Data from SMART-TRIAL can be exported in a .csv (comma-separated values) file, xlsx file or a PDF file. Both file types can be imported into statistical tools such as SPSS, R, and SAS. For statistical purposes the format "Form Based" is recommended.
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 and xlsx export file with all Adverse events reported using the AE module.
- Medication and Medication Accounting - Generates all medication (concomitant and IMP) and all medication accounting will be exported. These are collected in a single .csv and xlsx file.
- Only Medication Accounting - Generates only the medication accounting file in a csv and xlsx format.
- Queries - Will export all queries on the site(s) selected, including the full query trail. Each row in the file is one query action (create, respond, close, reopen). Also contains the original answer value along side the new values. Available as a csv and xlsx.
Process based exports:
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All Event Data - Generates a .csv and xlsx 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 and xlsx for each site is made available for download.
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Scheduled Events - Generates a .csv and xlsx 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.
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Unscheduled Events - Generates a .csv and xlsx file with all the Unscheduled visits, for the selected sites.
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Discontinue Events - Generates a .csv and xlsx file with the Discontinue event, for the selected sites.
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External Events - Generates a .csv and xlsx file with External data added to a data event in SMART-TRIAL.
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Randomization List - Generates a list of the randomization of the subjects
Form based exports
- Form Answers: Generates a .csv file or sheet in an xlsx file, per form that is selected for export. Each file will contain all instances where the form has been answered (for the selected sites), one instance/record per row. Known as the "long format", with a data event column denoting when the form was answered. Does not include AE form used in the AE module.
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.