The system assigns the trial you import from ClinicalTrials.gov the Data Table 4 Category (funding source) Industrial/Other. To specify whether the trial is Industrial, or to specify if an Other trial is National or Externally Peer-Reviewed, contact the CTRO for assistance at ncictro@mail.nih.gov. For funding source definitions, see http://cancercenters.cancer.gov/GrantsFunding/DataGuide#dt4.

How to Register New Complete Trials

1. On the toolbar, click Register Trial, and select your trial's Submission Category (funding source) from the drop-down list, either National, Externally Peer-Reviewed, or Institutional.

   To read a definition of each of the trial submission categories (study sources), click View Trial Category Definitions, click the Help icon () next to each category, or refer to http://cancercenters.cancer.gov/GrantsFunding/DataGuide#dt4.

   
   

   The Register Trial page appears.

   
   The system can create an XML document that is formatted to facilitate trial registration with ClinicalTrials.gov. The document it creates contains all the information that you submit during registration and all the trial data abstracted by the CTRO. If you indicate that you do not need to register the trial with ClinicalTrials.gov, you will not be asked to provide regulatory and responsible party information.

   By default, all sections of the registration form are displayed.  To collapse or  expand each section individually, click the Collapse or Expand icon on the right side of the section title as shown in the figures below. To collapse all sections, click Collapse All.

   

   
   

    

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

   Be sure to provide information for all fields marked with an asterisk (*). If you cannot complete the registration of a trial in one Registration session, you can save a draft of the trial details you have completed. Later you can return to complete the registration in another session.

   
   

   Instructions for registering Complete trials

   XML required. Enable "Upload from NCI CTRP" in ClinicalTrials.gov?	If you require an XML document to register your trial with ClinicalTrials.gov, select Yes. If you are not going to submit your trial to ClinicalTrials.gov, select No. The option you select here dictates which sections you will be required to complete. For example, if you select No, you will not be required to complete responsible party and regulatory information. If you select Yes, NCI will be added as a collaborator to the Funding Source.
   Various	Select or enter the appropriate information in the text fields and drop-down lists as appropriate according to the detailed instructions provided for each of the following sections: Recording Trial Identification Information Recording Trial Details Recording Lead Organizations and Principal Investigators Recording Sponsors and Responsible Parties Recording Data Table 4 Information Recording NIH Grants Recording Trial Statuses Recording Trial Dates Recording INDs and IDEs Recording Regulatory Information Recording Trial-Related Documents
   Save as Draft	Click to save a draft of the record so that you can complete the registration at another time. You must have provided, at the minimum, both the Lead Organization and Lead Organization Trial Identifier to save a draft. The system saves your draft, assigns it a unique ID (for tracking purposes), and sends you an email message confirming that the information has been saved. You can end your Registration session and retrieve your draft later to complete the registration.
   Review Trial	Click to initiate the system check for errors and missing information. The system displays the results in a message at the top of the Review Trial Details page. Indicators mark specific fields that you must complete or correct in order to submit the trial. The Review Trial Details page is read-only. To make changes to the trial data, follow the instructions in Editing Trial Details.
   Cancel	Click to cancel the registration. A pop-up message prompts you to confirm cancellation. If you choose to cancel the registration, you will lose all data that you may have entered.

3. Correct any errors if indicated, and repeat the previous steps as many times as necessary until the trial is error-free.

4. To continue with the trial registration, scroll to the bottom of the Review Trial Details page, and then click Submit. To prevent creating a duplicate record, do not click Submit more than once. If you have to make changes after you click Submit, contact the CTRO at ncictro@mail.nih.gov rather than using your browser's Back button to make changes.
   The registration notification message system sends you an email message to acknowledge that the trial has been submitted. Later it sends another email message to notify you when your trial has been accepted or rejected.

You can register Industrial/Other trials in the CTRP by importing them directly from ClinicalTrials.gov. You must enter a ClinicalTrials.gov Identifier (NCT ID) for each trial you register. If the trial you want to register does not have an NCI ID, or if you do not know it, contact the CTRO for assistance at ncictro@mail.nih.gov. 

How to Register Industrial Trials

1. On the toolbar, click Register Trial, and select Industrial/Other.

   To read a definition of each of the trial submission categories (study sources), click View Trial Category Definitions, or, click the Help icon () next to each category.

   

   The Import ClinicalTrials.gov Trials page appears.
   

2. Enter the ClinicalTrials.gov Identifier, and then click Search Studies.

   The system searches for the ID you entered. If it finds a match in the CTRP, you can not import the trial.

3. If the system does not find a match in the CTRP, the trial record from ClinicalTrials.gov appears.
   

4. Click Import Trial From ClinicalTrials.gov.

   While it is possible for two users to attempt to import a trial at the exact same time, the system cannot process simultaneous imports. If you receive an error message the first time you attempt to import a trial, wait a short while, and then try again.

   The trial is registered in the CTRP and assigned a unique NCI identifier with the processing status Submitted. The system synchronizes the imported record in the CTRP with the one in ClinicalTrials.gov.
   

5. To add your site as a participant in the trial, click Add My Site. The Add Participating Site page appears.

   
   The Participating Site list contains all organizations in the Organization Family associated with your CTRP account.

6. From the Participating Site list, select the organization that you want to add to this trial. Click Next. Another Add Participating Site page appears.

   

7. Complete the fields as per the instructions in Adding Your Site to Abbreviated Trials, and then click Save.

   The system sends you an email message when the CTRO has accepted the trial for registration in the CTRP. If your trial is not Industrial, contact the CTRO at ncictro@mail.nih.gov to request categorization of the trial as either National or Externally Peer-Reviewed.
   

The system synchronizes Industrial and Other trials currently registered in the CTRP with ClinicalTrials.gov trials every night by comparing their ClinicalTrials.gov Identifiers. The system updates CTRP trial records with the data imported from ClinicalTrials.gov if it finds matching records.

You can print a copy of the trial details to facilitate the review and/or keep for your records. You must review the trial in order to access the print feature.

How to Print Trial Information

1. Scroll to the bottom of the Register Trial page, and then click Review Trial. If necessary, provide any missing information.
2. Scroll to the bottom of the Review Trial Details page, and then click Print.

During the course of registering a trial, you can save the information you have already provided as a draft , and return to it later. Once you retrieve your draft, you can complete the registration or delete the draft altogether.

How to Complete or Delete Saved Drafts

1. Retrieve the draft by searching for it using the Search Saved Drafts option. (For details, see Searching for Trials .)
   Saved draft records are listed on the Search Results page.
   
   
2. Do one of the following in the appropriate Action column on the right side of the table:
   
   1. To delete the record, click Delete. The draft record is deleted from the system permanently.
      - or -
   2. To complete the record, click Complete.

The Register Trial page displays all the information you provided previously. You can complete the rest of the information by following the steps in Registering a Complete Trial.