MCC eTMF/TMF Metrics Leadership Team Progress Webinar

Monthly Archives: December 2015

MCC eTMF/TMF Metrics Leadership Team Progress Webinar

Tuesday, December 22, 2015

The Metrics Champion Consortium (MCC) held a member only session on 20 November that provided an update on the progress made by the MCC’s eTMF/TMF Metrics Leadership Team. During the session, the MCC outlined the stages of the MCC Metrics Development Process, a proposed basic and advanced Metric Framework that accommodates paper and eTMF processes and a TMF Artifacts Mapping Tool (based on the TMF RM V3).

During the session, the MCC also announced the launch of a new survey where it will ask members for feedback regarding the TMF Critical Success Factors (CSFs) and Key Performance Questions (KPQs) discussed during the webinar.

If you are a MCC member and wish to participate in the guided review of the TMF metrics, log onto the MCC Member Portal to see the list of open surveys which includes, Guided Review of TMF Key Performance Questions. Contact Customer Service for any assistance.

Survey results will be shared with a now-forming MCC TMF Working Group that will make recommendations on the initial set of TMF metrics. You can signup to be part of this working group at the end of the survey.

The MCC also has available the recording of this session for MCC members. This can be found in the Workgroup News section of the TMF Workgroup page on the MCC Member Portal.

Please contact Linda Sullivan at lsullivan@metricschampion.org for additional information.

To learn more about membership options or to register to become a member of the MCC, please CLICK HERE or contact Terry Holland.

MCC Members Learn About electronic Clinical Outcome Assessments (eCOA) and Begin to Define Performance Metric Set

Monday, December 21, 2015

In early 2015, Metrics Champion Consortium (MCC) member organizations – sponsors and electronic Clinical Outcome Assessment (eCOA) vendors – requested that the MCC facilitate the development of a standard set of eCOA performance metrics to include in the growing MCC library of clinical metric sets. They believed that the time was right to establish an initial set of measures since the use of eCOA (sometimes referred to as electronic Patient Reported Outcomes – ePRO) has continued to grow and evolve. This growth is partially due to it being one of several tools that helps support the current emphasis on patient-centered clinical research.

In response, MCC launched the eCOA Performance Metrics Initiative to define a standardized set of eCOA performance metrics to be used by clinical trial sponsors, CROs and eCOA vendors to assess the timeliness, quality and effectiveness of the eCOA setup and data collection services. Utilization of these metrics will enable organizations to understand how well the process is being executed and managed throughout study start-up, conduct and closeout.

During the first phase of metric development process, MCC worked exclusively with the eCOA Leadership Team – comprised of representatives from ten member organizations (sponsors, eCOA vendors, CROs) – to establish the foundation on which to build the metric set. Specifically, they used the MCC Metrics Development Process to develop an eCOA Process Map, define nine eCOA Critical Success Factors (CSFs) and draft 28 Key Performance Questions (KPQs). In the final phase of the development process, MCC members will define a set of metrics that answer the high priority KPQs.

Additionally, members of the Leadership team hosted an eCOA Basics webinar to provide MCC members with an overview of eCOA that included topics such as, Types of eCOA measures, the eCOA Regulatory Landscape, and the Impact on Data Quality and Subject Retention. MCC members are invited to visit the Education and Training section of the MCC Member Portal to view the archived recording of the session [free of charge] as well as additional information about the eCOA Metrics Initiative.

MCC Member Feedback Survey

MCC is conducting a brief survey designed to gather information from MCC Member organizations about the eCOA CSFs and KPQs. If you are a MCC member and wish to participate in the guided review of the eCOA CSFs and KPQs, log onto the MCC Member Portal to see the list of open surveys which includes, MCC Member Guided Review of eCOA/ePRO Key Performance Questions (KPQs). Survey results will be shared with a now-forming MCC eCOA Working Group that will make recommendations on the initial set of eCOA metrics. You can signup to be part of this working group at the end of the survey.

To learn more about membership options or to register to become a member of the MCC, please CLICK HERE or contact Terry Holland. MCC Members are invited to contact Customer Service for assistance with establishing user accounts and accessing the MCC Member Portal.

Time Extended for MCC Clinical Development Sponsor KPI Industry Survey

Many Sponsor organizations use Key Performance Indicators (KPIs) to provide visibility into the success of their corporate clinical development strategies. Those same organizations are interested in knowing whether they measure the same KPIs as their peers. To understand whether Sponsors utilize a similar set of KPIs, the MCC has designed a survey to gather information from the Sponsor clinical development (Phase I-IV) community about their use of KPIs. We believe this to be the first survey on the topic of KPIs for the clinical research industry.

The survey launched in Q3 of 2015, but due to recent increased interest in this topic, the survey will remain open through 2016 January.

PRIOR TO STARTING THE SURVEY, please obtain a recent copy of your organization’s Corporate Clinical Development KPI report for reference while completing the survey. To take the survey, please click HERE.

Individual survey responses will be kept confidential and an overview of aggregated survey results will be shared with survey respondents [if you provide your contact information]. This survey takes approximately 10 minutes to complete.

In addition to sharing survey results with participants, the MCC will host a webinar (for MCC members only) in early 2016 to further discuss the analysis of the results. An announcement will be posted prior to that webinar.

If you have any problems with the accessing the survey, please contact Customer Service for assistance. To learn more about membership options or to register to become a member of the MCC, please CLICK HERE or contact Terry Holland.

MCC Clinical Trial Performance Metric Sets Ready for a Checkup

The MCC Clinical Trial Performance Metrics as well as several other metric sets are a few years old and it’s time for them to be reviewed for improvement opportunities. MCC is launching multiple metric set checkups by inviting all MCC members to participate in a guided review process.

While many of the MCC metrics provide the desired performance feedback needed in organizations, it’s likely that there are others that require enhancing. MCC members with metrics experience will have the opportunity to influence change in metrics that may need enhancing or to affirm the metrics that should remain as is. Over 80 metrics are up for review.

New Way to Classify MCC Metric Sets

The MCC is aligning the metrics for review with the MCC Development Process that was released in 2015. The process consists of:

  • Critical Success Factors (CSFs), which describe what must be done well to be successful,
  • Key Performance Questions (KPQs), which identify what you need to know to determine whether the CSF is being achieved, and
  • Metrics, which answer the KPQs.

Each metric set will be released for review as the metrics that support a Critical Success Factor (CSF). There are a total of 13 CSFs that align with clinical trial areas of responsibility such as Site Performance, Data, Monitoring, Safety and Vendor Oversight. Regardless of your functional area, you’ll want to review the metric sets for CSFs that align with your areas of responsibility.

To learn more about the MCC Metrics Guided Review Initiative, we invite members to log onto the MCC Member Portal. At the top of the homepage you will see links to a table of the CSF metric sets along with a link to download the companion document to the initiative titled, “Overview of the MCC Metric Sets Guided Review Initiative“. The CSF table contains links to five metric sets that are available to review now. MCC will continue to release metric sets though January 2016 and will announce each metric set ready for review through emails and LinkedIn as soon as it becomes available.

Survey results will be shared with a MCC Working Group for each CSF that will make recommendations for their metric set. You can signup to be part of a working group at the end of each metric set’s guided review.

Please contact Linda Sullivan for additional information.

To learn more about membership options or to register to become a member of the MCC, please CLICK HERE or contact Terry Holland.

Closing in on an Initial set of CAPA Metrics

The Metrics Champion Consortium (MCC) is launching a Metrics Development Working Group to define a standardized set of CAPA performance metrics to be used by clinical trial sponsors and CROs to assess the timeliness, quality and effectiveness of the CAPA process. Utilization of these metrics will enable organizations to understand how well their CAPA process is being executed.

In 2015, the MCC formed a CAPA Leadership Team comprised of eight MCC member organizations; both sponsors and CROs. They made use of the MCC Metrics Development Process to develop a CAPA Process Map, define five CAPA Critical Success Factors (CSFs), list six Key Performance Questions (KPQs), and draft six metrics that align with the KPQs. They also drafted definitions for nine common CAPA terms. The MCC is now conducting a brief survey designed to gather feedback from MCC Member organizations about the draft set of CAPA metrics.

If you are a MCC member and wish to participate in the guided review of the CAPA metrics, log onto the MCC Member Portal to see the list of open surveys which includes, MCC CAPA Draft Metrics Set – Member Feedback 2015-2016. Contact Customer Service for any assistance.

Survey results will be shared with a now-forming MCC CAPA Working Group that will make recommendations on the initial set of CAPA metrics. You can signup to be part of this working group at the end of the survey.

In addition to this survey, the MCC also has available the recording of a recent presentation on the CAPA Leadership Team’s results as well as an overview document on the status of the CAPA Metrics Development initiative. Both of these are available to members and can be found in the WG Resource Center section of the Clinical CAPA Workgroup page on the MCC Member Portal.

Please contact Linda Sullivan at lsullivan@metricschampion.org for additional information.

To learn more about membership options or to register to become a member of the MCC, please CLICK HERE or contact Terry Holland.

MCC Teams Up with Halloran Consulting to Offer a New Membership Option for Small/Mid-sized Sponsors

MCC’s Linda Sullivan and Halloran Consulting’s Laurie Halloran and Dyana Boutwell hosted a Special Webinar for Small/Mid-sized Biopharma Sponsors Looking For Clinical Trial Oversight Solutions. During the session, they discussed clinical trial performance management solutions designed for small/mid-sized sponsors and the launch of the MCC’s Small/Mid-Sized Sponsor Community of Practice (CoP) Group. CLICK HERE to view the session.

New Enhanced MCC Membership Option Includes Special Monthly Newsletter

Organizations that don’t have time to attend the small sponsor CoP meetings or need additional support to implement metrics can opt to subscribe to the new enhanced membership program. This option allows organizations to join a special support group that receives a unique set of benefits in addition to the basic MCC membership: Halloran representation at MCC meetings and a monthly newsletter to keep you up-to-date on MCC work group discussions and deliverables. The MCC-Halloran Newsletter provides the insight and knowledge your organization needs to implement a set of actionable metrics designed for use in small companies. CLICK HERE for additional information.

Feedback Survey

MCC invites all small/mid-sized sponsors to complete a brief survey to let us know about: 1) your organization’s interest in participating in the Community of Practice Group and 2) topics you would like to see the group explore. CLICK HERE to take the MCC Small/Mid-size Sponsor Feedback Survey.

How to Join the Community of Practice Group

If your organization is not a member of the MCC, contact Teresa Holland (tholland@metricschampion.org) for membership details.

MCC members can register for the CoP by adding it to your user profile. Please contact Customer Service (customerservice@metricschampion.org) if you need to assistance.