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eCRF Wiki Reconstruction

eCRF Wiki Reconstruction. Outline of Pages. Home Page Title Project Overview CRF Harmonization Process (Graphic) CRF Modules Table Demography Module Narrative Round 1 Modules Round 1 Leads and Participants Round 1 Status Module Metrics Lessons Learned

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eCRF Wiki Reconstruction

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  1. eCRF Wiki Reconstruction

  2. Outline of Pages • Home Page • Title • Project Overview • CRF Harmonization Process (Graphic) • CRF Modules Table • Demography Module • Narrative • Round 1 Modules • Round 1 Leads and Participants • Round 1 Status • Module Metrics • Lessons Learned • Quick Links – This will be a section on the side of the home page • Project Management • Meeting Schedule • Agendas/Meeting Minutes • Working Group Leads and Membership • CRF Activities • REDCap • BRIDG Harmonization • CDISC

  3. Home Page • Title: CRF Harmonization and Standardization • Project Overview • The CRF Project is an initiative is based on the Clinical Trials Working Group (CTWG) report of 2005, in which the NCI clinical trials enterprise is reviewed, with recommendations for improvement. One of the recommendations is for the NCI to 'develop a library of harmonized case report forms (CRFs) for use in NCI sponsored trials, based on stakeholder consensus'. review and create new elements as needed, and maintain collections of metadata in caDSR. The Institute of Medicine (IOM), a committee that reviews the roles of various stakeholder groups involved in cancer clinical trials and recommends a serious of changes across the board released a report in 2010 that also recommended the implementation of CRFs to aid trial efficiency. This initiative was developed in 2006 to create a set of CRF content that is reviewed by our community, harmonized and agreed upon, and then registered in electronic systems (caDSR) for use by the community-at-large in applications (Clinical Data Management Systems, CDMS). Metadata curators act as members of each workgroup, review and create new elements as needed, and maintain collections of metadata in caDSR. Once the active creation and community harmonization is completed, the project will transition into one with an implementation, oversight, and governance activity. Content will be used to collect clinical trials reported data for a variety of CTWG, clinical trials, and research activities that scale in the coming years.

  4. Home Page CRF Harmonization and Standardization Process

  5. Home Page • CRF Question Partition Categories • Mandatory: • A data collection variable that must be on the CRF (e.g., a regulatory requirement (if applicable)). Must be used. • Conditional: • A data collection variable that must be collected on the CRF for specific cases that may be dictated by local or sponsor defined business rules. • Optional: • A data collection variable that is available for use if needed. Usually collected due to the design of the protocol, like in instances where marital status or educational level are important indicators in a study.   • Non-harmonized: • A data collection variable that is, by consensus, to primarily belong to a different CRF module or is not belonging to any defined module.

  6. Home Page • CRF Modules • User will be able to click on a round or a module to get more information

  7. Home Page – Quick Link • Project Management • Calendar of Meetings • Agendas • Meeting Minutes • Working Group Leads and Membership • Contact Information

  8. Home Page • Metrics Brief Description • The CRF Harmonization & Standardization project was initiated to provide a harmonized and standardized set of variables to be collected for oncology clinical trials that could be implemented to facilitate data entry, and study aggregation, comparison and analysis.  Describe the metrics we are collecting. Do view metrics, choose a model • List modules in alphabetical order

  9. Demography Module • Round: 1 • Narrative • The Demography module was the only group of variables included in the first round of the CRF project. This was considered a pilot for the standardization and harmonization of CRF variables. The Demography module includes harmonized variables related to demographic information recommended for collection on all NCI sponsored clinical trials. • Demography Working Group Leads and Membership • *Leads will be bolded

  10. Demography Module Metrics • Metrics • Brief overview of metrics • General description of what they actually delivered • # of contributing organizations • Type of organizations • # of content rows • # of items in final deliverable

  11. Project Management – Quick Link • Brief Description • Calendar of Meetings • Agendas • Meeting Minutes • Participating Leads and Organizations

  12. CRF Activities – Quick Link • REDCap • BRIDG Harmonization • CDISC

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