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loanranger

02/05/21 11:30 AM

#344162 RE: Jhawker #344159

The source doesn't say so I believe that defaults to calendar days. I found it here:

"When Do I Need to Register?

The responsible party (that is, the sponsor or designated PI) for an ACT must submit the required clinical trial information no later than 21 days after enrollment of the first participant."

https://clinicaltrials.gov/ct2/manage-recs/fdaaa


The full Rule is here:
https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission

loanranger

02/05/21 11:51 AM

#344176 RE: Jhawker #344159

ps. "Enrolled" is defined as the signing of an informed consent to participate in the trial. The day the first person does that is the Study Start Date.

https://clinicaltrials.gov/ct2/manage-recs/faq#fr_28