Audit findings per site

Monthly Archives: July 2014

Audit findings per site

Monday, July 21, 2014

MCC has just published an executive summary of its Risk Based Monitoring Usage Survey. We’ve also just released our Metrics Search Engine that allows you to find the right metrics for your situation and level of expertise. Check out our web site for details. In April, we looked at eCRF data entry cycle time as a useful RBM metric. This month, let’s look at another metric that’s very important in a Risk-Based Monitoring (RBM) environment: Audit Findings per Site. 

CLICK HERE for the full article.

MCC Lab Metrics Update: Lab Metrics version 2.1 now available

Thursday, July 17, 2014

The MCC released updates to the Lab Metric definitions on July 1, 2014. Version 2.1 adds new descriptors and features to the metrics defined in version 2.0. Specifically, the new release includes the following new features to each of the 12 metrics in the set:

  • Level of Metric – Whether the metric is a Set Up/Relationship metric or a Sample Collection & Review metric
  • The Key Question that the metric will answer
  • Why is the question important? What related action steps might be taken based on the response?
  • Wiki Terms – definitions of terms used in the metric

These new metric features have been added to the new MCC Metric Search Engine. Additionally, the MCC Lab Metric v2.1 Excel file – which includes an updated metric viewing template – is available for download in the Existing Metric Set member only area of the website (for those who wish to look at the metric set via the old spreadsheet method).

MCC Members Decide to Utilize the MHRA’s Definition of Critical & Major Findings as the Reference Model for MCC Metrics

Wednesday, July 16, 2014

MCC will adopt the MHRA’s Definition of Critical & Major Findings as the reference model for MCC metrics. Overall, the MHRA’s definition has greater specificity and the “critical” findings definition include important areas not cited in other regulatory authority definitions (i.e. TMF not available or incomplete; inappropriate, insufficient or untimely corrective action of previously reported Major non-compliances).

MCC Relationship Metric WG is Defining Quantifiable Metrics to include in the MCC Metric Set

Monday, July 14, 2014

The MCC Relationship Metric WG met on 25 June 2014 to discuss moving forward with defining quantifiable metrics that organizations can utilize to assess sponsor/CRO relationships. During the meeting, the group narrowed down the options to the following seven possibilities:

  • On-time deliverables
  • On-time plans
  • Collaborative effectiveness
  • Outsourced cost of non-quality per subject
  • Staffing availability
  • Actual vs baseline budget
  • Scope changes

It’s not too late to get involved! Before moving forward, work group members have been asked to review the metrics listed above and detailed descriptions listed in a slide presentation available on the MCC website (Relationship WG area). If you are interested in more information about this work group, please contact Linda Sullivan at