Signature Recruitment Strategy Agreement Template Made Easy

Signature recruitment strategy agreement template

[Music] [Music] hello everybody welcome to our July I got the month right and it's almost August yeah welcome to our July webinar let me pull up the files this is on regulatory for research clinics for research clinics and somebody pointed out to me and that clay animation video was very well received oh yeah people like that oh my face um yeah they like that a lot more than my regular videos kind of this point are lower than your face yeah yeah so regulatory Doc's in clinical research and one of the viewers from Australia let me know that they won't be attending because they have different regulatory documents in Australia fair enough fair enough but the process is the same I'm sure there's still IRB forms the solution no somebody else there's still financial disclosure forms but fair enough so let's get right into it Chris you can't see the screen but I will just read things out to you four concepts a little spitfire rapid-fire these topics and you will start talking oh yeah we will both do it okay so thank you everyone again if you join late or a colleague or a friend joins late you will get the replay link sent to you so let's move on to the next slide the first slide again very well done by Amy movies yes these are they did they've been reviewed in there that's how I did the animation video is because of these slides I had to actually edit some slides this time there was something missing amy amy was missing the protocol signature page section so you'll see when that slide comes up the design looks uh-uh the meeting keeps disconnecting me but it's okay we're gonna bear through this okay so the first thing is the 1572 right it's called the statement of investigator the investigators agreement this document holds the p.i responsible for the overall conduct of the study at the site would you agree it's the most important document in clinical research No are you okay so explain contract there was a two webinar four webinars ago country yes from a business game that's right from a regulatory standpoint yeah the 1572 maybe maybe the delegation and do these log that's uh well I know I don't know I would probably argue the delegation of these laws a little more important okay maybe are you gonna argue for both right fittings on you or the other mm-hmm 1572 is essentially your contract with the FDA okay so the 1572 will and by the way anyone that has never seen one this slide is blurry but you can just google FDA 1572 form and you'll get one and you can download and look at it okay so it has the name and address of PII name and address of labs name an address of IRB name of sub eyes and coordinators name and description of protocol so in a nutshell what the 1572 is is a contract this is how all was explained to me I just said you were listening when I was a coordinating of the contracts that contract with the FDA when I first started out as a coordinator one of my monitors sat me down and said this is the most important document young man this is the PI's promise to the FDA that they are liable for everything that goes on at the site and fluid and this is the audio keeps going in and out but this is when you are dealing with P is on the contracting side on the business side let's say you're a site owner and you're trying to recruit a P I which we've done webinars on in the past this is the thing that they will bring up if they know something about research and say hey well I'm liable for everything why am I only getting 10% they'll bring that up but that's a different webinar not this one we're not getting into all that we're just good this is the first one okay next one financial disclosure forms Chris Arbor what do you think about financial disclosure forms I'm just what you're what are they so first of all yeah first of all these are all start up we got to differentiate between startup regulatory and then ongoing regulatory maintenance can you give guru nation an idea of this darn up regulatory number ongoing maintenance so Starla Tory or the you the documents that are necessary for you to establish your site with both the IRB the FDA and the sponsor all right so the the storm of documents wouldn't typically include your 1572 your financial disclosure forms your IRB initial submission your protocol signature page and your IV signature page and often not always - you see an IV signature page but I'd say more than 50% of time thanks for going through all the slides sorry that's correct now when amendments occur to the study or there's a change in the study of some nature say the spot those PA changes the site moves you'll have to redo some of these documents so mean and says Dan had mentioned say the same moves well you're going to you'll have to file with our be because again do address for the site you'll probably even have to redo your financial disclosure forms depending upon how what information was initially required on those if there was no address you do not if there was an address listed then you have to redo those so you might have to go through all of the documentation again dependent upon what was initially gathered and what list of the address of the site again that's that's your maintenance along with your your delegation of duties log which I forgot to mention on initial start up you'll have individuals added or removed from the study and you have to maintain that as well so a lot of novice sites myself included when I started get overwhelmed when they get a start up a regulatory packet sure and the email you know is written making it seem like all those documents are so complicated you know you're out all these directions like three pages were sometimes three pages of directions for like six forms right so it could be overwhelming and just know that this webinar is here to demystify this yeah and for start-up regulatory all you got to worry about is the fifteen sent me to the FDF IRB questionnaire protocol signature page investigator brochure signature page there's if there is one ICF template if there is one and we're gonna get into all these here now that's not to say you won't ever see those forms again after your start up regulatory phases over that just gets into the maintenance phase right which we're gonna get into this might become a very long webinar so please bear with us okay but okay financial disclosure form so assigned FDF is required for every person included as a P I sub by our coordinator on the 1572 basically anyone who's inbox six on the 1572 form a financial disclosure form and this form declares that the person signing it has or has not any financial interest in the company sponsoring the study they're allowed to have financial interest in the company they just have to disclose that okay and every sponsor is different sometimes it's fifty thousand worth of equity sometimes it's sixty sometimes it's twenty five every sponsor is different I've seen usually I've seen those numbers or and sometimes days they include family members of the investigator so maybe if the PI doesn't know any stock in a company but maybe the wife does and that company is sponsoring the study they still have to disclose that right but usually there's a threshold if you own more than X amount and remember owning equities is a market so that number can change every day so sometimes you may not even know that you have reached that threshold unless you check so when in doubt just disclose okay next slide protocol and signature page again part of the startup regulatory and also part of the maintenance you'll get the protocol hopefully the PI reads it hopefully the coordinator reads it hopefully get trained on it you don't need to document any training until the SIV which is the site initiation visit so you don't need to worry about any delegation of duties log or any training logs although we're gonna get into those during the regulatory maintenance phase but for the startup phase you don't need to worry about those logs all you need to worry about is the protocol and the signature page you don't need to worry about actually doing the training and documenting the training just yet that's gonna happen you're gonna get plenty of training at your and after the site initiation visit so that's going to happen next slide delegation log I'll keep this delegation log and I wanted to get into you one more slide because the delegation log does not apply for startup so we're gonna come back to the delegation log that's what I just talked about but it's not part of the startup regulatory uh what is part of the startup regulatory are credentials like Seavey's GCPs I ate a certificate studies specific training certificates medical licenses now the studies specific training certificates you don't necessarily need it studies startup does it everybody need to produce medical license no who does those required for doctors nurses and other medical staff so if you're a certified medical assistant you should I realize since there if you were a LVN you should have your license you know if you're a coordinator and you don't have any medical license yeah or you finish college but you don't have a medical license like me right then you don't put that in there well just giving the extreme yeah but if you have a full bottom a certificate or ECG training certificate or something along those lines you put it in there and this is part of the startup regulatory so Seavey's must be current and must be signed dated what's that one no more than two years old aha explain why don't know I obviously don't know why but every time they went to current and must be current two years yeah mm-hmm I don't know what why that's kind of off two years but that it is GCP certificates you know that's funny because it used to be I believe they wanted to see that yearly right I don't think that's required any longer a matter of fact the others for clients they only allow you to do it every two years somebody is correcting us on the CBS okay must be current but FDA does not require a signature some sponsors do I think I'll do as well so you might be right in a textbook setting but in the practical industry real world I've never had a sponsor except a CV that's not dated so we just make sure that that's that's part of our SOPs well we go off a long tangent on the difference between what sponsor is doing with it yeah I mean if we want to admit it when it's tangible if you want to get into the FDA requirements you could be a high school dropout and BAPI you could be a grade school dropout and be FBI right yeah you can there's a requirement for the FDA all you have to have all you need a show for the FDA as far as they're concerned is that you have knowledge of that therapeutic area she said as she agrees so she says relax I added that part she said I agree yeah so another one some sponsors only require GCP every three years definitely it was just that yeah it used to be a year they were almost all a year now do you know what the FDA requires some DCP I just think they require GC you know again this is where there's a huge difference just require GC certification I don't believe I've seen a you know a time period of time frame on what it needs to be renewed yeah I think if you had a twenty-year-old GCP certificate I think that you could be fine with it I mean they may not - ray right that's a good age right if you don't give any specific guidance on that they give very bad guidance so generally boils down to industry best practices boils down to sponsor your best practices and then the site SOPs and the ultimate lights up to the PI right right because he or she is signing that form the 1572 and so you know but some sponsors only required you to be every three years that's good members we use for juicing training they'll allow you to do it once every two years yeah - you haven't seen one year I've seen 2 years 3 ears is a lot but maybe that's the case to you I've seen one year in two years when I when I was coordinating back in my day it was every year yeah and now I think it's become more prevalent - in site selection visits where they asked I've heard this a few times now where they asked how often do you require GCP certification renewal GCP foundation because they want to make sure it's not ten years right before it was just fairly well known it was a year but that's changed it seems to be changing to me mm-hmm it's it's more like whoever typed that four years it's more they're leading in warm-ups 2pi another person commented medical licenses in Canada are renewed every year so we need it every year so every country is their friend that's crazy in the u.s. it's every every state is different actually yeah California's four yeah so that's the credential I don't talk about Aida because that's the one that confuses a lot of new people yeah that's really relatively simple if you're going to be shipping biological samples what does i8a mean what does it stand for I think it's international that was Leonard Cole with maybe traffic is an air transportation authority station yeah that's I'm probably right yeah kugel - yeah International Air Transport Association okay it's shipping hazardous Goods right if you're shipping I was going to change what it said it said biological but change it to as we're just videos that question but you know if you're doing research it's the dry ice that's the main concern and then the blood second segment logics yeah yeah okay the penalty is I think $250,000 fine if you shift without yeah so whoever is viewing the processing the labs and shipping the lab samples needs that a certificate that P I does not need that unless they're shipping labs so Saab I does not need that unless they're shipping laps a coordinator doesn't necessarily need that unless they're shipping labs so only the ones who are shipping the labs need the i8 a certificate studies specific training and certificates this is for the maintenance part of the regulatory not the startup and I let me get to my slide training log we're gonna get back to this because this is part of the maintenance of the regulatory IRB approvals this is part of the startup and we discussed it but and it's so IRB approval as part of the start-up regulatory and it's part of the maintenance regulatory so when a site is getting approved for a study they have to submit an they have to get IRB approval call also called site activation so they got to send the initial survey now every year sites must renew it so this is part of the startup and maintenance okay initial and continuing reviews need to be filed so don't let your IRB renewal expire because then your protocol deviation any patient that you see while you're not IRB approved is a deviation question I've heard that sponsor sometimes submit to central IRB is on behalf of site is that your experience tooth yes sometimes they do but the sponsor can't the sponsor is not in my opinion the sponsor is not able to effectively and and the mic keeps cutting in and out the sponsor is not able to effectively answer all the questions in an IRB initial survey like they asked very specific things that a sponsor would not know unless they asked the site but then that's more work than just having the site do it so what the sponsors do what is common is they get the protocol approved they get the central recruitment marketing materials approved and they'll get the informed consent template approved but as far as the site activation and site approval usually the sites are the ones responsible for that and my experiences but you're right about the fact that sponsors do submit on behalf of the sites for protocol informed consent marketing material right there you're Experian my correct obviously I haven't been listening for us pretty slick right chris is in the process of buying a new house exactly very stressful times in the sabra household okay very day attention no don't worry I got this man it's the IRB approvals that's we have a very engaged audience that makes sense to me the the commenter says Thanks good good to hear so IRB approval that's gonna be startup and maintenance if he now we're gonna find my slide that I made if we find it if we don't oh my slide was the protocol signature page so that is missing from here but the protocol oh no this is my slide we already went over it so that's the startup regulatory now let's go through all the slides that we skipped to talk about the maintenance and enviable Investigator brochure is another form that is part of the startup so an investigator's brochure is the document that contains all the known data pertaining to the study drug and must be filed and it's almost rarely read by anyone have you ever met anyone that read the investigator brochure a few students a couple doctors that are truly interested but even the doctors usually aren't interested and then students right unless they're curious about somebody says yes my P I so their P I read stem s here brochures I mean and so you know some doctors are interested in it and they should be but what I've noticed is most doctors are that's gonna be a real a lot of voicemail most doctors will refer to the investigator brochure when there's an adverse event this person calls every day at this time it leaves a two minute voicemail really yes yeah you hear sorry everybody okay so that's the investigator brochure we don't want to violate any HIPPA laws while we're doing this webinar we're recording live from a clinic so needed for identifying sa ease of specific interest and management my P eyes do read yes they do some do most just glanced through the known essays and AES but sponsors make that clear at the investigator meeting anyways they kind of do an investigator brochure overview when you go to an investigator meeting yes we do have the recording of these webinars don't worry so that's the investigator brochure the last of the the last of the startup regulatory items so let's go through the so that's the startup regolith or it only took 22 minutes which is not bad and any questions just type them in let's go through the maintenance so a lot of these forms like I said it's maintenance and startup so we're gonna repeat now the 1572 we're done with start-up you will react Splore the 1572 anytime there's a change of VI sub i address lab IRB right 1572 needs to be so if anything listed on the 1572 has changed 1578 so even even some investigator who's been removed from the trial needs to be requires or somebody at it right you need a new 1572 right so any changes to the 1572 anything that's listed any change in there including from the sponsor side requires a new 1572 mm-hmm or this guy on the side yeah so your throughout a study you'll be you know as sub eyes come and go usually it's when sub eyes are added and or removed as when the 1517 needs to be updated and that will trigger new financial reforms if there's a new sub i added or a new coordinator added that goes on box six that's going to trigger a new financial disclosure form for that person so this is where the FDF becomes part of the regulatory maintenance as well as the startup protocol anytime there's a protocol Amendment right the protocol signature page needs to be redone and but now that now that we're in maintenance in that startup phase we got to fill out the delegation logs and the training logs so whenever there's a new staff member at the SIV you will fill out your delegation log for the site and the training log but we'll get to the training log for the delegation log if it's not already filled out by the SIV it will be done before you're initiated before the site is initiated which means before the site is a lot to screen well that's not always true so when is it not true well you're currently CRE on a study in which that was not the case yeah but that was not proper for the bed site right but somehow they got the initiation I've seen patients in the delegation dubois was employed correctly yeah not good right not good so it does happen oh it happened a lot of things happen but it doesn't address the delegation log needs to be completed prior to site being initiated the document lists who is responsible for each task in the study the PI somebody's come in think a 1572 does not necessarily need to be updated to remove a sub I as per FDA guidelines it may be updated to reflect the change upon the next revision this is where we get into the FDA and the sponsors again this is a common theme what the FDA says is very vague what the sponsor requires sometimes is not so big so every monitor I've had when a sub by is gone they want that 1572 updated it doesn't matter what the FDA says they do in excess of what the FDA says in almost every in almost every case they do in excess of what the FDA says so you might be right again as per textbook right that's not the general consensus when you work in research yeah question on 1572 uh y'all are funny but I worked with a site that added all coordinators to 1572 yeah is this recommended or what are your thoughts that's something that's changes over time that's required it's it's now standard I don't require it is a not a word we should use no I think even that day says oh the FDA or anything when it says in regards to that I just read this but it says something along the lines of anybody will have a direct directness for what I'm looking for reflect my reflection directly responsible for for gathering data in the study contribution of data yes thank you thank you that's not me that's a comment that's exactly what it says something like that will be reflected on the 1572 so you know you can make arguments here would that be like a recruiter probably not right they don't need to be on the 1572 but would a what if the recruiter is a backup coordinator yeah made them or an RN who is administering the IEP yeah probably so when in doubt it's not a bad idea to do an excess of what is required well again I think that a remand is an L right but let's say you didn't know right might as well just be safe yeah you got everybody on there yeah right you put through recruiter when I was learning research and I didn't want to ask questions back in Oh 506 I would put everybody on there and let my monitor tell me who I should take off right because I'd rather have that happen and may get deviate yeah get in trouble later so that's the thoughts on that that's the delegation log okay yeah so each person who signs the delegation log needs to have also documented training and we're gonna get to that slide training log also done at the SIV the first training is done at s IB or prior to SIV another question does IRB need to approve anybody added to the delegation log I've heard this in some cases not in my experiences in the United States but I've never worked with a local IRB I've only worked with central arabes so at universities and hospital I Arby's I don't know they they could require anything this person says it was a local IRB then that's yeah they have their own requirements and they talk about excessive with a sloka Larabee's orgasm and what the central IRB are typically only looking at the coordinator in that VI and typically and every one small they're gonna look at the satellite - they want to have that listed but it's generally just the coordinator in the DI for sure the pi4 sure the PA but outside of that usually the coordinator and every once in a while the P I back up in being back up yeah so usually local Larabee's another question I would like to know which important documents should be filed in the pharmacy file for the IP we actually have a slide for IP related documents investigational product logs so usually it's the IP order forms the shipping documents to confirm receipt a log of kids received and dispensed which is also called an IP accountability log right usually they have a master IP accountability log and a subject specific IP accountability log the master keeps cutting in and out but the master IP log goes in the Reg binder and the individual IP accountability logs for the patient's go into source documents for the patient's and then the packing slips and I also consider temperature logs part of regulatory documents for the IP so that's which documents should be filed in the regulatory binder for the investigational product section but every site has its own SOPs so maybe they have separate book and note to files in the right binder of where these files are killed mm-hm just like there's a section in the Reg binder for contracts however most sites don't put their contracts in there they just have a note to file contract is kept in the whatever business development office wherever it is wherever it is right so hopefully that answers your question so a training log ok this is probably where sites when it comes to maintenance this is probably where the many sites don't spend enough time on you could never over train have you ever heard of a site over training their staff ever well I'll take those stuff further I think even see how easily they do because it's not data right right there I mean CRA is really our like one of their metrics is to make sure they're resti being visits right so training is you know there's a section in the monitoring report for regulatory than they ask if any new training logs have been updated and but you know if somebody's busy with a lot of data they're not going to necessarily get to that even if they aren't that busy it seems they overlook a lot of these minor things in the regulatory reminder right so training logs super important first of all training training could be done at any time for any reason usually it's the P I that trained staff but it could be the site director somebody who's qualified to train somebody somebody else right it could be done for any reason any time the CRA can recommend training the CRA can actually do the training at the SIV and she or he can actually document that they were the trainer that needs to be done but most often training logs are updated whenever there's a protocol amendment which happens on average three or four times a study so that's at least three or four times that you have to go back to this log and again everyone on the delegation log needs to be retrained on the protocol right maybe you can argue that if someone's not delegated for let's say the protocol was amended for just one assessment well people who don't do that assessment maybe don't need to be trained on that but I've always gone excessive with that and just trained everybody I can make an argument why you would train everybody well specifically P is anybody that's directly involved oh the P I for sure anybody that's directly involve patients coordinators backups to both of course you're not gonna retrain the recruiters they right yeah someone's asking is there any guidance on how to determine what kinds of trainings need to be documented it sounds like it's generally based on protocol changes it is but like I said it could be anything anything at all let's say someone let's say a staff member is not doing a ECG properly or let's say what's another one but why correctly write the say that protocol requires that or the contract requires that gotta be interested in three days and the sponsors thrown a tizzy over this and once the staff retrained right right someone else brought it up in good one corrective and preventive action plans right that's that would be more with any of these items actually that would be document on the training log - right because before you get to a Kappa you probably have required someone saw the need for training and it's still not getting corrected right right another question does the pharmacist have a copy of the protocol and a copy of the delegation log so most sites don't even have pharmacists okay so I'm not sure I understand that question but it decides that do have a pharmacist of course they get a copy they're supposed to be trained on the protocol and yes they will be on a delegation log so yes there are many sites that do have pharmacists most don't most have a coordinator acting as a pharmacist or the PI cos elves acting as a pharmacist and a trick question yeah go ahead for you would like this you don't think that's around joking but so a change in SOPs [Music] they you're supposed to have a training log for the SOPs and changing the SOPs the site should have its own training lock like a master training log right I changed in SOPs would require training yeah yep as long as you're doing it on the master training log for that if it's something that's not protocol specific and somebody will reset up it's not even a trick it's the master you get a master training log right you don't put it on this if you don't put it on the study specific training log and your monitor says hey you've updated your SOPs they need also updated our master training log so we're good and they can insist that you put it on the site specific training log and then you can get into these little arguments that many people like to get into you which are meaningless at the end of the day because they don't do anything just do what they say pretty much I've learned to just do what they say yes unless they're telling you to do something against protocol sometimes they do that I got a yelling match for the CRE over this recently that was years ago okay Oh yelling match well maybe we'll have time to talk about there maybe we'll save that for the podcast yeah let's leave that for the podcast we'll make everyone have to go subscribe random musings from the clinical trials guru everyone okay so delegation log credentials training log IRB approvals ok screening and enrollment log ok sites must maintain an up-to-date log that lists each subjects subject ID name and initials sometimes that name again this is one of those areas where sometimes I've seen names and there I've seen I've seen required I've seen logs where the sponsor required Social Security numbers I've seen logs where the they wanted some kind of site ident is some kind of subject identifier I've seen logs where they required the driver's license number it seems to be in violation of no but it was there but usually it's be identified its initials subject ID date of birth usually with that if you know obvious somebody's driver's license you have right and so the argument is do you need to put that in the ring binder and with the subject screening in a romantic and again it boils down to the site SOPs the FDA guidance on this is slim not very helpful okay so that goes in there and that's another thing that sites don't when they're especially when they get busy they don't maintain their screening and enrollment log like it's a very frequent action items that monitors fund is you have an updated your screening or enrollment log since the last time I came so you need to go do that why did the series ask for this not because they want to give you a hard time but because they're required to scan copies of all these documents when they go back they're required to do this ok another log I'm not sure if it's on here is the informed consent log which is very much related to patient lives so the informed consent log is one that needs to be maintained as well and a lot of sites do not maintain those so that's another frequent action item safety reports there's a section in the Reg binder and again this is one for the maintenance of the regulatory binder safety report so sites must file sushar suspected on suspected serious adverse reaction reports in the regulatory binder whenever there's a SAE that is suspected meaning it's suspected to be related to the IP and unexpected meaning that should say unexpected not unsuspected unexpected means that the that the SAE is not listed in the investigator brochure so whenever an SAE happens in any study utilizing that investigational product the site the sponsor in the IRB send a sushar report to all the sites participating in that study and all the p.i all the pies participating in this study need to acknowledge that they've received and read this Susur report by signing and dating and filing in their rep binder and when the CRA comes if you're on a study with a long list of susur's CRA comes with a log and they literally check to make sure that every single Suzy report on their log is in your reg binder signed and dated by the PA so that's what two sirs are in a nutshell and that's what you will be dealing with there let's see if there's any more slides and get your questions in whenever you can newsletters and correspondence so any IRB CRO monitor and sponsor correspondence need to be filed there's a section and the regulatory binder for that correspondence can be in the form of printed emails from the sponsor or CRO confirmation and follow-up letters from monitors need to be filed in the Reg binder usually they need to be signed by the PII that they've been looked at the reason is there's usually tons of action items on these things so you're documenting that somebody's aware the PA is aware of these action items and action items are created so that the sites can resolve them they're not created just for fun so that's where the action items are documented in the follow-up letters monitor visit logs also need to be filed and updated at every visit but that's done by the monitor sometimes they forget sponsor issued newsletters also need to be filed Clea waiver or a CLIA certificate so at least in the United States every site needs to have a clear clear waiver or a CLIA certificate and it's run by the by the federal and by the state okay although most sites use central sites use a central lab a CLIA waiver is still required in those cases so now I got another question do safety reports distributed by IRB need to be acknowledged do safety reports distributed by IRB need to be acknowledged sounds like a duplicate of what sponsor sends it's it's the Susur report that needs to be filed anything that IRB sends should be an IRB section and that's it so any other questions let us know this could be a difficult topic I know when I started out in research I was overwhelmed with regulatory I mean it was hard enough to handle the patient visits and the source and recruit patients and manage my budgets and do the business development and then last thing I wanted to think about was regulatory but that's if you really think about it probably the most important because this is a highly regulated industry what is a CLIA waiver that's in the United States it's a central lab certificate you need to have a lab certificate from the state and the federal it's called a CLIA so if you don't if you're not sure what that is you need a Google CLIA and your state to see what the requirements are whether you can get a waiver or whether you can get the actual certificate how often do you have to report protocol deviations to the IRB I've had different opinions from different sponsors on this I have some sponsors telling us that you need to send protocol deviations today or B every single time and I've had some sponsors tell me that you only need to send protocol deviations when they affect subjects safety I've always I always err on the side of caution and I send every deviation to the IRB the IRB yeah this person's correct if you're in doubt contact your IRB and ask if it's a reportable deviation or contact your CRA and ask somebody somebody commented I arby's would tell us not to send but we would still submit regardless that's that's a good strategy to I mean it's always better to err on the side of caution and get it documented if somebody tells you it's not required get it in an email so hopefully that is it and I will send the replay to everybody that registered and anybody that needs our site services for business we get the studies for you we do the feasibility surveys for you we're your lifeline you can call us at any time myself Chris and the rest of our staff to ask any questions you ever may have about regulatory I apologize for the mic cutting in and out got to figure that out with the webinar but that's what our consulting services are and anyone interested in hiring us for that text me email me give me a call other than that I look forward to interacting with all of you on social media or elsewhere and I will take a few more questions and then we will go so would like one session related to you medical device regulatory documents so I'm I can't do that yet because I'm I will as far as medical devices are concerned a medical device regulatory the regulatory documents are no different if you're a site the regulatory process is the same where it differs between a drug or a device or a diagnostic is from the sponsor level so that's another area where that's another reason why people are overwhelmed when it comes to regulatory because what the sites deal with when it comes to regulatory is pretty straightforward what the sponsors deal with when it comes to regulatory like I've been in this industry for 13 years and I don't understand all the pathways there's different pathways that sponsors need to take depending on what type of investigational product they're dealing with so medical devices falls under a certain pathway but when it comes time to doing the actual study and when it comes time to for the site to maintain a regulatory binder or to do regulatory documents for a study startup they're all the same it doesn't matter if it's a device an investigational product a diagnostic that's the same all the stuff we covered is the same what you're asking is medical device regulatory documents from the sponsors perspective from a regulatory pathway and I am no expert on the people who know those things charge three to five hundred dollars an hour so it'd be very expensive to get one of those people on a webinar and I don't think most of us in the industry really care about that I think those of you on this podcast are looking to be CE Ras or are looking to open clinics or have clinics and you don't need to confuse yourself there's going to be plenty of for you to be overwhelmed with it without having to worry about regulatory pathways you can google it there are some pretty complex pathways if deemed non-reportable so someone's commenting submitted per the IRB guidelines if deemed non-reportable have the P I initial and date the section that states its non-reportable yeah and see every every IRB is different - so it just it really varies from study to study sponsored a sponsor IRB to IRB when in doubt ask and document ask via email rather than the phone because it's easier to document in an email for sites without a local lab you guys are asking lots of questions which is very good for sites without a local lab you mentioned a clear waiver is still required correct or a certificate I don't know the state its states are also overseeing this is a clear waiver study-specific know a clear waiver is site-specific many medical offices already have a clear waiver and then if those offices are also doing research but under a different business name for example if dr. Johnson medical practice has a CLIA waiver and dr. Johnson owns a research clinic within the same office called south coast clinical trials south coast clinical trials will need to file for its own CLIA waiver as well even though dr. Johnson already has a clear waiver it needs to be in the entity name of the research clinic second question any other documents under the lab category that are typically needed for sites using a central lab you'll need a lab manual there's not really much you do there except training the staff that are processing labs and that's it thanks Chris and Dan tell Chris to lower his price or yeah we I'm not sure if we could lower our consulting price because we do we're actually significantly less than our next lowest cost competitor so we were already pretty low but as I hear you as far as having the modified one date class that's something we can consider in the meantime we don't mind doing these things for free I mean we do these one-day classes on these webinars so if you ever have a topic you need help with just let us know and we might do a webinar on it another question so if our office is not processing or shipping then they need a CLIA in addition to the lab CLIA I'll Google yeah just Google the CLIA waiver or CLIA certificate in your state need to have a current copy of the lab administrator license on the file that's correct if it's a central lab they will provide that for you but you need to make sure you have that on file there's a lot of details this is still overly simplified your webinar we did not we didn't open our egg by noon just dissect everything in there we just covered the most important concepts and the most important things in there but yes you're right on that yeah I don't mind getting into the details I mean I'm all well you know one of the commenters is saying we should do a one-day webinar where we charge and we just go like three hours into it or four hours five hours into it consulting services oh we have a copper Chris is back you bought your house yet Wow congratulations so tell them about our conference well we don't we can't announce it yet but tell them Florida hold what city Orlando Orlando be in Orlando and we don't have a name for it yet it was the unconference but we're gonna go with that it'll be something similar to that most likely where instead of just hearing what's good term for this crowd well you said it's uh you might as well just roll with it so instead of not getting direct answers to any questions you may have or things of this nature instead of hearing industry hyperbole like we always do where they talk about things that mean nothing to you like patient centricity and site centric and just nonsense I'm not saying those things are not since I'm saying that those phrases are nonsense because they're just buzz words thrown around that lose their meaning we're gonna have a real conference where we're gonna actually provide value and everyone that gets in there it'll be an unconference yep and everyone's gonna get something you know if you're a site you're gonna get to meet other site owners and maybe walk away with some studies if you're somebody that wants to be a CRA or you are a CRA you're gonna meet people from different sponsors and CEOs and sites maybe they're looking for consultants there's gonna be a lot of value and getting back that we create but what we really want what I really wanted Chris to go is what Chris doesn't read minds what well you said yesterday you said we should start doing this in our webinars so this would be a good spot to test out our materials mm-hmm right that we'll be using at the conference yeah to see if you know people who've paid for this material this three-hour material if they found it beneficial how much commenter who sir dinner up Chris commenter who the commenter that mentioned that we should do a one-day webinar class how much would you be willing to pay and how many hours would you expect just reply in the comments I forget who you were but that's a not a bad idea I never thought of doing that we got so much going on who's gonna think of one more thing leave the comments but yes so what do you guys well this person's common thing that and we're gonna add sin I won't be mad if you leave now what do you guys want to get out of a conference list your I wish I could unmute people because a lot of you are on the phone unfortunately it's muted and I can't unmute in a webinar I can unmute in a meeting but not in a webinar so just chat or text me later the conference is gonna be in September in Orlando so this person says I would pay for info that's not basic intro research so like our CRA Academy but they're saying that's too expensive so they want like a lite version of the Siri Academy not light on the concepts and that wouldn't be a good testing ground for well for example I think I know where this person is getting into in our Syria Academy we have like 12 modules okay why don't Liz I'll just take one at random week one a site selection visit so I think what they're saying is I would pay for like a three-hour webinar on site selection visits where you just go in-depth but I don't want to pay for the whole thing right so maybe like 300 bucks 200 bucks with and she's saying yes exactly see I get I get what home because I'm on social media I'm still what what material specifically are they looking to have covers per module per topic like well we have just a car but they're gonna have to be different because they're not the actual module is it's gonna be a live webinar like those right where we just go in-depth and people just type questions if you could break down the modules yes so people are telling us they want those we got some more work to do Priss you won't be getting any sleeping in new house do a test and see what happens then go from there as to your live meeting yep yeah was the microphone cutting in and out bad or was it just the more annoying for me my mic kept cutting in and out this any meeting is doesn't like my mics FOMA on this end do two mics yeah mic wasn't bad glad I enjoyed it I can see when the mic goes out so I just tried to not talk so it'd be like weird pauses in between my thoughts right but whatever intermittently but you picked up right where you left off okay yeah I'm gonna contact you any meeting and see what's going on with the mic somebody trained site so it wasn't bad I'm glad I joined I appreciate picking your brains absolutely thank you for the good idea thank you for the support if there's no more questions we're gonna go record a podcast right now this will be episode 173 so the next one will be 174 yes certain No a little bit of Rancho no thank you everybody adios and goodbye [Music] [Music] [Music] [Music]