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IMPORTANT NOTE:
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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.
Planned longitudinal studies are usually pre-programmed with expected time points or visit descriptions and the expected samples to be collected 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 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.
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are also pre-set. This saves time for the study team by as fields are autofilled with expected values which can be overridden if necessary.
Example of a Planned Visit & associated specimens
Longitudinal studies have several expected visits for each participant. Each visit can be pre-programmed to autofill the expected samples and values into the standard fields.
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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. |
Documenting Visit
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Details
Each visit will have different characteristics and these can be (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 assoicated with a visit include:
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To record the clinical data at the time of specimen collection, choose ‘Collect Visit’ from the specimen table on the Participant overview page. |
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It is possible to record only the visit date and site |
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and proceed directly to ‘Collect Specimens’ either from the Add Participant page or from the specimen table on the participant overview page. |
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Collecting visits or specimens directly from Participant overview page:
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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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