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 Interventional Trial Details Recording Non-interventional 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 Recording Interventional Trial Details and Recording Non-Interventional 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 must provide a Lead Organization trial identifier for each trial you register. Optionally, provide a ClinicalTrials.gov Identifier.

How to Complete the Trial Identifiers Section

1. Indicate whether or not you require an XML document for registration with ClinicalTrials.gov. The default is Yes. If you select No, you will not be asked to provide regulatory and responsible party information.

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

   
   Instructions for recording Trial Identifiers for Complete trials
   

   Field Label	Description/Instructions
   Lead Organization Trial Identifier*	Enter the unique identification assigned to the protocol by the sponsoring organization, 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, for example, NSAGP-B-40.
   ClinicalTrials.gov Identifier	If the trial has been submitted to ClinicalTrials.gov previously, enter the number assigned to the trial by PRS (ClinicalTrials.gov). The CTRP renamed the previous identifiers "NCT Number" and "NCT ID" to "ClinicalTrials.gov Identifier". You cannot change the ClinicalTrials.gov Identifier once you have added it. If you need to make changes thereafter, contact the CTRO at NCICTRO@mail.nih.gov.
   Other Trial Identifier	Enter an additional trial identifier such as unique identifier from other registries, NIH grant numbers, or protocol numbers assigned by the Review Board, and then 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 identifier you have added, in the Action Column, click Delete.

How to Complete the Trial Details Section

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

Instructions for recording Interventional Trial Details

Field Label	Description/Instructions
Title*	Enter the official name of the protocol provided by the study principal investigator or sponsor. (Limit 4000 characters) For example: "Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Metastatic Adenocarcinoma of the Prostate"
Phase*	Select the phase or stage of the clinical trial as defined by the US FDA, from the drop-down list. The following list provides valid values.
Is this a Pilot?* This field is displayed only if you selected NA from the Phase drop-down list.	Select Yes or No from the drop-down list to indicate whether the trial you are registering is a pilot trial.
Trial Type*	Select the trial type indicated in the protocol. Interventional is the default.
Primary Purpose*	Select the primary reason for conducting the trial. The following list provides valid values. Optionally, if the primary purpose is Other, type a detailed description of the trial’s purpose in the text field provided. The text field is displayed only after you have selected Other. The limit is 200 characters; the system counts down the character numbers as you type.
Secondary Purpose	Select one of the following reasons for conducting the trial. If the secondary purpose is Other, enter a detailed description of the trial’s purpose in the text field provided.
Accrual Disease Terminology*	Click to select the disease terminology used to report subject accruals for this trial.

 
How to Complete the Trial Details Section

Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. All fields in this section are required.

Instructions for recording Trial Details

The Lead Organization is the institution that is the principal administrative organization responsible for the study. Each trial can have one Lead Organization only.

You must complete both fields in the Lead Organization/Principal Investigator section.

How to Complete the Lead Organization/Principal Investigator Section

1. Next to the Lead Organization field, click Please Select the Lead Organization.
   The system displays your affiliated organization first, followed by affiliated organization family members. Organizational roles are displayed when applicable.
   
2. Select the appropriate organization from the list. If the organization is not listed, click Search, and search for the organization as per the instructions in Looking up Registered Organizations .
   
   1. If the search does not return your trial's lead organization, you can register it in the system at this point. To register an organization, follow the instructions in Adding Organizations to the CTRP.
3. Next to Principal Investigator click Look Up Person, and search for the principal investigator as per the instructions in Looking Up Registered Persons.
   
   1. If your trial's principal investigator's name is not listed, you can register it in the system at this point. To register an investigator, follow the instructions in Adding Persons to the CTRP.

Complete this section only if you indicated that you require an XML document to register your trial with ClinicalTrials.gov.

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

1. Sponsor. Name of the primary organization that oversees the implementation of the study and is responsible for data analysis. For applicable clinical trials, sponsor is defined in 21 CFR 50.3.
   - or -
2. Principal Investigator. The individual who serves as the principal investigator and is designated as responsible party, consistent with the conditions described in the statute.
   - or -
3. Sponsor-Investigator: The individual who both initiates and conducts the study.

You must complete all fields in the Sponsor/Responsible Party section. The fields displayed depend on your selection of the Responsible Party role, as shown in the images below.

If you select Sponsor (above), you do not submit any further information about the Responsible Party.

If you select Principal Investigator (above), this section expands to display the investigator's title and organization affiliation. The system populates the Investigator's Name field with the name you selected as Principal Investigator in the Lead Organization/Principal Investigator section.

If you select Sponsor-Investigator (above), this section expands to display the investigator's title and organization affiliation. Although the system populates the Investigator's name field with the name you selected as Principal Investigator in the Lead Organization/Principal Investigator section, you can select another person for this role.

How to Complete the Sponsor/Responsible Party Section

Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. All fields in this section are required.

Complete all fields in the Data Table 4 Information section. The Trial Submission Category (study source) or Data Table 4 Funding Sponsor Type fields are pre-populated with the sponsor type.

 How to Complete the Data Table 4 Information Section

1. Hover your mouse over Please Select the Data Table 4 Sponsor Organization. A list of organizations appears.

2. Select the name of the external sponsor or funding source as defined by the Data Table 4 report. See Looking Up Registered Organizations. (If your trial's funding sponsor is not listed, you can register it in the system at this point. To register an organization, see Adding Organizations to the CTRP.)
   
   The organization you selected appears under the Data Table 4 Funding Sponsor field, along with an option to delete the sponsor.
   
   
   

   A trial can have multiple sponsors. Repeat the steps above to add other sponsors. The system ensures that you don't duplicate an existing sponsor.

3. To delete an existing sponsor, click Delete Sponsor. You can not "undo" the deletion but you can add the sponsor back if necessary.
   If you have selected a lead organization for the trial and if that lead organization belongs to an organization family, the Program Code field is available. The Program Code field lists all program codes available for that organization family. If you are a site administrator, an option to manage program codes is also available.

4. If you want to specify a program code for the trial, select one or more codes in the Program Code field.
5. If you want to manage program codes, save a draft of the trial details you have completed. Then you can do one of the following:
   1. Retrieve that draft trial for completion, return to this Data Table 4 Information section, and click Manage Program Codes.
   2. On the toolbar, click Administration > Program Codes > Manage Master List.

This section pertains to Complete trials. You must record NIH grant information for your trial, including the funding mechanism, institute code, serial number, and NCI division/program. You can add up to five NIH grants.

For a complete guide to NIH grant information, see the Grants and Funding page at http://grants.nih.gov/grants/funding/funding_program.htm.

How to Complete the NIH Grant Information Section

1. Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. All fields in this section are required if your study is funded by NIH.
   Instructions for recording NIH Grant Information

   Field Label	Description/Instructions
   Is this trial funded by an NCI grant?	If the trial is funded in part or whole by an NCI Grant or Contract, select Yes. Otherwise, select No.
   Funding Mechanism	Enter the initial letter(s) and or number(s) in the Funding Mechanism field and then select the NIH unique identifier from the drop-down list. The funding mechanism is a 3-character code used to identify areas of extramural research activity applied to funding mechanisms. 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. For a list of valid codes, see Funding Mechanism Codes.
   Institute Code	Select the two-letter code identifying the first major-level subdivision, the organization that supports an NIH grant, contract, or inter-agency agreement. The support may be financial or administrative. For a list of valid codes, see NIH Grant Institute Codes .
   Serial Number	Enter the five- or six-digit number generally assigned sequentially to a series within an Institute, Center, or Division, for example, 123660. If you selected CA in the Institute Code field, the system displays the top ten grants that match the sequence of serial numbers as you type them one-by-one. By selecting a grant from the list, you ensure that you record a valid serial number.
   NCI Division/Program Code	Enter the initial letter(s) of the division or program code, and then select the code for the organizational unit that provides funding for the study, from the drop-down list. For a list of Division and Program Codes, see  NCI Division and Program Codes .

2. Click Add Grant.

   The Add button is operable only after you have provided the grant information in all fields.

   The grant is displayed and added to the trial, and the Grant fields are reset.

3. If your trial is funded by more than one grant, repeat the steps above, and then click Add Grant.
4. To delete a grant record from a trial, in the Action column, click Delete.

Trial status refers to the current stage or state of a clinical trial or study relative to other stages and its ability to enroll participants/patients.

Valid trial statuses used in CTRP are mapped to ClinicalTrials.gov-defined recruitment values. ClinicalTrials.gov status definitions are provided in Trial Status Values in the CTRP and ClinicalTrials.gov.

If you add a status that does not conform to the rules provided in Registering New Trials , the system displays errors and/or warnings. Warnings indicate that fixing the record is optional. However, Errors indicate that you must correct an invalid transition in order to submit the trial for registration.

If you register a trial after it has reached any Closed to Accrual related trial status or a Complete trial status, you must create a complete Trial Status History by adding all previous statuses in order, as per the rules provided in Registering New Trials .

How to Complete the Trial Status Section

1. Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. All fields in this section are required.
   

2. Click Add Status.
   The new status record is displayed.

   

3. If the system indicates that the status you added is invalid, do one of the following.  

•  To edit the status, in the Actions column, click the Edit icon and make changes as indicated in the Error and/or Warning message.
  
• To delete the status, in the Actions column, click the Delete icon. Enter a comment indicating the reason why you deleted the record, and then add the correct status information.

Trial Status Transitions

The Trial Dates section captures start, primary completion, and completion dates as they occur according to the rules specified in Registering New Trials . 

How to Complete the Trial Dates Section

1. Select or enter the appropriate information in the text fields and drop-down lists. An asterisk (*) indicates a required field.
2. Indicate whether the dates you entered are Actual or Anticipated.

Start, Primary Completion, and Completion Date Rules

Enter the IND/IDE number and grantor fields only if your trial is/was conducted in the United States. You must indicate whether your trial qualifies as an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) protocol.

There are several dependencies between elements in the IND/IDE section. Follow the instructions below in the order in which they are presented.

How to Register IND/IDE Trials

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

   Instructions for recording IND/IDE Information

   Field Label	Description/Instructions
   IND/IDE Types*	If the trial involves an Investigational New Drug Application, select IND. If the trial involves an Investigational Device Exemption, select IDE.
   IND/IDE Number*	Enter the number assigned to an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) You can enter the IND number in many formats. For example, for a biologics (BB) IND that contains the number 1234, you can type BB1234, 1234, or BB_1234. For IDE trials, type the IDE number associated with the grant.
   IND/IDE Grantor*	Select one of the following organizations that holds the IND/IDE approval: For IND trials: Center for Drug Evaluation and Research Center for Biologics Evaluation and Research For IDE trials: Center for Devices and Radiological Health Center for Biologics Evaluation and Research
   IND/IDE Holder Type*	Select one of the following holder types: Investigator Organization Industry NIH NCI
   NIH Institution, NCI Division/Program Code* (required if the holder type is NIH or NCI)	Select a code from the drop-down list. If you selected NIH from the IND/IDE Holder Type list, see NIH Institution Codes for valid values. If you selected NCI from the IND/IDE Holder Type list, see NCI Division/Program Codes for valid values.
   Expanded Access?	If an experimental drug or device is available outside any clinical trial protocol, select Yes.
   Expanded Access Type* (required if you selected the Yes check box in the Expanded Access? column)	Select one of the following access types: 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?	Select the Yes check box in the Exempt? column if the investigational product does not require FDA approval .

2. Click Add IND/IDE.
3. To delete an IND/IDE record from a trial, in the Action column, click Delete.
4. Optionally, to add another IND/IDE record, repeat the steps above.

Complete this section only if you indicated that you require an XML document to register your trial with ClinicalTrials.gov.

How to Complete the Regulatory Information Section

Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*) indicates a required field. See the ClinicalTrials.gov Protocol Data Element Definitions for definitions for these fields.

Instructions for recording regulatory information

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.