101.5 Collect Samples

Specimen Collection process

As previously mentioned it is possible to collect visit and specimen information on a single page. This step bypasses the Visit Page and navigates directly to the Specimen collection page. This can be done either when adding a new participant to the CP or for an existing participant.

  • If you are adding a new participant, select the ‘Proceed to Collection’ button at the bottom of the page.

  • If the participant already exists in the CP, navigate to the participant’s overview page.

    • There may 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’.

       

      Collect specimens at a visit

       

  • 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)

  1. Default settings are as follows but these can be edited as needed:

    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’. Note that this value will apply to all specimens collected. If a single specimen has a quality issue, you will need to navigate to that sample and change the quality description.

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

  3. 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 (detailed description is covered in ‘Containers’ section.

    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.

     

Example of editable fields of a ‘Planned’ specimen collection:

On the screen shot below you can see the following collection tasks which were performed:

  • Entered collection & received dates,

  • Edited 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.

To collect planned specimens after collecting a Visit

  1. Navigate to the Visit overview page under which the specimens will be collected by choosing the Visit from the Occurred Visits page.

  2. If no specimens are displayed in the ‘Specimens’ table, select ‘Show Pending’ from the ‘More’ button on the Specimen Table displayed on the Visit Overview page.

  3. Select all or some of the specimens to be collected. Once selected, the ‘Collect’ button will be displayed. Choosing ‘Collect’ will navigate to the Specimen Collection page as described previously. Enter or edit details as needed.