Overview

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. Clinical Studio 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 medications 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 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.  

Note: Site and Study form types can also be used as log forms in the Site Document Manager page and the Study Related Records page. For those form types, the relation must be set as one to many.

Record Relation: Batch (Batch Registration)

A process must exist for registering subjects with the system. That process in Clinical Studio 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 a 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 - Subject Registration for more information on how to register subjects.




Placement of Log Forms

Clinical Studio has two distinct pages for accessing subjects and the complete subject record. Those pages are the Subject Manager page and the Subject Visit and Events Manager page. Depending on the relational type of your log form, the log will be placed on one of these two pages. (Subject pages are accessed from the Subject menu. When the Subject Manager… link is selected, the Subject Manager page is displayed for the Site selected using the dropdown list located below the header. The Subject Visits and Events Manager page is accessed by clicking on the link (Subject Profile ID) in the Subject column.


One to One Log Form Placement

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. Clinical Studio 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 functionality is slightly different.


The figure below shows the configuration option in the Form Builder that allows you to choose where the log will be placed.



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 Manager Page Placement

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 to the log as shown in the following figure. In Clinical Studio, the log is a table which 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, they 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.



Subject Visits and Events Manager Page Placement

If the Subject Record (page) is selected from the One to One Location drop-down as shown in the figure below, the log will be placed on the Subject Visits and Events Manager page.



The Subject Visits and Events Manager page has a separate section for all log forms as shown in the figure below. This form will be added to that section. Notice the Withdrawal form is now in the Log Forms section of the Subject Visits and Events Manager page as shown in the figure below.



When data is entered on a One to One location log form assigned to the Subject Visits and Events Manager page, the system will only allow a single record in the log. When the record is entered, the Add New button is not available.


The sequence of Log Forms on the Subject Visits and Events Manager page is determined by the Sequence form attribute designated on the Form Builder. The Subject Withdrawal form used in the example was assigned a Sequence value of 10 as shown in the following figure.



The Existing Forms table in the Form builder shows the Sequence of all the forms currently being used in the study as shown in the figure below.

 


The forms currently designated as log forms for the ABC Study are the Medications Log assigned Sequence 7, the Adverse Event/Hospitalization form assigned Sequence 8 and the Subject Withdrawal form assigned Sequence 10. As noted previously, the Sequence number assigned to the form determines the order in which they will appear in the Subject Visits and Events Manager page as shown in the Log Forms figure above.   


One to Many Log Form Placement

All Many log forms will be placed on the Subject Visits and Events Manager page. This allows your Site Coordinator (or another designated role with the appropriate rights granted) to enter more than a single record per 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).


Deleting a Log Form

Delete a log form by clicking and confirming the delete of log form (row). This allows your Administrators (or another designated role with the appropriate rights granted) to delete log forms at the row level in the Subject Visits and Events Manager page.