Updated ClinicalTrials gov (markdown)

calexh-sar 2021-04-02 00:21:11 -04:00
parent 5d2d76e741
commit 83b3784586
1 changed files with 16 additions and 4 deletions

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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 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:
- Interventional
- Observational
- Observational - Patient Registry
- Expanded Access
### Protocol Builder Interface ### Protocol Builder Interface
This workflow does not rely on data from PB. This workflow does not rely on data from PB.
@ -8,12 +15,17 @@ This workflow does not have any CRC1 stats.
### Study Dashboard Menu Dependencies ### Study Dashboard Menu Dependencies
| State | Condition | | State | Condition |
|----------|-----------| |:--------:|:---------:|
| required | | | required | Datastore dsCTG is "true" |
| disabled | | | disabled | Datastore dsCTG is null |
| hidden | | | 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 ### Workflow Description
When available, the ClinicalTrails.gov workflow allows the Coordinator to enter the study's NCT number obtained from the site and indicate the study type.
![image.png](https://images.zenhubusercontent.com/5f0623d8a1d620a9f39301dc/8167df78-f023-4367-b61b-d56a78f1f411)
### Documents ### Documents
No documents are produced from this workflow. No documents are produced from this workflow.