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Consent initials

hey guys welcome back to the clinical trials guru again it's the clinical trials guru com where I bring you content on a regular basis I'm trying to get 24 7 at least as far as accessibility so get me on cyberdust linkedin twitter facebook youtube email dan at the clinical trails grew calm texting 94 94 156 256 call me at that same number 94 94 156 256 however it is you want to talk snapchat whatever it is I don't care I'm also coming out with a linkedin group shortly today's video / podcasts is at least I'm going to try to keep it on the short side okay we're going to get into you three topics three questions that I got that I didn't cover in my last podcast which I thought were pretty good and I wanted to spend some more time and I want to rush through them in the last podcast to keep that one short so I'm making this other podcast so the three topics are going to be the first topics an interesting informed consent issue and maybe an ethical dilemma that a principal investigator is facing the second issue is in regards to what is the best kind of software to store and manage your study participant database your calendars that you can share with your all your researchers at the clinic so patient database shared calendar well what kind of databases can you use basically okay and my answer is going to probably surprise you although it shouldn't surprise many of you but it probably will and the third one was actually about a something related to recruitment and I'm going to have to pull it up here soon but I'll remember it as we go along so the first one there's I got a question from someone who will remain anonymous of course and by the way all you guys are going to be anonymous so hey then a quick question regarding a real situation is it okay to leave out of the ICF which is the informed consent form one or a couple of possible risks and just mentioned that other risks may be discussed with a study dr. a study doctor has a very strong concern that there is a very realistic long-term complication as a result of participation in the study he/she is discussing that possibility with subjects while consenting however this specific risk never has been listed in the informed consent please note the p.i is actively participating in an ICF drafting and approval process do you think it is right hope to hear your and others opinion so obviously I don't know the specifics and I don't i'm not a clinician i'm not even going to try to get into that and this really depends what phase it is if it's a phase 3 that means that they had two phase one in the phase 2 studies to gather enough data and for some reason the fact that it's not listed on the informed consent means an IRB approved that they approve that that omission from the ICF and the question is why and you can speculate as to why maybe there's not enough data showing that it's a possible risk maybe it's just this particular pies opinion and he has every right not only their right but their responsibility to tell his patients that are consenting what he thinks about the study drug but that doesn't necessarily mean that it needs to be in the informed consent on the other hand it might need to be in there and just to be on the safe side if I was your pie because he is part of the committee that drafts the informed consents he may have a conflict of interest they may be perceived as such later by a regulatory agency they may ask him why didn't you speak up at that time or her him or her why didn't you speak up by the time so just to be on the safe side I would set up if I were the p.i a teleconference between him the IRB and the sponsor and the CRO if there is one and talk about his reasoning for why he thinks it should be in there and why he why he's telling all his study participants during the consenting process that this risk is a possibility from the IP this teleconference should be it doesn't have to be recorded but someone should be taking notes to have some kind of proof that it did occur and that your P I did his part to bring up his concerns so that's what I would do and if you can't find a mutual time for the IRB and the sponsor and the P&ID all meet together the P I should call the IRB and the sponsor separately and have separate discussions that's what I would do now it could just be that there's not enough data to support it and the IRB was okay with that so there's a lot of things that there's a lot of ways this can go and I yeah just for you know to keep this video short those are my two suggestions or those are my suggestions and my two reasons for why the ICF does not have that particular adverse event okay next question it's in regards to what kind of software should we be using at a research clinic and I'm finding it here yeah hey then so any advice for what kind of soft database we can be using such as for electronic medical records patient database having a shared calendar something that we can all collaborate on at the clinic we have a somewhat small clinic with about five coordinators 1p I and what would you suggest so here's what i would do there's a lot of software out there that is designed and specifically for clinical trials there's one I'm not going to mention their names I have nothing against them but they are very expensive and I've never used well I think the back i have used their product once i didn't pay for it i got a free trial and it was something like 400 bucks a month those make sense for a really large clinic okay like I'm talking 20 coordinators or more for in your case what I would do and this is where I say this answer would surprise most people I'm all about bootstrapping I'm all about using free resources when you can and if you use my strategy it's actually HIPAA compliant too because you're not putting any identifying information for patients now before with that being said this is not an electronic medical record system for that you need to actually follow the federal guidelines for EMRs okay that's totally separate if you're using electronic medical records you have to comply with that with those systems I know very little about those but when it comes to managing your own site and having your own patient database use something like Excel something as simple as an excel spreadsheet that the site director or the team leader keeps a file of and anytime there's a new patient coming your clinic add them to their now in order to keep it HIPAA compliant you can just put initials and a phone number and diagnosis okay another thing I use as far as the show calendar is Google Calendar Google Drive Google Drive is fantastic I've used it with much success at some of my smaller clinics you can put patient initials on certain dates and you can write what study they're coming in for this works really well for small clinics so you put patient initials the visit that is going to be occurring so like C dash L screening on october first and you can even put the time everyone who you give access to you and your google drive so in your case like five or six people will be able to see that and we'll be able to schedule and coordinate their schedules accordingly so that you don't put too many subjects or study participants on one day because someone didn't know that these people are being scheduled so using google calendar and of course use the initials you never want to put the patient's full name on these things even though Google Drive google claims it's secure and it's HIPAA compliant but just to be on the safe side initials visit and study okay and if you guys have acronyms for the studies even better most studies have an acronym even better should this get in the wrong hands your Excel spreadsheet is just to have the patients names and phone numbers easily accessible for you although if you have an electronic medical record system you can use that but it's more complicated because you each user needs privileges to get into that thing whereas the study participants that you will put in your Excel spreadsheet are people who have already indicated that they are interested in being contacted about studies so definitely check with your own site SOPs for that and have processes and procedures in place should you ever get audited by a regulatory agency the processes and procedures are in place and make sure that you are following your own procedures okay and related to following is following up all right this is an especially in RM when we're dealing with and we are facing the present situation which is September 2014 where there is a low study supply out there okay so you have a lot of research clinics competing to get the same studies from a few sponsors who are actually willing to do studies at this time so what you do what do most sites do most sites attempt an email and a phone call the sponsor may usually they won't answer the phone so you'll leave a voicemail and you'll send an email and that's it that's where they stop and that's not what you should be doing okay you should be calling every day finding different people you can talk to you until you get concrete information about whether your site has a realistic chance of participating in the study or not so until you hear sponsor telling you they're not needing any more additional sites at this time but we will put you in our database and make sure you get put in their database until you hear that don't stop calling okay and even after you hear that still keep regular follow-ups like once a month would be ideal you don't want to annoy these people either once a month with an email and maybe a nice handwritten letter from your clinic adds a little extra touch you do we can in this market right now okay but follow-up it follow-up does not mean one email and a phone call that's it no follow-up means every day until you hear from somebody and if you're getting the runaround find other people to talk to until you get some solid information all right that's what you guys should be doing there was a question on recruitment that I'm not able to pull up right now but when i do i'll do another video on that okay so anyways thank you guys for watching this is dan from the clinical trials guru calm and i wanted to give my clinical trial guru producers an acknowledgement here it's south coast clinical trials sarah elizabeth sigler resolve research solutions accurate clinical trials Earnhardt clinical trials ptnr Patrick stone darshan Kulkarni biopharm systems I'm wire mosey o st. Paul Medical Research Center atria clinical trials phlebotomy services LLC and I think there's a few more I don't want to leave them off we've had a new a few recent add-ons here rheumatic disease Clinical Research Center Glen exes researcher LLC coastal Connecticut research LLC atria clinical research management thank you guys all for watching listening interacting with me I keep your questions coming however you want to send them to me just get them out to me dan from the clinical trials guru com take care