Klinera

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KlinEra eTMF provides regulatory agencies a clear view of the story of a clinical trial to ensure compliance with GCP. The use of metadata offers both inspectors, and users, a powerful search capability for quick retrieval of documents.
KlinEra began providing dedicated eTMF services in 2005 and eTMF design is based on DIA reference module.
How Klinera eTMF Helps
We build our platform to maximize standardized flexibility. Our implementations team configures eTMF to match Sponsor existing workflows but also gives you the ability to standardize those processes across your entire network.
Most importantly, TMF is compatible with regulatory requirements for eTMFs–including FDA, the EU, and UK regulations:

With all of these tools, Klinera can easily keep your eTMF compliant.

The 3 core TMF metrics

TMF completeness

When it comes to measuring the completeness metric, TMF should contain all information and tell an accurate story of what happened in the study?  TMF will be considered complete when all the documentation collected throughout a clinical trial is available in the TMF in an organized and auditable way.
Completeness metrics are calculated based on the status of artifacts; complete, expected, missing, lost, or revisited. The primary calculation that we see is percent complete, which can be determined using the following formula:
Percentage complete = total number of final artifacts / total number of expected artifacts.

TMF Timeliness

KlinEra eTMF systems are required to be maintained up to date throughout the study, and inspector will want to see proof that the information provided was done so in a timely manner.
The TMF Guideline states that “the clinical trial master file shall at all times contain the essential documents relating to the clinical trial”. Similarly, the ICH E6’s Guideline for Good Clinical Practice shares, “Filing essential documents at the investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management of a trial by the investigator, sponsor and monitor.”
That’s all fine and good, but how do we calculate timeliness today? Timeliness measurements include days to review, days to filing, percentage late filing, and issue resolution time. But the primary indicator we use to show the timeliness of TMF process over time is the percentage filed on time. You can calculate it using the following formula:
% Filed on time = (final artifact date – artifact creation date) < expected days to filing / total final artifacts 
Timeliness is key when compiling the TMF as the longer it takes to get information into the TMF, the higher the risk that information may be inaccurate or lost.

TMF Quality

The quality metric is a measure of whether document content, metadata, and indexing are complete and accurate. Klinera look at artifacts reviewed, ICF reconciliation, artifacts audited, rejection rates, anomaly rates, and risk scores when measuring quality. There are two standard metrics we typically see with regards to quality:
% Reviewed = final artifacts reviewed (manual QC) / total final artifacts  
And
Rejection Rate = total artifacts rejected / total final artifacts
Quality is typically evaluated on an artifact-by-artifact basis through manual QC and review processes, but rarely do we focus on the larger picture of the TMF. To truly evaluate quality, we should also be looking more holistically at our ability to tell an accurate story across artifacts. We don’t want to get sucked into one specific aspect of TMF quality and miss large-scale gaps and incoherencies.
What Does Inspection Readiness Mean?
Inspection readiness refers to the requirement to ensure that all clinical trial documentation and systems are up to date at all times. That means that every day, systems are updated, inspected, and maintained in a state that is ready for an external auditor to access the systems and conduct an inspection.
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