Part 4 of the Study Management video series explains the steps required to enroll patients into your configured studies.
Next Video – Study Management Part 5: Create Kits
Introduction – 00:00
Hi there, and welcome to part 4 of our look at Freezerworks Pinnacle. So far in this series, we've created a study with two arms and then modeled Visits for both of those Arms. Today, we'll finally get our study into the database and begin enrolling patients into it.
Activating Studies – 00:29
Now, if your workflow simply entails creating Kits rather than enrolling Patients, you may want to skip to the next video where I go over how to create kits when patients haven't been enrolled yet. Anyways, since I deactivated my study in Part One of this series, I'll need to reactivate it now before I can enroll Patients. So I open my study, check on the Active box, and then save it. With our Study Active, let's return to the Splash Screen.
Creating Patients – 01:00
Now, Patient Enrollment is currently done on an individual basis, you must open Patient records to enroll them in studies, or you can enroll them as you're entering them into your system. Let's do that now, let's go to Inventory Management and Add New Patients. So, we've got a new patient, let's fill out his information - Gordon Ramsay, 12/18/1972. Alright, we got our patient, Gordon Ramsay.
Enrolling Created Patient – 01:42
To enroll him into a study we'll go to the Study Enrollment Page. The top box here will list each study arm this patient is currently enrolled, in while the bottom box is where you can store the locations of Informed Consent Documents. To enroll the patient in a study, click the Enroll button. This opens the Enrollment overlay. First, you'll select the study you're trying to enroll the patient into. If you have a lot of studies to look through, use the filter tool above the list of studies to narrow it down, as you type the Study name the list filters automatically. Once you highlight the desired Study, the Arm drop-down gets filled with the Arms configured for that Study. If no arms are configured for the study, this drop-down will simply deactivate. Select your Arm, then if you'd like, you can provide a Site for the enrollment (where the enrollment occurred). The sites available are the ones assigned to the study during configuration, which we went over during Part 2 of this series. This is optional and purely referential, and this Site is separate from the Site or Sites where visits will eventually take place, though it may not be different. Once you have selected a Study and an Arm, click Accept. You'll be taken to the second page of the Enrollment overlay. On this page, you'll see the Study you’re enrolling into in the window title, and the Study Arm and Site are listed in bold above all the other enterable fields. If any of this information is incorrect, feel free to click the Select Study button to return to the first page and change some things.
Patient Enrollment and Participant Study ID – 03:20
Anyways, to enroll the patient you are required to provide a Participant Study ID, this will act as the unique link between the Patient and the Study Arm. The Patient can have the same Participant Study ID across different studies, but no two patients can have the same ID within the same study. If you hadn't already guessed, this field is very important for receiving and data retrieval.
Patient Enrollment and The Enrollment Date – 03:46
The Enrollment Date is the next field to note here, as it will dictate when Visits are expected to take place. The time intervals you selected when modeling your Visits will start from the enrollment date, so this field is integral if you will be creating kits and pre-generating study data according to date ranges rather than Patient to Patient or from the Study. Will discuss kit creation in full in the next video, for now, I'll just select May 1st.
Finishing Patient Enrollment – 04:15
The rest of the fields here do not affect work in Freezerworks as of yet, that we do plan on implementing flags and/or restrictions based on Consent and Assent requirements. For now, though, these fields are referential only. The same can be said for the Discontinuation Date and Reason. These fields will not un-enroll a Patient from the Study, but they do provide a space for you to maintain that type of information. When you’ve filled out the form to your satisfaction, click Enroll. You are returned to the Study Enrollment page, with the enrollment entered in the list box. If I wanted to modify the enrollment at all, a double-click will open it or I can highlight it and click Modify. Take note that when modifying a Patient's enrollment, you will not be able to change the Study or the Arm it is enrolled into. If you need to enroll it in a different Study, do that instead.