Page History

The Responsible Party can be either a sponsor or a principal investigator (PI). The term "responsible party" is either of the following:

• Sponsor of the clinical trial (as defined in 21 CFR 50.3 or successor regulation)
  - or -
• Principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements for the submission of clinical trial information.

If the Responsible Party is the Principal Investigator, this section expands to display the investigator's title and organization affiliation. The investigator's name is generated from the name you selected as Principal Investigator in the Lead Organization/Principal Investigator section.

If the Responsible Party is the Sponsor-Investigator, this section expands to display the investigator's name and title. The investigator's name is generated from the name you selected as Principal Investigator in the Lead Organization/Principal Investigator section. However, you can change the investigator's name in this case.

How to Complete the Sponsor/Responsible Party Section

In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

Instructions for recording Sponsors/Responsible Parties

How to Complete the Central Contacts Section

In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. All central contact information is optional.

You can associate, or link, collaborating organizations with the trial you are abstracting. Collaborator information is included in the Protocol document or in the uploaded Participating Sites document. It is optional for Abbreviated trials.

To delete a previously linked collaborator, see Deleting Collaborators From a Trial.

Linking Collaborators to a Trial

How to Link Collaborators to a Trial

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Administrative Data menu, click Collaborators.
   The Collaborators page appears. NCI is added as a collaborator automatically.
   
   
3. Click Add.
   The Collaborator page displays the fields for the organization data.
   
   
4. Next to the Organization Name field, click Look Up and follow the instructions in Searching for Organizations .
   The City, Country, and Zip/Postal Codes fields are populated with the organization information you selected.

5. From the Functional Role drop-down list, select the collaborator’s role in the trial. The following table lists functional role values.
   Valid values for functional roles

   Functional Role	Definition
   Funding Source	Source of the funding mechanism
   Agent Source	Source of drugs used in the trial
   Laboratory	Clinical research workplace

6. Click Save.
   The collaborator is linked to the trial.

Deleting Collaborators From a Trial

If a collaborator currently linked to the trial you are abstracting is incorrect, you can delete it from the trial.

How to Delete a Collaborator From a Trial

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Administrative Data menu, click Collaborators. The Collaborators page appears.
3. To disassociate the collaborator from the trial, click the Delete icon, and then confirm the action in the pop-up window.

Editing Collaborator Roles

If the role of a collaborator currently linked to the trial you are abstracting is incorrect, you can change the functional role.

How to Edit Collaborator Roles

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Administrative Data menu, click Collaborators. The Collaborators page appears.
3. To change the collaborator’s role in the trial, click the Edit icon. The Collaborator page displays the current collaborator organization name, and current functional role.
   
4. From the Functional Role drop-down list, select the appropriate role.
5. Click Save.

The information you are required to provide depends on the Board approval status and other indicators, as noted in the instructions that follow. Human subject safety information is optional for Abbreviated trials.

Some fields in this section are optional, and some may be required only when you have selected certain attributes in preceding fields. For example, if the Board Approval Status is "Submitted, exempt", the Board Name, Board Affiliation, and Board Contact fields are mandatory, but the Board Approval Number is optional.

The following table provides a matrix of field requirement dependencies.

Matrix of field requirements

How to Abstract Human Subject Safety Information

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Administrative Data menu, under Regulatory Information, click Human Subject Safety. The Human Subject Safety Information section appears.
   

   Include Page
   Display Organization and Person Details - Include v4.4 Display Organization and Person Details - Include v4.4

   
   
3. In the Board Approval Status field, select the current state of the trial with respect to Investigational Review Board (IRB) approval. Status definitions are as follows:

   • Submitted, Approved - IRB approval has been requested and obtained 

   • Submitted, Exempt - IRB has granted an exemption in response to the approval request

   • Submission Not Required - Study does not require human subjects review

   • Submitted, Pending - Study is pending IRB review

   • Submitted, Denied - IRB has denied approval for the study

4. If you selected anything other than Submission Not Required, continue with the next fields. Otherwise you are finished with human subject safety abstraction.

   Note
   The Board Approval Status must correlate with the current Trial Status as follows: If the current Trial Status is In Review, the Board Approval Status must be Submitted, Pending. If the current Trial Status is Withdrawn, the Board Approval Status must be Submitted, Denied. For other rules regarding Board Approval Status, see Trial Completion Criteria.

   In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field for Complete trials.

   Field Label	Description/Instructions
   Board Approval Number*	If the trial has been submitted and approved, type the number assigned to the protocol by the human subjects review board in the field. If the number does not appear in the IRB approval document, enter the date.
   Board Name*	Click Look Up to search for and select the Board name. If the name is not listed, register it with the CTRO. See Searching for Organizations . When you select the Board name, the contact information is displayed automatically in the fields provided. If you registered a new organization with the CTRO in the previous step, the system will notify you when the record is added so that you may continue your abstraction. If applicable, complete any of the contact fields that are missing information.
   Board Affiliation	If the status is other than Submission Not Required, enter the name of the affiliated organization.

5. To save the details you have abstracted, click Save.

NCI-Specific Information applies to Complete and Abbreviated trials. For Abbreviated trials, indicate whether or not the trial is Industrial.

Included in this section is the option, for certain trials, to include them in, or exclude them from, the batch of trials that CTRP sends to ClinicalTrials.gov via FTP nightly.

How to Abstract NCI-Specific Information

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.

2. On the Administrative Data menu, click NCI Specific Information. The NCI Specific Information page appears. It displays different fields according to the trial's Data Table 4 category (study source) and the criteria described in the matrix in Conditions for Sending Trial Information to ClinicalTrials.gov. 
   

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   Display Organization and Person Details - Include v4.4 Display Organization and Person Details - Include v4.4

   
   

    

   The following factors determine which fields appear on this dialog box:

   • If the lead organization for the trial belongs to an organization family, the Program Code field is available. The Program Code field lists all program codes available for that organization family.
   • CTRP does not send Abbreviated trials in the batch files, and therefore does not display the option to indicate whether to send the trial.
   • For a Complete trial that has been sent to ClinicalTrials.gov in the batch files previously, CTRP does not display the option to indicate whether to send the trial in the future.
   • For a Complete, NCI-sponsored trial, CTRP displays the option to indicate whether to send the trial in the future and the Comments field. The default setting for this option depends on whether the trial has been sent to ClinicalTrials.gov previously:
     
     • For an original submission (which therefore has not been sent to ClinicalTrials.gov previously), the option to indicate whether to send the trial defaults to Yes, but CTRP displays the option to exclude the trial in the future.
     • For a trial that may have been updated and that had not been sent to ClinicalTrials.gov when submitted originally, it defaults to No, but CTRP displays the option to send the trial in the future.

3. In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

   Field Label	Description/Instructions
   Reporting Data Set Method*	Specifies how CDUS accruals are submitted to CTEP. Select one of the following methods used for the principal investigator summary report:  Abbreviated - Requires minimal subset of data for reporting (for example, demographics) Complete - Larger set of data (for example, includes outcomes) AE (Adverse Events). Adverse events statistics are reported Info This field does not reflect the trial category, even though it uses similar terminology.
   Data Table 4 Funding Category	Select one of the following types of external sponsor or funding source (study source) based on the role/responsibility/participation in the study: Include Page Trial Categories - Include v4.4 Trial Categories - Include v4.4 Refer to http://cancercenters.cancer.gov/GrantsFunding/DataGuide#dt4 and http://cancercenters.cancer.gov/GrantsFunding/eData#dt4 for further information.
   Data Table 4 Funding Sponsor/Source	To add a sponsor, click Add Sponsor and search for the name of the external sponsor or funding source as defined by the Data Table 4 report. (See Searching for Organizations .) Info A trial can have multiple sponsors. The system ensures that you don't duplicate an existing sponsor. Anchor 5424 5424 Anchor 7098 7098 To delete an existing sponsor, click Delete Sponsor. You can not "undo" the deletion but you can add the sponsor back if necessary. Refer to http://cancercenters.cancer.gov/GrantsFunding/DataGuide#dt4 and http://cancercenters.cancer.gov/GrantsFunding/eData#dt4 for further information about specific Funding Sponsors.
   Industrial?	For Abbreviated trials, indicate whether the trial is an Industrial trial, or other category, according to the matrix in Industrial? Values. Anchor PO-5365 PO-5365 Because most Abbreviated trials are Industrial, the default value during trial registration is "YES". For Consortia trials, select one of the other values.
   Program Code	The Program Code field lists all program codes available for the organization family of the lead organization. Select one or more program codes. The program codes are generally entered by the trial submitter. To view or modify a different family's program codes, refer to the Registration Site Administration chapter of the Registration User's Guide.
   Send Trial Information to ClinicalTrials.gov?	For Complete trials, select one of the following to indicate whether to send the trial information to ClinicalTrials.gov in the automated nightly batch updates (via FTP): Yes. Trial will be sent. No. Trial will not be sent. Anchor 8120 8120 Info If you select Yes, the CTRP system sends the information to ClinicalTrials.gov. If PRS indicates to the CTRP system that it processed the trial successfully, the CTRP system does not display this option in the future for this trial. For further information about this field, see Conditions for Sending Trial Information to ClinicalTrials.gov.
   Comments	Enter a comment about your selection.

4. Optionally, to view the details of the Data Table 4 Funding Sponsor/Source (if already recorded), click the Details icon ().
5. To save the details you have abstracted, click Save.

Industrial? Values

For Abbreviated trials, indicate whether the trial is an Industrial trial or other category, according to the Data Table 4 Category values below. The Consortia Trial Indicator is internal to the CTRP system.

Conditions for Sending Trial Information to ClinicalTrials.gov

Following are the inclusion criteria the system uses to determine the set of CTRP trials to send to ClinicalTrials.gov:

1. The trial is NCI Sponsored. Trials are funded under an N01/N02 contract or have an IND held by CTEP, where NCI is listed as the sponsor.
   AND

2. Has been fully abstracted.
   AND
3. The Send Trial Information to ClinicalTrials.gov field is set to Yes. 

The System will exclude from sending all trials that meet one or more of the following criteria:

1. Observational trials.
   OR
2. Industrial trials.
   OR
3. Trials with the Send Trial Information to ClinicalTrials.gov field set to No.
   OR
4. CCR trials.

Trials are conducted in participating sites. You must provide information about the site itself (organization), the investigator(s), and primary contacts (if a central contact is not provided). Optionally, you can include contact information for a person’s title (functional role) rather than a person’s name. When you add a participating site to a trial, link (associate) an organization, site, investigator(s), and primary site contact information to it.

Information about participating sites can be included in the protocol document or in the Participating Sites document.

How to Abstract Participating Site Information 

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.

2. On the Administrative Data menu, click Participating Sites. The Participating Sites page appears.

3. Click Add.

   Anchor
   particpatingsites particpatingsites

   The Participating Sites page displays three tabbed sections: Participating Site, Investigators, and Contact. The Participating Sites tab is displayed by default. 

   Section
   Column width 45% Add/Edit Participating Site- Complete Trial Column width 45% Add/Edit Participating Site - Abbreviated Trial

   Note
   You must abstract the Participating Site information in the order indicated by the tabbed pages.

4. In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

   Field Label	For Complete Trials (C) For Abbreviated Trials (A)	Description/Instructions
   Organization Name*	C, A	Click Look Up and follow the instructions in Searching for Organizations . For Complete trials, the City, State, Country, and Zip/Postal Codes fields are populated with the organization information you selected.
   Local Trial Identifier*	C, A	Enter the site trial identifier.
   Site Recruitment Status*	C, A	Optionally, to view the trial’s recruitment status history, click History.   Select the status from the drop-down list. Valid ClinicalTrials.gov recruitment values are provided in Site Recruitment Status Definitions. Note The system validates all status transitions when you save a trial status record. If you add or update a status transition that does not conform to the rules provided in Trial Status Transitions, the system displays errors and/or warnings. Warnings indicate that fixing the status record is optional; you do not have to resolve the transitions. However, Errors indicate that you must resolve the transitions by correcting trial status records in the  Participating Sites Status History window. You can not check in the trial until you correct all status transition errors. Anchor 8518b 8518b For a comprehensive matrix of valid transitions, see Trial and Participating Sites Status Transition Rules. Anchor 8750 8750
   Site Recruitment Status Date*	C, A	Enter the date that the status was recorded. The date must be the current date or earlier.
   Site Recruitment Status Comments	C, A	Enter one or more comments about the site recruitment status.
   Target Accrual Number	C, A	If the lead organization or participating site is a member of a Cancer Center family of organizations, enter the accrual number.
   Date Opened for Accrual	A	If applicable, enter the date that the trial was opened for accrual. Note You must enter a date here if you also provide a Date Closed for Approval date.
   Date Closed for Accrual	A	If applicable, enter the date that the trial was closed for accrual. Note If you enter a date here you also must provide a Date Opened for Approval date. The Date Closed for Accrual can not be in the future.

5. Click Save.

6. Click the Investigators tab.

   The Investigators tab displays the trial investigators that may have been added during trial submission or abstraction.

   Section
   Column width 45% Investigators Tab for a Complete Trial Column width 45% Investigators Tab for an Abbreviated Trial

7. Click Add and search for the investigator’s name by following the instructions in Searching for Persons .
   
8. When you find the investigator in the search results list, assign the investigator role, either Principal Investigator or Sub Investigator, and then click Select.
   The person's record you selected appears on the Investigators tab.
   

9. If you want to indicate that an investigator is the primary contact, click the Set as Site Primary Contact icon next to this investigator's record.

   Note
   You will not be able to complete the abstraction if you do not indicate the primary contact.

10. Click the Contacts tab.
    The Participating Sites page displays the Contacts tab.

    Note

    You must link a Participating Site to the trial before abstracting the site PI and contact information. You can add a contact by providing a person’s name (i.e., someone who is associated with the trial itself), or you can add a generic contact (i.e., someone who is associated with the site but not necessarily the trial) by providing a person’s title (functional role). You can not provide both types of contacts in the same record.

    
    If you designated a primary investigator as the primary contact (on the Investigators tab), the investigator's name is displayed automatically on the Contact tab.
    

11. Next to the First Name field, click Look Up and search for the contact person’s name by following the instructions in Searching for Persons . The person’s name you selected appears in the Name fields on the Contact tab.

12. In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

    Field Label	Description/Instructions
    Phone Number Anchor 6044 6044	Enter the contact’s primary telephone number (as 123-456-7890), including an extension if provided. You must provide either the contact's phone number or email address. You can provide both if the information is available.
    Email Address	Type the contact’s primary email address. You must provide either the contact's phone number or email address. You can provide both if the information is available.
    Status	This field is populated by the system after you click Save.

13. Click Save.

Abstracting Participating Site Information for Complete Trials

How to Abstract Participating Site Information for Complete Trials

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Administrative Data menu, click Participating Sites. The Participating Sites page appears.

3. Click Add. The Participating Sites page displays three tabbed sections: Participating Site, Investigators, and Contact. The Participating Sites tab is displayed by default.

   

    

   Info
   title Enter information in the Participating Site page first
   You must abstract the Participating Site information in the order indicated by the tabbed pages.

4. On the Participating Sites tab, next to the Organization Name field, click Look Up and follow the instructions in Searching for Organizations .
   The City, State, Country, and Zip/Postal Codes fields are populated with the organization information you selected.
   In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

   Field Label	Description/Instructions
   Local Trial Identifier	Enter the site trial identifier.
   Site Recruitment Status*	Select the status from the drop-down list. See  Site Recruitment Status Definitions .
   Site Recruitment Status Date*	Enter the recruitment status date. The date must be the current date or earlier.
   Site Recruitment Status Comments	Enter one or more comments about the site recruitment status.
   Target Accrual Number	If the lead organization or participating site is a member of a Cancer Center family of organizations, type the accrual number.

5. Click Save.
   The organization is linked to the trial. The system sets the Status to "Pending" until verified during the curation process.
6. Click the Investigators tab.
   The Investigators tab displays the trial investigators that may have been added during trial submission or abstraction.
   
   
    
7. Click Add and search for the investigator’s name by following the instructions in Searching for Persons .
   When you find the investigator in the search results list, assign the investigator role, either Principal Investigator or Sub Investigator, and then click Select.
   The person's record you selected appears on the Investigators tab.

8. If you want to indicate that an investigator is the primary contact, click the Set as Site Primary Contact icon next to this investigator's record.

   Note
   You will not be able to complete the abstraction if you do not indicate the primary contact.

9. Click the Contacts tab.
   The Participating Sites page displays the Contacts tab.

   Note

   You must link a Participating Site to the trial before abstracting the site PI and contact information. You can add a contact by providing a person’s name (i.e., someone who is associated with the trial itself), or you can add a generic contact (i.e., someone who is associated with the site but not necessarily the trial) by providing a person’s title (functional role). You can not provide both types of contacts in the same record.

   
   If you designated a primary investigator as the primary contact (on the Investigators tab), the investigator's name is displayed automatically on the Contact tab.
   

10. Next to the First Name field, click Look Up and search for the contact person’s name by following the instructions in Searching for Persons . The person’s name you selected appears in the Name fields on the Contact tab.

11. In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

    Field Label	Description/Instructions
    Phone Number Anchor 6044 6044	Enter the contact’s primary telephone number (as 123-456-7890), including an extension if provided. You must provide either the contact's phone number or email address. You can provide both if the information is available.
    Email Address	Type the contact’s primary email address. You must provide either the contact's phone number or email address. You can provide both if the information is available.

12. Click Save.

Site Recruitment Status Definitions

Adding Generic Participating Site Contacts

How to Add a Generic Participating Site Contact

1. Next to the Generic Contact field, click Look Up Generic Contact.
   The Select Generic Contact window appears.
   

   Tip
   You can search for an existing generic contact. To do so, enter part or all of the generic contact's role, and then click Search.

2. Click Add Generic Contact.
   The Add Generic Contact window appears.
   

   Anchor
   5864 5864

   
   
3. Type the appropriate information in the Title, Email, and Phone fields, and then click Save.
   Your new record is displayed in the Select Generic Contact window.
4. In the Action column, click Select.
   The Participating Sites page displays the contact information you selected.
5. Click Save.

Abstracting Participating Site Information for Abbreviated Trials

How to Abstract Participating Site Information for Abbreviated Trials

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Administrative Data menu, click Participating Sites.
   The Participating Sites page appears.
   

   Anchor
   participatingsite participatingsite

   

3. Click Add. The Participating Sites page displays three tabbed sections: Participating Site, Investigators, and Contact. The Participating Sites tab is displayed by default.

   

4. In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

   Field Label	Description/Instructions
   Organization Name*	Click Look Up and follow the instructions in Searching for Organizations .
   Local Trial Identifier*	Enter the site trial identifier.
   Site Recruitment Status*	Optionally, to view the trial’s recruitment status history, click History. Select the status from the drop-down list. Valid ClinicalTrials.gov recruitment values are provided in Site Recruitment Status Definitions. Note The system validates all status transitions when you save a trial status record. If you add or update a status transition that does not conform to the rules provided in Trial Status Transitions, the system displays errors and/or warnings. Warnings indicate that fixing the status record is optional; you do not have to resolve the transitions. However, Errors indicate that you must resolve the transitions by correcting trial status records in the Participating Sites Status History window. You can not check in the trial until you correct all status transition errors. Anchor 8518c 8518c
   Site Recruitment Status Date	Enter the date that the status was recorded. The date must be the current date or earlier.
   Site Recruitment Status Comments	Enter one or more comments about the site recruitment status.
   Target Accrual Number	If the lead organization or participating site is a member of a Cancer Center family of organizations, enter the accrual number.
   Date Opened for Accrual	If applicable, enter the date that the trial was opened for accrual. Note You must enter a date here if you also provide a Date Closed for Approval date.
   Date Closed for Accrual	If applicable, enter the date that the trial was closed for accrual. Note If you enter a date here you also must provide a Date Opened for Approval date.

5. Click Save.

Editing and Deleting Participating Site Records

If a participating site record currently associated with the trial you are abstracting is incorrect, you can edit or delete the site.

How to Edit or Delete a Participating Site From a Trial

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Administrative Data menu, click Participating Sites.
   The Participating Sites page appears.

3. To delete a participating site from the trial, in the Delete column, select the Delete check box, and then click Delete at the bottom of the list of records.

   Warning
   If you delete a participating site from a trial, the system deletes all of its associated accrual data. Anchor 6298 6298

4. Confirm that you want to delete the site(s) in the pop-up window.
   

5. To modify participating site's information, click the Edit icon.
6. Make changes as necessary, and then click Save.

Editing and Deleting Participating Site Recruitment Status Records

The system validates participating site recruitment status transitions according to the criteria described in Abstracting Trial Status Histories.

How to Edit and Delete Participating Site Recruitment Status Records

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Administrative Data menu, click Participating Sites.
   The Participating Sites page appears.
3. Click Edit.
4. The Add/Edit Participating Site page appears.
   
5. On the Add/Edit Participating Site page, click History
   The Participating Site Recruitment Status History window lists all recorded statuses for the site.

   Anchor
   sitestatushistory sitestatushistory

   Anchor
   8156 8156

   
   
6. Optionally, to view the Audit History of a recorded status, click the View Audit Trial icon (magnifying glass).
7. To validate the transitions from one status to another as they were recorded, click Validate Status Transitions.
   The system displays errors and/or warnings if any of the transitions and/or dates are invalid.
   

8. To correct warnings/errors in a record, click the Edit icon.
   The Edit Participating Site status dialog box appears.
   

9. Select a new status from the Participating Site Status drop-down list. If the date is different from the one recorded, enter it in the Status Date field.
10. Enter comments in the field provided, and then click Save.
11. To delete a status record, click the Delete icon, enter a comment, and then click Delete Status.