Transcript for:
Clinical Data Management Webinar

Hi all welcome to the clinical data management webinar my name is Chaitanya I'll be taking a today's session regarding clinical data management so as I can see over here eight people has already joined this session Okay, so we have Nikhil, Amit, Nalini and then we have Kabir, Natasha, Vinayak, Sarita and Rahul over here. Welcome all. So, I am expecting couple of more people to join this class. Meanwhile, I will do one thing.

I will introduce myself. My name is Chaitanya. and I'm principal data manager okay so we have Anisha or here with us and Rahul also joined okay welcome welcome Rahul welcome Anisha we were just starting the class with my introduction and so I am Chaitanya working as a principal data manager I am having eight plus years of experience in CDM that is clinical data management and i worked on various tools such as oracle clinical rave inform etc apart from that i worked on sql plsql sas for reporting purpose I am well versed with ICGCP and 21 CFR part 11 everything. So whatever it is related with the data management I worked on everything. And so right now I am working with great online trainings as a trainer.

So let me start with the agenda of today's session. So the main agenda for this session is what you will get from this training. Okay.

So today's agenda. So we have listed down that few topics over here according to your expectation or what you will get. after this session and what you will get during this training everything okay so the first thing is what is clinical trial so we will talk about the clinical trial what it means and what is the history of the clinical trial, how the trial will flow as per the guidelines or that is ICGCP and everything.

Okay. So after that, we will talk about the clinical data management. What are the different stages of the clinical data management and which are the different phases and what is the role of the data manager during each phase and everything.

we will come with this in this topic that is clinical data management what is clinical data management okay then we will talk about our training program so this is the most important part for this session we will we will teach you our about how to enroll uh in this course and how you will get the study material after enrollment and how you will get all the softwares and how you will get different books for your reading okay so how if you stuck somewhere so how we can resolve all these things okay so everything about the training program you will get all this thing all this information over here and The next is scope of CDM. That is also the most important topic for today's session. In this topic, you will get to know what is the scope, how many companies will offer the CDM jobs.

Okay, so how you will get the job and how we can help out to you. for your desired data management jobs okay so then we'll talk about the different activities of a data manager okay what the data manager will do during each and every trial or you can say what the data manager will do in the setup of database, conduct of database and closeout of the database. So don't bother about all these things setup and conduct and closeout at this point of time.

I am sure by the end of the session you will get to know, you will understand very well understand about all these activities of data management that is major activities. So thank you. at last we will have one question and answer session you can directly ask the question uh to me in this after this session or you can you can if you can just ask question anywhere okay so um i'll do one thing uh we'll do one thing we will make this session as an interactive session okay so if you have any doubt or any query or any question so you can directly just stop me anywhere in the session and you can quickly write it write it down on the chat window um then i'll i'll reply to that i'll reply back with that questions answer or if you want to talk with within the class so just let me know i'll unmute you unmute you then you can directly ask the question in the session okay okay so uh i am going to start the class uh now uh with the very first topic that is what is a clinical trial okay so so let let let it be started uh with the class uh now as with our first topic what is clinical trial clinical trial is a trial of a new medication formula or new formula or a new device on human subjects or means on human bodies is known as clinical trial okay so what we are going to consider in this clinical trial why we are going to inject or why we are going to dispense this new medication to know the efficacy that is means effectiveness of the medication okay Is there any effectiveness of the medication?

Is there any side effect for this medication? All these things we got to know via clinical trial. So in a general word or in a broader aspect, we can say that what the body will do with that medication and what that medication will do with that body. with that human body all these things we we need to know for the new medication new medication that is known as clinical trial okay so it is it is just not it is not just like we can directly dispense the medication to any human body and um take the results and take the results or adverse dimension effectiveness that is efficacy or side effects everything so in this case there are so many risks for example if the medication is Medication is went on wrong way so there might be chances of the adverse event or maybe there might be chances of the serious adverse event such as death or permanent physical disability or long term hospitalization and everything. So it can happen over there.

So to avoid such a circumstance, such adverse event or such tragedies. In 1946, New Rumble Code has been prepared which has certain rules. The first and most important rule was that Inform consent should be taken from the patient or patient before involving him or her into the trial without knowing that patient that we are going to insert this medication to you and we don't know that result. Because this is a new medication without taking consent from the patient is not considered according to the Nuremberg code. But in 1962 that Nuremberg code has been amended.

amended just because of the thalidomide tragedy thalidomide okay so i'll i'll tell you the thalidomide tragedy thalidomide is a medication which which is working as a sedative or you can say that one as a sleeping pill okay so the reaction of the thalidomide appears on the neonates not on the human being who is taking the medication okay for example the mother has taken the medication then the reaction of the that medication appears on his newborn baby that is fecolomia fecolomia means that is shortening of the limbs you can see over here in the picture the babies were born with the short limbs okay so uh after that that harris amendment has uh amended again in 1940s 1979 with belmont report and after that in 1997 ich international hormone international conference for harmonization has come up with a good resolution that is known as good clinical practices gcp isis gcp has created in 1997 okay so now everyone everyone has agreed to follow these rules before testing any medication or device on human subject so these are the major rules icgcps okay so don't bother about uh icgcp what are the different rules and everything so we will have a separate session on that one we will discuss more on that session uh what are the different rules and regulation for the icgcp okay so Just for this session, you can say that according to the ICGCP, there are 7 major steps which needs to be done for each medication to to be launched into the market. Okay. So, according to the ICGCP, first step is preclinical trial or preclinical testing. It means the testing of new medication on animal subjects to know the dose, how much quantity we can inject or we can give to the human body. Okay.

To dose and safety, whether it is safe to give that medication on the human body. to know all these things pre-clinical testing needs to be done that is testing on the animal bodies okay so once the medication has completed the pre-clinical testing then the data needs to be submitted to the regulatory authorities in the form of INDA Investigational New Drug Application Once the investigation new drug application is filed then we have to start the clinical trial on human subjects that is phase 1 phase 2 phase 3 and phase 4 trials okay so according to that according to the icgcp in the phase 1 trial healthy volunteers needs to be considered not the patients okay healthy volunteers are chosen to determine the safety and exact bearable dose on human body okay so In Phase 2, 100 to 300 patients. In Phase 1, healthy volunteers. In Phase 2, patients.

Patients need to be selected to evaluate effectiveness of the medication, that is, efficacy on a particular disease, along with side effects. Okay? So, is there any hazardous side effects? Is there any serious adverse event? a small adverse event everything which is especially related with that disease particular disease so all these things uh when we got to know in the phase two trials once the medication has completed the phase two trials in a successful format then the next phase will come as phase three in which one thousand to three thousand patients selected across the area or region or across the countries.

So, in this phase 3, we need to verify the effectiveness and long term usage of that medication to monitor if there is any adverse event or if there is any serious adverse event on taking of that long term medication. All these things we need to know in the phase 3 trials. After that, we will go through the steps.

If the medication has successfully completed the phase 3 trials then NDA needs to be submitted, new drug application and if that regulatory authorities such as FDA or European Union, all these things if they agreed with that new drug application then you can launch this medication into the market directly. For example, if you want to to launch the medication in the into the us market then you need to submit nda file into the usfda US FDA and after that only you will get the permission to sell your medication into that US market. So the next phase is Phase 4 studies. In Phase 4, it is also known as PMS, Post Marketing Survivalance. Once the medication is released to the market, any serious adverse event related to that medication needs to be reviewed or observed.

So So, pharmacovigilance studies are there to get to know that the medication's effect or adverse event across the world. So, according to the pharmacovigilance, we need to prepare the C-OMS and that C-OMS needs to be submitted to that particular regulatory body. to know that the adverse event whether it is this is a serious event and it is related with that medication if there are so many adverse events which so many serious adverse events which are related with that medication then medication needs to be withdrawn from the market okay so on in general note from Phase 1 to Phase 4, the data needs to be submitted to the regulatory authorities.

It is not just the data. All the things. The data, graphs, charts and listings all these things we need to submit to that particular authority okay so so you have i think you have better understanding now what is clinical trial so we have completed this topic over here now that our next topic is what is clinical data management okay so you Okay, so as we have seen in the our previous slides, clinical trial has four phases and for each phase, each phase data needs to be submitted to the regulatory authorities.

For example, consider FDA, Food Drug Administration from US. After each phase that complete data needs to submit to FTA, now the question arises what the data we have to submit to the FTA, who will collect the data and how to manage the data and in which form we need to submit the data and what you will get. If the data is submitted in the wrong manner or wrong format. So, all the answers of these questions you will get to know in this slide. What is clinical data management?

So, the first step of each phase is protocol. Protocol is a document. It is also known as backbone of the entire trial.

okay or entire phase okay so uh it contains the complete structure of the trial how the trial will flow how many subjects are required what is the phase two three and phase four studies then what are the enrollment criteria and uh which phase this study will run either in phase one or either in phase two or either in phase three and for which disease we need to submit the data and how what is the age of the patient is required whether he'll you all healthy volunteers are required or patients are required all these things the data all these things you will come to know from this protocol only. Okay, so and for this disease which assessments are required? How many visits are there for this particular phase?

And how you will dispense the medication? Whether you will inject the medication or you will give the medication to directly via oral route. and how do they collect the data and what actual assessments assessments you can say that one for example vital signs or for example blood pressure or for example ecg and everything what what different types of type of assessments you need to collect from this from this trial everything it is written in this protocol okay so Now, uh, okay, so...

So the protocol is the backbone of the entire trial. So now based upon the protocol, sponsor needs to select the investigator i.e. doctors. And if it is required then there is staff also to investigate and collect the data from the particular patients.

via assessments or medical exams for example ECG blood pressure monitoring etc okay selection of investigator is totally based upon their qualification and experience okay so qualifications and experience based investigators needs to be selected okay for example if it is a cardiovascular study means heart related study then we need to uh sponsor needs to assign the pay doctors which has a specialty in the heart that is cardiac cardiac patients cardiologist okay uh okay the next step is once the investigator selection is completed then uh next step is approval process and a sponsor has to take approval from the local regulatory body bodies such as irb investigational regulatory body okay etc after completion of three states Next is the patient recruitment. So it is totally based upon the protocol requirement. According to the exclusion criteria and inclusion criteria.

Which patients are needed? and which patients are not required in this protocol. So, according to that one, investigator needs to select the patients.

Okay. And the main criteria of selection of the patient is based upon their voluntary involvement, that is informed consent, according to informed consent. Okay.

So, once they recruited, After that, the data which is collected from these patients needs to be recorded into the case report forms i.e. CRFs. the CRFs and these CRFs, the data from the CRF form get stored into the database and and the data needs to be entered into the database and validate by the data manager so how they will validate and what the data entry they will do all these things we will see later in the slides only so after that the complete data came then database lock will happen ok so complete and accurate data loaded into the database then database log will happen and the data will flow to the data analysis that is reporting okay according to the data SAS programmer will produce reports tables listings and graphs and that graphs and listings and reports will come to the sponsor and that particular company company companies business office or business meeting will happen according to that one that is known as a result meeting and they will decide whether we have to submit this data to the fda or not once that results are positive then they will submit all these things to the fda for further submission Once it is submitted and approved then the medication will come into the market. So here is the complete process of each and every phase.

So now where is the position of the data manager? So you can see over here the data manager will do the data entry validation. Ok, that's not the data entry and validation. They will design the CRFs and from the designing of the CRF to database lock.

Complete data handling or data management will be done by the data manager only. okay so the next topic is what is CDM okay so you can see over here the data that is known as you can see okay it's just just come we will have a one example over here so if you consider if it is a phase 3 trial and we have 3000 patients. And for each patients, there are four to five visits.

For each visits, there are 10 to 15 assessments. For example, urine test, liver function test, blood chemistry, or medical history etc etc so there so just like that there are 10 to 15 tests only okay and all this test will get repeated into the all four or five widgets okay so the data will come in the form of junk okay so you can see in the picture the data will come in the form of junk over here okay so to collect the data uniform data in a particular manner into the database and that data needs to be accurate okay and A readable format means what you can say SAS readable format data needs to be managed by the data manager. And that data will go to the SAS people and they will produce the reports or graphs according to that data and data and it will get published for the to the. FDA or any regulatory authorities. Okay, so here is an example of CDM.

It means, CDM is just not means that handling of the data. It means just. It starts with the designing of the data to the submission of the data to the stat people, that is reports producing people, that is SAS people. So to design the data.

from data to database archival we need certain softwares or certain uh database databases for example oracle clinical inform ray of open open clinica etc etc so we will have a short description or short training over here in this classes in our regular classes occur in for the Oracle clinical inform open Glica and they okay so we will discuss all these things in later classes okay so okay so more we have completed what is clinical trial what is clinical data management okay so now the next topic is what is our training program okay so Okay. okay so let me start with very basic how does the course work okay right so uh okay so uh Our training program, a typical online course on Great Online Training Center, consists of just not live courses, that is webinar, which is, you can see over here, this is a webinar. So, it is not just like only webinars. It consists of so many combinations of things like assessments and everything.

I'll share all these things over here. So, Once you register for the course, you will get all the course material, Supportive books, software, installation guides, labs and everything available on our website So just register under our course and you will go to the website you will get all these things. Okay, then if you need to attend this live session, then you can directly attend the session via websites or you can schedule a call according to that according to the schedules.

So So okay so which all the session will be the interactive sessions and you can directly ask the question to the instructor or you can clarify your doubts if after the class or after some time you have you have some question or you have some queries or doubts you can directly call to our support team or you can raise a support ticket on our website An executive will be assigned to work on your ticket and then they will respond to you and they will be very happy to respond to your ticket via email or call. Apart from that we have a structure of one to one help also. So you can for example let's say you stuck in some installation or you stuck in some designing of the CRF or something. You stuck over there so you can directly reach out to team and they will help you out. So for every module.

so this is the uh structure how you will you will get opportunity to get in touch with the support team and then for every module you will have a session wise quizzes or assignments which you have to take after every class to reinforce your understanding okay so Okay, so according to the functionality of the CDM, we have distributed this training structure into the three different phases. That is study startup, in this one, CRF designing, checks writing, quality control, control and card assurance will come. So all these things you will get to know in the regular classes. So don't bother about all these things right now. So after that, the cleaning process, how to do the data entry, how to write the discrepancy management, how to interact with different stakeholders, how to handle the deviations, reports and development, IVR and everything, everything you will get to know on that.

cleaning process sessions only okay so after that uh close out how what will be the responsibilities of the data manager of in pre-closer and how to unlock that database and how to log the database all these things you will got to know um all these things in that our training sessions and after that once you completed all this year trainings or you can say webinars and sessions we will give you one project we will be assigned to you on the basis of all the important and major activities of the data manager and this project you need to submit within the time period a given time period and it will be it will be evaluated by the page and support team and based upon that one you will given a review or you will given as well as a great certificate or as well as so this certificate you can um show to your company or it is all it is already available it will be available on online or on our website so you can show at the time of interview to your company and apart from that if you want to go with the ccdm examinations so ccdm can certified clinical data manager so you can go for that one we will give you a chance to take mock sessions on that examination and all these things we will take some mock examinations and everything so for you for the ccdm examinations okay so we have completed this about our training programs and apart from that if you want to if you want something else for example in the our training program we have 25 days trainings okay so you can see over here these are the different days and each day we have different topics over here and according to the topic you need to complete the training and you need to go for the assessment or activities okay so so okay so uh next topic is uh scope of cdm okay so our next topic is scope of CDM okay so you can see over here i have listed down the few of the clinical research and data management companies over here and it is not a complete list you can say it is a list of companies which will work on the clinical data management or clinical research in just in India and you can see or you can just observe the there are a lot of jobs in the various websites or data for data managers or portals are there in which there are a lot of jobs for the data management okay you can just go to the internet and you can see over here over there there are so many companies offering jobs it's not just a complete full day jobs you can see that there are so many companies are offering offering home-based jobs also for the clinical data management okay so you have the great bright feature for if you come up with the data management activities and with this training so you will have a bright bright feature okay so next topic is data management management activities so uh Before we start all the activities of the data management, I have prepared one roadmap. So according to the roadmap, first thing is protocol understanding. So protocol as I said in the previous slides, protocol is the backbone of each and every trial.

So we need to understand the protocol first. and we need to find out the different primary and secondary in points according to the protocol and what are the in points and everything we will discuss in our regular classes and we need to design the CRF edges according to that particular protocol ok so how many widgets will be there and how many assessments needs to be performed All these things, the all these things data will be there in the protocol and according to that protocol, we need to design that pages, CRFs. Okay. So what is the CRF page and how it will looks like, we will come up with the next slide over here. Okay.

Next, after that, we need to design the checkpoints and visit structures. Okay. how many visits are there and what are the checkpoints we will come up in the next slides okay so after that we need to come to that data clean the data with via discrepancy management so what is the discrepancy management and everything We will see in the later slides and how to manage the vendor data, IVRS data, IWRS data, all these things we will see over here. Okay, so after that coding and SAE management and then lock and unlock activities. Okay, so here is the roadmap, complete roadmap.

First, we need to understand the protocol. According to protocol, we need to design the CRF. According to the CRF, we need to design the checks.

According to the checks, we need to complete the discrepancy management and we need to handle the different data. This data, checkpoints, discrepancy management, it is related with the CRF designing. And after that, vendor data, means data from the different stakeholders, for example, labs and everything.

We need to manage all this data and after that, coding and assay management. and then log and log okay so we will go with the each and every topic in a short short period of time okay so uh you can see over here this is a an example of the crf in this one in the crf there are two two parts first part is permanent or database defined part and second part is uh the interval part okay so for example protocol id center id subject id data visits and subject initials all these things it is a protocol defined or database defined field okay so there are two parts of crf designing first part is a permanent part and second part is a investigator interval part first part for example protocol id center id subject id data phases and subject initials all these things are the database defined part and the second part is investigator has to enter the data for this second part for example date of birth sex of birth race and everything Okay, so this is an example of the demography CRF. So, the first permanent part, investigator doesn't have to enter any data over there because it is already defined. Once you did that, the patient is got involved and this part will come automatically on each and every pages okay and but the later part the for example date of birth sex of birth and race everything investigator has to enter the data according to that one okay so this is this is an example of the crfh okay we will uh have a different session on this crf designing and we have the so many activities on crf designing and everything we will see all these things in the our later classes okay okay so the next point is checkpoint development once the crf is got developed then we need to understand the discrepant data discrepant data means the potential risk or potential hazard in the data we need to identify that one and we need to develop the checkpoints to identify that date for that data for example subject age is out of range you can see over here demographic page subject age is out of range according to the protocol patient which has age less than 18 years is not enrolled but investigator has entered the day age is 17 years then this query this check will automatically fire and it will ask the investigator with that message that the date of worth value entered may be invalid please confirm and correct the date of birth okay so this type of edit checks will be available in the database and we need to design all these things gain the correct and accurate data.

So the next is discrepancy management. Discrepancy management, the data, the checkpoint, if the investigator has entered the correct data then it will get automatically obsoleted. Means the check will get obsoleted.

You can see over here this system is obsolete. Means the investigator has changed. changed the data resolution data changed okay so investigator has changed the data then only that discrepancy will get automatically closed okay if investigator has some justification on that one So, investigator enter that comment and wrote it directly to the data manager that saying that okay we have included the patient with 17 years of age only. okay so we need to accept that one now so if it is a protocol deviation if it is a violation of the protocol even though we need to accept that one so that type of data will come to the data manager and and data manager needs to resolve all these things in this format this is an example of oracle clinical and Data manager needs to close all the discrepancies which is routed by the investigator or someone else for example CRA or sponsor and everything which is routed to him.

He needs to close all the discrepancy in this. tool that is uh oracle clinical informant etc okay so so this is this is known as discrepancy management Okay, so here in the example of RDC, this is a front view of Oracle Clinical. So in this one, you can see over here that different colors of pages are there.

Red colors means the discrepancy is routed to the data manager who is responsible to answer that discrepancy. And yellow color means? The discrepancy is routed to someone else, not the particular data manager. And white color means there is no discrepancy in this page.

Means this page has the correct and accurate data. Plus, it has the... sign means investigator has confirmed that the data is written over here is correct one only and plus it has the right symbol it means that particular CRA has verified the data okay so all these things we will see in the later our later classes regular classes how to resolve this discrepancy and how to route the discrepancy and everything we will see over there.

So, next is the medical coding. Why coding is required? What it means? Coding means, for example, fever.

Fever. In India, fever is... fever means high body temperature okay so in india we will call it it's as a fewer and in japan it will call as a hey if you are in russia it is called as increase in body temperature or in u.s they will call as a fewer okay so these are the different terms but the disease is the same so if If it is phase 3 trials or phase 2 trials and it is multi centric or the trial is running in multi countries So their doctor will write the name of the medication or name of that particular disease in their ways Or they can write generic name of the medication for example paracetamol and for example all these things have the same medication that is known as paracetamol.

So to avoid such a bias between that particular medication or particular disease, we need to code the term in the alphanumeric format. So there is a particular hierarchy of the medication hierarchy of the diseases and terms are there. So we will get to know all these things in our medical coding session. So there are different dictionaries are there to code these terms.

For example, for example medra medical dictionary for regulatory activities who did world health organization drug dictionary okay so medra is just for the diseases which disease and procedures surgical procedure and medical procedures and diseases medra will responsible to code all these things who did all the medication name of the medic medication, whether it is written in a generic form or any form, this who did he will code who did he will assign when some some particular code to that that particular medication and everything. Okay, next is a co start. This is the FDA's coding symbol for the thesis of adverse event reaction top. this is for the adverse event reactions only adverse events reaction terms only okay next is a whole art world health organization adverse reaction terminology okay so these are the four major dictionaries uh generally we have to use uh to code particular medication or to code particular medication medical history or medical conditions okay so so this is known as coding after that uh external data management okay managing of the data from the laboratory okay so there are two types of laboratories are there first is a local lab second is a central lab local lab Local lab means some assessment will be done in that particular area, specific area or near to the doctor. And for some of the tests, the blood sample or urine sample or something needs to be sent to that particular central lab, which is located far away from the investigator, that is known as central lab data.

data management okay so we need to handle the data from the local lab and central lab and we need to load the data into the database according to um according to the patients and according to the patient's data and gender and everything okay so next topic is sae management uh serious adverse event management okay so we have the project database apart from the project database we will have a safety database for example aries g arbos aries sapphire and everything okay so the data which has the cd service event will be captured into the safety database and the data which is written in that crf edges are loaded from the third party vendors or different vendors stakeholders will be moving into the project database ok so we need to reconcile the data whether the data written in the or updated in the project database is same as the data recorded in the safety database or the recorded in the safety database or we need to reconcile the patient number which is in project database is correct and safety database is the same one and we need to check whether sex and age and everything is written is correct or not okay so you can see over here this source documents data will come into the database safety database via se reporting okay and case report forms from the crfs which we designed in the form of database to have to know okay so the source documents data will come into the safety database vs sae reporting and case report forms data will come into the project database via sae and efficacy reporting okay so what is efficacy reporting and sae reporting all these things we will get to know in that our regular essay management classes because it is a very vast topic so we cannot complete all these things over here so okay so once the data is got we have collected the complete data and the data is cleaned means that we have the complete and accurate data then we can go for the lock of the data ok so here in the example of the code list difference code list for the for the studies and according to that we can log the data and and if required we need to take permission from the regulatory bodies and the authorities and according to that we can unlock the data also to update or modify something something in the database okay if you miss or if investigator missed something or something is not collected or something uh the investigator wants to update that one then we need a we need it If the investigator wants to update something then we need permission from the regulatory authorities and then we can unlock the data and with the privileged access only. So after unlocking the investigator needs to update the data and then after that again we need to log the data and submit to the. Start people and then start people will prepare the reports and that will be get submitted to the FDA so here is the complete process of the database lock and unlock and How the data manager will do their activities and everything so if you have any question you can Ask me right now You can post your comments or your Questions on the on our website that is greatonlinetrainings.com and You can register over there or you can connect directly to our support team via our website that is greatonline.in. Okay, so thank you.