NIH | National Cancer Institute | NCI Wiki  

Error rendering macro 'rw-search'

null

You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 8 Next »

The following table describes the data elements displayed in the NCI As Sponsor Trials report for each trial:

Data ElementDescription
NCI_IDIdentifier assigned to this trial by the CTRP.
Lead_Org_IDIdentifier assigned to this trial by the lead organization. For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers.
TitleOfficial name of the protocol provided by the study principal investigator or sponsor. For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers.
Lead Org PO IDIdentifier assigned to the lead organization by the CTRP. For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers.
Lead_OrganizationName of the principal administrative organization responsible for this trial's research protocol. For more information, refer to Abstracting Sponsors and Responsible Parties.
NCT_IDIdentifier assigned to this trial by the National Clinical Trial program (ClinicalTrials.gov). For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers.
CTEP_IDIdentifier assigned to this trial by the CTEP (Cancer Therapy Evaluation Program). For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers.
DCP_IDIdentifier assigned to this trial by the DCP (Division of Cancer Prevention). For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers.
Funding MechanismUnique, three-character code for the funding mechanism of a grant on a trial. NIH assigns these codes to areas of extramural research activity. For more information, refer to Abstracting Funding.
NCI Division/ProgramNCI organizational unit that provides funding for the trial, as identified in an IND, IDE, or grant record. For more information, refer to Abstracting INDs and IDEs or Abstracting Funding.
Institution CodeNIH institution associated with the trial, as identified in an IND or IDE record. For more information, refer to Abstracting INDs and IDEs.
IND/IDE GrantorName of the organization that holds the IND/IDE approval for the trial. For more information, refer to Abstracting INDs and IDEs.
IND/IDE Holder TypeType of organization that holds the IND/IDE approval for the trial. For more information, refer to Abstracting INDs and IDEs.
IND/IDE NumberNumber assigned to an IND or IDE. For more information, refer to Abstracting INDs and IDEs.
IND/IDE TypesValue indicating whether the trial involves an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE). For more information, refer to Abstracting INDs and IDEs.
Section_801_IndicatorValue indicating whether the FDA-regulated interventional trial is an applicable trial as defined in US Public Law 110-85, Title VIII, Section 801. For more information, refer to Abstracting Regulatory Information.
Principal_InvestigatorPrincipal Investigator (PI) for the trial. For more information, refer to Abstracting Sponsors and Responsible Parties.
Sponsor_OrgName of the primary organization that oversees implementation of study and is responsible for data analysis. For more information, refer to Abstracting Sponsors and Responsible Parties.
Responsible_PartyName of the organization responsible for the trial. The responsible party can be either a sponsor, principal investigator (PI), or sponsor/investigator. For more information, refer to Abstracting Sponsors and Responsible Parties.
Summary_4_Funding_SponsorCTRP organizations listed as Data Table 4 Funding Sponsor for the trial. For more information, refer to Abstracting Sponsors and Responsible Parties.
Trial_StatusCurrent stage or state of a clinical trial or study relative to other stages and its ability to enroll participants/patients. For more information, refer to Abstracting Trial Statuses and Trial Status Values in the CTRP and ClinicalTrials.gov.
Trial_Status_DateDate on which the current trial status became effective. For more information, refer to Abstracting Trial Statuses.
Trial_Start_DateDate on which the enrollment of participants for the trial started, or is expected to start. For more information, refer to Abstracting Trial Statuses.
Primary Completion DateDate on which the final subject was examined or received an intervention, or the date on which that is expected to happen. For more information, refer to Abstracting Trial Statuses.
Primary Completion Date TypeValue indicating whether the completion date is the one on which the trial is expected to complete (Anticipated), or the date on which it actually completed (Actual). For more information, refer to Abstracting Trial Statuses.
Submitting_Org_NameName of the organization that submitted the trial.
Current Processing StatusValue indicating the current processing status of the trial. For more information, refer to Abstracting Trial Statuses and Trial Processing Statuses in the CTRP.
Study_CategoryThe Data Table 4 Funding Sponsorship or Trial Submission Category (study source): Complete or Abbreviated. For more information, refer to Abstracting NCI-Specific Information.
Submission NumberValue identifying the trial record in the sequence of submissions for that trial. An original submission is submission 1. For more information, refer to Processing Trial History Information.
Trial Submission TypeValue indicating whether the trial record is an original submission or an amendment. For more information, refer to Processing Trial History Information.
Trial Summary Report Sent DateDate on which the system sent the Trial Summary Report (TSR) to the principal investigator or trial submitter. For more information, refer to Processing Trial Milestones.

  • No labels