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Page History
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Recording Trial Identification Information
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| MultiExcerptName | submittrialid |
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How to Complete the Trial Identifiers Section
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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.
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Field Label
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Description/Instructions
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Lead Organization Trial Identifier*
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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.
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ClinicalTrials.gov Identifier
If the trial has been submitted to ClinicalTrials.gov previously, enter the number assigned to the trial by PRS (ClinicalTrials.gov).
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The CTRP renamed the previous identifiers "NCT Number" and "NCT ID" to "ClinicalTrials.gov Identifier". |
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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. |
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Other Trial Identifier
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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.
Recording Trial Details
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Recording Lead Organizations and Principal Investigators
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| MultiExcerptName | submittrialleadorganization |
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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.
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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. |
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- 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 Adding Organizations to the CTRP.
- 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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| MultiExcerptName | submittrialsponsor |
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Complete this section only if you indicated that you require an XML document to register your trial with ClinicalTrials.gov.
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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 text fields and drop-down lists. The following table describes the fields. All fields in this section are required.
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Field Label
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Description/Instructions
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Sponsor*
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Click Look Up Sponsor and search for the organization as per the instructions in Looking Up Registered Organizations.
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Responsible Party*
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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.
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Investigator*
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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 .
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Investigator Title*
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The system populates this field. Enter a new title in the field provided if other than Principal Investigator.
Investigator Affiliation*
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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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| MultiExcerptName | submittrialfunding |
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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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Recording Trial Details
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Recording Lead Organizations and Principal Investigators
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Recording Sponsors and Responsible Parties
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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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| MultiExcerptName | submittrialgrant |
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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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| MultiExcerptName | submittrialstatus |
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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
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| MultiExcerptName | submittrialdate |
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Data Table 4 Information
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Recording NIH Grants
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Recording Trial Statuses
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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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