Amino Atlas Research · not recruiting

The pathway

What a Clinical Trial Notification is

What it is ✓ The rule

Under a Clinical Trial Notification, the sponsor tells the TGA about a trial an ethics committee has already approved. Supply is lawful only inside that trial.

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The TGA does not evaluate the product. Supply goes only to the people enrolled in the trial, under its protocol.

What it is not

It is not a retail channel. Calling customers participants does not make a trial.

The steps, in order
  1. Choose one condition that has no registered trial and an outcome that can be measured.
  2. Find a principal investigator at an institution that has its own ethics committee.
  3. Have the product made to pharmaceutical manufacturing standard, with release testing of every batch.
  4. Write the protocol, the investigator's brochure (saying plainly there is no published controlled human data), the participant information and the insurance.
  5. Submit to the ethics committee (usually 30 to 60 days).
  6. Lodge the Clinical Trial Notification with the TGA.
  7. Obtain the state authority to hold the substance at the trial site.
  8. Run the trial, report safety events to the TGA and keep every record.
  9. Publish the result, whatever it is.
What participation would mean

If a study is approved, taking part would start with informed consent. Anyone could leave at any time, without giving a reason.

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It would mean joining an ethics-approved study. A named doctor would be responsible for each participant's care, and for follow-up afterwards.

Tell us you are interested

Status: not recruiting. No ethics approval exists yet.

This form opens when we have somewhere to keep what you send. Until then, use the contact page.

What we keep: your name, email and role, and the date you sent them. Nothing else.

It is not a medical record and is never shared. Email us and it is deleted.

We will only contact people with information an ethics committee has approved.

Questions? Use the contact page.