The Adjudication Folder Administrator performs these steps to configure the adjudication folder and tools. Note that the role of folder administrator does not include global permissions within this type of folder, and specifically does not include Adjudication Lab Personnel or Adjudicator permissions. Only adjudicators and designated lab personnel can see and edit the information on role-specific tabs they will use in the process.

Set Up the Adjudication Folder

  • Create a new folder of type Adjudication.
    • All users with folder read permissions are able to view the Overview tab. The wiki there is intended to be customized with protocol documents or other framing information, but should not reveal anything not intended for all adjudicators and lab personnel.
    • The available tabs and which users can see them are shown in the following table:
Tab NameAdjudication Roles Granting Access
OverviewAll users with Read access to the folder.
Administrator DashboardAdministrators, Lab Personnel, Infection Monitors, Data Reviewers
UploadLab Personnel
Case DeterminationAdjudicators
Infection MonitorAdministrators, Infection Monitors
ManageAdministrators

Manage Adjudication Options

The Manage Adjudication web part on the Manage tab allows you to:

  • Specify the file prefix used for uploaded cases. Options are:
    • Parent Folder Name
    • Parent Study Name (requires that the adjudication folder be a study subfolder).
    • Text: Enter expected text in the box, such as "VTN703" here.
  • Select the number of Adjudicator Teams (from 1 to 5, default is 2).
  • Specify whether HIV-1, HIV-2, or both determinations are required (default is HIV-1 only)
  • Configure the assay results table to include additional columns if necessary.

The format of a case filename is PREFIX_PTID_DDMMMYYYY.txt. PTID is the patient ID. For instance, VTN703_123456782_01Aug2015.txt as used in our example. Prefixes are checked for illegal characters, and if you leave the text box blank, the filename is expected to be _PTID_DDMMMYYY.txt.

Once a case exists in the adjudication folder you will no longer be able to edit the admin settings, so the web part will simply display the selections in force.

Assign Adjudication Roles and Permissions

In the adjudication process, the objective is adjudication determinations which are reached independently and blinded to each other. Each Adjudicator Team can be a single person, or may include an additional backup person in case they are unavailable. Both team members are equally empowered to make the determination for the team.

The Adjudication Users table on the Manage tab is used to give access and roles to users within this folder. No user can appear twice in the table, and when you insert a new user and grant one of the adjuication roles, you assign the relevant permissions automatically. No explicit setting of folder permissions is required.

You will need to identify at least one member of lab personnel and at least one member of each adjudication team. Additionally, you can assign the other roles for notification and data access purposes. Additional people to be notified may also be specified and carry no distinguishing role.

  • Click the Manage tab.
  • Click Insert New Row on the Adjudication Users table.
  • Select the user from the dropdown.
  • Select the role from the dropdown. Options are:
    • Adjudicator
    • Data Reviewer
    • Folder Administrator
    • Infection Monitor
    • Lab Personnel
    • To Be Notified
  • Click Submit.
  • Repeat to add other necessary personnel to fully populate the table.

Assign Adjudicator Team Members

The Adjudicator Team Members web part is populated with the defined number of teams and pulldowns for eligible users. Users given the role Adjudicator in the Adjudication Users webpart will be available to select from the team member pulldowns. You must select at least one adjudicator per team. If you select a second, or "backup" adjudicator for one or more teams, no distinction is made between the back-up and primary adjudicator within the tools; either may make the adjudication determination for the team.

Use the Send notifications checkboxes to select which adjudicators will receive notifications for each team. In circumstances where both adjudicators are available and receiving notifications, they will communicate about who is 'primary' for making decisions. If one is on vacation or otherwise unavailable, unchecking their checkbox will quiet notifications until they are available again.

This screencap shows the two webparts populated using example users assigned to the roles. The Name column shows the Role Name, not the user name. There is one of each role, plus a total of four adjudicators. Adjudicators 1 and 3 make up team 1, and adjudicators 2 and 4 are team 2.

To change adjudication team assignments, first delete or reassign the current team members using the edit or delete links on the table, then add new users. You can only have two users on each team at any time. When you assign a user to a role in this table, the associated permission is automatically granted; you need not separately set folder permissions. Likewise, when you remove a user from any role in this table, the associated permission is automatically retracted.

Specify Supported Assay Kits

The folder administrator also defines which assays, or assay kits, are expected for the cases. All assay kits available are listed in the Kits table. The Manage tab Supported Assay Kits web part shows kits for this folder. To add a kit to this list:

  • Click Insert New Row in the Supported Assay Kits web part.
  • Select the desired kit from the pulldown.
  • Click Submit.

Customize Case File Format

The uploaded case file must be named with the correct prefix, and must include all these columns at a minimum:

  • ParticipantID
  • Visit
  • AssayKit (kits must be on the supported list)
  • DrawDate
  • Result
Any other columns present in the case file that you want to be able to access within LabKey must also be present in the assay results table. To see current fields or add additional fields to the assay results table, return to the Manage Adjudication web part and click Configure Assay Results.

Any columns present in the uploaded case file which are not included in the assay results table will be ignored. At the time of upload, the user will be warned that the extra columns will not be stored anywhere, but the upload will proceed successfully.

Assay values uploaded are both case-insensitive (i.e. GEENIUS, Geenius, geenius are all accepted) and spacing-insensitive (i.e. "Total Nucleic Acid" and TOTALNUCLEICACID are both accepted). Dates within the uploaded data are converted to four digit representations (i.e. '16 will be displayed as 2016).

Next Steps

The adjudication lab personnel can now use their tools within the folder to initiate a case. See Initiate an Adjudication Case for the steps they will complete.

If additional columns are necessary, or changes must be made to assigned personnel later in the process, you (or another folder administrator) will need to perform the necessary updates.

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