Validate Study

Study validation is important before you start your study! It is done to ensure that your study is created correctly, that all ranges are set correct, your show rules are correct, answer possibilities are correct etc.  

The purpose of the validation testing is to ensure that your study design setup in SMART-TRIAL meets the requirements for its defined protocol as specified in the study protocol, it is not for whether the study is performed correctly! 

To validate your study:

  1. Find our study validation report here

  2. Set your study in Test Mode, see our Test Study, article. 

  3. Create New / Enroll Subject(s), 1-5 test subjects. To enroll a subject, you must first Create a Process and Create a Site, for the subjects to be enrolled in. 

  4. Go through your entire process and Fill Out Form Answers for all forms. 
  5. While you fill out forms, remember to check your limits, show rules, etc.

  6. When you have answered all forms, Export .csv and Print Form. See the section below on How to print forms.  

  7. Import the .csv file correctly into Excel, see our Import Data into Excel article. 
  8. Check that the exported data is the same as the data in your printed forms.

  9. Once the validation of data has been made, fill out the Study validation report.

  10. Save the exported Data, Forms, and Study Validation Report so it is possible to refer to these papers when the study has been started. 

Make sure to press Save and Continue on all your forms when you answer the forms, just like your subjects would do when answering forms!

How to print forms:

You use printed forms to validate your study and compare them with the answers from the .csv files. 

To print forms:

  1. Go to [Study Name] > Site overview.
  2. Find the subject you want to print forms from and press their subjectID or similar to go to their subject profile.
  3. Click on Record History
  4. Press the Print icon. This will print the entire enrollment including unscheduled events

  5. Print or Save your forms for later use, when validating your study. 

If you need to print your form without answers, see our Print Forms article.