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How to Register New Complete Trials
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You must provide a Lead Organization trial identifier for each trial you register. Optionally, provide a ClinicalTrials.gov Identifier.
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Recording
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Trial Details
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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
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Field Label
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Description/Instructions
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Title*
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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"
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Phase*
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Is this a Pilot?*
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This field is displayed only if you selected NA from the Phase drop-down list. |
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Trial Type*
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Select the trial type indicated in the protocol. Interventional is the default.
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Primary Purpose*
Select the primary reason for conducting the trial. The following list provides valid values.
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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. |
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Select one of the following reasons for conducting the trial.
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Click to select the disease terminology used to report subject accruals for this trial.
Recording Non-Interventional Trial Details
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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
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Field Label
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Description/Instructions
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Title*
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Enter the official name of the protocol provided by the study principal investigator or sponsor.
For example: "Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Metastatic Adenocarcinoma of the Prostate"
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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.
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Select N/A for observational and ancillary-correlative trials. |
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Is this a Pilot?*
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This field is displayed only if you selected NA from the Phase drop-down list. |
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Trial Type*
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Select the trial type. Non-Interventional is selected by default.
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Select one of the following trial types:
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Primary Purpose*
Select the primary reason for conducting the trial. The following list provides valid values.
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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. |
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Study Model Code*
Select the primary strategy for subject identification and follow-up. The following list provides valid values.
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Recording Lead Organizations and Principal Investigators
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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
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Recording Sponsors and Responsible Parties
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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:
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.
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Recording Data Table 4 Information
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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
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The text field is displayed only after you have selected Other. |
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Time Perspective Code*
Select the temporal relationship of observation period to time of subject enrollment. The following list provides valid values.
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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. |
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Site Principal Investigator*
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Click Look Up Person and search for the principal investigator. See Looking Up Registered Persons .
Recording Lead Organizations and Principal Investigators
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The Principal Investigator is the individual who is responsible and accountable for conducting the clinical trial. The PI assumes full responsibility for the treatment and evaluation of human subjects, and for the integrity of the research data and results. |
- 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.
- 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 .
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 - Next to Principal Investigator click Look Up Person, and search for the principal investigator as per the instructions in Looking Up Registered Persons.
- 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.
Recording Sponsors and Responsible Parties
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Recording NIH Grants
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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
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The system will not display this section unless you indicate that you require an XML document. |
The Responsible Party can be either a sponsor, principal investigator (PI), or sponsor/investigator. The term "responsible party" is either of the following:
- 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 - - 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 - - Sponsor-Investigator: The individual who both initiates and conducts the study.
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For further elaboration on the definition of these roles with respect to responsible party, see http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf. |
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.
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Before you begin, complete the Lead Organization/Principal Investigator section. Doing so will ensure that the Sponsor/Responsible party section is pre-populated when applicable. |
How to Complete the Sponsor/Responsible Party Section
Select or enter the appropriate information in the textfields 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 InformationField Label
Description/Instructions
Sponsor*
Click Look Up Sponsor and search for the organization as per the instructions in Looking Up Registered Organizations.
Responsible Party*
Indicate the party who is responsible for the trial. Select one of the following options:
Sponsor. Name of primary organization that oversees implementation of study and is responsible for data analysis. If you select this role, you do not submit any further information about the Responsible Party.
- Principal Investigator. Primary medical researcher in charge of carrying out a clinical trial's protocol. If you select this role, 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.
- Sponsor-Investigator. The individual who both initiates and conducts the study. If you select this role, 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.
Investigator*
If the Responsible Party is the Principal Investigator, you can not change the person's name.
If the Responsible Party is the Sponsor-Investigator, you can change the person's name. To do so, click Look Up Sponsor, and follow the instructions in Looking Up Registered Persons .
Investigator Title*
The system populates this field. Enter a new title in the field provided if other than Principal Investigator.
Investigator Affiliation*
If the Responsible Party is the Principal Investigator, you can change the affiliated organization. To do so, click Look Up Organization, and follow the instructions in Looking Up Registered Organizations.
If the Responsible Party is the Sponsor-Investigator, you can not change the affiliated organization.
Recording Data Table 4 Information
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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.
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The lead organization or at least one participating site must be a Cancer Center organization. |
How to Complete the Data Table 4 Information Section
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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.
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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.
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- Retrieve that draft trial for completion, return to this Data Table 4 Information section, and click Manage Program Codes.
- On the toolbar, click Administration > Program Codes > Manage Master List.
Recording NIH Grants
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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.
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| If the Lead Organization for the trial is a Cancer Center organization, you must record a valid P30 grant. |
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
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
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Field Label
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Description/Instructions
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Funding Mechanism
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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.
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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.
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Institute Code
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Serial Number
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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.
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NCI Division/Program Code
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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 .
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Click Add Grant.
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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.
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Recording Trial Statuses
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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.
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The system validates each new status as you add it, as well as when you review the trial information before submitting the trial for registration. |
If you add a status that does not conform to the rules provided in Trial Status Transitions , 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.
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How to Complete the Trial Status Section
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Click Add Status.
The new status record is displayed.
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- 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.
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Trial Status Transitions
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Recording Trial Dates
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How to Complete the Trial Dates Section
- Select or enter the appropriate information in the text fields and drop-down lists. An asterisk (*) indicates a required field.
- Indicate whether the dates you entered are Actual or Anticipated.
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Recording INDs and IDEs
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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
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
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Field Label
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Description/Instructions
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IND/IDE Types*
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If the trial involves an Investigational New Drug Application, select IND. If the trial involves an Investigational Device Exemption, select IDE.
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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 Trial Status Transitions , 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.
How to Complete the Trial Status Section |
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IND/IDE Number*
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Enter the number assigned to an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE)
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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. |
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IND/IDE Grantor*
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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
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IND/IDE Holder Type*
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Select one of the following holder types:
- Investigator
- Organization
- Industry
- NIH
- NCI
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NIH Institution, NCI Division/Program Code* (required if the holder type is NIH or NCI)
Select a code from the drop-down list.
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Expanded Access?
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If an experimental drug or device is available outside any clinical trial protocol, select Yes.
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Expanded Access Type* (required if you selected the Yes check box in the Expanded Access? column)
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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
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Exempt?
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Select the Yes check box in the Exempt? column if the investigational product does not require FDA approval .
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Recording Regulatory Information
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The system will not display this section if you indicated that you do not require an XML document for 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.
Instructions for recording regulatory information
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.
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You must select YES in the FDA Regulated Intervention Indicator field if the trial includes an IND or IDE. |
Section 801 Indicator*
For interventional trials, 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.
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If you indicated that the trial is applicable under Section 801, the Delayed Posting Indicator field becomes available and defaults to No. This field is read-only. You may request a change in its value by submitting a request to the CTRO at ncictro@mail.nih.gov. |
Delayed Posting Indicator*
This indicator becomes available only when you indicate that the trial is applicable under Section 801. Only the CTRO can modify this indicator’s value:
- A No value indicates that any devices in the trial have already been approved or cleared by the US FDA, and so there is no need to delay posting of trial information information on ClinicalTrials.gov.
- A Yes value indicates that the release of trial information on ClinicalTrials.gov is being delayed until after an interventional device has been approved or cleared.
To change this indicator’s value, submit a request to the CTRO at ncictro@mail.nih.gov.
Data Monitoring Committee Appointed Indicator
Optionally, indicate whether a data monitoring committee has been appointed for this trial by selecting Yes or No.
All fields in this section are required.
Include Page Trial Status Fields - Include v4.4 Trial Status Fields - Include v4.4 Click Add Status.
The new status record is displayed.- 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.
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Trial Status Transitions
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Recording Trial Dates
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The Trial Dates section captures start, primary completion, and completion dates as they occur according to the rules specified in Start, Primary Completion, and Completion Date Rules.
How to Complete the Trial Dates Section
Start, Primary Completion, and Completion Date Rules
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Recording INDs and IDEs
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Recording Regulatory Information
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Recording Trial-Related Documents
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