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Updated ClinicalTrials gov (markdown)

Shane 2021-04-05 09:45:02 -04:00
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ClinicalTrials-gov.md

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### Business Requirements ### Business Requirements
- If applicable, the study must be registered with [ClinicalTrials.gov](https://register.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 study must be registered with [ClinicalTrials.gov](https://register.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 Clinicaltrials.gov NCT number.
- If applicable, the will provide the study's type, which will be picked from the following list: - If applicable, the Coordinator will provide the study's type, which will be picked from the following list:
- Interventional - Interventional
- Observational - Observational
- Observational - Patient Registry - Observational - Patient Registry