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Data Entry/Tracking Issue

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  • #25307

    Freddy J
    Participant

    I am currently working on a project that is looking reduce the cycle time it takes to obtain important information from physicians related to a clinical study. The physicians send a report to a coordinator via fax and the majority of the time much of the information is missing. It is the job of the coordinator to enter the information into a database and then request the missing information from the physician. Unfortunately, the coordinators are saying that they spend the majority of their time performing data entry which leads to a lack of a proper follow-up process. There is currently no consistent tracking method/tool in place and the process is extremely inconsistent (root causes). We want to streamline the process so they spend less time on data entry and spend more time on quality follow-up. Any suggestions?

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    #60932

    Brit
    Participant

    Probably not what you want to hear, but physicians need to feel the need for providing the data, or you will continue to have the problem of incomplete data.  Make sure to communicate this to them – how will they benefit?  If the data has to be entered (i.e., not electronic, scanable, etc.) then you will have to do the manual data entry nonetheless. 
    So, I suggest you try to ge the right information first.  An electronic form requiring fields to be filled out before it is submitted would be the best bet. But then you have the problem of the physicians filling out the form at all.  Not an easy solution.  If you stay with paper – only do the data entry after you send back and recieve again then completed form.  If it is a study, then set you sample size parameter and shoot for that number at a mnimum.  Only spend time entering data that is complete, if possible.

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    #60938

    Nwajei
    Participant

    I am currently working on the implementation of EDC as part of our Lean Six Sigma program and realized that most of your problems will be eliminated by some sort of EDC.
    Data is entered at the physicians office and checks are implemented to make sure that, missing fields are not allowed and mistakes are corrected before the data is send into the database.  I am documenting a lot of time, money savings and improved personnel efficiencies.

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    #60939

    Freddy J
    Participant

    Frank:
    Thank you for your reply. We are currently working on an EDC, but not for this portion of the study. The portion I am currently working on is related to Serious Adverse Event reporting, for which a different database is currently used (ARISg).  I know that a limited amount of licenses are given to users of ARISg (internal access only) more or less to monitor access. The investigators of course are not able to access information from ayone else for various regulatory issues. Are you currently using EDC for SAE reporting somehow feeding into an ARISg-like database?

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