The Study Document Manager is located under the Study menu. This is where users with appropriate role permissions are able to centrally manage all files (e.g. images, documents, media) which have been uploaded to forms in the study. Keep in mind, this page will display all files that have been uploaded across the entire study, so should only be made accessible to appropriate users. In Role Security, it's listed as Document Manager application.
Here is an example of the table users will see on the Study Document Manager page:
Notice the uploaded file name (highlighted above) displays as a link to open and view the file with the document viewer integrated in Clinical Studio. This alleviates the need to download the file.
The Date Uploaded, Name, Form Name, Document Type and File Type columns (highlighted below) are sortable columns. They can be sorted by selecting the corresponding column header.
The Download icon (highlighted below) can be used to download the selected file for viewing, printing or saving in another location.
The three filters highlighted below can be used to search large lists for specific files.
Study Documents could also refer to defined data collected which are not related to subjects. Instead, these forms are related to the study as a whole.
Defining a Log Form for Study Documents
Study Log Forms are defined in the Form Builder 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 check box 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. You must select "Many" when used as study documents. 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 Study
The Record Relation instructs the system how to relate a log form entry to the current study. There are 3 types of Record Relations. They include One, Many and Batch.
IMPORTANT! Site and Study form types in the Site Document Manager must be set as one to many.
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 documents to the current Study. A good example of this would be the Protocol. The potential exists to be updated during a study. The system will allow the Study Managers to log as many forms as needed.
Log Forms allow sequential study or site related forms to be entered into the system. Log forms allow you to keep a log of site documents. 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.
An example of Study Document Log is below for Protocol which could be updated during study.
To access the Study Document Log go to Subject Menu option Access Study Related Documents as shown below:
Click on link (Study Information Form in this case) will bring up the following log form.
Click the Add New Study Information Form to add new information or click on status icon to review/edit existing entries: