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Page: ClinicalTrials gov
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5 ClinicalTrials gov
calexh-sar edited this page 2021-04-13 12:49:55 -04:00
Table of Contents

Business Requirements

  • If applicable, the study must be registered with ClinicalTrials.gov prior to enrolling the first patient. Clinicaltrials.gov is a registry and results database of publicly and privately supported clinical studies. Registration of "applicable clinical trials" is required by FDAAA 801, NIH policy, ICMJE and CMS. It is the responsibility of the "sponsor" to register all applicable clinical trials.
  • If applicable, the Coordinator will provide the study's Clinicaltrials.gov NCT number.
  • If applicable, the Coordinator will provide the study's type, which will be picked from the following list:
    • Interventional
    • Observational
    • Observational - Patient Registry
    • Expanded Access

Protocol Builder Interface

This workflow does not rely on data from PB.

CRC1 Stats

This workflow does not have any CRC1 stats.

Study Dashboard Menu Dependencies

State Condition
required Datastore dsCTG is "true"
disabled Datastore dsCTG is null
hidden Datastore dsCTG is "false"

The datastore dsCTG is set when the Coordinator answers the question "Does study need to be registered at ClinicalTrials.gov" in the Core Info workflow. An answer of "Yes" sets dsCTG to "true" and an answer of "No" sets dsCTG to "false".

Workflow Description

When available, the ClinicalTrials.gov workflow allows the Coordinator to enter the study's NCT number obtained from the site and indicate the study type.

image.png

Documents

No documents are produced from this workflow.

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