Part 2 of the Study Management video series is an in-depth overview of Study Configuration. Learn how to manage studies, add multiple arms, attach documents, update study versions, and more.
Next Video – Study Management Part 3: Model Visits
Introduction – 00:00
Hello, is it me you're looking for? Welcome to part two of our look at Freezerworks Pinnacle. Last time we glossed over the entire study management process, starting with study configuration.
Create & Manage Studies – 00:23
Let's dive into that now. I'll show you how to configure a study with multiple arms and assign it contacts, sites, and security settings. To begin, open Configuration - Configure Studies. The Study Management mini-menu will appear - click the Studies button. This opens the configure Studies list view. There are three tabs available here:
- Active Studies
- Inactive Studies
After you save a Study configuration, anytime you make changes to it you will be asked if you'd like to create a new version of the study. This will create a read-only snapshot of the study before modification and put it on this tab for documentation purposes.
So, let's create a study, click Add New. To start, you’ll want to give your Study a name. The Study Title will probably be where you'll enter your studies, real, probably longer name, whereas you'll want to use the Study Name field as a sort of shorthand. Study Name is what will be used throughout the program to identify the study. You will then want to indicate where your most common time interval is for visits. Do you time your Visits most by days, by weeks, months, or years? You can always change the interval when actually modeling your visits, but a good selection here will speed up your work later. The rest of the fields on this tab are completely optional and referential only. They do not affect any work done in Freezerworks at this time. The same can be said for the IRB/Consent tab. There is no requirement in Freezerworks at this time to provide IRB information. In fact, if you'd like to hide these fields in Freezerworks, there is an option in System Properties you may want to check off. In the future, these consent options will restrict data entry and coincide with birth dates of participants. For now, though, they are strictly informational.
Add Arms – 2:30
Let's return to the study tab now, and add some Arms to our Study. Check on Enable Study Arms to activate the Arm configuration box at the bottom of the form. A Default Arm is provided automatically, let's leave that be is our first arm for now, and create our second one instead. Before that though, a quick note that each arm contains its own Visit model, so if your Visit models are going to be similar, you may want to create one Arm’s model then duplicate that arm to pre-fill the models of successive arms. Click Add and the Arm overlay will appear; just like before with Study Name and Study Title, enter the real name for the Arm in the Arm Title field, and provide a shorthand version for use in Freezerworks with the Arm Name field. The Description, Date Opened, and Date Closed fields are again optional and purely referential. Click Save to finish adding your Arm. Now I'm going to open the default arm and edit it to match my study. Remember that you can add as many Arms as needed for your study.
Attachments, Contacts, Sites, & Security – 03:35
Now, let's quickly run through four of the other pages here. The attachments page is where you can store the locations for any documents important to your study. It works just like other attachments pages in Freezerworks. The Contacts page is where you can assign Contacts, which are people records marked as Study Contacts, to the Study. This is helpful for users to find points of contact when running the Study. The Sites page is where you assign Sites to the Study. The Sites you assign will be the ones available for selection in the Site Name field when enrolling patients and receiving samples for the study so that you can record were both Enrollments and Visits take place. Finally, the Security page is where you will define the access other users have to Patient, Sample, Aliquot, and Test records associated with the Study. This works a lot like Owner Level and Freezer Level security and must be turned on in System Properties to take effect. Furthermore, you can select the exact users that will be allowed to edit the Study Configuration itself on the right side of this screen. However, users must have permission to Manage Studies in order to edit a configuration in the first place.
Conclusion – 04:50
Well, that about does it for this video. Let me save this study for now so that we can continue our work next time, but before I do, I'm going to check off the Active checkbox so that none of my users will be able to enroll Patients and start using the Study before I’m actually finished configuring it. In our next video I'll reopen my study and show you how to model Visits. Thanks for watching, see you next time.