Defining Log Forms
Log Forms allow sequential study, site, or subject-related data to be entered into the system. That means if you have data that follows a sequence, is not scheduled, and does not fall within a defined time interval it should probably be defined as a log form. Log forms allow you to keep a log of subject events. These logs can be extremely detailed. TrialKit creates a table to house log forms. That table contains summary data from each log entry. When you drill into the actual form the information is displayed in detail.
A good example of a log form is Concomitant Medications. Medications are not usually prescribed to be taken within a given interval. Usually, there is more than one medication prescribed per subject. Medications do follow a sequence; usually, start date and stop date. Therefore, the medication form should be defined as a log form. The system keeps a log of medications for each patient and the entire study.
Another good example of a form that should be defined as a log form is the Withdrawal or study exit form. Subjects can only withdraw from the study once. A subject’s withdrawal is not scheduled and is usually unexpected but nevertheless, the withdrawal must be tracked. Thus, if the Withdrawal form is defined as a log form then the system can provide a log of all the subject withdrawals for the entire study.
This document will explain how log forms work and lay out some parameters for declaring a log form. In addition, it will explain the three types of log forms (One, Many, and Batch) in detail.
Defining a Log Form
Log Forms are defined in the Form Builder for the form type of study, site, or subject located in the study menu. Log Forms are defined from the Form/Page Properties under the Data section as shown in the figures below. If the form being created should be designated as a Log Form, simply select the checkbox in the field next to Log Form. Log Forms can be one of three types: One, Many, and Batch as shown in the figure on the right. The drop-down field is associated with Record Relation is shown below. The type selected tells the system how the log data is related to the subject which is explained in further detail in the following sections.
Relating Log Form Data to the Subject
The Record Relation instructs the system how to relate a log form entry to the current subject. There are 3 types of Record Relations. They include One, Many, and Batch.
One to One Relation (Record Relation: One)
The Record Relation of One, instructs the system that this log form will have a one to one relationship with the current subject. That means, there can only be a single form completed per subject. A good example would be death or withdrawal. These forms only need to be completed once for each subject. The system will restrict these forms to one per subject.
One to Many Relation (Record Relation: Many)
The Record Relation of “Many” instructs the system that this log form can have one or more (many) related records to the current subject. A good example of this would be Adverse Event or Medications. The potential exists that you could have many Adverse Events per subject or many Medications per subject. The system will allow the Site Coordinator to log as many forms as needed.
Record Relation: Batch (Batch Registration)
A process must exist for registering subjects with the system. That process in TrialKit is known as the Registration Process. It is where a single subject or batch of subjects is registered with the system. Once registered, the subject records can be added and accessed. The registration form, which is declared in Study Configuration under the workflow tab is always designated as a Log Form. Subjects can be registered one at a time or in a batch. When Subjects are registered in a batch as shown in the figure below, they most likely share some common characteristics. That may be gender, age, lot number, etc. Pre-clinical (Animal) studies and registries are two good examples of batch registration. In a Pre-clinical study, a batch of 30, six month old, female mice may be received and need to be registered within the study. This is accomplished through batch registration. See the help document Subject Manager for more information on how to register subjects.
Placement of Log Forms
One to One Log Forms
Because a one to one log form has only a single related record, it can be placed on either the Subject Manager page or the Subject Visits and Events Manager page (web only). TrialKit has a configuration option in the Form Builder where the placement of the actual log can be designated. Depending on the page where the log is placed, the access point for the form is slightly different for end-users. Note, the app does not distinguish the two options here and will always only display the form within the subjects' records.
The first figure at the top shows the configuration option in the Form Builder that allows you to choose where the log will be placed. These options are available in both the app and web form builders.
Forms designated with a Record Relation of One can be placed on either the Subject Manager page or the Subject Visits and Events Manager page.
Subject Record Page
If the Registration (page) is selected from the One to One Location drop-down, a Subject dropdown list will appear on the Subject Manager page below the registration table. The Site Coordinator (or another user with the appropriate granted rights) can then select the subject profile ID for which they wish to enter data into that log form (in this case the Subject Withdrawal log) and click the Add New button as shown in the figure below.
Once a subject registration has been completed, they will be added as an option in the subject dropdown list shown below the table. In TrialKit, the log is a table that houses all the log records and contains summary data along with a record status that drills into each individual form. Once a Subject has been entered, it will no longer appear in the Subject drop-down list. That is how the system enforces the one to one relationship to the Subject Registration page.
On the mobile app, this type of form will only display as a log forms option after opening up a specific subject.
Batch Registration Form Placement
Only the Registration form, declared on the Workflow tab when from the Study Configuration Settings page can be a batch log form. That form is always placed on the Subject Registration page as the very first log form. It is the form where subjects are registered with the system. After a subject is registered, all related forms can be accessed and completed by the Site Coordinator (or similarly named role with the appropriate rights granted).
Show In Log - Defining Log Table Columns
Any form that is defined as either a log form or a registration form must have at least one log field defined. These are the fields that will be displayed in the log table when viewing the subjects records.
Note: The mobile app will only display whatever the first two log fields are for a given form.
Defining a log field is done within the form builder in the field properties by checking the "show in log" attribute as shown below in red box:
This same action must be taken on the Registration form which has been defined for the study.
If you open the subject manager and get this error, its because this has not yet been done:
General Error: There are no fields defined for this study's enrollment log. At least one field must be defined to show in the log
If a field is shown in the log, the log table headers will follow this priority for displaying the column name:
Reporting label
Associated text label
Field name
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