IMPORTANT NOTE:
Multiple Visits: xxx
Each visit sample: xx
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, site at which the visit occurred, clinical diagnoses and clinical status.
Planned longitudinal studies are usually pre-programmed with expected time points or visit descriptions based upon each study’s unique design. Each ‘Visit’ is pre-programmed with the expected primary specimens to be collected by the study coordinator and, 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. The two-step process allows you to record clinical information about the patient at each visit prior to recording sample collection.
Example of Events (Visits)
Longitudinal studies have several expected visits for each participant. Each visit can be pre-programmed to autofill the expected values into the standard fields.
This is an example of 3 expected visits in our Demo Study. Different biospecimens will be collected at each time point.
This is an example of the expected primary specimens to be collected at the Baseline visit:
1 Urine and 4 Whole Blood samples, each of which will be used to process into different biospecimens after they are received at the lab.
Expanding each of the primary samples by clicking on the arrow to the left of the description will show the expected derivatives and aliquots to be processed after receipt of the whole blood. The lab will creat 6 aliquots of plasma and 3 aliquots of PBMCs from 24 mL of whole blood received in the CPT tube.
Each protocol will be designed to specifically represent the biospecimens expected for that protocol.
Visit Level Page
Each visit will have different characteristics and these can be recorded on the visit page.
The standard fields include:
Visit date
Status: (Complete, Pending, Missed, Not Collected)
Visit Site
Clinical Diagnosis (multiple select): ICD 10 codes
Clinical Status
This page can be skipped if no clinical information will be recorded or to record it later.
To record the clinical data at the time of specimen collection, choose ‘Collect Visit’ from the specimen table on the Participant overview page.
To skip the visit data page, you can record only the visit date and site by proceeding directly to ‘Collect Specimens’ either from the Add Participant page or from the specimen table on the participant overview page.
Collecting visits or specimens directly from Participant overview page:
Bypass Visit collection page from ‘Add Participant’ step.
By choosing 'Proceed to Collection' upon registering a participant, the Visit page will be skipped and you will be navigated directly to the planned specimen collection page for the visit chosen.
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