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About Trial Registration
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How to Register New Complete Trials
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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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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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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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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
Trial Status Transitions
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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
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.
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You can edit the details of the trial that you are registering before you submit the trial to the CTRP. If you want to edit a registered trial that you own, follow the instructions in Updating Trials. How to Edit Trial Details
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