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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.
   

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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 If the current Trial Status is Withdrawn, the Board Approval Status must be Submitted, Denied.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.

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.
   

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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 . Anchor indcode indcode 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. 
   

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   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.

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?). 

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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 . Tip title 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. Anchor grantcode grantcode
   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.