Page History
...
Field Label | Description/Instructions | ||
---|---|---|---|
Trial Oversight Authority Country* | Select the name of the country in which the oversight authority organization is located. | ||
Trial Oversight Authority Organization Name* | Select the name of the organization that oversees the trial from the drop-down list. | ||
FDA Regulated Intervention Indicator* | Indicate whether the trial is regulated by the FDA by selecting Yes or No.
| ||
Section 801 Indicator* | For interventional trials, indicate whether the FDA-regulated interventional trial is an applicable trial as defined in US Public Law 110-85, Title VIII, Section 801 by selecting Yes or No.
| ||
Delayed Posting Indicator* | This indicator becomes available only when you indicate that the trial is applicable under Section 801. Only the CTRO can modify this indicator’s value:
To change this indicator’s value, submit a request to the CTRO at ncictro@mail.nih.gov. | ||
Data Monitoring Committee Appointed Indicator | Optionally, indicate whether a data monitoring committee has been appointed for this trial by selecting Yes or No.
|