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Initials clinical trial agreement template

hey guys welcome back to the clinical trials guru.com again it's d clinical trials guru calm email me your questions dan MD clinical trials guru calm I'll keep you anonymous I'm also on every social network you can think of so today's question it's going to be a quick video right I had some questions can you explain the process for an initial study start up like what documents and binders are created and what binders should be updated from a clinical research coordinator aspect so when it comes to start up you're gonna get a regulatory packet if you're using a central IRB you're gonna get a regulatory packet from the sponsor or the CRO and as a matter of fact if you're using a local RP you'll still get the regulatory packet but because your IRB is different the IRB aspect which I'm going to talk about in a little bit is going to be handled differently so central IRB is definitely easier if you have the option so you'll get a regulatory packet that will consist of informed consent template if your central IRB again if you're a local IRB you'll get a template but you it has to be approved by your local IRB if you're a central IRB you'll get a template where you update your phone number your address Pai name emergency hours phone number and the IRB has already approved the script so you'll get that you'll get a 1572 which is usually not pre-populated meaning the sponsor did not put investigator name Adria sub investigators on there sometimes you'll have the protocol title on the box I believe it's box five so you'll get the 1572 that you'll have to complete you'll get financial disclosure forms for your PI and for your sub investigators again you'll have to put in their names your site name and then don't have to check one of the boxes that applies to them you'll have to get the IRB questionnaire so the IRB wants to know a little bit more about your site a little bit more about your p i-- how much staff you have to dedicate to this trial so again if you're using a central IRB it's relatively easy it's usually like a 10 to 12 page document that they the IRB is just asking different questions have you ever been audited by the FDA has a study participant ever sued you things like that I'm trying to think what else there you'll get the investigators brochure you'll get the protocol you'll get the protocol receipt an acknowledgement letter you'll also get the IRB acknowledgement letter that the PI needs to sign and state that he or she has read those things and is familiar with the protocol and the investigator brochure so you can get away with just one binder as your regulatory binder what causes these regulatory binders to get full is the safety reports as the studies ongoing so as the studies ongoing you may start with like a pretty thin binder and as you start getting these safety reports from your IRB or from the sponsor you have to file those in there you also file any other correspondence between you and the sponsor you and a CRO and the REC binder another thing in the Reg binder is the delegation of duties Lugg so it's very important that the PI goes through and lists every single staff member that will be associated with the trial and then they all have the initial and date after their responsibilities are put on the delegation of duties log so that also goes in the Reg binder so that's kind of what you have to deal with when it comes to study start up and if you're the coordinator lucky you you will get the fun task of doing all of this because the P I usually just signs it you may or may not get the task of doing the contract and budget usually rare that a coordinator will be asked to do the contract on budget but that's also part of the state startup process so you can't start the clinical trial even if all your regulatory stuff is done and approved you can't start a clinical trial if you don't have an agreed-upon clinical trial agreement a CTA and a budget so you have that those are usually kept in a separate binder because the FDA can look at everything in the Reg binder but they cannot look they do not have to look at the budgets and contracts unless you put the budgets and contracts in the regulatory binder so my recommendation is don't put them in there you don't want the FDA to look at anything else that they have to look at all right so and then you ask the question about recruitment look up on my blog I've got a page dedicated to recruitment and probably like a 30 to 40 minute video so just go to my blog and look at patient recruitment slash patient recruitment services I have like a book literally a book that I wrote how to recruit clinical trial study participants that you can read for free on there it's also $2.99 on Kindle it's a little nicer format but you can read it for free on the blog if you can't afford to 99 and you can also watch my video it's like 30 minutes hopefully this and that helps you out let me know if you have any other questions and keep these questions coming dan at the clinical trials guru com take care