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New Participants CSV

Video:

Pre-Requisites

  1. The user having create/update participants access.

  2. The user having access to CP under which the participants have to be registered.

Steps to import CSV

  • Go to the Participant's list page of the protocol under which the Participant has to be created or updated.

  • Click on the 'More' button and select 'Biospecimen Data.'

  • Select 'Participants' from the 'Select Record Type' dropdown and click on 'Download Template File' to download the template file.

  • Enter all valid data in the template file as mentioned in the below ' Data Dictionary' table

  • Upload the filled template file in the 'Input Records File' field, select 'Import Type' as 'Create' to create or 'Update' to update participants

  • Click on the 'Validate and Import' button

  • Refer 'Import status' to check the status of import job

You can update participants based on any of the following:

  • EMPI

  • MRN and its Site

  • CP Short Title and PPID

Note: On updating the activity status of the participants to 'Disabled',  any dependent data like visits or specimens collected for this Participant will be deleted. This is the force delete feature available on the UI as well.

Sample CSV

Download

Data Dictionary

Column Name

PHI field?

Datatype

Mandatory?

(Create)

Mandatory?

(Update)

Description

Permissible Values

Validations

Column Name

PHI field?

Datatype

Mandatory?

(Create)

Mandatory?

(Update)

Description

Permissible Values

Validations

Identifier

No

Number

No

No

System auto-generated unique number for every Participant

This can be retrieved using the query interface(Registration ID). The query for the desired participants and include the 'Registration ID' field using 'Columns' in the results view.

Mandatory while updating PPID. 

CP Short Title

No

String

Yes

Yes

Collection Protocol to which the Participant to be updated belongs.



Should be an existing CP

PPID

No

String

Depends

Yes

PPID of the Participant to be updated



Should be unique within the CP

It should be left blank if auto-generation is ON. 

Registration Date

No

Date

Yes

No

The date of participant registration.



Select the correct date format from UI based on the data in the file

Registration Site

No

String

No

No



The Site where the Participant enrolled in the study/protocol.







External Subject ID

No

String

No

No

Unique study or system ID assigned to participants by external systems like OpenClinica, REDCap, etc.





Activity Status



String

No

No

Activity status of the Participant

  • Active

  • Disabled

'Disabled' status cannot be used when registering/creating a participant.

Default Value: Active

To remove the Participant, update the activity status to 'Disabled'.

 

 

Data Entry Status(v10.2)

No

String

No

No

Specify data entry mode of participant

  • DRAFT

  • COMPLETE

Introduced in v10.2.

When in draft mode, no validations will be shown, user can add data and save information. 

Reason



String

No

No

Specify reason for disabling a participant



Minimum of 10 characters.

First Name

Yes

String

No

No

First name of participant





Last Name

Yes

String

No

No

Last name of participant





Middle Name

Yes

String

No

No

Middle name of participant





Phone Number

Yes

String

No

No

contact number of Participant

 

 

Date Of Birth

Yes

Date

No

No









Death Date

Yes

Date

No

No







Gender

No

String

No

No



  • Female

  • Male Gender

  • Unknown

  • Undifferentiated



Race#1

No

String

No

No

Add an extra column for the Participant with multiple races. E.g.

Race#1, Race#2, etc.

  • American Indian or Alaska Native

  • Asian

  • Black or African American

  • Native Hawaiian or other Pacific Islander

  • Not Reported

  • Unknown

  • White



Vital Status

No

String

No

No



  • Alive

  • Dead

  • Unknown

  • Unspecified



Ethnicity

No

String

No

No



  • Hispanic or Latino

  • Not Hispanic or Latino

  • Not Reported

  • Unknown



SSN/NIN

Yes

Integer

No

No

Social Security Number/National Identification Number

SSN for US locale

NIN for other countries



Should be unique within OS

eMPI

Yes

String

No

No

Enterprise Master Patient Index



It should be unique within the system.

PMI#1#MRN

Yes

String

No

No

Medical Record Number

Need to be specified if the update should be based on MRN

It should be unique within the Site.

PMI#1#Site Name

No

String

No

The Site which issued the MRN

It should be an existing site.

Custom fields update

OpenSpecimen allows adding custom fields to the main participant page using the 'Forms' feature and attaching the form at the 'Registration Custom Fields' level. Refer to 'Custom Forms' for more details on adding these fields. Once these fields are added, the participant bulk import template gets automatically updated with these fields. To update the values for such custom fields for specific participants, follow below steps:

  1. Navigate to the participant list page of specific collection protocol

  2. Click on 'Import' and download the template for Participant

  3. The template will have the columns for custom fields and the columns specified in the above table.

  4. Fill the template with the data for the custom fields along with the PPID of the participants for which the data needs to be updated and the CP short title.

  5. Upload the file with import type as 'Update.'

  6. Once uploaded, check the status under 'View past imports.'

Got feedback or spotted a mistake?

Leave a comment at the end of this page or email contact@krishagni.com