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

1. 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.
   
   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.

   Field Label	Description/Instructions
   Status*	Select the current curation status. For status descriptions, see Changing the Curation Status .
   Address Information* section	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.
   Contact Information section	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. If you provide an email address, you are not required to provide a phone number, and vice versa.
   Comments	Enter any information that you want associated with the person record.

2. Click Save.

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.
   
   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: Modifying Person Details Managing Clinical Research Staffs Managing Health Care Providers Managing Organizational Contacts Managing Other Person Identifiers	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.

How to Modify Person Details

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.
   The Person Details page appears. You are required to complete all fields marked with an asterisk.
   
   
   Person Details Page – Basic Identifying Section
   Follow the steps in Creating New Person Records . If you need to change the curation status, see Changing the Curation Status before you continue to the next step.
3. Click Save.

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

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.

Person Details Page – Assign Person Roles Section

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

How to Manage Clinical Research Staffs

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.

3. In the Assign Organizational Roles section toward the bottom of the Person Details page, click the CRS (Clinical Research Staffs) tab. This is the default tab, so you may find that it has already been selected for you.
   The CRS page displays the research roles currently assigned to the organization (if applicable).

   You can sort the records

   Click the column heading once to sort the records in ascending order.  An arrow head indicates whether the sort order is descending or ascending. Click the column heading again to reverse the sort order.

   
   
   Manage Clinical Research Staff(s) page

4. 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.

5. To add a role, click Add Clinical Research Staff.
   The Create Clinical Research Staff page appears.
   
   Create Clinical Research Staff Page – Role Information 
6. Click Select Affiliated Organization. The Find Organization(s) page appears.
7. Search for and select the affiliated organization. For instructions on finding organizations, see Searching for Organization Records  .
   The organization you selected is displayed in the Clinical Research Staff Role Information section.
8. From the Role Status drop-down list, select the curation status of the clinical research staff role. If you have supplied all the necessary information, select Active.
9. In the Address Information section, click Add Postal Address, and follow the instructions in Entering Address Information .
   The information appears in the Address Information section.
   
   Address Information Section
10. Do one of the following to continue:
    
    
    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.

11. Complete the remaining Contact Information fields.If you provide an email address, you are not required to provide a phone number, and vice versa.

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

12. Click Save, then click Return to Person Details.

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

How to Manage Health Care Providers

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.

3. In the Assign Organizational Roles section toward the bottom of the Person Details page, click the HCP (Health Care Provider) tab.
   The HCP page displays the research roles currently assigned to the organization (if applicable).

   You can sort the records

   Click the column heading once to sort the records in ascending order.  An arrow head indicates whether the sort order is descending or ascending. Click the column heading again to reverse the sort order.

   
    
   Manage Health Care Provider(s) Page-Assign Roles
   

4. 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 .

5. To add a role, click Add Health Care Provider.
   The Create Health Care Provider page appears.
    
   Create Health Care Provider Page – Role Information 
   
6. Click Select Affiliated Organization.
   The Find Organization(s) page appears.
7. Search for and select the affiliated organization. For instructions on finding organizations, see Searching For Organization Records .
   The organization you selected is displayed in the Health Care Provider Role Information section.
8. From the Role Status drop-down list, select the curation status of the organization role. If you have supplied all the necessary information, select Active.
9. Optionally, in the Certificate/License Information field, enter the appropriate number.
10. In the Address Information section, click Add Postal Address, and follow the instructions in Entering Address Information .
    The information appears in the Address Information section.
    
    Address Information Section
11. Do one of the following to continue:
    
    
    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.

12. Complete the remaining Contact Information fields. If you provide an email address, you are not required to provide a phone number, and vice versa.

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

13. Click Save, then click Return to Person Details.

You must identify each organization, including each organizational contact, uniquely.

How to Manage Organizational Contacts

1. Navigate to the record of interest. 
2. In the Action column for a given organization, click Curate.

3. In the Assign Organization Roles section toward the bottom of the Organization Details page, click the Org Contact (Organizational Contact) tab.

   You can sort the records

   Click the column heading once to sort the records in ascending order.  An arrow head indicates whether the sort order is descending or ascending. Click the column heading again to reverse the sort order.

   
   The Org Contact page displays the research roles currently assigned to the organization (if applicable).
   
   Assign Organizational Roles - Organizational Contacts Tab

4. Follow one of the options in the table below to continue assigning roles:
   Options for assigning roles to an organization

   If there are...	And...	Do this
   No organizational contact records displayed	You want to add a role	Proceed to the next step.
   One or more organizational contact records displayed	The information for them is correct	Proceed with other aspects of the organization curation.
   One or more organizational contact records displayed	The information for them is incorrect	In the Action column for the record you want to modify, click Edit, and proceed to the table below.

5. To add a role, click Add Organizational Contact.
   The Create Organizational Contact page appears.
   
   Create Organizational Contact Page – Upper Sections

6. 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.

   Field Label	Description/Instructions
   Title*	Type the title of the contact role.
   Role Status*	If the associated contact has not been curated (i.e., it is pending), select Pending. Otherwise, select Active.
   Contact Type*	Select the appropriate contact type. Valid values are as follows: IRB Responsible Party Site

7. In the Address Information section, click Add Postal Address, and follow the instructions in Entering Address Information .
8. Click Save.
   The information appears in the Address Information section on the Create Organizational Contact page.
   
   Create Organizational Contact – Address Information Section
9. Do one of the following to continue:
   
   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.

10. Complete the remaining Contact Information fields.

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

11. Click Save, then click Return to Organization Details.

You must identify each person in the P/O Curation Portal uniquely in any given role.

How to Manage Identified Persons

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.

3. In the Assign Organizational Roles section toward the bottom of the Person Details page, click the OPI (Other Person Identifiers) tab.
   The OPI page displays the research roles currently assigned to the organization (if applicable).

   You can sort the records

   Click the column heading once to sort the records in ascending order.  An arrow head indicates whether the sort order is descending or ascending. Click the column heading again to reverse the sort order.

   
   
   

4. 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 person identifier role records displayed	You want to add a role	Proceed to the next step.
   One or more person identifier role records displayed	The information for them is correct	Proceed with other aspects of the person curation.
   One or more person identifier 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.

5. To add a role, click Add Other Person Identifier.
   The Create Other Person Identifier page appears.
   
   Create Other Person Identifier Page – Role Information
   
6. Click Select Affiliated Organization.
   The Find Organization(s) page appears.
7. Search for and select the affiliated organization. For instructions on finding organizations, see Searching For Organization Records .
   The organization you selected is displayed in the Other Person Identifier Role Information section.
8. From the Role Status drop-down list, select the curation status of the organization role. If you have supplied all the necessary information, select Active.
   The organization you selected is displayed in the Identified Organization Role Information section.
9. If appropriate, change the Role Status to Active.

10. Complete the rest of the Assigned ISO II (International Organization for Standardization Instance Identifier) fields to create a unique identifier for the affiliated organization in its current role. 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.

    Field Label	Description/Instructions
    Displayable	Indicate whether the identifier is intended for human display and data entry. Select TRUE to indicate that it is displayable; and FALSE if it is not.
    Extension*	Type the identifier that, when joined with the root, identifies the organization/role as a unique object.
    Identifier Name	Type the human-readable, descriptive name for the namespace represented in the root.
    Reliability	Optionally, specify the reliability with which this identifier is known. The HL7 Identifier Scope code values are as follows: ISS (issued by system). The identifier was issued by the system responsible for constructing the instance. VRF (verified by system). The identifier was not issued by the system responsible for constructing the instance,but the system that captured the ID has verified the identifier with the issuing authority, or with another system that has verified the identifier. UNV (unverified by system). The identifier was provided to the system that constructed the instance, but has not been verified. (e.g., a value entered manually into a system by a user.
    Root*	Type the name of the parent organization that guarantees its global uniqueness.
    Scope	Optionally, specify the scope code. Valid HL7 Identifier Scope code values are as follows: BUSN (business identifier). An identifier whose scope is defined by business practices associated with the object. In contrast to the other scope identifiers, the scope of the use of the ID is not necessarily restricted to a single object, but may be reused for other objects closely associated with the object due to business practice. OBJ (object identifier). The identifier associated with a particular object. It remains consistent as the object undergoes state transitions. VER (version identifier). An identifier that references a particular object as it existed at a given point in time. The identifier SHALL change with each state transition on the object. That is, the version identifier of an object prior to a “suspend” state transition is distinct from the identifier of the object after the state transition. Each version identifier can be tied to exactly one Control Act event which brought that version into being (though the control act may never be instantiated). Applications that do not support versioning of objects must ignore and not persist these IDs to avoid confusion resulting from leaving the same identifier on an object that undergoes changes. VW (view specific identifier). An identifier for a particular snapshot of a version of the object. This identifies a view of the business object at a particular point in time, and as such identifies a set of data items that can be digitally signed and/or attested. This is in contrast to the Version Identifier which identifies the object at a specific time, but not the amount of information being asserted about the object. This identifier would be changed when a transformation of the information is performed (e.g., to add code translations, to provide a simplified textual rendering, or to provide additional information about the object as it existed at the specific point in time).

11. Click Save, then click Return to Person Details.

The curation status you select for a record affects the way in which the CTRP displays and stores it, as follows:

• Nullified – Record is a duplicate of another trial. Record remains in the CTRP database, but is no longer displayed. If you nullify a record, you must select a duplicate (i.e., the record you want to keep),to replace it. For complete instructions, see Resolving Duplicate Records.

  You can not nullify an organization that has been assigned a structural role owned by CTEP-ECM (Cancer Therapy Evaluation Program-Enterprise Core Model).

• Active – Record is accurate and complete. Record is displayed in the Inbox.

  If the P/O Curation Portal receives a request for a change in the record, it displays the record in the Inbox marked as “Change Request.”

• Inactive – Record is no longer valid. Or, an entity role or relationship is no longer valid.
• Pending – Record is inaccurate or incomplete; or, CTEP has updated the role and the CTRO has not yet reviewed the record or changed the status to "Active" or "Nullified". Record remains in the CTRP database, and is displayed in the Inbox unless it is nullified.

How to Change the Curation Status

1. In the Basic Identifying Information section, select the current status from the New Status drop-down list.
   
   Basic Identifying Information section – Status Selection  
2. Scroll to the bottom of the page and click Save.

The CTRP system retains all records, even after you have deleted them. However, the system does not display deleted records. They remain in a Nullified state, and are not available for curation.

How to Delete a Person Record

1. Navigate to the record you want to delete. See Navigating Records in Tables or Searching for Person Records .
2. In the Action column for a given person, click Curate.
   The Person Details page displays all details about the person provided to date.
   
   Person Details Page – New Status List
3. From the New Status drop-down list, select NULLIFY.
4. At the bottom of the page, click Save.

You can import existing person records from CTEP to the P/O Curation Portal rather than entering them into the system manually. The P/O Curation Portal system populates its records with the CTEP data based on the CTEP IDs you provide. Persons imported from CTEP are designated "Pending" until they have been curated. When the curator changes the status of the organization to "Active", the system changes any associated research organizations or health care facilities that have CTEP IDs to "Active" automatically.

How to Import CTEP Person Records

1. On the main menu, in the Person section, click CTEP Import.
   The CTEP Person Import page appears.
   
   CTEP Person Import Page
2. Do one of the following to import the data:
   
   • To import multiple records simultaneously, under File, click Browse, and navigate to the file containing the IDs you want to upload. The file must be in the form of a text document, with each of the CTEP IDs listed individually on one line.
     - or -
   • To import individual records, in the CTEP ID field, enter the CTEP ID of the organization record you want to import. This function enables you to import new organizations as they are added in CTEP rather than having to import an entire batch of records that you may have imported previously.
3. Click Upload.

The P/O Curation Portal displays person records in the Inbox that are available for curation. You can search for a particular person in the list by sorting records (see Navigating Records in Tables , or, to search for a particular person in the CTRP system, you can query the database using a number of predefined search criteria.

How to Search for a Person

1. On the main menu, under Person, click Search.
   The Find Person(s) page appears.
   
   Find Person(s) Page

2. Provide as much information as you can about the person. You are required to provide at least one search criterion.
   The following table describes the available search criteria other than name and email address.
   Organization search criteria

   Search Criteria	Description
   Organization Affiliation	Enter part of the organization’s name, or, to narrow your search, type the entire name.
   CTEP Person Identifier	Enter the Cancer Therapy Evaluation Program's identification number.
   PO ID	Enter the number that NCI assigned to the person.
   Status	Select the current curation status. For status descriptions, see Changing the Curation Status .
   Address Information	Enter or select information in the address fields.
   Has Pending CRS Role(s)	Select this check box to limit your search to person records that have Clinical Research Staff roles pending curation.
   Has Pending HCP Role(s)	Select this check box to limit your search to person records that have Health Care Provider roles pending curation.
   Has Pending OC Role(s)	Select this check box to limit your search to person records that have Organizational Contact roles pending curation.
   Has Pending OP Role(s)	Select this check box to limit your search to person records that have Other Person Identifier roles pending curation.

   If you select two or more pending role check boxes, search results include only those person records that contain all selected pending role criteria. For example, if you select the Has Pending CRS Role(s) and Has Pending HCP Role(s) check boxes, the results include only those person records that have both pending CSR roles and pending HCP roles.

3. Click Search.
   The results of your search are displayed in a table below the search criteria fields. 

   You can sort the records

   Click the column heading once to sort the records in ascending order.  An arrow head indicates whether the sort order is descending or ascending. Click the column heading again to reverse the sort order.

   
   
   Search Person – Search Results

   Search tip

   If the person you were looking for is not listed, you may have searched too narrowly (that is, you may have provided too much information about the person). If the list of results is very long and contains many persons that are similar to yours, you can narrow your search by providing more information. If you still don’t find your person in the CTRP system, you can register it as a new one. For instructions, see  Creating New Person Records.