Visit-level data fields are designed to record clinical details that can change over specific to that point in time. Each visit has its own unique characteristics, such as date, site at which the visit occurred, clinical diagnoses, and clinical status (which can change over time).
Planned longitudinal studies are usually pre-programmed with the time points or expected visit descriptions expected for participants and the expected samples to be collected based upon study design. Each ‘Visit’ is programmed with the expected primary specimens to be collected by the study coordinator and, in each study’s unique design. In some cases, the processed specimens derived from the primary samples . Therefore the visit descriptions and specimens will differ for every protocol.
Specimen and visit level data can be collected in a single step or in two steps. The single step process bypasses the visit page where detailed clinical data is recorded.
Single-step Specimen Collection process
Collect Visit and specimen information on a single page. This step bypasses the Visit Page and navigates directly to the Specimen collection page.
From the participant overview page, there will be one or two tables displayed: ‘Occurred Visits’ (if any previous visits exist) and ‘Pending Visits’. From the ‘Pending Visits’ table, select the down-arrow next to ‘Collect’ and select, ‘Specimens’.
The Specimen Collection page is displayed for the visit. There are two sections:
The upper section displays visit level fields (red)
The lower table displays the expected specimens at that visit (blue)
Default visit fields can be edited as needed, default settings are as follows:
Visit Date will default to the current date
Visit Site is usually set in the protocol
Collector and Receiver will default to current user
Quality defaults to acceptable, any other choice will apply to all specimens collected
Collection and Received dates need be specified, set time if necessary
Planned Specimen table: record any necessary data that differs from expected.
Quantity: editable if volume or other quantity unit is different than programmed value
Container: choose any manually selected containers to store primary samples
Label printing should be pre-programmed but can be manually selected
Status defaults to collected, but can be set as otherwise if a sample was not collected.
Example: Final Specimen Collection page following data entry and editing:
Entered collection & received dates,
Edit volume of total blood for plasma and PBMCs,
Selected container to store PAXgene tube,
Selected manual printing of label for PAXgene tube
Click ‘Submit’ to collect samples as described.
System navigates back to the Participant overview page and the summary of the visit collected will appear in the ‘Occurred Visits’ table and will disappear from the ‘Pending Visits’ table.
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are also pre-set. This saves time for the study team as fields are autofilled with expected values which can be overridden if necessary.
Documenting Visit Details
Each visit will have different characteristics (e.g, date of visit, new diagnosis, visit site, etc.). These are recorded on the visit page. It is possible to record vist data at the time of sample collection or record it later.
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The standard fields associated with a visit include:
This process is recommended if collecting clinical data at the time of specimen collection. Note that any of the visit information can be edited at a later date.
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Editing Clinical data after |
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specimen collectionIt is common that clinical diagnoses or pathology is not obtained until after specimen collection occurs. If this is the case, the Clinical information can be added or updated at any time using ‘Edit’ on the Visit page.
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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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DELETE BELOW
Need a section on collecting unplanned specimens.
Need an unplanned specimen collection page, covered:
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Next section should be on collecting pre-planned derivatives and aliquots. This will vary depending on protocol. Might be part of original collection. So it’s tough to cover. But I think it belongs in its own page. Collecting pre-planned processing events 
Then creating unplanned deriv and aliqs.
That begs the question of if we need to have a separate page that describes Events and SRs.
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In order to grasp this, we first have to cover what derivatives and aliquots are, which is on the derivative/aliquot page that occurs after this step.
Need to revisit the below section: I don’t think it’s necessary now.
Specimen Data Entry
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CPs in which no Visit Level data is necessary, one can proceed directly to specimen collection from the Participant Registration page.
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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.
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From the Visit Overview Page, the expected specimens are shown in the Specimens table.
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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.
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The Specimen Collection page will display all of specimens that were chosen in the previous step.
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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.
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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.
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Collection Date and Received Date will default to the current date and time, but may be edited if different.
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If necessary, edit the sample quantity if it differs from expected.
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Details about sample Quality may be chosen, if desired. The dropdown list is on the right side of the screen.
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If the sample is to be stored, then the Container location can be chosen by clicking on this icon:
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This will open up the search for available containers. Click the search button to search for avialable locations.
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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.
To skip the step of recording clinical data about the visit, navigate directly to the Specimen Collection.
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