[Music] it's not that i don't want you here it's something about the way you stare at me hey my loves all my cra babes all my clinical research babes so i'm coming to you guys with a video um basically on seven monitoring tips to help you conduct interim monitoring visits so these are your on-site visits that happen between what we would would be your siv and your closeout visit so that those those visits that are right in between you know the bread and the butter the the stuff you know this the the real nitty-gritty stuff of what you will probably doing and preparing for throughout your like time away from the sites right so stay tuned for the tips you guys because i i use these tips anytime i'm preparing for an on-site visit um you might have other tips if you have other tips for you know new cras who aren't really sure um or who are like learning put them in the comments please put them in the comments because this is a community we're trying to help each other um and you know you never know who you might be helping because people might be in the comments that might read stuff you know i'm like you know what or if you have any questions in the comments you put them in the comments as well all right so let's get started first things first before anything else you have to confirm the visit with the site staff right so you need to make sure that just you coordinate with them give them like what i normally do is i send an email and i just introduce myself not even introduce myself but just like you know greet them you know um hi i hope all is well and i don't put like smiling faces i want them to feel the warmth because i never want to go onto a site with like any type of like you know because you're not the boss sometimes some some craz kind of feel like they're the ball you're not the boss okay so we're a team we are a team so you come in you answer you send you send that email you just say hey you know i hope all is well and you give them like three days three different dates with like times um that might work for you know for you and hopefully one of the dates will work for them or you can give them an opportunity to uh pick their own date and then you see if it's able to be fit into your schedule so so for instance i like my visits to either be on monday tuesday or wednesday i will not i repeat i will not schedule a visit for friday unless it's like we're at a database lock um this is just like imperative that this happens now other than that i'm not scheduling a visit on those days i like to personally i don't really even like to do mondays because i don't like having to come in from the sunday i like tuesdays and wednesdays those are heavy monitoring days for me um but yeah and so then once they agree to the date then you make sure immediately you lock them in you put a meeting um appointment on the calendar invite all the important um attendees um so the pi on your clinical research coordinator you know your study coordinator um you your manager just let them know because it's very important to let your managers know when um you'll be leaving the state just so like people know where you are you know because it's it's dangerous you know people need to know where you are um and uh your study lead you know and if there's like a regional causal that you know is above the study lead or that this are the cra lead then you add them on as well all right so next things you know that comes up number two is to schedule your flight your hotel and your rental some people like to catch ubers i hadn't the reason why i don't prefer to catch ubers in some of these like remote places because sometimes like once i have to go to kalamazoo michigan okay and i got to the airport and there were no ubers or lifts they were like it was such a remote and small town it's like it's not far from chicago but it's like they're more just like there's not a lot of activity going on there so i get there i land i try to look for a uber in the lift and it's like there aren't any i'm like what do you mean there aren't any like i'm from philly so i'm like i'm i'll be in new york i'm even philly like i'm just like this is crazy what do you mean there's no ubers it's 20 this was last year so it was 2021 so i had to get like an emergency i had to call conquer their after hours number and get an emergency um rental and i got like the last rental on the lot so i prefer driving if you have a workable phone and you have a gps just get a rental so what i like to do is um i like for my hotel to be close to the hospital right so whatever site you have to visit because i sometimes you gotta go in the morning and you have never been to this city before sometimes so you don't know what their rush hour traffic looks like in the morning um going to work so i like to choose one that's like within like a mile like five minutes away from whatever hotel i'm staying at so i use the zip code from the address and i put that into conquer and i um that's how i find the closest you know and it might not be closest to the airport but essentially like i like to schedule my visits like this i come in the night before the day before most of time is the day before i use that day to kind of like explore the city go out to restaurants go into their town i do all that the day before and then when i come back to my room i um then i like prep my stuff for tomorrow right i pack my bag everything because i like to leave after my visit i like to go straight to the airport and be out some people like to come back to their hotel and relax and unwind and then work on the report no no no i'd like to be home so i'm a remote employee for a reason i'm not remote because i want to be everywhere i like to utilize you know i i'd like to be home it's up to you if you if you are okay with staying on site for whatever reason or staying in the city for whatever reason and that's on you but when i have a back-to-back trips i want to be home as much as possible so um [Music] because i pay rent here and my stuff is here so yes that's what i would do in those instances i like to leave at the same time the same day but the thing with that is like sometimes you know it gets it gets kind of rough to do that um because sometimes like you'll find yourself like rushing to the airport so you have to kind of a lot like the right amount of time so i like to go into the site around like like eight nine o'clock sometimes i don't really want you there that early sometimes they want to see more like nine so that they can get everything ready because they might like you know it might take them a little while to get everything gathered but i like to get there around like 8 30 9 o'clock and i like to be out by one or two that's the latest that's like a that's like the later end so that means like all the prep work that you did the night before the weeks prior to all of this you need to make sure that you are doing sufficient amount of prep work so that you when you get in there you're just like hey okay let me see the binders have everything laid out for me um have all the charts laid out for me have all the source documents laid out for me so that you you come in with your mindset just like i did as much prep work i started my report i started answering questions on the report that i already knew the answers to or that i've discussed with the um study coordinator do all that stuff before you get there some people like to you know just get there and kind of just like no not me because i'm leaving at two because my flight is at five i'm going back home tonight okay okay so tip number three review your monitoring plan before you go on site i know when you trained for the study right for the protocol you probably went through and you read through your monitoring plan go through it again go through it again and highlight certain areas that um you know are are important or pertain to this type of visit that you're going to go on and then i like to make notes i i'm a person that like all right after you've been monitoring for a while you kind of know you know you're like all right boom boom boom boom all right cool but for those who are not at that step yet make a checklist if you're if your um company does not provide a checklist for what to do while on site which luckily you know the one that i'm currently at now does but the previous one i don't believe they did i think i had to just like kind of use like the things i learned from my mentor make a checklist and even if they give you a checklist i make a checklist from that checklist because i like it to be extremely simplified i'd like to know like all right one kim do this two do this all right we're gonna look for this boom because sometimes i know what will happen like you'll be on site you'll or maybe this doesn't happen anybody it happens to me though like i can get sidetracked like in like one area a little bit too long and i like i said i'm on i'm on a time crunch because i need to get out here by two um to at least get to the airport by 2 30 to be there you know what i'm saying so to be able to leave on time so i like to make an additional checklist so even if even if that means like you highlighting um aries in the monitoring plan then that's what you need to do and bring your monitoring plan with you print it out have it on your your desktop or something um but just make sure that you have easy access to it and also i would say that all the documents that you need sometimes like having internet connection when you're at the hospital sometimes can be sparse or if you're using like your hot spot which i oftentimes use my hot spot because sometimes the passwords that they give me is wrong or wrong or whatever um have everything every document just like already on your desktop where you don't have to use like internet access to get them if you know what i mean um because there's nothing worse there's nothing worse than going on site and the internet's not working and you have to get on your vd your virtual desktop and you can't get on it because you don't have no internet access that is been there done that don't do it learn from my learn from my mistakes okay tip number four review the previous reports so review the previous report before going on sites okay so for instance if this is a site that you like inherited from somebody else you go in with you and do your due diligence like you might think like oh this is this was a good monitor um you know like i don't i don't really have to like do too much do go above and beyond and treat it as if it was a totally new site um that just got activated you know what i'm saying like because you really don't know what the last monitor was like they might seem proficient in other areas when you're talking to them but they might not be that proficient in their work and since we all work individually like everybody has different like styles right so i would review the last monitoring report go through it with a fine tooth comb so when you go on site you can ask like hi you know i read i read the sqv report and i saw that you guys will be using this method of temperature monitoring is this still the same may i see the calibrations like you know like make sure that you are in the know of what's happening on the site prior to it could be the previous um entering interim monitoring visit report um but just go through those areas to make sure that you're not missing anything because now this person might this person who you inherited the site from might no longer be with the company and you might not be able to ask them any questions regarding their their report so you need to make sure that you're going on site and doing what you need to do right all right so for this tip this is tip number five um i might look down a little bit because there are like because i have my laptop in front of me with the notes for this video um just so that i don't miss anything but the tip number five is to run reports before going on site so you're going to run like the safety reports um you're going to run you're going to check for like the training statuses the edc reports the query reports ixrs drug reports right on the tmf site level inventory reports and like and go through your regular regulatory trackers so your site i mean your company might not provide a regulatory tracker um but if you but you should have a regulatory tracker in another video i can go into what should be in a regulatory tracker and what you know because that's like that's a whole nother subset of like information that can't fit into this video i just cannot um but yeah so you want to run all these reports so that you're also aware so honestly the prep work for going on site might be more extensive than the actual visit itself and that's fine that actually is if that is happening that probably means you're going to have a very successful visit because unless i mean let me not say successful visit because sometimes you might find a lot of issues on site which is i'm sorry i know it's hard when a site is a mess and you have to go up in there and clean it all up i know i know i know difficult for all my you know veteran cras you know who went through that i get it um but like i said make sure that you're just doing your due diligence and you're running these reports and you're going through not just running the reports but go through the reports check everything look to see you know what they need what don't they have um what hasn't been done what should be done and sometimes what i like to do if i notice that they are having like a reoccurring problem with like not getting certain things done or be or they're late with certain things give them like you know ideas of like things that other sites have done or you when you were a coordinator if you ever were a study coordinator things that you've done to make sure that you um are holding certain you know things to a certain standard and making sure that you're getting certain things done in a certain in a timely fashion right um so that's my tip number five so let's go into number six so this is tip number six i kind of touched on this topic prior in another tip um but this is basically for you to go over you know the previous report so that you can start answering questions on your current trip report okay so like i said it's good practice to start your trip report when you're on site when you're already on site right like when you're actually there sometimes you start the trip report a little too early a day or two early and then somebody has to cancel the fly gets canceled gets delayed this has happened to me before and then now you have to go through a whole process to just change the dates on the report and go through people who like control that part of whatever system you guys use wait so you get on site to truly like start the report start typing your notes into the report um and sometimes a lot of the questions and the answers will remain the same from the last report so say this has been your site for a while you can copy and paste certain parts that have not changed and that makes your like your life easier it makes making your doing your trip report easier right so that's my tip number six so we have one more tip you guys one more one more and then this last tip it kind of goes into the previous tip is have your report open so that you can answer questions in real time honey let me tell you answering questions in real time all right say for instance you don't answer questions in real time right and you go home and you have like another another trip coming up and you're prepping for that i'm trying to tell you it is so easy to forget things that happen because you're going through so much especially like if this is the first patient or even like the site has a lot of patience you might have gone through a lot of patience you might have went through the edc so many times and your eyes are bleeding because trust me when i tell you after an imv sometimes my eyes are bleeding when i leave because you're imagine that you're going through everybody else's work right so make sure it's right so just answer your questions in real time when you answer your questions in real time you save yourself a lot a lot a lot of trouble right so thank you guys thank you guys thank you guys thank you guys thank you guys for watching um like i said if you have any other tips for like you know imv trips um visits like that you use put them down in the comments you know teach me some stuff because i don't know everything you know like i haven't been a cra for that long but these are just the tips of the trade that i have learned and picked up from some really amazing mentors i've had some really top-notch mentors that like they were my mentor but then like shortly after they mentored me they got into some like crazy high roll within the company so like because these people were like truly sought after like they were really good employees like really really good so i've had some great great great great great mentors that have put in like amazing word for me like you know with those people those with those higher ups and the companies so that is these are my tips you know like i said you guys comment like and subscribe i'm going to bring you guys more content more cra stuff more clinical research stuff i'm planning on making a video of how to get started in clinical research because i've been getting that question a lot like people have been asking me things like hey i'm a coordinator what should i do i've never been in research what should i do um i'll make a video like that i'll make a video like that because i really think like people who might end up finding my videos they're finding them on the strength of like they were like they're trying to learn about this field so um i definitely want to get them the right information on how to get into the field how to get started where to start what companies are good companies to start at right um and i might i might have to do some more research on the company portion but like i said you guys thank you so much comment like subscribe and stay tuned for your next video because they're coming all right thank you guys bye