so hello everyone welcome to a brand new video on case report form in clinical research a lot of students and clinical research professionals requested me bring a video on this particular topic to understand how exactly case Report Form plays an important role in clinical research so in this particular video we'll be looking at all the aspects of CRF and how does it impact clinical research I would also like viewers to kindly subscribe to this channel so that it brings me additional motivation and it takes takes a lot of efforts for me to bring quality content so a subscribe to the channel would be highly appreciated so without wasting further time let's start this [Music] session so in this particular session we'll be focusing on what exactly is case Report Form followed by the various designing component that comes into CRF as well as we'll understand the difference between the case report form and electronic case Report Form followed by that we'll see how a good designed case Report Form looks like and what are the errors to avoid when you design a case report form for clinical trial so let us first understand what exactly is a case report form so a case Report Form or CRF is an electronic or paper document which is used in a clinical trial to record the protocol and required information about each participant so whenever you conduct a clinical trial you collect data regarding the efficacy of the medication and also regarding the data of the study participants and this case Report Form enables us to collect data in a structured and for formatted pattern so that that data can easily be collected processed analyzed and then finally reported so case report form is nothing but a well structured form that is based on your protocol and your study hypothesis and which collect Optimum amount of data that helps you to understand how exactly the trial is progressing how the data is recorded and how that data can be processed and analyzed further so case Report Form also becomes a main tool for the investigator to collect all the information from the clinical trial participant and which is why there is a dying need for a CRF to be completed by each participant because whenever you enroll a participant in clinical trial you would like to understand all the aspects right from his demographics from his medical history from his uh concomitant medication so based on that you analyze the data and how your medication or your investigational product is functioning so case Report Form provides a structure to collect that data efficiently also the sponsor uh and the investigator together they they have certain CRF guidelines okay which helps the site staff to train on the case Report Form okay before collecting and entering or reviewing the data so before you collect the data or uh screen or enroll a particular participant the site staff as well as the sponsor trains all the members so that they can efficiently collect only pertinent data okay so whatever data is being collected in a case report form that has to be approved from regulatory authorities as well as your ethics committees so the teams are also trained on how to collect that data and what should be the parameters to collect that data so that is regarding case Report Form now let us look how a case report form is designed so a well-designed case Report Form should represent the essential contents of the protocol and an ideal situation the case Report Form it Des design once the study protocol is finalized okay this is because once you finalize the study protocol you finalize all the steps that you would carry out once the steps are laid down then you have to create a form to capture all those steps okay so once you decide a protocol and then the CRF is designed now it is being increasingly recognized that the design of the CRF may that be paper or the electronic is a very key quality step in ensuring that optimal amount of data is required and that is optimally collected now this optimal amount of data can be from the protocol related data the data on Regulatory Compliance the data on the safety components of the clinical trial participants then again whatever the study hypothesis is there for example if you're doing a study on type two diabetes milit then your hypothesis is that certain type two diabetes subjects have this kind of criteria your medication would be helpful in doing that so the study hypothesis component is also carried out and captured in CRF design then the site workflow okay for example when the blood collection would be done then when the ECG would be done when the IP would be injected so CRF is also designed in a sequential manner so if you carefully see a case Report Form if you get that opportunity even in the electronic format you would understand that it is design in a manner which clearly highlights the steps from 1 to 2 3 to 4 okay and also what format the data is required for example whenever you record date of birth for example so it is always uh in a format called as DD mmm and y y y y okay so this particular format eliminates the interpretation or misinterpretation ation and streamlines the data requirement okay that is why designing a case report form is very critical so that it reduces the error in the first place and helps you collect that data in an efficient manner so that is regarding case Report Form design so now there are two types of case Report Form one is paper and another is electronic so initially when the clinical trials were being conducted in the last Century there were case report forms but with the Advent of Technology we have moved this case report form into digital formats okay so if you're a clinical research professional I'm sure you work on a lot of electronic data capture system please comment in the comment box which particular EDC system do you like I personally like Viva W so now let us understand what's the difference between case report form and an electronic case report form so so the paper case report form is obviously the traditional way to capture the data and a better option if the studies are very small and if they do not vary that much in design whereas the electronic case Report Form are considered to be the optimal choice because if you conduct study globally into multiple sites and if the data set is large then maintaining all those kind of paper record is very difficult and in comparison to that if you have an electronic system which is on a single server on a single website which is being accessed by various clinical researchers across the world then data collection becomes centralized okay so that is how the paper as well as electronic CRF differs okay you need to understand when to use paper and when to use the electronic forms again the electronic case report forms are preferred over paper because obviously they are less time consuming because you have to electronically enter the data okay and it is a way more efficient uh Manner and also uh a lot of sponsor and pharmaceutical uh company carry out large multicentric trial so obviously for the ease of administration for the ease of data management they do prefer to have electronic case Report Form system than the paper CRF system also the paper CRF have to be maintained and uh protected uh very well so that they are not tone or not misplaced as the time passes okay that is why uh handling paper CRF becomes difficult at time and also as we move ahead uh with the age of Technology the data collection would evidently be in the electronic format always so that is how uh the there's the difference between the CRF of paper and electronic and finally uh the case Report Form electronically is designed in a way that data entry can be done with zero or minimal error because the system would accept your data or your data entry in one single format okay if you don't enter in that format it clearly shows you error so that you understand that what format has to be used next thing is the regulatory authorities are also readily accepting these submissions for validated electronic data capture systems so now if the data capture systems are appropriately validated they follow code of Federal Regulation and they have systems which clearly demonstrate the change in the data format uh the audit trail that it develops so it clearly helps to understand what data was initially entered how it was changed and why it was changed so the Version Control the audit control the trail it clearly makes the electronic data capture systems more efficient and future proof now let us understand the example of a poorly designed as well as a well-designed CRF so if you see on the left so this is the poorly designed CRF now in this if you see the date of visit is just left blank but when you see here the date is clearly mentioned and required in ddmm YY format so now when it comes to this you would not have any second thought or confusion while entering the date because it clearly expects you to enter in a format but when it comes to this particular system you would see that date can be entered in any format whatever the subject chooses same goes with the blood pressure the blood pressure here for example 120 by 80 so sometimes people if uh the blood pressure is 120 by 90 they would just add 1 120 obl 90 but when it comes to case Report Form you would understand that the blood pressure is 120 by 90 and they have to enter a zero here in this particular thing so you would understand that it is 90 and not 190 and there is no confusion or data entry error so that is how welld designed case Report Form makes a difference the same goes with pulse temperature respiration you understand what unit are requested from me okay temperature is in degree Celsius or degree Fahrenheit and the respiration is in what format so a welld designed case Report Form makes all the difference whenever you conduct a clinical trial and look for data collection another example of poorly designed as well as welld designed case Report Form would be this particular demographics form so if you see on the left they have asked you regarding uh the date of birth again which race do you identify or relate to but when it comes to year year the date date of birth format is mentioned okay as well as when it comes to race they have clearly mentioned that which particular race do you uh belong to or do you identify so they have given you all the options which they have designed in the protocol okay and you elimin eliminate any kind of surprises or any kind of Errors when it comes to adding data that is required okay next thing is the ethnicity of the data so you would understand what kind of ethnicity they are require and what kind of trial they conduct on which particular subject population okay so a very welld designed case report form as you can see here clearly highlights in what particular format the data is required how that data is to be entered and what kind of data collection methods are being followed okay it removes the kind of uncertainness and variation in the data that is why case report form is one of the most critical tool that you use in clinical research and that plays a very important role so thank you for watching this video I hope this video was helpful for you to understand the importance and role of case Report Form if you like this video please share it with your friends and subscribe to the channel oh