Exported Data Files

Data from SMART-TRIAL can be exported in a .csv (comma-separated values) file, xlsx file or a PDF file. Csv files can be imported into the most commonly used statistical programs for instance SPSS, while xlsx files allow the data export to be directly opened in Microsoft Excel. 

Selecting data to export

It is possible to export different data from SMART-TRIAL:

Study specific data:

  • Study Overview - Generates a PDF file with an overview of the study; number of patients, number of AE reports/ SAE reports and how many subjects are ongoing/complete/excluded and the number of subjects on each site.
  • Adverse Events - Generate a .csv export file with all Adverse events.
  • Medication and Medication Accounting - Generates all medication (concomitant and IMP) and all medication accounting will be exported. These are collected in a single .csv file.
  • Only Medication Accounting - Generates only the medication accounting file.

Site specific data:

  • All Event Data - Generates a .csv file with all event data (Data for Scheduled, Unscheduled, Discontinued, and external events). Including a matching “Data Code” .pdf file with information to translate the values in the .csv for each site is made available for download. 

  • Scheduled Events - Generates a .csv file with data for all planned data events (regular events and multiple activation), and a matching “Data Code” .pdf file with information to translate the values in the .csv for each site is made available for download. 

  • Unscheduled Events - Generates a .csv file with the Unscheduled visits Forms.

  • Discontinue Events - Generates a .csv file with the Discontinue event Forms. 

  • External Events - Generates a file with External data added to a data event in SMART-TRIAL.

  • Randomization List - Generates a list of the randomization of the subjects

Data Codes - Depending on the question type, the data is coded so that the values of the answers have a different meaning. Therefore a “Data code”.pdf file is generated along with the .csv or .xlsx file to decipher the meaning. The data is organized in the .csv and .xlsx as shown in the Exported Data Format article. Patients will be found in rows and their data in columns. 

Learn more about how to read Form Answers and Data code in our Exported Data Format article.