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This section provides instructions for curating person records, including searching for and creating new persons, and assigning them roles.

 

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Creating New Person Records

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Under some circumstances you may be required to create a new person record. For example, you may receive a request to create a person record from someone who is abstracting a registered trial but is unable to find the primary investigator’s record in the database.

How to Create a Person Record

On the main menu, under Person, click Create.
The Create Person(s) page appears. There are three main sections of information: basic identifying information, address, and contact information.
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Create Person Page – Sections Displayed Side-by-Side
Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table. Items with an asterisk are required fields.

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Field Label

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Description/Instructions

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Status*

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Select the current curation status. For status descriptions, see Changing the Curation Status .

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Address Information* section

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Provide as much information about the person as possible. All fields, except Address Line 2, are required. If the person is located in a country that does not use postal codes, type NULL in the Postal Code field.

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Contact Information section

Warning

To avoid loss of data, after completing each field in the Contact Information section, click Add.

Provide as much information about the person as possible.

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Comments

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Enter any information that you want associated with the person record.

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Creating New Person Records - Include v1.1.3

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Curating Person Records

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Curating Person Records - Include v1.1.3

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Modifying Person Details

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Modifying Person Details - Include v1.1.3

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Assigning Roles to Persons

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Assigning Roles to Persons - Include v1.1.3

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Managing Clinical Research Staffs

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Managing Clinical Research Staffs - Include v1.1.3

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Managing Health Care Providers

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Managing Health Care Providers - Include v1.1.3

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Curating Person Records

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The following records are available for curation and appear in your Inbox when you log in:

  • Records that have the curation status "Active"
  • Records that have the curation status "Pending"
  • Records that contain a role that has the curation status "Pending"
  • Records for which there are one or more requests for changes

You can curate them in any order, sort the table to curate them in a specific order, or search for a particular record (see Searching for Person Records) .

How to Curate Person Records in Your Inbox

  1. On the main menu, under Persons, click Inbox.
    All Person records (except those that have been nullified) are displayed. The number of changes, if any, that have been requested for each record is displayed in the Status column.
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    Entity Inbox - Person
  2. In the Action Column, click Curate.
    To ensure that there are no duplicate, or near-duplicate records in the system, search the CTRP database for the same person name. See Resolving Duplicate Person Records If you find a duplicate record, proceed to Deleting Person Records. Otherwise, continue to the next step.
  3. Review the data on the Person Detail page, and then continue with one or more of the appropriate options in the table below.
    Options for curating person details

    If the data is...

    Do this

    Result

    Correct and complete

    Change the curation status to Active. See Changing the Curation Status .

    The record is saved “as is” and you are returned to the Inbox. Because you activated the record, it no longer appears in the Inbox. You are now ready to curate the next record.

    Not acceptable, that is, some or all of the data in the record is obviously wrong, or the record is a duplicate of another

    Change the curation status to Nullified.

    The record is nullified, and you are returned to the Inbox. Because you nullified the record, it no longer appears in the Inbox. Although the record is essentially deleted and removed from view, the system stores the record with a status Nullified. You are now ready to curate the next record.

    Not complete, or not accurate, and you are not able to provide all the information needed.

    Modify the record as needed, keep the curation status, Pending, and click Save.

    The record is saved as "Pending" and you are returned to the Inbox. You are now ready to curate the next record.

    Not complete, or not accurate, and you are able to provide all the information needed.

    Complete the record as needed, change the curation status to Active, and click Save. See the instructions provided for the following tasks:

    The record is saved as "Active" and you are returned to the Inbox. Because the record is now complete, it no longer appears in the Inbox. You are now ready to curate the next record.

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Modifying Person Details

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How to Modify Person Details

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Assigning Roles to Persons

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Because clinical trials can involve a network of persons and organizations, one of the key functions of a curator using the P/O Curation Portal is to identify the interrelationships among them. You can identify persons by the role(s) they play in support of various clinical research activities.

The two main types of roles are as follows:

  • Structural role – Permanent role of a person as defined by an organization. Defines the relationship between a person, an organization, and a trial. Structural roles do not have to be scoped by another person.
    There are several types of predefined structural roles, as follows:
    • Clinical research staffs
    • Health care providers
    • Organizational contacts
    • Other Person Identifiers
  • Functional role – Temporary role based on activities a person participates in.

 

How to Assign Roles

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  1. Navigate to the record of interest. See Navigating Records in Tables or Searching for Person Records .
  2. In the Action column for a given person, click Curate.
Tip
titleInformation on Tab Labels

The Person Details page displays all details about the person provided to date. The tab labels in the Assign Organizational Roles section at the bottom of the page display the number of each role already associated with the person that you are curating (if applicable). The letter "P" beside the role label on each of the tabbed pages indicates that at least one role is pending curation.

Note

You must assign the Clinical Research Staff and Health Care Provider roles.

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Person Details Page – Assign Person Roles Section

 

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Managing Clinical Research Staffs

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Each person in the P/O Curation Portal must be identified uniquely in the current role.

Tip
titleInformation on Tab Labels

The Person Details page displays all details about the person provided to date. The tab labels in the Assign Organizational Roles section at the bottom of the page display the number of each role already associated with the person that you are curating (if applicable). The letter "P" beside the role label on each of the tabbed pages indicates that at least one role is pending curation.

How to Manage Clinical Research Staffs

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Follow one of the options in the table below to continue assigning roles:
Options for assigning roles to a person

If there are...

And...

Do this

No clinical research staff role records displayed

You want to add a role

Proceed to the next step.

One or more clinical research staff role records displayed

The information for them is correct

Proceed with other aspects of the person curation.

One or more clinical research staff role records displayed

The information for them is incorrect

In the Action column for the record you want to modify, click Edit, and proceed to Select Affiliated Organization.

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  1. To change the information in the address section, click Edit.
    - or -
  2. To delete the address information, click Remove.
    - or -
  3. To add another address, click Add Postal Address.

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Tip

Remember to click Add after you complete each of the contact information fields.

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Managing Health Care Providers

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Each person in the P/O Curation Portal must be identified uniquely in the current role.

Tip
titleInformation on Tab Labels

The Person Details page displays all details about the person provided to date. The tab labels in the Assign Organizational Roles section at the bottom of the page display the number of each role already associated with the person that you are curating (if applicable). The letter "P" beside the role label on each of the tabbed pages indicates that at least one role is pending curation.

How to Manage Health Care Providers

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Follow one of the options in the table below to continue assigning roles:
Options for assigning roles to a person

If there are...

And...

Do this

No health care provider role records displayed

You want to add a role

Proceed to the next step.

One or more health care provider role records displayed

The information for them is correct

Proceed with other aspects of the person curation.

One or more health care provider role records displayed

The information for them is incorrect

In the Action column for the record you want to modify, click Edit, and proceed to Select Affiliated Organization .

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  1. To change the information in the address section, click Edit.
    - or -
  2. To delete the address information, click Remove.
    - or -
  3. To add another address, click Add Postal Address.

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Tip

Remember to click Add after you complete each of the contact information fields.

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Managing Organizational Contacts

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