How To Handle Data (Be a Data Manager) in a Clinical Trial

Clinical trials are facilitated to test the effectiveness and safety of a new drug. A clinical trial is a complicated procedure with equally complicated sets of data. These sets of data have to be competently managed and recorded to ensure that the clinical trial and the consequent study will derive an accurate and correct result. Handling data in a clinical trial is a laborious task. If you want to know how to do this, this article will show you how.

  • Transcribe the data. The data has to be first collected from the trial site. The data are usually in the form of notes written by the investigators (doctors) and/or nurses. Once the data are all in, you have to transcribe them in a form. Because accuracy is important in a clinical trial, you have to make sure that all the data are correctly transcribed. Otherwise, the result of the clinical trial won’t be reliable and accurate. After transcribing the data, you have to print out the document and run a final review.
  • Send the document. The document should be now sent to the trial site. A monitor will have to check the document against the information in the form. When both sources of information are found to have accurate and similar information, the document will then be sent to the company or organization facilitating the clinical trial. The data should again be entered in another database. Clinical trials usually make use of a specific program for data entry, which makes the job a lot easier to do.
  • Spot errors. After entering the data, you need to again check that the details are accurate and correct. Sometimes erroneous details are encoded in the database, which can compromise the credibility of the clinical trial. There are errors that you can easily spot using database features. Some, however, need to be meticulously spotted with the eye. In this case, you have to read through all the entries in the database and determine whatever errors there are.
  • Send a query. A query should be sent to the trial site to clarify an obviously erroneous detail. This is important in establishing the accuracy and credibility of the trial. Remember: You should never make your own assumptions and correct the data on your own or leave a dubious detail uncorrected. Both of these will affect the result of the clinical trial. Errors are sometimes as simple as a patient’s age, while there are times they include small details on patient drug reactions, temperature, and medical conditions.
  • Encode the correct detail. The investigators will clarify the error and send you the correct detail, which you should then encode in the database. You need to continue spot-checking and clarifying errors until the study is clean, accurate, reliable, and correct. This is going to be a long procedure and very laborious, so you have to prepare.

If you want to someday assume this job, you have to assess your skills now. For one, you need to be very meticulous and detail-oriented, as you need to pore over even the minutest detail. And more importantly, you need to have an interest in the field of science.


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