Manage most of your data collection from a site overview. In site overview, each data event is represented by a square with a color and an icon, indicating the current status of the data event. To learn more about the overview of a subjects’ progress within the study, read our Site Overview article.
To fill out form(s) answers:
- Go to Sites > [Site Name]. A site overview will appear here.
- Find the subject you want to collect the data from and click on the data event you wish to complete. This will open a sidebar containing information about the selected data event, as well as actions you can take.
- Depending on your process setup, you will be presented with either:
- Visit Event - If the data event has been activated, you can fill out the form(s) associated with the data event.
Subject Event - Subject data event triggers an email/email and SMS to be sent to the subject. You can monitor if the form has been filled out, resend the email, or fill out the form for the subject.
To access and fill out the forms press Start data event, the data event is activated and you can Fill out the form(s), afterward click Save/Save and continue. Form answers will be saved and the data event will obtain a new status.
If you navigate away using the menu or browser's back button, all data entered into the active form will be lost. Forms that have been previously completed will not be affected by this action.
SMART-TRIAL allows you to perform the following actions on each question during the fill out process:
- Add Note - Adds a note to a question/answer.
- Remove Answer - Removes answer from the question and brings it back to its empty state (especially useful in Yes/No and multiple choice question types, where it is not possible to "uncheck" your answers).
- Answer not Available - Marks question as "Answer not Available" and allows you to complete the form and move on in the process.
To access these actions, click on "Options"icon in the top right corner of the question.
Form Status Indication
Forms in SMART-TRIAL can obtain the following statuses:
- New Query - Form contains an open/responded query.
- Completed - All required questions have been answered and no validation errors are present.
- Incomplete - Only some of the questions have been answered.
- Missing data - Form contains missing data due to answer marked as not available, or due to changes made to the form after Amendment.
Question Status Indication
SMART-TRIAL provides visual feedback on the question in the following situations:
- Validation error - When the answer does not match previously specified criteria (min/max values, min/max number of choices, etc.)
- Exclusion - When answer results in exclusion.
- Answer marked as not available - When there is missing data due to question marked as Answer not Available.
- Missing data - When there is missing data due to changes made to the form after Amendment.
- Question was not answered - When the question was not answered (review mode).
To edit form(s) answers:
- Go to Sites > [Site Name].
- Click on the data event you want to edit the form answers for and select View form answers.
- If all mandatory questions were answered and form(s) completed, click Edit Answers button. This will activate the editing mode and you will be able to edit the form answers.
To save the changes, click Update and provide a reason for why you are changing the answers to this form. You will be asked to fill out a reason for change if you have either edited some form answers or if you have made changes on an incomplete data event.
To discard all the changes, click Discard and no changes will be applied.
SMART-TRIAL logs every change made to questionnaire data and stores information such as when by who and a reason why the change was made. Access a change log by clicking on the Change log button when in Review/Update form view. Change log will be updated when a reason for the change is given in relation to making changes to already saved data in an incomplete or completed form.A dialog box will appear and provide information on all changes made to the answers in the form.