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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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. 

4. 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

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

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

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   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.

      

7. 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

8. 

   Click ‘Submit’ to collect samples as described.

9. 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. This Visit page can be accessed during the collection process using the Collect Visit feature. Choose ‘Visit’ from the ‘Collect’ button in the Pending Visit table on the Participant overview page.

2. 

3. This navigates to the Visit page which displays additional fields not found during the Single step process.

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   1. Clinical Diagnoses can be entered in one of two ways. Multiple diagnoses may be chosen.

      1. Typing any part of the description of the clinical disease will display the matching choices in the dropdown.

      2. Typing the ICD 10 code (without ‘.’) will display the matching diagnosis. Note: OpenSpecimen uses ICD 10 diagnosis codes to record clinical disease descriptions which enables data querying and manipulation across studies.

      3. Example: typing ‘diabetes’ will display all subtypes of any ICD 10 containing ‘diabetes’.

         1. 

   2. Clinical Status can be used to record if a participant is a No Diagnosis / Control or to record their clinical status as related to the specific study. Each study will choose their own usage of these terms.

   3. 

      Surgical Pathology Number may be entered, if available.

   4. Comments is available for Visit specific comments

4. Fields are saved by selecting:

   1. ‘Create’ directs the user to the Visit overview page where details can be viewed and reviewed and edited if necessary; OR

   2. 'Proceed to Collection' directs the user to the Specimen Collection page

      

5. Once a Visit is collected, the Visit Overview Page is displayed

   

6. If there are multiple visits, each visit will have its own Overview Page and its own forms attached if any are attached at the Visit Level.

   1. For each visit, the menu bar on the left shows 4 tabs and defaults to ‘Overview’:

       

      

       

7. If a Path Report is available as a .pdf, it may be uploaded from the Path Report tab.

8. If form-specific data is to be entered, any attached forms can be accessed from the Forms tab.

9. The Specimen Tree tab functions as it does for Participants, by displaying the the specimen tree on the screen being viewed.

10. The Visit Overview page is also available to view by selecting the ‘Event Label’ under ‘Occurred Visits'

    1. 

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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. Then choose ‘Edit’ for the Completed Visit.

   

3. Edit or update any fields as described above.

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Need a section on collecting unplanned specimens.

Need an unplanned specimen collection page:

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Need a page 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

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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.

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