Data Management and Post Market Study

The situation: data management in a Post Market Study (PMS) was neglected, with clinical monitoring managed by a separate Contract Research Organization (CRO). The Sponsor had two years’ worth of data representing 30 patients on paper Case Report Forms (CRFs) and no Electronic Data Capture (EDC). They would like to close out the study, write final reports, update their Technical Files, and write papers for publication.

RQMIS joined the Sponsor and was given a 3-week deadline for submission of the initial draft of the manuscript for publication. To meet the deadline RQMIS did the following:

• Assigned Data Management Team
• Created Data Management Plan (DMP)
• Entered the two years of paper data
• Developed a code book

With the deadline met and the paper out for publication, RQMIS was asked to officially close the study. Data Management developed a query rubric and manually queried all CRFs for sites to which to respond. Once the investigational sites – all located in Europe -- responded to all queries, Data Management was able to clean the database and perform a final database lock. Simultaneously, the Clinical Team worked with the monitoring CRO to get close-out visits scheduled with all Investigational Sites.

In addition, the PMS had a radiographic component. The radiographic images were not analyzed due to a lack of Sponsor oversight. RQMIS reinitiated communications with the radiographic core lab and worked hand in hand with them to get all images analyzed in a timely manner.

Once all data was locked, and with study closeout on the horizon, the Clinical Team was able to write the necessary reports for both close-out and insertion into the Technical File. RQMIS:

• Analyzed all clinical and radiographic outcomes
• Wrote the body of the Clinical Evaluation Report (CER) and Clinical Investigation Report
• Updated the TF with the CER

In less than 6 months, RQMIS was able to get this study data cleaned, queried, and locked, officially closed out the study, and the published data both in the Sponsors TF as well as in a journal.