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Table of Contents

In participant-centric studies, participant data like name, age, sex, etc., is collected along with the specimens. The study can be -

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In planned studies, it is pre-defined predefined what type of specimens are to be collected and how they have to be processed. These details can be set at the collection protocol (CP) level, which will make data entry simpler. 

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  1. Select 'Collection Protocols' from the left side menu or home screen
  2. Click the 'Create' button from the protocol's list page.
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  3. Enter the required information according to your study and click the 'Create' button
    Example: Creating a CP for the 'Lung cancer research study.'
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Details for all the fields on the CP overview page, 

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  1. Go to the CP in which you want to add the consents.
  2. Click the 'Consents' tab from the left-side menu.
  3. Click 'Add Statement'. A drop-down list of existing consent statements will appear. 
  4. Search for the required consent statement using its code or the statement itself and click 'Add.'
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If you are not planning to use a consent feature for your CP, select 'Consent Waived?' as 'Yes.' This will hide the consents tab from the participant level page.
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Setting up a specimen collection calendar

For longitudinal collections, you can configure event points and specimen requirements. The more you pre-define predefine CP events, the fewer data entry has to be done on a day to day basisdaily. The system can handle all kinds of deviation (like collected less quantity than planned) during collection.

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  1. Click the 'Events' tab on the left-hand side of the CP details page.
  2. Click 'Add Event' and enter the required information.
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Field
Mandatory?
Description
Event codeNoIt's a shortcode for an event that can be used for specimen barcoding or auto label generation.
Event Point (number)NoTimepoint within the study calendar on which the specimen collection or registration is due. It decides the order of events displayed in on the CP and participant overview page. You can edit the event point to change the order of events. 
Event Point Unit (new in v4.3)NoTimepoint units like Days, Weeks, Months, and Years.
Event Point LabelYesA unique name within the CP for this time point. For example, Pre-Surgery, Surgery, 90-day follow-up, Relapse, etc.
Default SiteNoYou can select the default site for the event timepoint.


Note

For an unplanned CP, it is not required to pre-define predefine event time points. However, it is mandatory to have at least one event defined in the current version. 


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  1. Click 'Add Specimen Requirements' and enter the required information.

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Field Title

Mandatory?

Description

NameNoThe user-friendly name for the requirement. (Used for display and query. E.g., Pre-op blood.)

Code

No

A short unique code that is used for auto-labeling specimens. e.g., WBEDTA stands for whole blood in EDTA

Stored in the repository?

No

Whether the specimen would be fully utilized in processing or stored in the repository, E.g., 'Whole blood' will be stored in aliquots.

For setting up auto container allocation, refer to https://openspecimen.atlassian.net/wiki/x/KABLB

Sort Order (Number)NoThis field is used to decide the order of the specimen requirement(SR). By default, SRs appear in the order they were added by you. If you wish to reorder the sequence of SRs to accurately mimic the collection process, edit the SR, and assign new values to the sort order.
Collection ContainerNoType of container used for specimen collection.


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  1. Click the dotted menu of the specimen and click 'Create Derivatives'
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  2. Enter the required information and submit
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  3. To add aliquots, follow the same steps and select 'Create Aliquots'
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Info

To create aliquot with 0 quantity, you need to ask the super admin to enable "Mandatory Aliquot Quantity" under the "Settings" card.


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  1. Go to the events page of a CP.
  2. Click the dotted menu for the event/SR and click ‘Edit.’
  3. Do appropriate changes and click ‘Save.'

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Copy Event/SR

Some studies may have similar events or SRs. In such cases, you can copy the event/SR. Copying an event also copies all the SRs under it. Similarly, copying the SR also copies all the child SRs under it.


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  1. Click on the dots beside the SR/Event -> Select ‘Copy’.

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Delete Event/SR

You can delete unwanted events/SR, e.g., event/SR created by mistake.

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  1. Go to the events tab of the collection protocol.
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  2. Click on 3 dots present against the event label and select the option 'Close.'
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  3. Click on 'Yes.'
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  5. The event is closed. The 'Closed events' cannot be displayed under the pending visits table of the participant overview page.
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  6. To reopen the event, click on the 3 dots present against the closed event and select the 'Reopen' option. It reopens the event.
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Close and Reopen SR:

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  1. Go to the events tab of the collection protocol. The specimen requirement table is present against events.
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  2. Click on 3 dots present against the specimen requirement and select option 'Close.'
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  3. Confirmation popup is opened. Click on 'Yes.'
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  4. The SR is closed. The specimen pending count is zero against the event under the pending visit table.
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  5. To reopen the SR, click on the 3 dots present against the closed SR and select the 'Reopen' option. It reopens the SR.
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  6. The events are can now be seen under the pending visits table of the participant overview page.

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Impact of closing an event/SR:

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