compare it to existing information Data Item Related information on EDGE EDGE Definition/Comments A. Project Level Information A1. Study/Project Identifiers Study Short Title/acronym Project Display Title Study Acronym Study Title (full) Not clear how this is included To be discussed NIHR portfolio ID/UKCRN number NIHR Portfolio Study ID NIHR Assigned Unique Identifier (AKA - UKCRN ID) Protocol Number (or not Not currently included? To be discussed applicable/unknown) (not version actual number) Lay summary from ethics form Project Description Lay man s description of the study A2. Study/Project Definers & Metrics Study Type Project Type Includes a drop down list to discuss further Portfolio Banding 1, 2, 3 using NIHR Not currently included? To be discussed Definition Recruitment national Actual recruitment To be confirmed? Recruitment target Project Target Participants The total number of patients required to participate and complete the study in order to fulfil the required quota as defined by the study sponsor Portfolio status adopted/non-adopted NIHR Portfolio Eligibility Type of NIHR adoption (Drop down box to discuss) Clinical Speciality Group NIHR definition of the 30 groups Not currently included NIHR Topic is included which is defined as The NIHR classification of disease area Funding Stream commercial/non commercial NIHR Industry Study Identification of Industry involvement with the study (includes a drop down list to discuss further) Current RAG Status Not currently included? To discuss further
17 Proposed Solution: Next steps to define our minimum data set and compare it to existing information Data Item Related information on EDGE EDGE Definition/Comments B. Trust Level Information B1. Trust Project Study Identifiers Amendment number Not currently included? To be discussed Contracts Not currently included? To be discussed B2. Trust Study/Project Metrics Recruitment predicted Project Site Target Participants The suggested target number of participants to be recruited at a specific study site as identified on the local SSI form Recruitment screened Screened Definition to be confirmed Recruitment actual Actual recruitment Definition to be confirmed 70 Day Bench Mark (yes/no) Not currently included To be discussed RAG status Not currently included To be discussed B3. Trust Study/Project Contact Details Principle Investigator Principal Investigator Local Lead investigator for each site or NHS Trust Lead Nurse Project Site Lead Nurse(s) Site Nurse(s) / Nursing Managers Trial Co-ordinator/Data Contact Not currently included To be discussed Local Collaborator Co-investigators Definition to be included B4. Trust Study/Project Timelines Submissions Date Project Site Date R&D Submission The date which the site information was submitted to the R&D department for local approval NHS permission Project Site Start Date The date of NHS Permission Letter Site Initiation Visit final site initiation Project Site Date Initiation Visit The date which the Site Initiation Visit has taken place visit Open to recruitment date Project Site Date Open to recruitment The date which the site is open and able to recruit patients. This date may differ from the site start date. Actual Start Not currently included? To be discussed if this differs to open to recruitment date? Actual End Dates Clarification needed Project Site Actual Recruitment End Date The date the site closes to recruiting new patients. This date may differ from the sites proposed recruitment end date.
18 Proposed Solution: Further collaboration and sharing of data and information Collaborative with all local stakeholders in order to define a shared minimum data set across the new network Work with EDGE to set up appropriate sharing and visibility around this data set within the system Share practice across different Clinical Research Networks and review progress
19 What have we learnt? Importance of engaging all key stakeholders across West of England Co-operation Commitment Consistency Need for resource and support from all organisations for initiative to succeed Clearly define definitions of metrics and requirements
20 Example 3: Benchmarking paediatric oncology research data UK wide plans to improve data in the field of children s cancer and leukaemia research
21 The Context: National targets or metrics may not reflect details of specific areas Research into paediatric oncology and haematology is clearly of great importance Research generally considered standard of care in the children s cancer and leukaemia field Children s cancer is managed through 13 Primary Treatment Centres across England Expectation all centres will open all major studies All patients eligible for a study will be offered opportunity to participate in research Bristol Primary Treat Centre predicted recruitment for 2013/14 noted that of 22 studies only 2 were predicted to recruit more than 6 patients per year (half predicted recruitment of 2 patients or less)
22 The Challenge: Current national metrics won't highlight the story behind the data How could or should paediatric oncology respond to the national metrics for research activity? Can the Children s Cancer and Leukaemia community improve data in order to understand their activity better? What is really of importance to measure for research in paediatric oncology research? How/where do we access this information? What should we do with it when we get it?
23 Proposed Solution: Benchmarking and brain-storming day to review data Engagement was requested from paediatric oncology community to attend a benchmarking event Representatives included clinical leads, research nurses, clinical trial units, network managers and national leads Outlined four/five focus areas Feasibility Set Up (times & portfolio) Recruitment Data Completeness
24 Proposed Solution: Benchmarking and brain-storming day to review data Feasibility Set Up (times & portfolio) Recruitment Data Completeness What data do we want? How do we action and analysis this? Where do we get hold of this data? How do we accurately define this data?
25 What have we learnt? Benefits of engagement across a wide range of stakeholders Collaboration Commitment Consistency Dedication from stakeholders to maximise existing data and information Importance for national agreement on details
26 In Summary: All examples of practical approaches include three key ingredients that will determine their success Collaboration & Co-operation Commitment & Co-ordination Clarity & Consistency
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