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Table of Contents

The custom Forms and the custom fields can be integrated at different levels to capture additional information during data entry.

Collection Protocol (CP)-specific forms, such as registration forms, specimen forms, and visit-level forms can be associated with one or multiple collection protocols.

User-related forms, including user registration forms and user profile forms, can be linked to one or multiple institutes.

You will only be able to see those custom form levels for which you can create associations.

Attachment Level

The CP-specific forms such as registration, specimen, and visit level forms can be attached to one or multiple collection protocols. Also, the User related forms such as user form and user profile form can be attached to one or multiple institutes.

Custom form

The forms attached at custom form level such as participant, visit, or specimen level will appear in the forms tab

...

Click to view the levels and description

...

Level

...

Description

...

Participant Forms

...

  • Forms linked at the participant level will be available under all the CPs.

  • Data entered at the 'Participant' level will be available under all CPs the participant is registered to.
    E.g., If P1 is registered under CP1 and CP2, 'Participant Contact Details' entered for P1 under CP1 will also be available under CP2.

  • Forms added at this level will be available under the forms tab for that participant.

...

Registration Forms

...

For CP-specific participant forms. E.g., 'Smoking history', which might only be required under Lung Cancer Protocol.

Forms added at this level will be available under the forms tab on the participant form page.

...

Specimen Array Event

...

To add custom fields to the 'add event page' of the array. Multiple forms can be attached at this level. While adding an event, click the dropdown button in the event field to select the form.

...

Specimen Event

...

Add ‘custom events’ to describe different stages of a specimen life cycle, e.g., Nano-drop event. Refer to the wiki page for more details.

...

Specimen Forms

...

Forms linked to this level will be available under the forms tab of any collected specimens of the attached CP.

...

Specimen Slide Event

...

To add custom fields on the add event page for the slide. Multiple forms can be attached at this level. While adding an event, click the dropdown button in the event field to select the form.

...

User Forms (New in v8.0)

...

To add forms at the ‘User’ level. The forms can be added to capture training records, and so on. Refer to the wiki page for more details.

...

Visit Forms

...

Forms linked to this level will be available under the forms tab of any occurred visit of the attached CP.

Custom field

...

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Attach Form

A user can attach forms at three levels depending on the role assigned to the user. For example: Super admin users have access to attach forms at the system level, whereas admin users can attach forms at the collection protocol level to which they have access.

  1. At system level

  2. At collection protocol level

  3. At collection protocol group level

At System Level

Forms attached at the system level apply to every collection protocol, container, and user across all institutes within the system.

  • Only the Super Admin can attach forms at this level.

  • There are two types of associations where the form can be attached at the system level 

  1. Direct Attachment at the System Level:
    Certain associations allow forms to be attached directly at the system level, such as collection protocol custom fields. This approach ensures that the form is accessible across all collection protocols within the system.

Select 'Forms' from the navigation menu or the home screen
Expand
titleClick here to view the levels and description

Level

Description

Collection Protocol Custom fields

To add custom fields on the ‘create collection protocol"’page. E.g., 'IRB document', 'CTRI number.'

Container Custom Fields

To add custom fields on the ‘create container page’. E.g., 'Vendor name.' 

DP Requirements Custom Fields

To add custom fields on the ‘create DP requirements page’. E.g., 'Specimen quality.' 

Distribution Protocol Custom Fields

To add custom fields on the create distribution protocol page. E.g. 'Grant Number'

Order Custom Fields

The forms can not be attached using 'Association' option from the form page. It can be attached either at the system level or the Distribution Protocol level. Refer to Adding custom fields to Order level for more details.

Project Custom Fields

To add custom fields on the ‘create new project page’. E.g., Instructions 

Registration Custom Fields

To add custom fields on the ‘participant registration page’. E.g.'Marital Status', 'Age' etc. 

Service Request Custom Fields

To add custom fields to the ‘create request page’ of a project. E.g., Requestor Notes

Site Custom Fields

To add custom fields to ‘create site page’. E.g., 'Site phone number'.

Specimen Array Event

To add custom fields to the ‘add event page’ of the array. Multiple forms can be attached at this level. While adding an event, click the dropdown button in the event field to select the form.

Specimen Custom Fields

To add custom fields to the ‘main collect specimen page’. E.g., 'Processing Site', 'Tube Type' etc.

Visit Custom Fields

To add custom fields to the main visit page, e.g.,' Primary Diagnosis.' 

Expand
titleClick to view the steps to attach the form at different levels
steps with example

  1. Select 'Forms' from the navigation menu or the home screen.

  2. Navigate to the form overview page and click on 'Associations'

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  3. Click on 'Add'

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  4. Select the ‘Collection protocol Custom Field’ level from the dropdown and click on 'Add'

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  1. At All Present and Future Collection Protocols:
    There is other type of association where users can choose the option ‘All Present and Future Collection Protocols’ when linking the form. This setting ensures the form is automatically applied to both existing and future collection protocols in the system.

Expand
titleClick here to see the steps

  1. Navigate to the form overview page and click on 'Associations'

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  2. Click on 'Add'

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  3. Select the ‘Registration Form’ level from the dropdown, select 'All Present and Future Collection Protocols' then click on 'Add'.

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At Collection Protocol Level

Forms attached to individual collection protocols take precedence over system-level or Collection Protocol Group (CPG) associations. Regular users with form access, in addition to administrators, can attach forms at this specific level.

expand
Expand
titleClick here to view details...

  1. Navigate to the form overview page and click on 'Associations'

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  2. Click on 'Add'

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  3. Select the

level from the dropdown and

  1. ‘Registration Form' and name of the ‘Collection Protocol’, click on '

Add'
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  • Select the CP-specific level, e.g., registration, specimen, or visit form and select a specific CP

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    • Check the 'All Current and Future Collection Protocols' checkbox to link the form with all protocols in the system.

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    • If you want to link it to more than one Collection Protocol, click in the collection protocol box and select one or more collection protocols to which the form has to be linked.

    In the case of custom fields (for example, forms attached at Distribution Protocol Custom Fields, Container Custom Fields, etc.), it will get attached to all distribution protocols or containers across the system.

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    Following are the levels where the forms can only be attached by the Super Admins

    CP custom field

    Container custom filed

    DP requirement custom field

    DP custom field

    Participant form

    Project custom field

    Registration custom field

    Service request custom form

    Site custom field

    Specimen array event

    Specimen slide event

    User profile form

    Attachment of Forms as Custom Form

    The forms attached at levels such as participant, visit, or specimen level will appear as a separate form

    1. Add’

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    At Collection Protocol Group Level

    Users can attach a form at the CPG level to enter data across all collection protocols in the group, thereby overriding system-level associations.

    Expand
    titleClick to view the steps

    1. Navigate to the CPG and click on the 'Forms' tab

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    2. Select the level for attaching the form participant/visit/specimen.

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    3. To attach a form at the 'Custom Field' level, click the 'Add' button next to 'Custom Fields'.

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    4. If you wish to attach the form at the ‘CustomForm' level, click on the ‘Add’ button present beside 'Forms’.

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    Attachment level and Description

    The customs forms can be attached at various levels based on the data entry needs.

    Expand
    titleClick to view the levels and description

    Level

    Description

    Participant Forms

    • Forms linked at the participant level

    will be available under all the CPs

    • are accessible across all Collection Protocols where the participant is registered.

    • Data entered at the

    'Participant' level will be available under all CPs the participant is registered to.
    E.g., If P1 is registered under CP1 and CP2

    • participant level (e.g., 'Participant Contact Details'

    entered for P1 under CP1

    • ) will

    also

    • be available

    under CP2

    • in all collection protocols participant is associated with.

    • Forms added at this level will be

    available

    • listed under the participant’s forms tab

    for that participant

    • .

    Registration Forms

    For CP

    • Collection Protocol-specific participant forms (e.

    E.

    • g., 'Smoking

    history', which might only be required under Lung Cancer Protocol.Forms added at this level will be available

    • History' for Lung Cancer Protocol) are available only within the relevant Collection Protocol.

    • These forms will be listed under the forms tab on the

    participant

    • participant’s form page.

    Specimen Array Event

    To add custom fields

    • Custom fields can be added to the '

    add event

    • Add Event' page

    '

    • of the array.

    • Multiple forms can be attached at this level.

    While

    • To select a form while adding an event, click the dropdown button in the event field

    to select the form

    • .

    Specimen Event

    • Add

    ‘custom events’

    • ‘Custom Events’ to describe different stages of a

    specimen

    • specimen’s life cycle

    ,

    • (e.g., Nano-drop event

    . Refer to the wiki page for more details

    Specimen Forms

    • Forms linked

    to

    • at this level will

    be available

    • appear under the forms tab

    of

    • for any collected specimens

    of

    • within the attached

    CP

    • collection protocol.

    Specimen Slide Event

    To add custom fields on the add event

    • Custom fields can be added on the 'Add Event' page for the slide.

     Multiple

    • Multiple forms can be attached at this level

    .

    • While adding an event, click the dropdown button in the event field to select the desired form.

    User Forms

    (New in v8.0)To add forms

    • User forms can be added at the ‘User’ level

    . The forms can be added to capture training records, and so on. Refer

    • for capturing training records and other information

    • For more details, refer to the wiki page

    for more details

    • .

    Visit Forms

    • Forms linked

    to

    • at this level will be

    available

    • accessible under the forms tab

    of

    • for any

    occurred

    • visit

    of the attached CP.

    Attachment of Forms as Custom Fields

    The forms attached at custom field level, e.g., specimen custom fields or container custom fields, would appear on the main data entry screen.

    Description
    Expand

    Level

    • within the attached collection protocol

    Collection Protocol Custom fields

    • To add custom fields on the

    ‘create collection protocol"’page. E.g., 'IRB document', 'CTRI number.'

    • ‘Create Collection Protocol’ page, such as 'IRB Document' or 'CTRI Number'.

    Container Custom Fields

    • To add custom fields on the ‘create container page’. E.g., 'Vendor name.' 

    DP Requirements Custom Fields

    • To add custom fields on the ‘create DP requirements page’. E.g., 'Specimen quality.' 

    Distribution Protocol Custom Fields

    • To add custom fields on the create distribution protocol page. E.g. 'Grant Number'

    Order Custom Fields

    The forms can not

    • Order custom fields cannot be attached using the 'Association' option from the form page.

    It

    • Instead, can be attached

    either

    • at the system level or the Distribution Protocol level.

    Refer to Adding custom fields to Order level for more details.

    Project Custom Fields

    • To add custom fields on the ‘create new project page’. E.g., Instructions 

    Registration Custom Fields

    • To add custom fields on the ‘participant registration page’. E.g.'Marital Status', 'Age' etc. 

    Service Request Custom Fields

    • To add custom fields to the ‘create request page’ of a project. E.g., Requestor Notes

    Site Custom Fields

    • To add custom fields to ‘create site page’. E.g., 'Site phone number'

    .

    Specimen Array Event

    To add custom fields to the ‘add event page’ of the array. Multiple forms can be attached at this level. While adding an event, click the dropdown button in the event field to select the form

    • .

    Specimen Custom Fields

    • To add custom fields to the

    ‘main

    • main collect specimen

    page’.

    • page, E.g., 'Processing Site', 'Tube Type' etc.

    Visit Custom Fields

    • To add custom fields to the main visit page, e.g.,' Primary Diagnosis.' 

    Enabling Multiple Records for Forms

    Some data for the forms like test results, surveys, etc., might have to be collected multiple times. To do this, check the ‘Multiple records allowed’ checkbox while attaching a form at a particular level.

    ...

    Editing attachment Level for the Form

    ...

    Edit Attachment

    Forms can be edited at the Participant Forms, Visit Forms, Specimen Forms, and Registration Forms levels, you can edit the form. For example, the form you can have a single record or modify a form to include multiple records, as demonstrated below.

    Expand
    titleClick to view the steps

    • Click the 'Edit' icon

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    • Unselect Select the multiple records allowed and click on 'Update'

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    Delete

    ...

    Attachment

    When no Data Exists

    You can directly delete the attachment from different levels when there is no data present related to that form

    Expand
    titleClick to view the steps

    • Navigate to the associations and click on the 'Delete' icon

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    • Click on 'Yes'

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    Follow these steps ONLY when there is no data present in the forms or in a case where the data need not be preserved. Otherwise, deleting the attachment level leads to the deletion of related data.

    ...

    When Data

    ...

    Exists

    When deleting an attachment level leads to the deletion of the data related to those forms. In this case, the data needs to be preserved, and then the form can be reattached to another level. You can follow the below steps:

    Case 1: Changing the attachment level from ALL to single/multiple CP

    Expand
    titleClick to view the steps

    1. Go to the Collection Protocol list page → More → Export.

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    2. Select the name of the form in 'Record Type' and click on 'Export'. A CSV file containing the form records will be exported.

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    3. Navigate to the 'Associations' from the form overview page

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    4. Add the new attachment level and click on 'Done.'

    5. Go to the exported form records CSV (exported in step 2) in any text editor.

    6. Remove the first column (Identifier) and save the file.

    • If the new attachment level added was CP specific,
      Navigate to that CP’s patient list view page
      Click ‘More’
      Select ‘Biospecimen Data’.

    • If the new attachment level added was not CP specific
      Nanigate to the Collection Protocols list page
      Click ‘More’
      Select 'Biospecimen Data'.

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    7. Select the form name from the 'Record Type' dropdown and click on 'Validate and Import.'

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    Case 2: Changing the attachment level from single/multiple CP to ALL

    , the associated data is also removed. To ensure data preservation, first, save the data before deleting the attachment level. Afterward, you can reattach the form to a different level. For more detailed instructions, please refer to the wiki page.

    Enable Multiple Records

    To collect data from forms such as test results or surveys multiple times, ensure you select the ‘Multiple records allowed’ checkbox when attaching the form to a specific level. This setting enables the form to be used repeatedly for data collection.

    Expand
    titleClick to view the steps

    1. Navigate to CP's participant list page, to which the form is attached, click on 'Export.'

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    2. Select the form name from the 'Record Type' dropdown and click on 'Export.'

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    3. Repeat steps 3 to 6 from Case 1.

    If you wish to attach the same form at the same level to multiple collection protocols, this can be done using Collection Groups. You can refer to Collection Protocol Groups for more information.

    Case 3: Changing the attachment level from single/multiple CPs to CPG

    ...

    screenshot

    • Select ‘Multiple records allowed’

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    Enable Notifications

    Users can receive notifications about adding or editing form associations. Additionally, you can choose to include the form data in these notifications by selecting the corresponding checkbox.

    Expand
    titleClick to view the steps

    1. In this case, navigate to the CPG and click on the 'Forms' tab.

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    2. Select participant/visit/specimen where you want to attach the form.

    3. If you wish to attach the form at the ‘Visit Custom Fields' level, click on the 'Add’ button beside it.

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    4. If you wish to attach the form at the ‘Visit Forms' level, click on the ‘Add’ button present beside 'Forms’ title.

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    1. While adding an association, select ‘Send Notification’

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    2. Select the user group from the ‘Notification Recipient' dropdown and click on 'Add’

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    Note: The notifications are only sent to the User Groups and not to the individual users.