Abstracting Administrative Information v4.4

General trial details include the following main categories of data:

• ClinicalTrials.gov XML Required indicator (displayed for Complete trials only)
• Trial title
• Trial description
• Other identifiers
• Lead organization/Principal investigator
• Sponsor Responsible party (Complete trials that require an XML document for submission to ClinicalTrials.gov only)
• Central contact

Unless otherwise noted, you are required to complete all information provided on the General Trial Details page for Complete trials. This information is optional for Abbreviated trials. Most elements are provided via CTRP Registration.

How to Abstract Trial Descriptions, Titles, and Identifiers

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 General Trial Details.

   The General Trials Details page appears.

   

   General Trial Details Page, Upper Section – Complete Trial

   

   General Trial Details Page, Upper Section – Abbreviated Trial
   

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.

   You can expand text fields and table cells to reveal all of their content

   To increase the size of a text field or table cell, click and drag the lower right corner handle.

   Section	Field Label	Trial Category (Study Source)	Description/Instructions
   NA	ClinicalTrials.gov XML required?	Complete	Select the appropriate option to indicate whether an XML document is required to register the trial with ClinicalTrials.gov.
   Title	Acronym	Complete and Abbreviated	Type the abbreviation (initial letters) by which the trial is known.
   Title	Official Title*	Complete and Abbreviated	Ensure that the title is accurate and complete (as it appears in the Protocol document). Make any necessary changes or additions.
   Alternate Titles	Category	Complete and Abbreviated	If you discover that there is a spelling or format error in the title as registered in the CTRP, next to Category, select Spelling/Format, enter the corrected title, and then click Add Alternate Title. If you discover an error that does not fall into the Spelling/Format category, next to Category, select Other, enter the corrected title, and then click Add Alternate Title.
   Trial Description	Keywords	Complete and Abbreviated	Trial descriptions can contain a keyword or series of keywords that can help to classify the trial. You can enter up to 4,000 characters. Although Keywords are included in Administrative abstraction, any changes to them (e.g., via an update from ClincialTrials.gov or the CTRP Registration user interface) require Scientific Acknowledgement.
   Other Trial Identifiers	Lead Organization Trial Identifier*	Complete and Abbreviated	Enter the ID exactly as it appears in the Protocol document. For Inter-Group trials, type the Lead Group’s trial number. For multi-site trials that have no assigned single center, use the protocol ID. Example: NSABP-B-40
   Other Trial Identifiers	ClinicalTrials.gov Identifier	Complete and Abbreviated	Enter the trial identifier assigned by ClinicalTrials.gov. Provide the exact number, including the ClinicalTrials.gov prefix. Example: NCT00012345
   Other Trial Identifiers	CTEP Identifier	Complete	Optionally, in the CTEP Identifier field, type the trial identifier assigned by the Clinical Therapy Evaluation Program.
   Other Trial Identifiers	DCP Identifier	Complete	Optionally, in the DCP Identifier fields, type the trial identifier assigned by the Division of Cancer Prevention.
   Other Trial Identifiers	Other Trial Identifier	Complete and Abbreviated	If appropriate, select either the Obsolete ClinicalTrials.gov Identifier or Duplicate ClinicalTrials.gov Identifier type from the Other drop-down list. Enter the trial identifier for the ID type you chose above, or enter another ID, such as a unique identifier from other registries, NIH grant number, or protocol number assigned by the Review Board. Click Add Other Identifier. Repeat this step for each additional identifier. The ID you added is displayed in the Other Identifier list. To delete an existing identifier, in the Action column, click Delete. To edit an existing identifier, in the Action column, click Edit. Make changes as necessary, and then click Done. When you save changes to the trial, the system checks the ClinicalTrials.gov Identifier you entered to ensure that no other registered trial has the same one. The system displays an error message if it finds another trial with the same ClinicalTrials.gov Identifier. If this occurs, check the number you entered and try again.

4. Do one of the following to continue:

   1. If the trial that you are abstracting is an Abbreviated trial, click Save

      - or -

   2. If the trial that you are abstracting requires an XML document for submission to ClinicalTrials.gov, complete the Sponsor and Responsible Party and Central Contact sections.

      - or -

   3. If the trial that you are abstracting does not require an XML document for submission to ClinicalTrials.gov, complete the Central Contact section.

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.
   

   Displaying Organization and Person Details

   You can display the details of any organization or person, including their CTEP and PO IDs, that appears on abstraction pages by clicking the Details icon () located next to an organization or person name field.

   
   
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.

   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.

Complete this section if the trial includes an Investigational New Drug (IND) or Investigational Device Exemption (IDE) as per US Food and Drug Administration regulations. If the trial was registered without IND/IDE information, you can provide it here. IND/IND information is optional for Abbreviated trials.

The choice of values for some fields in this section depend on values that you have selected in preceding fields. For example, if the IND/IDE Type is "IND", the Grantor must be either "CDER" or "CBER". Further, if the Grantor is either "CDER" or "CBER", and the Holder type is anything other than "NIH" or "NCI", NIH Institution / NCI Division/Program names are not available for selection.

How to Abstract IND/IDE 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 Trial IND/IDE. The Trial IND/IDE page appears. The IND/IDE Information section lists any IND/IDE records for the trial.
   
3. To add an IND/IDE record, click Add. The Add IND/IDE section displays IND/IDE data fields.
   
   

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
   IND/IDE Type*	Indicate the type of protocol.
   Number*	Type the IND/IDE number.
   Grantor*	Select the grantor from the drop-down list. Valid values are as follows:  CDER – Center for Drug Evaluation and Research CBER – Center for Biologics Evaluation and Research CDRH – Center for Devices and Radiological Health
   Holder Type*	Select the holder type from the drop-down list.

5. Do one of the following:
   
   • If you selected any value other than NIH or NCI, skip the next step.
     - or -
   • If you selected either NIH or NCI for the Holder Type, proceed to the next step.

6. 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
   NIH Institution / NCI Division/Program*	If the holder type is NIH, select the associated NIH institution. For a list of valid values, see NIH Institution Code Values . If the holder type is NCI, select the associated NCI Division Code. For a list of valid values, see NCI Division/Program Codes.
   Expanded Access Indicator*	Indicate whether or not the drug or device is available outside any clinical trial protocol.
   Expanded Access Status*	If you selected YES in the Expanded Access Indicator field, select the status of the drug or device access from the field if changes have been requested and information provided. Valid values are as follows:  Available - Expanded access is currently available for this treatment. No longer available - Expanded access was available for this treatment previously but is not currently available and will not be available in the future. Temporarily not available - Expanded access is not currently available for this treatment, but is expected to be available in the future. Approved for marketing - This treatment has been approved for sale to the public.
   Exempt Indicator	If the trial is exempt from IND/IDE regulation, select Yes.

7. Click Save. The IND/IDE record you just created is added to the list of existing records.
8. To make changes to a record, click the Edit icon in the Edit column next to the record you want to modify, and make changes in the Add IND/IDE page.
9. To delete a record, click the Delete icon in the Delete column.
10. To add another IND/IDE record, click Add, and complete the steps above.
11. 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. 
   

   Displaying Organization and Person Details

   You can display the details of any organization or person, including their CTEP and PO IDs, that appears on abstraction pages by clicking the Details icon () located next to an organization or person name field.

   
   

    

   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 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: Trials are categorized by type of Data Table 4 Funding Sponsorship or Trial Submission Category (study source).   Complete Trials: National: NCI National Clinical Trials Network (NCTN) and other NIH-supported National Trial Networks. Externally Peer-Reviewed: R01s, SPORES, U01s, U10s, P01s, CTEP, or any other clinical research study mechanism supported by the NIH or organizations on this list: Organizations with Peer Review Funding Systems. Institutional: In-house clinical research studies authored or co-authored by Cancer Center investigators and undergoing scientific peer review solely by the Protocol Review and Monitoring System of the Cancer Center. The Cancer Center investigator has primary responsibility for conceptualizing, designing, and implementing the clinical research study and reporting results. It is acceptable for industry and other entities to provide support (such as drug, device, or other funding), but the trial should clearly be the intellectual product of the center investigator. This category may also include: Institutional studies authored and implemented by investigators at another Center in which your Center is participating. Multi-Institutional studies authored and implemented by investigators at your Center. (Note: National and externally peer-reviewed studies should be listed with those categories, not as Institutional studies.) Abbreviated Trials: Industrial: A pharmaceutical company controls the design and implementation of these clinical research studies. 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 .) A trial can have multiple sponsors. The system ensures that you don't duplicate an existing sponsor. 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. 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. 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.

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

   

   Add/Edit Participating Site- Complete Trial

   

   Add/Edit Participating Site - Abbreviated Trial

   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. 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. For a comprehensive matrix of valid transitions, see Trial and Participating Sites Status Transition Rules.
   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. 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. 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.

   

   Investigators Tab for a Complete Trial

   

   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.

   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.

    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	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.

   

    

   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.

   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.

   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	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.
   

   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.
   
   
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.
   

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. 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.
   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. 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. 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.

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

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.
   
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.

Regulatory information includes human subject safety review and IND/IDE data. Some fields in this section are visible only when you have selected YES or NO indicators in preceding fields. Other fields may be visible but may not contain indicators. Regulatory information is optional for Abbreviated trials.

How to Abstract Regulatory 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 Regulatory Information.
   The Regulatory Information page appears.
   

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 for Complete trials only.

   Field Label	Description/Instructions
   Trial Oversight Authority Country*	Select the name of the country in which the oversight authority organization is located. After you make your selection, the oversight authorities registered in the country you selected are listed in the Trial Oversight Authority Organization Name field.
   Trial Oversight Authority Organization Name*	Select the name of the organization that oversees the trial from the drop-down list.
   FDA Regulated Intervention Indicator*	Indicate whether the trial is regulated by the FDA by selecting Yes or No. You must select YES in the FDA Regulated Intervention Indicator field if the trial includes an IND or IDE. If the trial is interventional and you indicated that it is regulated by the FDA, the Regulatory Information section displays fields for Section 801. You are required to complete these fields.
   Section 801 Indicator*	Indicate whether the FDA-regulated interventional trial is an applicable trial as defined in US Public Law 110-85, Title VIII, Section 801 by selecting Yes or No. If you indicated that the trial is applicable under Section 801, you are required to complete the Delayed Posting field.
   Delayed Posting Indicator*	Indicate whether the release of trial information on Cancer.gov is being delayed until after an interventional device has been approved or cleared by selecting Yes or No. Select No if the trial does not include a device.
   Data Monitoring Committee Appointed Indicator	Optionally, indicate whether a data monitoring committee has been appointed for this trial by selecting Yes or No. This information is required for compliance with the Public Law 110-85 of the Food and Drug Administration Amendment Act of 2007. If you are unsure about how to classify a trial, or what information to provide, contact the FDA's regulatory affairs office.

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

Trial status refers to the current stage or state of participant/patient enrollment at the participating site level. Trial Start Dates and Primary Completion Dates are related to the current trial status. See Trial Status Rules and Trial Status Transitions.

Status information is optional for Abbreviated trials.

The Trial Status abstraction workflow is slightly different for Super, Administrative, and Scientific Abstractors. Although each of the abstractor roles can change the status transitions, the trial check in/check out behavior varies. See the table in Checking In and Checking Out Trials for details.

Trial Status Abstraction

How to Abstract Trial Status 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 Trial Status.
   The Trial Status page appears.
   

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
   Current Trial Status*	Select the trial’s accrual status from the drop-down list. Valid values are as follows: Unable to render {include} The included page could not be found.
   Current Trial Status Date*	Enter the date on which the current trial status became effective. See Trial Status Date Rules .
   Why Study Stopped	If you selected the Administratively Complete, Withdrawn, or Temporarily Closed to Accrual status, type the reason why the study has ended or is not currently accruing. You can update your comment only for trials that are Temporarily Closed to Accrual. Optionally, enter any comments regarding the trial status.
   Trial Start Date*	Enter the date on which the trial started, or is expected to start. Indicate whether the start date is the one on which the trial is expected to start, or the date on which it actually started by selecting Anticipated or Actual. See  Trial Status Date Rules .
   Primary Completion Date*	Enter the date on which the final subject was examined or received an intervention, or the date on which that is expected to happen. Indicate whether the completion date is the one on which the trial is expected to be primarily completed, or the date on which it actually was primarily completed, by selecting Anticipated or Actual. See Trial Status Date Rules . Exceptions Primary Completion Dates are optional in the following cases: For non-interventional trials. For DCP trials, if you select N/A as the type. In both cases, the system excludes such trials when submitting XML documents to ClinicalTrials.gov.
   Completion Date	Enter the final date on which data was (or is expected to be) collected for the trial. Indicate whether the completion date is the one on which the trial is expected to be completed, or the date on which it actually was completed, by selecting Anticipated or Actual. See Trial Status Date Rules .

4. Click Save.
   The system displays a confirmation message if the status transition you added or updated conforms to the rules in Trial Status Transitions. Otherwise it displays warning and/or error messages.
   
5. If the system displays warning and/or error messages, click the History icon, and follow the instructions in Abstracting Trial Status Histories to correct them.

Trial Status Record Abstraction for Super Abstractors

How to Abstract Trial Status Information

1. Follow the instructions for abstracting Trial Statuses in Trial Status Abstraction for Admin Abstractors.
   Because you can abstract a trial status without checking it out, the system checks out the trial to you. This ensures that you do not invalidate previously validated records.
   If the system detects errors, it displays the Trial Status Validation window.
     
   
2. Click Trial Status History and follow the instructions in Abstracting Trial Status Histories .

Trial funding information is optional for Abbreviated trials.

How to Abstract NIH Grant 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 Trial Funding. The Trial Funding page appears. The NIH Grant Information section lists any NIH grant records for the trial. If an abstractor deleted one or more grant records previously, the Deleted NIH Grants section lists the deleted grant records.
   

    

3. If the trial is funded by an NCI grant, select Yes. Otherwise select No  (located next to Is this trial funded by an NCI grant?). 

4. To add an NIH Grant record, click Add. The Add/Edit NIH Grant section appears.
   

     
   

5. In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. All fields are required.

   Field Label	Description/Instructions
   Funding Mechanism Code	Type the initial letter and or number in the field and then select the code used to identify areas of extramural research activity from the drop-down list. See  Funding Mechanism Codes . Code selection tip Click the down arrow in the field, and then use the up and down arrow keys on your keyboard to scroll up and down the drop-down list. When you arrive at the appropriate code, press the Enter key.
   NIH Institute Code	Type the initial letter of the name of the primary organization responsible for funding the trial in the field and then select the institute code from the drop-down list. See NIH Grant Institute Code Values.
   Serial Number	Enter the five- or six-digit serial number.
   NCI Division/Program	Type the initial letter(s) of the division or program code and then select the code from the drop-down list. See NCI Division and Program Codes for valid values.

6. Click Save.

   The NIH Grant record you just created is listed in the table.

7. To make changes to the record, click the Edit icon (pencil) and make changes on the Add/Edit Grant page.

8. To delete the record, select the check box in the Delete column for each record you want to delete, and then click Delete. Or, to delete all records, click Select All, and then click Delete.

9. In the confirmation pop-up window, click OK to confirm that you want to delete the record(s).

10. In the Provide Reason for Deletion text box, enter the reason for deleting the record, and then click Done.

You must include only one of each of the following types of documents for original submission of Complete trials:

• Protocol document (complete protocol)

• IRB Approval

You must include only one each of the following types of documents for each submission of trial amendments:

• IRB approval

• Informed consent

• Protocol highlight change

• Participating site documents (if appropriate)

• Amended protocol and/or Change memo (summary of changes to the protocol)

You are required to supply your documents as Microsoft Word, Adobe PDF, Microsoft Excel, or WordPerfect files.

Adding Documents

How to Add Trial-Related Documents

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 Trial Related Documents.

   The Trial Related Documents page appears.

   

3. Click Add.

   The Add/Edit Document page appears.

    

   

4. In the Document Type field, select the type of trial document you want to add to the abstract from the drop-down list. Valid document types are as follows:

   • Protocol
   • IRB approval
   • Participating Sites
   • Informed Consent
   • Other
   • Change Memo Document
   • Protocol Highlighted Document

5. Click Browse, navigate to the document you want to upload in the File Upload window, and then click Open.

   Depending on your operating system, the File Upload window and the Open button may be named something else.

   The Trial Related documents page displays your new document in the table.

Editing and Replacing Documents

You can edit current trial-related documents by downloading them, editing them, and replacing them.
To delete, rather than edit, documents other than protocol and IRB approval documents, see Deleting Documents.

How to Edit and Replace Trial-Related Documents

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 Trial Related Documents.

   The Trial-Related Documents page appears.

3. To replace a document, click the Edit icon and upload a replacement document as per the instructions below. The replacement document must be of the same type as the original.

   The document is replaced and appears in the table. Continue with the steps below only if you want to modify an existing file.

4. To edit a document, click its file name link, save the file to a location on your local drive, and modify the file as necessary. You can save the modified file with the same name (that is, write over the original), or save it with a new file name.

5. On the Trial Related Documents page, click the Edit icon in the row of the document you downloaded.

   The Add/Edit Document page appears. Note that you are not able to change the document type.

6. Click Browse, navigate to the document you just edited, and then click Open. Follow your browser/operating system instructions to view or save the document

   The Trial Related documents page displays your modified document in the table.

Deleting Documents

You can delete a sub-set of current trial-related documents. Although you can not delete Protocol or IRB Approval documents, you can replace them. See Editing and Replacing Documents.

How to Delete Trial-Related Documents

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 Trial Related Documents.

   The Trial Related Documents page appears.

3. Select the Delete check box for each document you want to delete, or, click Select All to select all documents that are candidates for deletion.

   Check boxes are available only for those document types that can be deleted according to the constraints listed at the top of this page.

4. Click Delete.

5. On the confirmation pop-up window, click OK to remove the selected document(s) from the trial.

6. Enter the reason for deleting the document(s), for example, “Duplicate document” in the text box. The system counts down the character count as you type. The character limit is 200.

   

7. Click Done.