Before starting a study in SMART-TRIAL, it is important that the study setup is validated to ensure that the forms, process, sites, show rules, validation rules, process rules, and other settings are correct.
It is not necessary to validate SMART-TRIAL as a system as it is already validated. The validation is only to validate the study setup you have created in the system to ensure that the study is correct according to your protocol and CRFs. To access SMART-TRIAL's validation documentation, contact email@example.com.
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 or for SMART-TRIAL as a system!
To validate your study setup:
Find our study validation report here
Set your study in Test Mode, see our Test Study, article
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
- It is recommended to go through your entire process and Fill Out Form Answers for all forms to ensure that the setup is correct
While you fill out forms, remember to check your validation rules, show rules, process rules, etc.
When you have answered all forms, export the data and print the forms. See the section below on how to print forms
- Import the .csv file correctly into Excel, see our Import Data into Excel article
Check that the exported data is the same as the data in your printed forms
While performing the validation, fill out the Study validation report
- 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 or data entry personnel would do when answering forms!
How to print forms:
You can use printed forms to validate your study and compare them with the answers from the .csv files.
To print forms:
- Go to [Study Name] > Site overview.
- Find the subject you want to print forms from and press their subject ID or other identifier to go to their subject profile.
- Click on Record History
Press the Print icon. This will print the entire enrollment including unscheduled events
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.