Visit Data Entry
Visit-level data fields are designed to record clinical details that can change over time. Each visit has its own unique characteristics, such as Date and the Site at which the visit occurred. Clinical diagnoses and clinical status can also change over time.
Longitudinal studies are usually pre-programmed with the time points or visit descriptions expected for participants. Each ‘Visit’ is programmed with the expected primary specimens to be collected by the study coordinator. In some cases, the processed specimens are also pre-programmed.
The Visit page, as shown below, can be accessed using the specific participant’s overview page.
From the participant overview page, there will be two tables displayed: ‘Occurred Visits’ and ‘Pending Visits’. From the ‘Pending Visits’ table, select the down-arrow next to ‘Collect’ and select, ‘Visit’:
The participant’s Visit fields are displayed.
Enter the Visit Date as the date of collection, if available.
The Visit Site defaults to the Site associated with the MRN, if recorded during registration. If it differs, then choose the correct Site from the dropdown list. The field will auto-fill as the Site name is typed.
Clinical Diagnoses can be entered in one of two ways. Multiple diagnoses may be chosen.
Typing any part of the description of the clinical disease will display the matching choices in the dropdown.
Typing the ICD 10 code (without ‘.’) will display the matching diagnosis. Note: ICD 10 Codes are preferred as they are the standard for diagnoses and allow for easier data manipulation across studies.
Clinical Status and Surgical Pathology Number may be entered, if available.
A comments field is available for Visit specific comments
Fields are saved by selecting:
‘Create’, which directs the user to the Visit overview page where details can be viewed and reviewed and edited if necessary. OR
“Proceed to Collection' which directs the user to the Specimen Collection page.
Once a Visit is collected, the Visit Overview Page is displayed
If there are multiple visits, each visit will have its own Overview Page and its own forms attached if any are attached at the Visit Level.
For each visit, the menu bar on the left shows 4 tabs and defaults to ‘Overview’:
If a Path Report is available as a .pdf, it may be uploaded from the Path Report tab.
If form-specific data is to be entered, any attached forms can be accessed from the Forms tab.
The Specimen Tree tab functions as it does for Participants, by displaying the the specimen tree on the screen being viewed.
The Visit Overview page is also available to view by selecting the ‘Event Label’ under ‘Occurred Visits'
Once the Visit is collected, you can view the Specimens collected during the Visit.
Specimen Data Entry
CPs in which no Visit Level data is necessary, one can proceed directly to specimen collection from the Participant Registration page.
Each CP can be configured for multiple visits. Each visit can be configured to have specific specimens that are to be expected. The expected specimens will be displayed in the ‘Specimens' box on the Visit Overview Page for each visit.
For example, in the planned longitudinal study shown in this figure, there are 3 expected visits. T0D, T1D, and T30D.
At T0D (pre-surgical), there are 2 expected specimens:
Whole Blood (in ACD Vacutainer)
Buccal Swab
For unplanned studies for which specimen type cannot be predicted, no specimen type is shown.
From the Visit Overview Page, the expected specimens are shown in the Specimens table.
To collect one or more expected specimens, select the box next to the Description for the sample to be collected. Or select the top box (circled in red below) to select ‘all specimens’ and record all collections one one screen.
Once one or more samples are selected, additional options appear on the menu bar for the Specimens table.
Select the ‘+Collect’ from the bar to proceed to the Specimen collection page, where specimen-specific data will be recorded.
The Specimen Collection page will display all of specimens that were chosen in the previous step.
In this screen the Visit Site defaults to that entered for the Visit recorded in the previous step. If the Visit details were bypassed at the Participant Registration step, then you must enter the Visit Site here.
The Collector and Receiver will default to the current user. If these are other than the user, they may be chosen from the dropdown list, but the person must exist in the OS user list.
Collection Date and Received Date will default to the current date and time, but may be edited if different.
If necessary, edit the sample quantity if it differs from expected.
Details about sample Quality may be chosen, if desired. The dropdown list is on the right side of the screen.
If the sample is to be stored, then the Container location can be chosen by clicking on this icon:
This will open up the search for available containers. Click the search button to search for avialable locations.
You must have a container built and assigned to your Site in order to store specimens. This will be addressed in a separate Knowledge Article.
Selecting ‘Submit’ will navigate to the Visit Overview page and show the Specimen Table with the collected specimens indicated with a purple dot and the Specimen Label assigned according to the CP Label details set up at CP configuration.
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