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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 status (which can change over time).

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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.

Single-step Specimen Collection process

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  1. 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’.

     

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  2. The Specimen Collection page is displayed for the visit. There are two sections:

    1. The upper section displays visit level fields (red)

    2. The lower table displays the expected specimens at that visit (blue)

  3. Default visit fields can be edited as needed, default settings are as follows:

    1. Visit Date will default to the current date

    2. Visit Site is usually set in the protocol

    3. Collector and Receiver will default to current user

    4. Quality defaults to acceptable, any other choice will apply to all specimens collected

  4. Collection and Received dates need be specified, set time if necessary

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  5. Planned Specimen table: record any necessary data that differs from expected.

    1. Quantity: editable if volume or other quantity unit is different than programmed value

    2. Container: choose any manually selected containers to store primary samples

    3. Label printing should be pre-programmed but can be manually selected

    4. Status defaults to collected, but can be set as otherwise if a sample was not collected.

  6. Example: Final Specimen Collection page following data entry and editing:

    1. Entered collection & received dates,

    2. Edit volume of total blood for plasma and PBMCs,

    3. Selected container to store PAXgene tube,

    4. Selected manual printing of label for PAXgene tube

  7. Click ‘Submit’ to collect samples as described.

  8. 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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  1. The Visit page can be accessed after collection by selecting the ‘Event Label’ in the ‘Occurred Visits’ table.

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  2. Choose ‘Edit’ for the Completed Visit.

  3. Edit or update any fields as described above.

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