SAS Clinical programming – CDISC | SDTM | ADM | TLF Training by Naidu

Hi everyone and this is Naidu. I’m from great online training and today we are going to learn about clinical SAS and what exactly the relation between clinical SAS and our gentle SAS software and apart from that what are all those things included in clinical SAS and why we are calling it as a clinical SAS and all those stuff we will see, so introduction to the clinical SAS so what is the introduction to clinical SAS so generally we have a SAS software and why they’re using a SAS software in clinical sector so now you just go here and see this what is the relation between SAS and clinical related items are in the sense of clinical trials so most of you people already know that so most of the drugs being sales or being so what is bit consumed by the persons or also patients those drugs all are from FDI approved drugs if any pharmaceutical company or else any pharmaceutical what is that organisation they want to raise the drugs into the market compulsory the drugs need to be tested so tested in the sense how they can say it is tested, they need to do a clinical trial on the particular drug based on the clinical trial that reports will FDI will looking into that if all the reports of perfect perfect in the sense so each and every drug having some side effects but the side effects should be a very lesser than our benefits so then only the drugs will be get approved by the FDA so once that particular reports are reviewed by the FDA people, ok these drug they can release into the market then that report that particular drugs will be released and then that drugs will be selling selling into all the so countries and all but which reports they’re going to looking into that so FDA guys which report they look, the reports which are generated by the SAS programming that reports they will just have a look and they will just have a review on it and then they’ll release that particular drugs into the market so generally so when I say it is a clinical trial so what is the overall picture of the clinical trial so now you can able to see that so generally what clinical SAS programa will do so clinical SAS programa will read the protocol so based on the protocol will try to understand so what we need to do as a SAS programa, protocol is a document it is a just now our PDF document only but it have all the information about your clinical trial so nothing but so what the physician need to do that means we call it as in clinical programming principal investigator, what principal investigator need to do what statistician role is what the programmer role is how many patients is required and how many patients is need to enrolled from which country so like that all the information will be there in the protocol so it is approved protocol from the FDA so once they have done with a preclinical trials that means animal testing whenever they have done then they will give a permissions to do the clinical trials when I say clinical trials it’s a compulsory on human beings so once the clinical trials is done and the protocol is ready and they will send this protocol to the FDA for approval purpose that means this is all we are going to do in this particularclinical dries then they will give an approval for this particular protocol so based on the protocol onwards next step is for what we can say for the CRO companies what they do is they will look for the investigators and hospitals imagine they want to release the drug in the China so compulsory they need to do some clinical trials and China so that what they do they look for the some hospital who can provide the patients who are suffering with our diseased means our targetted disease imagine we have developed some drug called X, we means X CRO companies so the CRO companies developed some drug they want to test the drugs compulsory for testing purpose we need to have

patients and as well as we need to have doctors so in clinical terminology we call it as a instead of doctors we call it as a principal investigators or else we can call it is a PI and apart from that instead of patients we call it as a subjects so patient we call it as subjects so that we need to go for looking for a subjects and as well as investigator selection also, they’ll target for different different hospitals they will target it and they’ll take the investigators from their investigators in the sense the person who is responsible the activities whatever happened in that particular hospital during this total clinical trial period so that particular person we call it as investigator for that particular hospital so that he is the responsible for all those activities what to done and what not to done in that particular hospital to this patients so that is your investigator selection so once the investigators the CRO companies investigators selection processis done then each and every or every country wise they have their local ethics committees we can call it as a like local boards we can call it as so that means if they want to do a clinical trials so initially they want to apply for what is that permissions to do the clinical trials FDA has given a permissions to release the means to do the clinical trial but we need to get the approvals from the local ethics committees also so once they have given it approval ok they have ok you can do the clinical trial that means CRO companies will do the clinical trial then they start recruiting the patients so who are all the patient here, the patients in the sense the people who are suffering with our disease and apart from that in protocol we can say a set of rules so set of rules in the sense like the patient must be 18 years above old and patient should not be alcoholic patient should not having a smoking habit, patient must so must complete the previous dose of the 300 mg dose or something like that select that there is a set of rules we can call it as a those we can call it as a inclusion and exclusion criterias so that the inclusion and exclusion criteria’s they will looking into that and based on that they will recruit it if you just see in around seven patients we have one patient got selected the reason behind that is the patient fall under this category it have all the what is that all the criteria’s he met he is 18 years above old don’t have a smoking and habit and he don’t have alcohol habit also so that’s the reason why that patient is participated into the clinical right imagine if we need 400 members as a patients compulsory they will screen around 600 or 650 members they will screen it so most of the clay cases around 20% is the screen failure rate, screen failure in the sense that test what we are doing is screening screening means we will check all those activities what is required for us is there or not if those activities means those diseases or else those what is that habits and all if it is there then he’ll power follow the into a clinical trial otherwise he will be excluded from the study so those patients we call it as a excluded patients so this patient we call it as a so included patients once the patients are included then we start taking the information from CRF so we call it as in real-time case reportive form so the patient came to the hospital better we are taking an information like age, sex, height, weight, race, ethnicity and all those things we are taking it but where this information will store, will store it on white paper, No, CRF nothing but case reportive form the case reportive from is a document we use it as a to taking the information from the patient, case reportive form in the sense it is exactly like our bio data form so whatever we have it in bio data form we will have the same fields bio data form actually what we have like a name, address, email ID, phone number and educational qualifications and experience will have it in our bio data but patient information like in CRF, patient ID,

patient race, ethnicity, sex, gender and all we can able to see in one CRF that is called demographic CRF we have a different different CRF’s so we are going to talk about in detailed manner later on and first let me talk about a case reportive form so case reportive form is the tool to just pick the all the information from the patient , nothing but age ok, 28 they will enter case report form in the form of paper only for nowadays so what they do is the doctor beside there is a some person who is take caring of all those information from the patient ok, tell me your age, tell me your sex and ethnicity, race, gender and all those of whatever is required they’ll take it from the CRF that CRF is nothing but information about your patients so one patient for one CRF for one visit like that multiple patients multiple CRF’s and multiple visits information will captured and that CRF will send it to the data entry and validation team so here you can see there is a lot of people who are just entering the data into the databases so whatever the data they have collected it from there they’ll enter the data into the database and then so once the data is entered into the database so this is what how they’re doing the database so here we can see DB load and DB lock and before going to that there is a data entry and validation I said so what is data entry and validation what what exactly could be done nothing but imagine so whenever the person is entering the data imagine I’m the person entering the data some X data I’m entering it X data in the sense the list of people information the list of patients information I’m just entering into the that particular database the same work will give it to you also to do the same so what happened you all also enter the same data into the database and you also enter the same data into the database so what happened what is the use based on that there is a chance I do mistake somewhere but there is no case like you compulsory need to do the same mistake at the same place maybe you will also do the mistake but in a different place or else different patient and means data you entered you may do the mistake so in that case what happened when they are checking the days data between you my data with your data where exactly the wrong is between so they’ll compare it which one is the right and which one is the wrong they will decide it finally and then they will conclude it so this we call it as a double entering of the data and apart from the double entering of the data so this particular all the process our final motto our final aim is to avoid a error free data so that means to reduce the discrepancy in the data we call it as a terminology in clinical sector call discrepancy so they’ll try to reduce the data discrepancy so once the data discrepancy is reduced and they’ll enter the data into the database they’ll keep on enter the data into the database imagine around 5 people imagine the clinical trial is 400 people they recruited 400 people first time the patient came to the hospital around 10 times first time they came they take the information that information they will send it to the CRF and all to the this particular data entry and CDM team clinical management data management team the clinical data management team will enter the data at first visit information when again the patients is came for the second time so that again second patient’s time will come the data and they’ll enter it again third time , fourth time as per the protocol how many times we said to the subjects to attend the clinical trials will be based on that those many times the patients or else subjects will come into the clinical trials and then keep on taking that information in CRF that CRF will send it to the CDM team clinical data management team and clinical data management team will enter keep on the data into the data bases but here you can see there is a two things called DB load and DB lock so what is DB load and what is DB lock so DB load in the sense they’ll keep on enter the database so into database that is called loading the data but there is a another term called Diabase lock at certain point of time so there is no incoming flow of the data that means investigators have in a green signal that so we have completed all the visits what we have in the protocol based on the protocol we have completed all the study

there is no incoming flow of the data into the database you can lock it so CDM people will just looking into that all those things is ready so that they will take a just information from us like whatever the data we got it or not is there any still data discrepancy or else is there anything which is not captured or which is that see if you have something an issue with data we are not the responsible persons for that we need to just the flag it there is a data issue somewhere okay that data issues will be taken care by the CDM came itself we are the programmers here what we do is whatever the data is available in the database we try to use the data and creating a reports as per the FDA submission that’s what our job is so what happened so they will ask us okay is there anything like it is just normal check only it is not mandatory compulsory you need to means as a programa SAS programa you no need to give the message means the information like yea all the data is clear I have checked everything and something like that it is not required we just tell them okay what we got it we got it up to this it is fine and but so they will check in their end all the data is got it or not so based on that so the database lock so generally what is the problem when why they are checking with us means see if we are doing a clinical trial process of the report generation we have some issues but those issues will not caught by CDM people but still we are not informed those issues to the what is that to the team of the CDM team so then those are outstanding issues that means if they have not changed and then they have locked the database so that locking a database in the sense they’re not putting any lock to the database or something like that, that means there nobody is going to work on it is going to be freeze that means whatever the available data we have it we need to use the same the reason behind that is database lock is FDA is very important in database lock and all so whatever the reports we got it based on that results we will try to produce some reports but there is always chance that if we results are not perfect then there is a chance we can unlock it and then we can do some changes or something like that to avoid those things FDA is very concerned about if the data base unlock happen there is a crucial part in clinical sector that should not happen anytime the database lock should not be unlocked at all once the freezed it that’s it that is the final thing so then CD report the SAS people people will generate these reports those reports in the form of tables, listings, figures we call it as a data sets tables, listings and figures those reports we will send it to the result meeting, result meeting we can call it as a like the people who are spending money that means mostly the investor mostly the investors and as well as trial statisticians, trial programas all will involved into the particular meeting trial statistician in the sense the statistician who are working in this particular clinical trial study and who are all responsible for all the statistical things what happening in this particular total data analysis so that person is your trial statistician trial programmer in the sense the programmer who is involved to creating the reports and all from starting to end so mostly try programmer will involve only those why because you will not get even though if you get a job as a SAS programmer you will not get the invitation to participate in the result meeting and us so result meeting in the sense which is very secrecy one so that means how the results have gone based on that there is a fluctuation in stock market also so there is lot of people expectation on that yes there is upcoming drug in coming into this particular notice drug is coming so that that drug will change the future of know what is company like anything but the result meeting the come to know that the results are not that much good so then it will affect our stock market and almost with those reports and those things will not be what if we can say will not be disclosed at anywhere and now the result meeting when they satisfied, yes the results are all getting perfectly then they’ll submit this particular reports to the FDA so FDA will approve this particular drugs so that so see this particular report then only our clinical drug whatever we have done the clinical trial the mostly the clinical trial not only for drugs mostly for syrups and some

injections may be some what we can say all the medical devices suppose imagine they have invented some medical device that is a pacemaker so pacemaker in the sense it is instead of heart it will work like that it is working like all so even the heart also they want to release into the market compulsory need to that will do the clinical trials on that also so these are all are mandatory so the clinical trial SAS programmer do exactly talking about data analysis and reporting using a SAS software. Clear, so this is the overall picture of the clinical trial programa role what need to be done and next so introduction of SAS program so most of the people already aware of it so whatever we have the raw data that means the data which is available in data that means that particular database that we call it as raw data the database data will call it into SAS software in the some form of a data step so once we create the data step and we will create a SAS data sets. SAS data set in the sense it is a collection of tables and rows will create as a SAS data sets those data sets will used for reporting purpose so those reports will be generated this is the work flow of SAS programa or wherever you go in any of organization they will give you raw data you need to produce the reports this is the starting point and this is the ending point of your programa level so generally my question is why pharmaceutical companies depends on SAS programa what they need so why not the why the only SAS programmers in clinical sector is required that means we need to produce certain reports those we call it as a tables we call it as a listings we call it as a graphs or figures this we call it as a TLF’s or else we can call it as a TLG’s so the person must have an experience on creating a tables, listings, graphs and figures then only the person can survive in clinical sector job clinical sectors SAS job mainly and apart from that we need to create a data sets also so those data sets I’m going to talk about in later slide so this compulsory need to have an a good idea each and every person who are participating in clinical SAS programming role compulsory they need to aware how to create the table they need to aware how to create the listing, how to create the graph and as well as figure and next thing is like examples of table so this is how the table is looks like you just see the table demographic and baseline characteristics in that agewise how many people we have around total number of people in that particular clinical study is around total number of people in clinical sector for that particular treatment groupwise 31 and 29 total 60 members are participated in the clinical trial based on that females are 22 for this particular active drug taking people and nine members active drug taking people and here you can see here you can see that it’s impossible 29 members in that 29 so out of 16 is male and 12 is female are something like that maybe maybe some values values are missing or something like that happen because of that reason there is a chance to having a count is less than our encounter the total number of people who participated in the clinical trials 29 but here you just see 16 plus 12, 18 only one patient got missed here maybe there is a chance to that particular person as gender is missing in the sense due to some reason may be that is not captured or maybe the data records that records are not there in or database or something happened because of that the count is bit less than our total count right so now so this is all the information so how the table is looks like you can see how the listing is looks like the difference between table and listing table is nothing but so top to bottom it is nothing but a summary of output summary in the sense imagine if it is an around 500 members participate in the clinical trial so the 500 members data will be just like males are 200 females are 300 something like that that means summary of your outputs we call it summary of your data we call it as a table but listing is nothing but the total 500 people information also we will display it that is the best difference between table and listing and there is a one more thing called figure so mostly figures what they do is it is just for to see the data whatever the data we produced in the form of tables the same data they need it as a figures sometimes that means they want to see

the data in pictorial representation so that it will be bit easy for them for publications, for them to display some information yes our trend is going like this our drug is working fine so instead of having a values in table so just making as a some graph and so that how the graph trend is going on it’s keep on increasing or else keep on decreasing and all those stuff means it’s easily understandable to the persons in FDA or else maybe for any submission process so that’s the reason why figures also important and this is the latest one latest one in the sense compulsory the clinical SAS programa the person who want to do a clinical trial process a clinical trial SAS programming job he need to have an experience on CDISC that means clinical data interchange standard consortium SDTM so nothing but study data tabulation model and Adam so what happened apart from TLF’s tables, listings and figures compulsory the person need to have an experience on CDISC like clinical data interchange standard consortium and as well as DDM and ADM what is this CDISC is nothing but CDISC is a organization so it’s a free organization only so the people will give a set of rules they already kept set of rules to do the standardization standardization in the sense see Amay, Reddy’s like a company and another person is five means another company is Pfizer they are doing clinical trial they are sending a data to the FDA and I’m also doing a clinical trial I’m sending a data to the FDA but the problem is every person means every organization they’re falling their own standards but CDISC people what they have done generated they generated two things one is SDTM and ADM so SDTM in the sense whatever the study data study data in the sense the data which is collected directly from that patient that we call it as a source data that source data always in the form of SDTM that in much study data tabulation model format let it be any organization all the organization need to follow the same rules, the rule in the sense suppose imagine we call it as a subject ID another patient means another organization they’re falling at as a patient ID but it should not be the different names it should be the same name like patient ID and subject ID will be the same ok, that means it should be subject ID he also need to follow as a subject ID I’m also need to follow the subject ID so this is SDTM is nothing but to submit a raw data to the FDA ADM’s. ADM’s is nothing but analysis data models analysis data models in the sense if they want to send the data in the form of analysis data sets nothing but see there is a chance that whatever the data we have captured it from the patients we will not use the all the data for our analysis purpose what we do is we try to create a few variables and few observations containing a data as a special data sets that we can call it as a analysis data sets that means the data sets which is used specially for analysis those data sets we call it as a ADM’s we need to follow the ADM standards also that means whenever the data you are submitting to the FDA ADM data sets also need to be standard so that SDTM and ADM standards in every organization nowadays they’re following so compulsory you need to have an idea so what is SDTM and what is ADM and all then only you will be a perfect clinical SAS programmer job you will fit it but there is a chance it is a two things like so jobs are like mainly for TLF’s tables, listings and figures or jobs are mainly like CDISC nothing but SDTM, ADM people who already know the SDTM ADM also so that you decide if you know everything then you have a job of scope is more than normal people who have only know the TLF ok, that you decide and this is the CDISC the CDISC people SDTM and ADM’s will create who will send the SDTM, ADM’s to the FDA. Right, so the next one is you just see this these are the the list of companies what is available in US like how they are sending a data even GSK, Roche, Merck and what is Pfizer about and Lilly so these are all the pharmaceutical companies whenever they are submitting a data to the FDA it should be in a SDTM standard format, then only the FDA will approve this particular drugs so nowadays so step by step clinical trial programmer role earlier what I said I said like a overall picture of the clinical trial I said, in that I have said only one piece of information what is clinical SAS programmer role but now it is in detailed manner

of clinical SAS programa, whenever you get a job as a SAS programa a clinical SAS programa first of all you need to have an idea on trial protocol and then you need to have an idea on CRF then you need to idea on ECRF electronic format of CRF the difference between CRF and ECRF is CRF in the sense it is just a paper format of output ECRF is nothing but a electronic format of output we can see it as a PDF document. ECRF so once that ECRF we need to understand what is the annotation so in the sense they said ID patient ID but the patient ID how it is captured as a subject ID in our data set means the annotation is nothing but it is clearly saying that which field on the CRF is converted as a variable imagine it is an a sex sex is the field we have it in CRF how it is converted as a variable so that in the sex place itself they’ll clearly write a annotation that so annotation in the sense there is writing a label ok, sex is nothing but sex is the variable name suppose it is a imagine it is an a date of birth DOB is the variable name so that is called annotation the CRF’s after annotation will be called it as a annotated CRF so that annotated CRF’s will submit for SDTM creation the people who are working an SDTM data sets they’ll try to use the annotated data sets and they’ll try to use a another document called SDTM IG, SDTM implementation guide that guide also I’m going to explain these things later on first you need to understand SDTM and based on the SDTM they will create some data sets all the SDTM data sets whatever is required so what are all the documents are sorry whatever all the data sets we need to create and we need to submit for FDA that will be already decided and that will be already there in SDTM implementation guide when we are talking about SDTM in detailed manner then we will see what is SDTM and what all the information we have an SDTM and finally they are submitting this reports to the FDA. This is one branch one branch in the sense the people who only work with SDTM data sets to creating SDTM there is a chance to people work on SDTM to ADM conversions also so that what happened the SDTM data sets they’ll take it from SDTM to Adam Adam in the sense just imagine I will give an example like yes so they have collected some information from the patient the patient came to the hospital around 10 times but he came 9 times one time data is not there so SDTM data set we are not changing anytime anything like that it will be like a 9 times he came to the hospital so that nine-time nine-time information only will have it but ADM’s will try to impute that record we will take it that record from the previous data data results whatever we have it that we will take it from there and we will try to create it in ADM’s like that many things we will do all the derivation parts and everything they will give you wherever you get a job as a SAS programmer they will give you a ADM Specs so analysis data model Spec so based on that you need to derive analysis data sets we can call it as a so once this analysis data sets are ready so that data analysis data sets we will use it for creating a tables, listings and figures so once the TLF’s are ready again the TLF’s also we will submit for FDA and this ADM data sets also will submit for FDA submission process so this is all the overall clinical trial process in mainly for SAS programmer role in detailed manner except this there is nothing into your clinical domain this is all those things you need to know as a clinical SAS programa and next one is here that means this course anyone can learn like the Post Graduate, Graduate,, MCA ,M.Sc and all the pharmacy people anyone want to learn they can learn this course and so what is the job scope at your place means most of the people they already aware of it there is a good job scope in market right now for a clinical SAS programa job and apart from that it is a work from home jobs are more in clinical sector so that’s it so this is all about the overall view of a clinical trials and what I have expected to deliver today so like so I just given all the brief information like what is clinical trials and what is the process and all those stuff so, so this is all about clinical trial process Thank you for watching, bye