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Figure 1. Example Schematic of Performance Metrics within a Clinical Study.
MCC Metric Number | Definition |
1 | Number of calendar days from protocol synopsis to protocol approval |
2 | Number of versions prior to protocol approval |
3 | See Protocol Quality Score System |
4 | Contract execution timeliness (non functional outsourcing models) |
5 | See Site Selection Quality Score System |
6 | % country regulatory packets approved after first receipt |
7 | Timeliness of protocol approval to first site activated [country, region, study] |
8 - EDC | Number of calendar days from final approved protocol to final approved eCRF |
9 - paper | Number of calendar days from final approved protocol to final approved paper CRF |
10 | % monitoring plans completed prior to first site initiated |
11 | % planned sites activated |
12 - EDC | Number of calendar days from eCRF sign-off to database "go live" |
13 - paper | Number of calendar days from sign-off of final paper CRFs to database "go live" |
14 | Number of calendar days from Site Activation to FPFV (patient consented) [site, country, region, study level] |
15 | Number of calendar days from event threshold for change order (CO) generation to CO agreed and signed by both Sponsor and CRO. |
Copyright 2013 Society For Clinical Data Management - Page 12 of 20 – Metrics in Clinical Data Management
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Table 1. Examples of Common Study Metrics
Criterion | Study Startup | Study Conduct | Study Closeout |
Quantity | Number of expected subjects Total number of data fields (may be quantified differently by different organizations) | Amount of data entered Amount of data cleaned Expected amount of entered data compared to data in database | Final number of subjects Number of outstanding queries Missing pages report |
Cost | Total estimated resources (such as people, licenses, infrastructure, printing, etc.) needed for a study | Number of monitoring visits | Total study costs Average cost per subject enrolled |
Time | Projected overall study timeline Time needed for protocol/CRF review and finalization Final approved protocol to database activation | Time from subject visit to data available to CDM Time from subject visit to data cleaned and locked | Time from first subject enrolled to last subject visit Time from last subject visit to final database lock Time from final database lock to clinical study report |
Quality | Systems validation results | Number of queries and re-queries Number of data transfer errors Metrics generated from audit trail | Number of data errors per number of total data fields (error rate) (used in paper studies) Number of protocol deviations |
Performance | Number of programmed procedures that validate correctly | Comparison of data entry rates across sites Time from subject visit to data entered Average time for query resolution | Number of database unlocks to correct data errors Number of protocol amendments |
Copyright 2013 Society For Clinical Data Management
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