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

• Records that have the curation status "Active" with roles pending or change requests
• 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 (see Navigating Records in Tables ), or search for a particular record (see Searching for Organization Records ).

How to Curate Organization Records

1. On the main menu, under Organization, click Inbox.
   All organization records (except those that have been nullified) that require curation are displayed. The number of changes, if any, that have been requested for each record is displayed in the Change Request(s) column. You can access and curate pending roles associated with each organization record.
    
   
2. In the Action Column, click Curate.
   The Organization Details page displays all information about the organization provided to date.

3. To ensure that there are no duplicate, or near-duplicate records in the system, search the CTRP database for the organization name. See Resolving Duplicate Records .
   Review the data on the Organization Detail page, and then continue with one or more of the appropriate options in the table below.
   Options for curating organization details

   If the data is...	Do this	Result
   Correct and complete	Change the curation status to Active. See Modifying Organization Details .	The system saves the record. Click Inbox again and navigate to the next record. 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. See Resolving Duplicate Records and Deleting (Nullifying) Organization Records . Modifying Organization Details Managing Research Organizations Managing Identified Organizations Managing Oversight Committees Managing Health Care Facilities Managing Families	The system marks the record as Nullified and returns you to the Inbox. Because you nullified the record, it no longer appears in the Inbox. Although the system has removed the record 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 system saves the record as Pending and returns you to the Inbox. The record retains its Pending status. 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 Organization Details Managing Research Organizations Managing Identified Organizations Managing Oversight Committees Managing Health Care Facilities Managing Families	The system saves the record as Active and returns you to the Inbox. You are now ready to curate the next record.

There are three main areas of organization detail information: basic identifying information, address information, and contact information.

How to Modify Organization Details

1. Navigate to the record of interest.
2. In the Action column for a given organization, click Curate.
   The Organization Details page displays all information about the organization provided to date.
      

3. If you are not the record owner, click Override.
     

4. 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. If you need to change the curation status, see Changing the Curation Status before you continue to the next step.

   Status*	Select the current curation status. For status descriptions, see Changing the Curation Status . At this level, you can change the curation status for organizations with CTEP IDs. However, it would be better to perform a CTEP Import instead. (At the role level, you can not change the curation status for organizations with CTEP IDs.)
   Organization Name*	Enter the official name of the organization. The following organization names must remain as they are. Do not attempt to change these organization names, because these organizations act as Identifier Assigners on trials, so the system refers to them by their exact names: Org ID Organization Name 16108126 NCI - Center for Cancer Research 502 Cancer Therapy Evaluation Program 3830539 ClinicalTrials.gov 66707 National Cancer Institute Division of Cancer Prevention 154376 National Cancer Institute
   Aliases	Enter alternate names for the organization. Click Add after you enter each alternate name.
   Address Information* section	Provide as much information about the organization as possible. All fields, except Address Line 2, are required. If the organization 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 organization as possible. You are required to provide the organization contact’s full email address or phone number.
   Comments	Enter any information that you want associated with the organization record. See Adding and Viewing Comments for detailed instructions.

5. Click Save. 

How to Change the Curation Status

1. In the Basic Identifying Information section, select the current status from the New Status drop-down list.
     

   When you nullify an organization, the system ends all active family organization relationships as well.

2. Scroll to the bottom of the page and click Save.

Because clinical trials can involve a network of persons and organizations, one of the key functions of a curator is to identify the interrelationships among them. You can identify each organization by the role(s) it plays in support of various clinical research activities.

There are two main types of roles, as follows:

• Structural role– Permanent role of an organization as defined by another organization. Specifies capability and competency. Predefined structural roles are as follows:

  • Research organizations

  • Health care facilities

    Structural roles do not have to be scoped by another organization.

• Functional role – Temporary role based on activities that an organization participates in. Predefined functional roles are as follows:
  • Identified organizations
  • Oversight committees
  • Organizational contacts
  • Families

How to Assign Roles

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

The Assign Organization Roles section toward the bottom of the Organization Details page displays tabbed pages for each of the role types. Each page displays the roles currently assigned to the organization (if applicable).

Proceed to the instructions provided for each role type in the following sections:

• Managing Research Organizations
• Managing Identified Organizations
• Managing Oversight Committees
• Managing Health Care Facilities
• Managing Families

You must identify each organization uniquely and assign it a research role.

How to Manage Research Organizations

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 RO (Research Organization(s) tab.
   The RO 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 an organization

   If there are...	And...	Do this
   No research organization role records displayed	You want to add a role	Proceed to the next step.
   One or more organization role records displayed	The information for them is correct	Proceed with other aspects of the organization curation.
   One or more organization 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 the table below.

5. To add a role, click Add Research Organization.
   The Create Research Organization page appears.
   

6. Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table.

   Field Label	Description/Instructions
   Research Organization Name	Enter the organization’s name.
   Research Organization Type	Select the type of role to assign. Depending on the type you select, you may be required to provide funding information.
   Role Status	Select the curation status of the organization in its current role.
   Aliases	Enter alternate names for the organization. Click Add after you enter each alternate name.

   It is not possible to create or update a Research Organization to the ACTIVE state.

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 Research Organization page.
    
9. Do one of the following to continue:
   
   • To change the information in the address section, click Edit.
     - or -
   • To delete the address information, click Remove.
     - or -
   • 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.

An identifier allows someone to select one record, object, or thing from a set of candidates. Each organization in the P/O Curation Portal is identified uniquely. Additionally, each affiliated organization is identified in the context of its role.

How to Manage Identified Organizations

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 at the bottom of the Organization Details page, click the Identified Org (Identified Organization) tab.
   The Identified Organization Information 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 an organization

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

5. To add a role, click Add Identified Organization.
   The Create Identified Organization page appears.
   
   Create Identified Organization Page
   
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 Identified Organization Role Information section.
8. If appropriate, change the Role Status to Active.

9. 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 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).

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

Each organization in the P/O Curation system, including each oversight committee, must be identified uniquely.

How to Manage Oversight Committees

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

3. In the Assign Organizational Roles section at the bottom of the Organization Details page, click the Oversight Committee tab.
   The Oversight Committee 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 Oversight Committee Information Page

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 oversight committee role records displayed	You want to add a role	Proceed to the next step.
   One or more oversight committee role records displayed	The information for them is correct	Proceed with other aspects of the organization curation.
   One or more oversight committee 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 Oversight Committee Type.

5. To add a role, click Add Oversight Committee.
   The Create Oversight Committee page appears.
   
   Create Oversight Committee Page
   
6. From the Oversight Committee Type drop-down list, select the appropriate committee type. Valid values are as follows:
   
   • IRB (Institutional Review Board)
   • Ethics Committee
   • Research Ethics Board
7. If appropriate, change the Role Status to Active.
8. In the Address Information section, click Add Postal Address, and follow the instructions in Entering Address Information .
9. Click Save.
   The information appears in the Address Information section on the Create Oversight Committee page.
   
   Oversight Committee– 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.

    
    Remember to click Add after you complete each of the contact information fields.
12. Click Save, then click Return to Organization Details.

You must identify each organization, including each health care facility, uniquely.

How to Manage Health Care Facilities

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 Health Care Facility tab. This is the default tab.
   The Manage Health Care Facility 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 an organization

   If there are...	And...	Do this
   No health care facility role records displayed	You want to add a role	Proceed to the next step.
   One or more health care facility role records displayed	The information for them is correct	Proceed with other aspects of the organization curation.
   One or more health care facility 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 Editing Health Care Facility Records.

5. To add a role, click Add Health Care Facility.
   The Create Health care Facility page appears.
     
   
6. In the Health Care Facility Name field, type the name of the organization operating in the role of health care facility.

7. Optionally in the Alias field, e nter alternate names for the organization. Click Add after you enter each alternate name.
   

8. In the Address Information section, click Add Postal Address, and follow the instructions in  Entering Address Information .

   You cannot create or update a Healthcare Facility role status to ACTIVE.
   

   The information appears in the Address Information section on the Create Health Care Facility page.
   

9. Do one of the following to continue:
   
   • To change the information in the address section, click Edit.
     - or -
   • To delete the address information, click Remove.
     - or -
   • To add another address, click Add Postal Address.

10. Complete the remaining Contact Information.

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

11. Click Save, then click Return to Organization Details.
    The system assigns the health care facility a unique ID.

How to Edit Health Care Facility Records

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 Health Care Facility tab. This is the default tab.
   The Manage Health Care Facility page displays the research roles currently assigned to the organization (if applicable). 

   

4. Click Edit.
   The Edit Health Care Facility page appears.
   

5. If you are not the record owner, click Override.
   The Edit Health Care Facility page appears.
   
   

6. In the Health Care Facility Name field, edit the name of the organization operating in the role of health care facility.

7. Optionally in the Alias field, enter or edit alternate names for the organization. Click Add after you enter each alternate name.

   You can not update a Healthcare Facility role status to ACTIVE.
   

   
   

8. 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 on the Edit Health Care Facility page.

9. Complete the remaining Contact Information fields.

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

10. Click Save.

Users of applications that interface with the P/O Curation Portal, for example, Protocol Abstraction, can add, or request changes to, records in the system. New records appear in the Inbox with the status "Pending". Requests for changes to existing records that have been curated previously are also displayed in the Inbox, identified in the Status column by Change Request (n) where n is the number of requests.

How to Curate Records with Change Requests

1. On the main menu, click Inbox and locate the record with the Change Request indicator displayed in the Status column. Or, search for the organization if you know which record requires one or more changes. See Navigating Records in Tables or Searching for Organization Records .

2. In the Action column, click Curate.

   Screen layout

   Depending on your screen size and orientation, the system might display the two records side-by-side. In this case, the original record appears on the left side of the page, and requested changes appear on the right. Otherwise, the system might display the change request information below the original record.

   

3.  If you are not the record owner, click Override.  

   If more than one change has been requested, select a request from the Change Request Information drop-down list at the top right corner of the requested change record.
   Green asterisks next to data elements indicate changed values. 

     It is possible, though rare, for a change request to include values that are identical to the record you are curating. This can occur because of the differences in data between the time you curate a record and when PO fetches data from ECM.

   
      

4. Compare the information in each section of the original record with the corresponding section in the change request, and then do one of the following to modify the original record:
   
   • To modify the information manually, enter the new information exactly as it appears in the change request.
     - or -

   • To modify the information automatically, beside each detail for which there is a change, click Copy.
     The requested change is copied to the original record.

     You must enter aliases manually. Because Change Requests do not contain alias information, copying organization names from a change request record does not automatically modify the alias list.

     - or -

   • To delete a duplicate change request value, click Remove.
     The duplicate change request is deleted.
5. Complete any missing information in the updated record, and then 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. When you nullify an organization, you must select a duplicate organization.

How to Delete an Organization Record

1. Navigate to the record of interest. See Searching for Organization Records .
   In the Action column for a given organization, click Curate.
   The Organization Details page displays all details about the organization provided to date. 
    
   
2. If you are not the record owner, click Override.
3. From the New Status drop-down list, select NULLIFIED.
4. Follow the instructions in Resolving Duplicate Records to select a duplicate record.
5. At the bottom of the page, click Save.

An organization may belong to one or more families. Refer to Family and Organization Relationships.

How to Manage Families

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 Manage Family(s).
   The Manage Family(s) page displays the family(s) to which the organization currently belongs (if applicable).
   
   Manage Family(s) Page

4. Follow one of the options in the table below to continue assigning roles:

   If there are...	And...	Do this
   No research family records displayed	You want to add a family	Above the Action column, click Add, and follow the instructions in Adding Organizations to Families .
   One or more family records displayed	The information for them is correct	Click Return to Organization Details, and continue with the curation.
   One or more family records displayed	The family membership is not valid	In the Action column for the record you want to modify, click Remove.
   One or more organization role records displayed	The information for them is incorrect	In the Action column for the record you want to modify, click Edit, and follow the appropriate steps in Changing Functional and Hierarchical Relationships .

5. Click Save, and then click Return to Families.
   The organization is added to the family.

You can import existing organization 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. Organizations imported from CTEP are designated "Pending" until they have been curated. When you change the status of the organization to "Active", the system changes any associated research organizations or health care facilities that have CTEP IDs to the same status (i.e., "Active") automatically.

How to Import CTEP Organization Records

1. On the main menu, in the Organization section, click CTEP Import.
   The CTEP Organization Import page appears.
   
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, type 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 system maintains both CTEP and P/O Curation Portal IDs with each organization record imported.

How to Search for Organization Records

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

2. Provide as much information as you can about the organization. You are required to provide at least one search criterion.
   The following table describes the available search criteria.
   Organization search criteria

   Search Criteria	Description
   CTEP ID	Enter the Cancer Therapy Evaluation Program's identification number. The system searches for CTEP IDs associated with the organization's Research Organizations and/or Health Care Facilities and Identified Organization roles.
   Organization ID	Enter the number that NCI assigned to the organization.
   Status	Select the current curation status. For status descriptions, see Changing the Curation Status.
   Organization Name	Enter part of the organization’s name, or, to narrow your search, enter the entire name.
   Search Aliases	Clear this  check box if you want to exclude alternate names for the organization from the search criteria.
   Family Name	Enter part of the name of the family that the organization belongs to, or, to narrow your search, enter the entire name.
   Has Change Requests	Select this check box to limit your search to organization records that have change requests.
   Has Pending HCF Roles	Select this check box to limit your search to organization records that have Health Care Facility roles pending curation.
   Has Pending RO Roles	Select this check box to limit your search to organization records that have Research Organization roles pending curation.
   Address Information	Enter or select information in the address fields. You can select a State from a drop-down list if you select United States from the Country list first.

   If you select both pending role check boxes, search results include only those organization records that contain both pending HCF roles and pending RO 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 Tip

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

To ensure that there are no duplicate, or near-duplicate records in the system, search the CTRP database for the organization name before you create a new organization record or begin to curate an existing one. This is especially true for organizations with similar names. For example, organizations that are members of the same family may contain part of the family name.

If you find a duplicate record in the system, nullify the one you are currently curating. When you select the duplicate, the system merges the roles from the nullified organization to the duplicate one (the record
already in the system) automatically.

If the system detects conflicts when merging the roles of the nullified organization, it will nullify the conflicting information associated with the nullified organization and copy over any contact information to the role of the duplicate organization.

How to Search For Duplicate Records

1. Navigate to the record of interest. See Searching For Organization Records  .

2. In the Action column for a given organization, click Curate.
   The Organization Details page displays all details about the organization provided to date. 
   

3. If you are not the record owner, click Override.

4. From the New Status drop-down list, select NULLIFIED. See Changing the Curation Status .
   The Basic Identifying Information section expands to display a new Select Duplicate button.
   

5. To select the duplicate record (i.e., the record you want to keep), next to Duplicate Of ORG ID, click Select Duplicate.
   The Find Organization(s) page appears.
       
    
    

6. Provide as much information about the organization as you can, and then click Search. You must use at least one search criterion.
   The search results represent the organizations that you can select as a duplicate of the record you are curating.

   Do not select as a duplicate the same organization that you are currently curating. Doing so will nullify the organization.

   

7. To select the record that you want to replace the one you are currently nullifying, in the Action column, click Select. If the search results do not return a duplicate, click Back to Search Form and search for the organization using different criteria.
   The ORG-ID (organization identifier) of the duplicate you selected is displayed in the Basic Identifying Information section on the Organization Details page.
         

   The organization name and aliases will be merged into the Duplicate of the Organization.

8. Optionally, at the bottom of the Organization Details page, enter any comments you may have in the Comments text field.
9. Click Save. Or, to return to the organization without nullifying it, click Reset.
   Although the record you were curating is essentially removed from view, the CTRP stores the record with a status “nullified.” The status of the duplicate record you selected does not change.