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

Planned
Unplanned

In planned studies, it is pre-defined 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.

In unplanned studies, there is no predefined CP.

Follow the below steps to create participant-centric CP:

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a longitudinal Collection Protocol, subjects are followed over time with continuous or repeated timepoints to collect biospecimens. The list of biospecimens too be collected per timepoint and their processing details are predefined.

Introductory Video

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url	https://www.youtube.com/watch?v=-bDMJ3g3tYQ

In OpenSpecimen, you can create a CP with basic details for your study.

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Select 'Collection Protocols' from the left side menu or home screen
Click the 'Create' button from the protocol's list page.
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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,

Note

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The CP level PI and Coordinators will not be assigned roles automatically or by default.
After creating the CP, the admin has to manually assign specific roles to all the users who need to access the CP.

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Defining Consents

Consents statements are created at the system level by super admins and institute admins. Once created, the User can use it in multiple CPs. Refer 'Coded consents' for more details.

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Go to the CP in which you want to add the consents.
Click the 'Consents' tab from the left-side menu.
Click 'Add Statement'. A drop-down list of existing consent statements will appear.
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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Defining Timepoints

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.

Adding Events

An event represents one collection time point in which one or more specimens are collected. E.g. Day 0, Day 30, Cycle 1 etc.

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Click the 'Events' tab on the left-hand side of the CP details page.
Click 'Add Event' and enter the required information.
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Field	Mandatory?	Description
Event code	No	It's a shortcode for an event that can be used for specimen barcoding or auto label generation.
Event Point (number)	No	Timepoint 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)	No	Timepoint units like Days, Weeks, Months, and Years.
Event Point Label	Yes	A unique name within the CP for this time point. For example, Pre-Surgery, Surgery, 90-day follow-up, Relapse, etc.
Default Site	No	You can select the default site for the event timepoint.

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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.

Adding Specimen Requirements (SR)

Specimen requirement defines what specimens are expected to be collected and how they should be processed at each time point. E.g., Collect two whole blood specimens, process one into plasma and the other into the serum.

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

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Field Title	Mandatory?	Description
Name	No	The 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)	No	This 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 Container	No	Type of container used for specimen collection.

Adding Derivatives and Aliquots

A derivative is the parent specimen's processed outcome (e.g., plasma or serum from blood), whereas an aliquot is the smaller portion of the parent specimen.

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Click the dotted menu of the specimen and click 'Create Derivatives'
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Enter the required information and submit
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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.

Edit Event/SR

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The event and SR details can be edited using the ‘Edit’ option. To edit an event or SR:

Go to the events page of a CP.
Click the dotted menu for the event/SR and click ‘Edit.’
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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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. But only if you have not collected any data respective to those set events or SRs.

Deleted event/SR will not be visible in the CP.
No new visit/specimen can be collected for the deleted event/SR.

Impact of closing an event/SR:

Any visit and specimens collected before the deletion closing of the event will be visible after deletionclosing.
No new visit/specimen can be collected for the deleted closed event/SR.
Deleted event/SR will not be visible in the CP.

Close and Reopen Event/SR

Sometimes you may need to discontinue an event or SR. In such cases, the event/SR can be "closed."

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Go to the events tab of the collection protocol.
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Click on 3 dots present against the event label and select the option 'Close.'
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Click on 'Yes.'
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The event is closed. The 'Closed events' cannot be displayed under the pending visits table of the participant overview page.
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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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Go to the events tab of the collection protocol. The specimen requirement table is present against events.
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Click on 3 dots present against the specimen requirement and select option 'Close.'
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Confirmation popup is opened. Click on 'Yes.'
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The SR is closed. The specimen pending count is zero against the event under the pending visit table.
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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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The events are can now be seen under the pending visits table of the participant overview page.