Therapeutic Solutions International Inc (TSOI)

[BigBadWolf]

What studies need to be posted on ClinicalTrials gov?
ClinicalTrials.gov allows the registration of clinical studies with human subjects that assess biomedical and/or health outcomes and that conform to: Any applicable human subject or ethics review regulations (or equivalent) Any applicable regulations of the national or regional health authority (or equivalent)

Which Trials Must Be Registered on ClinicalTrials.gov?
The trial has one or more sites in the United States.
The trial is conducted under an FDA investigational new drug application or investigational device exemption.

https://clinicaltrials.gov/ct2/manage-recs#:~:text=ClinicalTrials.gov%20allows%20the%20registration,regional%20health%20authority%20(or%20equivalent)

Ongoing means, with respect to a clinical trial of a drug product (including a biological product) or a device product and to a date, that one or more human subjects is enrolled in the clinical trial, and the date is before the primary completion date of the clinical trial. With respect to a pediatric postmarket surveillance of a device product, ongoing means a date between the date on which FDA approves the plan for conducting the surveillance and the date on which the final report is submitted to FDA.

https://www.ecfr.gov/current/title-42/c ... )(Ongoing)

(FDAAA 801) requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant

Re: JadiCells won't always be JadiCells
Post by TimGDixon » Wed Jul 20, 2022 6:17 pm

That's right everything was submitted and is sitting there but hasn't been cleared yet and when it is we're not going to check the box to make it visible. That's what I'm saying.
“...my pathway led by confusion boats, mutiny from stern to bow... Ah, but I was so much older then I’m younger than that now...”