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101.4.1 Collect Planned Visits and Primary Specimens

101.4.2 Collect planned derivatives and aliquots

101.4.3

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.

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.

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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.

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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.

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Each protocol will be designed to specifically represent the biospecimens expected for that protocol.

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are also pre-set. This saves time for the study team as fields are autofilled with expected values which can be overridden if necessary.

Documenting Visit 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.

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It is possible to record vist data at the time of sample collection or record it later.

Expand
titleA closer look at capturing visit information

The standard fields associated with a visit include:

  1. Visit date

  2. Status: (Complete, Pending, Missed, Not Collected)

  3. Visit Site

  4. Clinical Diagnosis (multiple select): ICD 10 codes

  5. Clinical Status

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process is recommended if collecting clinical data at the time of specimen collection. Note that any of the visit information can be edited at a later date.

  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.

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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.

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Collecting visits or specimens directly from Participant overview page:

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  2. This navigates to the Visit page.

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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 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’.

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    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.

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      Cohort currently records only Case vs. Control. If your study has different designations for Cohort, these can be recorded with a custom field.

    4. Surgical Pathology Number may be entered, if available.

    5. Comments is a text field available for free typing.

  3. Visit data 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 Planned Specimen Collection page.

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  4. ‘Create’ navigates to the Visit Overview Page which displays the Visit details and the specimen table. All specimens will appear as ‘Pending’ (noted by the yellow dot next to the description).

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    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’:

       

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

    3. If Form-specific data is to be entered, any attached forms can be accessed from the Forms tab. (As as example, patient’s medications usually change over time and a different form can be completed at each visit for medications.)

    4. The Specimen tree tab functions as it does for Participants, by displaying the the specimen tree on the left side of the screen being viewed.

Editing Clinical data after specimen collection

It is common that clinical diagnoses or pathology is not obtained until after specimen collection occurs. If this is the case, the Clinical information can be added or updated at any time using ‘Edit’ on the Visit page.

  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.

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  3. Edit or update any fields as described above.

To skip the step of recording clinical data about the visit, navigate directly to the Specimen Collection.

  • 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.

  • Navigate to the Participant overview for an existing participant. Choose ‘Specimens’ from the ‘Collect’ button on the Pending Visits table.

Collect Specimens From Pending Visits Table on Participant overview

Collect Specimens from Add Participant page

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