ClinicalTrials.gov Protocol Submission Help

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This post is intended to help by outlining the process and procedures for submitting a protocol to ClinicalTrials.gov.

Who this applies to:

You are: wanting to start your own drug intervention protocol that is not currently receiving funding from your home institution. Your IRB has told you that since you are not receiving direct support from your home agency/hospital/school that the responsible party, you, must submit your protocol to ClinicalTrials.gov under a private account. You are probably also needing to do this because the FDA IND exemption submission form requires that you have a valid ClinicalTrials.gov ID number for them to even look at your application.

Generally most institutions have a single protocol submission account that lists the institution as the responsible party. In cases where the Primary Investigator is using funding from a private source the institution will try its best to not be held directly liable for your protocol. This is where they will force you to get your own account.

Caution:
Investigators using institution funds. In this case tell your IRB associate to create this account for you under your own institution. You will still have to fill in your own protocol info like below, but the account will belong to your institution.

Firstly:
Go to http://www.ClinicalTrials.gov and make your way to the Protocol Registration System Account Submission page: http://prsinfo.clinicaltrials.gov/

Click on Individual Account Application http://prsinfo.clinicaltrials.gov/indivApplication.html and fill in the necessary information. You should get in email in a day or two with a unique log-in ID and password.

Secondly:
Log into the registration system at http://register.clinicaltrials.gov and it will ask you a few questions to see if your protocol is going to be FDA regulated or not. If you are using a prescription only substance then your protocol is going to be FDA regulated. If you are using something that is over the counter, especially a herbal formula such as Huperzine-A for instance, then it is probably not FDA regulated. The FDA is responsible for ensuring the health and safety of food and drug manufacturers around the country. Some over-the-counter remedys, such as Huperzine-A, are classified as "foods" rather than "drugs." The difference here is that "foods" are regulated for hygiene, such as the FDA will inspect the plant to make sure that birds are not nesting and dropping on the product lines inside the warehouses, or everything is being refrigerated, products are being freshly ground and properly stored, etc... Drugs are regulated in these same ways but they are also regulated for potency (generally against a USP lot, more on this in another article).

Thirdly:
Follow the system prompts and it will get your protocol registered in the ClinicalTrials system by assigning a unique ID number. Things to be aware of: Be sure and use valid MESH id terms in your keywords and search terms submission, trying to get creative will only delay your submission. Be sure and outline the dose, route (oral, IV, etc), and frequency (BID, TID, etc...), or else you will be eventually flagged.

Please post if you have any other questions.