{"id":5497,"date":"2016-11-23T09:00:49","date_gmt":"2016-11-23T08:00:49","guid":{"rendered":"https:\/\/www.gkm-therapieforschung.de\/blog\/2016\/11\/23\/how-a-clinical-trial-management-system-ctms-can-improve-the-quality-of-your-study\/"},"modified":"2016-11-23T09:00:49","modified_gmt":"2016-11-23T08:00:49","slug":"how-a-clinical-trial-management-system-ctms-can-improve-the-quality-of-your-study","status":"publish","type":"post","link":"https:\/\/www.gkm-therapieforschung.de\/en\/blog\/2016\/11\/23\/how-a-clinical-trial-management-system-ctms-can-improve-the-quality-of-your-study\/","title":{"rendered":"How a Clinical Trial Management System (CTMS) can improve the quality of your study"},"content":{"rendered":"

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\"how<\/a>

\u00a9 evencake \/ Fotolia.com<\/p><\/div>\n

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As the coordinator or manager of a clinical trial, I have one simple goal: I want my clinical trial to be successful. After all, it is my responsibility.<\/p>\n

However, to guarantee success, I need to be able to manage my project efficiently<\/strong>.<\/p>\n

It is crucial that, at any time during the project, I have the possibility to get a good overview<\/strong> of the progress of my study; that I can plan tasks, activities and responsibilities; that I can track and monitor<\/strong> any action; and that I can easily organize all study relevant documents and information<\/strong>.<\/p>\n<\/div>\n

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But what system is suitable for this?<\/h3>\n
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Are simple lists that I generate in Excel sufficient for recording all relevant information and documents? Are my lists clear and well-structured so I can control the development<\/strong> of my study? Or should I rather implement a Clinical Trial Management System (CTMS)?<\/p>\n

Thoughts like these sound familiar to you? Well, let\u2019s get some answers to these questions. <\/p>\n<\/div>\n

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The devil is in the detail<\/h3>\n
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Like many decisions, also the right choice for an adequate management system lies in the complexity of your trial<\/strong>. Thus, in a first step become aware of how complex your study is \u2013 not only with regard to its design but also to its management.<\/p>\n

Which information do you need to record for a reliable planning and monitoring<\/strong> of tasks and activities in your clinical trial?<\/p>\n

You can only take the right decision, if you know your requirements.<\/p>\n

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\u201clistings can get out of hand quickly\u201d<\/p>\n<\/blockquote>\n

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Unfortunately, I observe that this decision is often made in favor of the MS Office package (or comparable programs) without such prior considerations.<\/p>\n

Indeed, people are used to work with these applications on a day-to-day basis and with the help of these programs it is very easy to come up with an adequate overview list<\/strong> in little time.<\/p>\n

The problem is: listings can get out of hand quickly. The result might be a plethora of documents and their different versions since all important information on project status, milestones, tasks, activities and documents must be depicted.<\/p>\n

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\u201cWhich version of which document shows me what I need to know?\u201d<\/p>\n<\/blockquote>\n

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This decentralized organization of information in multiple listings frequently leads to a great complexity and confusion<\/strong>.<\/p>\n

It can further happen rather easily that lists of different versions or revision status are in circulation. Which version of which document shows me what I need to know? In the worst case, members of the study team consequently work on the basis of divergent and\/or not up-to-date information<\/strong>.<\/p>\n

Also, it is rather difficult (or at least calls for a substantial programming effort) to check and verify data across different listings.<\/p>\n

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\u201cthe It-looks-completely-different-on-my-screen-Syndrome\u201d<\/p>\n<\/blockquote>\n

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But also simple technical issues<\/strong> like incompatible program versions being installed by different users can be frustrating. You might be familiar with the \u201cit looks completely different on my screen\u201d-syndrome?<\/p>\n

In brief \u2013 especially if you are running a complex trial<\/strong> with a large, perhaps international<\/strong> study team, simple lists probably will result in disappointment and confusion in the long run.<\/p>\n

Rather than providing you with a comprehensive presentation of your study relevant tasks, activities and documents, such listings might even complicate the management and monitoring of your trial.<\/p>\n<\/div>\n

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Get uncomfortable – for your comfort<\/h3>\n
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Now let\u2019s take a look at the alternative solution: How can a CTMS help to improve the working routine for you and your study team?<\/p>\n

Sure, the implementation of such a system goes along with an additional effort. And in the beginning, not everyone will be thrilled to have to leave the \u201ccomfort zone MS-Office\u201d.<\/p>\n

However, in my experience it is worthwhile the investment as the CTMS comes with several strengths and benefits:

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1. Availability<\/span><\/h4>\n

One big upside of a CTMS is its approach of centricity<\/strong>. Study-relevant data and information coming from different sources are organized centrally in one system.<\/p>\n

As such, the same level of information is made available to all members of the study team. Everyone is on the same page<\/strong> – at all time during your study.<\/p>\n

Beyond the collection of contact information, the recording and administration of the following data have proven suitable in practice:<\/p>\n<\/div>\n

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    \n
  • <\/i><\/span>
    regulatory status of the trial <\/div><\/li>\n
  • <\/i><\/span>
    CRF<\/div><\/li>\n
  • <\/i><\/span>
    remuneration <\/div><\/li>\n
  • <\/i><\/span>
    site specific study documents <\/div><\/li>\n
  • <\/i><\/span>
    monitoring activities <\/div><\/li>\n
  • <\/i><\/span>
    EDC user account management <\/div><\/li>\n
  • <\/i><\/span>
    IMP logistics and tracing <\/div><\/li>\n
  • <\/i><\/span>
    further logistics (e.g. laboratory, study material)<\/div><\/li>\n<\/ul>\n
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    <\/div>\n

    2. Continuity and topicality<\/span><\/h4>\n

    Since these diverse information on your trial\u2019s progress is collected all in one place, it makes the study management much more comfortable for the whole study team.<\/p>\n

    Continuous checks and follow-up of study activities and documents with regard to completeness<\/strong> and critical milestones<\/strong> can be performed straightforwardly.<\/p>\n

    Your trial thus proves audit readiness by all times.<\/p>\n

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    3. Integrity<\/span><\/h4>\n

    A CTMS provides you with a comprehensive overview of your study at every step.<\/p>\n

    Accordingly, you can continuously monitor the progress<\/strong> of your trial and selectively plan and control your activities.<\/p>\n

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    4. Reactivity<\/span><\/h4>\n

    As with the help of a CTMS you have your trial in view at all times, you are able to identify potential problems (e.g. logistical bottlenecks) at an early stage and can initiate corrective actions <\/strong>immediately.<\/p>\n

    Entry errors can be minimized by the use of a CTMS as it allows for (automated) quality checks within and between data sets.<\/p>\n

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    5. Flexibility<\/span><\/h4>\n

    Besides the described standards of data availability in the CTMS, the system is very flexible and can be tailored towards the specific needs<\/strong> of your clinical trial.<\/p>\n<\/div>\n

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    Conslusion:<\/h3>\n
    \n

    In summary, the use of a CTMS saves a lot of time and frustration during the course of a study.<\/p>\n

    Despite the initial effort of implementation, it improves study management as well as the daily routine of the project team.<\/p>\n

    A CTMS allows for continuous and up-to-date reporting<\/strong> during your study on a daily basis.<\/p>\n

    So why forgo the chance to improve the quality of your clinical trial?<\/p>\n

    Let\u2019s get uncomfortable!<\/p>\n<\/div>\n

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    [:]
    <\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"

    As the coordinator or manager of a clinical trial, I have one simple goal: I want my clinical trial to be successful. However, to guarantee success, I need to be able to manage my project efficiently<\/strong>. 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