Oracle Clinical Session 1

so I just still list down some of these applications which are apart authority pharmaceutical applications the first application is codes Oracle clinical and this is a clinical leader management system the second application which is a part of the already pharmaceutical applications suite is the Oracle a ers also stands for Oracle adverse event reporting system it’s the safety database where all the adverse events and serious adverse events will be stored and it can be synchronized with the Oracle clinical database the third one is Oracle TMS which stands for the Souris management system during during the process of collection of clinical leader on case report forms there are a lot of data that’s reported which are not standard medical terms so you have to convert go back in terms that are reported on the CRF into standard medical terms through by the use of medical dictionaries and the management of these medical dictionaries and diversions is done by the Oracle disorders management system the fourth application is site minder and trial minder so these are two applications or install at the side and with the sponsor respectively these applications are helped in the management of administrative data financial leader and regulatory data generated during clinical trials and therefore it’s also called a clinical trial management system so the clinical trial management system is because it is not it’s not used to collect and manage rockland if you later it is just used to manage administrative and regulatory data as well as financial data which helps the site and the sponsor keep on top of the clinical trial at any given point of time so these are the four four basic components of origin pharmaceutical applications suite and it defends that some companies might have all the four applications installed as part of the life science infrastructure however some of the companies might only have one of these installing okay so the instance that we working we’ll be working on is only having Oracle clinical as the component that’s being installed within within this particular software so to access that application the first step you need to do is get to this login page by using the URL and typing it into the Internet Explorer browser you then click on the login button and it opens a small window now this small window that opens up is a health maintain connectivity between the browser that you’re using and the web server which is actually serving the web app application Oracle clinical is a web-based application which essentially means that you access Oracle clinical / / / browser so you know you’re not using a client-server model here you don’t go into programs open a program and then connect to Oracle clinical so it’s not a client-server model instead it’s a web-based model where then you type in the URL connects to a web server which is located on the Oracle clinical application server that’s running and it helps you connect to the application over a simple simple browser now to maintain connectivity between the browser and the server that’s serving this application this small window opens up and you know if you close this window you lose connectivity to your server so you will not be able to access before many activities within Oracle clinical if you close this small window so the first step that you need to do is minimize this window and do not close it while you’re working on the application immediately after that small window opens the log and applet will also open this log and applet will only be shown to you if you have GNE shearer installed on your system because this isn’t this is a Java applet which allows you to securely login into the Oracle clinical application and unless they initiator which the plugin is installed on your system you will not be able to get to this point in so this is why we need to use a 32-bit operating system now once you go to the login screen you can enter a username and a password which I will be providing to you in the shop while are at the end of the session after the session I will be creating your usernames and passwords and sending them across to you in an email so you will get a username which starts with O PS dollar in Oracle clinical all user names start with OPH dollar which is a prefix to tell it to tell the database that this is the table that you want to connect to while authenticating this particular user so opiez dollars all this prefix do the username that’s provided to you by RFK

clinical administrator in this case my username is opa storage trainer so i’m going to enter that username here into the password which you want to use to connect to the app or to the database and then i would like to enter the name of the database to the wish to connect to now companies might be running multiple instances of the same database or multiple instances of various databases and you would like to choose which database you want to connect to and sometimes companies run a validation database which is separate from the production database so they might be running a validation database by the name of OSI validate where in this database is just used as a test server for clinical data management professionals to perform various clinical study tasks and the data within this validation database does not count or to be production data which means it’s not going to be submitted to the radiator authorities so this is just a playground for the clinical data management professionals to actually go ahead and plan the study and design their study and perform activities just on evaluate just to validate that they’re performing the tasks correctly so not nestle in a production environment but there’s also production database there in which to which you will connect you when you actually want to work on various studies being conducted by the company ok so if you’re working with live studies you’ll probably be given access to a separate database where life studies are located and you would be working on them so in this case the database name that we connect to is OSI prod OCP ro e and such the Oracle learning production database now I will be sending you this information or in the email as well so I will be sending you the link to login I’ll be sending you the name of the database plugin and I’ll be sending you your user names and passwords as well once you’ve herb so once you’ve got to this point and you’ve entered the username password and database name click on connect and that’s next to your Oracle clinical application so it’s what is trying to do right now is authenticating the user name and password against the database that you’ve entered to connect you if the authentication is successful because your username and password exists it will lock you into the system if not it will just give you an error stating that you are not authorized login into the application this conforms to the 21 CFR part 11 compliance which is a regulatory compliance that need to be that needs to be alert to by all by all IT systems in life sciences they have to revert to an FDA guideline for 21 CFR part 11 and that states that your username there should be a username and password that should be a window to any clinical data management system which means that only authorized users should be able to access the application at any given point of time and a combination of the username and passwords of each of those users will be considered as the electronic signatures okay so once you’ve logged in into the Oracle clinical application you’ll be greeted with this window if there are multiple applications installed right now there’s only Oracle clinical install here so you see Oracle clinical ocl four point five point zero that’s the version number that we’re working on if there are more application installed you’ll have more notes over here such as Oracle a ers an Oracle DNS and site minded reminder so there is only one node here which which means that or if you can place the only pharmaceutical application that’s installed for this instance now this entire window is called the navigation window because it is the home screen of the ordinary clinical application in this session I just intend to take you through the various components of Oracle clinical and briefly explain you the functionality of each of these subsystem we’ll be going into each subsystem in detail and so for every session we will be proceeding in such a fashion that I will be telling you about each subsystem what are the modules within each subsystem what function it performs I’ll be demonstrating that function to you as its performed in the industry and then I will be giving you an assignment of how you how you can practice to perform that same function using that subsystem so it will be divided into three parts a demonstration of an assignment and then a feedback which I’ll give you based on the assignment that you actually completed so this entire said this entire screen is called a navigation window and the menu that we see here is called the navigation menu so this set of menu items from admin plan design yoga library definition gandha error entry in labs this is called navigation menu ok the navigation menu is made up of several the navigation menu is made up of several small nodes and each of

these nodes is called a subsystem so we’ve got an administration subsystem a plan subsystem a design subsystem a global library subsystem definition conduct data entry and labs so each one of these is called a subsystem in Oracle clinical a subsystem has various modules which allow various functions to be performed by that subsystem ok when we click on a specific subsystem in Oracle clinical for example if you click on the plan subsystem it shows us a bunch of nodes and each of these nodes is called module so you’ve got a program’s module you could a query programs module organizational units module query organization its module regions large studies each module is used to perform a subset of the function that the subsystem performs so if plan performs end of 15 different functions program allow the program’s module allows a two or three out of those functions to be performed so it’s just a subset of basic functions that can be by the subsystem so the highest in the hierarchy here and this not this down for you as well so we have discussed here we’ve got a navigation screen and this navigation this navigation screen is made up of a navigation menu navigation menu in turn is made up of subsystems and subsystems actually help in performing a bunch of functions a bunch of clinical area management tasks so that’s what that’s what the roll out for subsystem is each subsystem is divided into several modules so you might have module one and you have module two and so on so you can have any number of modules within a subsystem each one of these modules is actually used to move the tables move the data between the cables of the clinical database so each module within a subsystem actually helps in the movement of the data between the tables of the clinical database so for example the program’s module is used to create a therapeutic area it allows a therapeutic area to be stored within a certain table within the clinical database and from the actual movement of data happens through the module it is not happening through the subsystem it is not happen through the form okay so the modules help in the movement of data between the tables of the clinical database sometimes a module may be further subdivided into sub modules so some modules also perform the same function as performed by the module which is that the sub module allows you to move the data between the tables of the clinical database but not all modules are divided into sub modules for example here the planned subsystem is divided into the program’s module but the program’s module is not for this divided however if I click on the design sub system the design subsystem is divided into the studies module which can further be subdivided into several sub modules so this is the subsystem design subsystem studies is the module and easy study design is the sub module both the module in the sub module helped in the movement of data between the tables of the canopy database so that is the structure of the navigation menu the navigation menu is made up of several different subsystems as we can see here each subsystem can be expanded to show what is known as module which helps in the movement of data between the tables of the clinical database and every module can also be subdivided into sub modules so some some modules can be divided into sub modules and some cannot okay just like a programs watch you cannot be further subdivided but the study is module you can be further subdivided you have any questions after here you could ask you know and unsteady questions that you have and then I proceed further okay so move further then of now we’ve discussed first what a navigation menu is we’ve got to discussed what a navigation screen is what our modules do our sub modules when you click on a module or a sub module it further opens

up what is known as a forum so if I click on the module clicking on a module will further open up a forum similarly if I click on the sub module it will also open up what is known as a forum so here I am clicking on the program’s module so when I click on the program’s module here it opens up a forum for me and this form is used to show a data which is related to that module so here the program’s module is actually used to create the therapeutic area we will discuss about each of these modules as we go through the various sessions but program module is used to create therapeutic areas so when I open up the programs module it shows me a forum which contains all the therapeutic areas that have previously been created and researched ok so a forum is a window which allows you to see the data within the database related to the module that you open the forum from so here this forum maintain programs and projects forum shows me the data related to the therapeutic area because I have opened it by clicking on the programs module so all is a user interface which allows you to view the data by fetching it from the clinical database please remember that if you perform any actions on this forum the actions are actually being performed with a module the forum is just a dumb interface which allows you to view the data and which allows you to make changes to the data the change is actually being performed by the modules itself so it’s it’s your window to the clinical database ok you will also notice that when a form is closed and there is a bunch of icons at the top here these icons are file edit navigate job they don’t do much if you’d like to exit out of the screen allow you to do that if you like to print this particular screen to a printer allow you do that just basic stuff it allows you to do it but what is important is that when when I actually highlighting this particular board so that you can identify how it changes now if I click on any of the modules and it opens up the form the navigation bar at the top over here will change so when I click on the program’s module and it opens up the form you see that this automatically changes to action move data or action move clearly they’re very special in hell so these bunch of items at the top here is called the inform menu so this right here is called inform menu so the info menu is a bunch of actions that you can perform on a given form so it’s a bunch of activities that you can actually perform on a given form it’s called the inform menu because it only opens up when a form opens the moment I close the form the info menu automatically disappears so if I give this form the info menu from the top is going to disappear if I open up form the in form menu will appear again so the info menu is a bunch of common functions that you can perform on any given form action move clear data query health and window these are buttons of the inform menu that perform the same functions irrespective which form is opened up ok if I want to clear the record if I want to clear the record for example I’m working on the first record here if I want to clear the record I can just click on clear record and clear that record for me but what a clear this first record again I can do that again so this function is common for the for any form that actually but there is a function called special info menu the special inform a new varies from the function of the special inform menu will vary from form to fall like in this form it only allows me to select a study but if I open up another form let’s say I go into the definition subsystem ehre collection modules and I open a data collection module we will see that the special info menu will actually change so here the special in for men you is will be slightly different if I click on the special inform man you will have much smoke functions that you can actually perform on this form so the functions that can be performed by the special info menu are restricted on a form to form basis however the rest of

the function in the inform menu can be performed irrespective on which differ in respective of which forms actually open up so again coming back to our programs form is that the simplest form that we work on so in the program’s form I can use the action in form menu to save a record I can view the audit information of any record for example I am working on the first record and I like to know which user created this record I can go to action audit and it will show me which user actually created this record on what date and time so this for record was created by OBS dollar trainer which is me on 1515 2009 at so-and-so time it was also modified by me on the 17th of May so it will tell you that each specific record it will give you an audit information or a log of who created that record and who modified that record similarly you can use the action inform menu to view the environment that you are working on so if I keep an environment in which it prepare me which is the user who’s logged into this database at this time what is the database that you go into what is the current study that you’re working on what is the version number of that study and other details such as what is the current date and also it will give you the technical name of the module you’re working on so in this case we are working on the program’s module but internally with an Oracle clinical programs module is referred to by this name which is rx a Fijian CA yes if this does not make any difference to the end-user who’s working on any study but it’s a good to know information in case you wanting to debug any particular module or send it with this information to the Oracle clinical administrator so let’s say your programs what you is not working correctly and you you Dell Oracle clinical administrator you send an email stating that the program’s module is not working correctly for you he might ask you to go into the environment variables and tell the technical name of the module so that he can troubleshoot in our database level okay so this just gives you more information about the window that you’re working on and the current environment for a clinical actual working on you also have an option to run bad shots batch of the non interactive programs in Oracle clinical – which do not interfere with your users tasks for example you’d like to run a report but you’d also like to keep working on this programs window you can do that using the badge office function until you further about what God jobs are when we go into discrepancy management and validation receipt of designing but at this time it’s good enough to understand that bad jobs are non interactive programs like running reports or executing validation procedures which do not interfere with the user’s tasks so they run in the background and you can get to them if you’d like to by going into bad jobs here which will show you all the bad jobs being run at any given point of time which one’s a failure which one’s a success and you can also do the output of each batch job now apart from that you can also print the screen if you’d like to or you can exit this form and you can also exit this form without saving similarly the move in for menu allows you to move back so if I am or if I’m at the food record and I go to move back it takes me back to the previous screen that has actually on so it takes me back to the navigation making the technique on the programs module here and I even move and I go into projects for example for any given program if I go into projects this is the second level within this screen so this is something that I didn’t tell you when I was telling you what form that each form can have multiple levels like this is the first level of a form if I exit out of this level actually it’s about the form completely but within the programs for my can have multiple levels so I can have a projects level like in this form in one of the projects level and this is the second level within this form if I want to move to the previous level I can click on back or I can just go and move back it takes me to the back or the first level within this form so the move button is your info menu allows you to move to different levels within the form it also allows you to move between fields so right now my cursor is on the first field if I’d like to move to the description Vale I can go on the move next week if I like to go to the second record I can go to move next record and we’ll go to the next record right here so at some times you might want to use these functions now clear and delete are two different functions so if I clear a record it does not get deleted so for example VMs 0 1 this is the therapeutic area of hope or for central nervous system if I want if I clear this record it does not mean I’m deleting it it gets clearing the record means it’s removing

it from the user interface of the form but it’s still existing within the database so if I was to go in a query in the query and execute the query again and fetch all the records BMS 0 1 will populate back here so clearing the record is not ending it if you’d like to delete your record you’ll have to go into data delete record and this will delete the record for good or and you’ll not be able get that information back again you can also insert a new record so if I’d like to insert a new record after BMS 0 1 I can go in the data insert record and it will have a new record right below this if I want to delete this record I will be needed if I want to duplicate a record I can also do that and it will delete that record and and create new record by the same name you can use the query inform menu to set various query parameters like here I’ve got several programs BMS 0 1 GSK jsk again and then Eli Lilly if I only wanna query for the BMS 0 1 program I can go in a query in the query and I can I can do search by first th BMS person gauge which means that I want to query for all those programs whose code has BMS in it it could have anything before which is signified the percentage it could have anything after which is signified by percentage again so percentage BMS person page will query for all those records of all those programs which have a code that has BMS somewhere somewhere in the board if I execute the query this time it will only fetch me one record which is v NS a reserved v ni 0 1 because this was the only one that contained v NS included in the list of values so you can set different query criteria based on which you can actually query the record one thing also you’ll note is that there is an option for count hits so in discrepancy management the number of discrepancies that are fetched a very very large so for a study you might have 3,000 to 4,000 the discrepancy that you’re working on you might not want to fetch all the discrepancies at the same time but you like to know that if you execute a query how many discrepancies will actually be fetched so in this case if I go to end the query and I would like to know that if I query for this criteria which is person age BMS first gauge how many query how many discrepancies will actually be commonly records will actually be fetched I can do that without executing the query and just clicking on complex when you click on count hit it it runs a query to the database giving you the numeric value of the records that will be fetched rather than the records itself so when you click on count hits it will tell you at the bottom that query will treat one record so it’s telling it’s not really query the database a or the record it’s great if the database for the number of records that to be fished for this grading criteria so of course if you have to give this query only one record gets fetched which is absolutely what a dump hits told us as I said the special info menu is a special set of functions for every given form in this case it’s only used to select the study the health and form menu allows you to base Eve you key definitions key definitions are shortcut keys that you can use within Oracle clinical and all the shortcut keys that you can use within Oracle clinical can be viewed under the key definitions module so there are three ways to perform functions within Oracle clinical you can use the inform menu or you can use this toolbar that you see right below inform menu which performs the same functions as the inform menu so the info menu and the toolbar perform exactly the same functions it’s just that the toolbar is more intuitive and it will give you two tips about what function can be performed by it for example if I put my cursor on this on this particular toolbar just give me a minute so if I put my cursor right here it will give me a due date that this one is actually used or so I have to close this form action so if I put my cursor here now it gives me a two day practices for next record so if you like to move to the next record you can do that if I’d like to save a form I could do that by just clicking on this record if I have to exit a form I can do it using this so the tools are from the same functions as the info menu so the first way to perform functions is using the information the second way to perform functions is using the toolbar the third way to perform functions in Oracle clinical is by using shortcut keys you can view all the shortcut keys with an Oracle clinical by going into the Health Menu key definitions I’ll show you all the shortcut keys that you can use within order clinical so over kind as you’re working on the application you can get acquainted to these shortcut

keys and use them if you have multiple windows open up you can switch between windows using the window or inform menu so I can go back to our my navigator window or I can go back to my in programs and projects form using the video or inform menu now whenever whenever a forum is open you will also see a bunch of nodes that are displayed on the forum these bunch of nodes that are displayed on the forum are called navigation buttons okay navigation buttons are a series of buttons on the form which allows you to perform a certain set of functions within it so for example on this form for viola and creating programs I can also create projects and I can assign my investigation your drug to every to a specific therapeutic area so projects can come found the sign or to navigation buttons here which allow you to perform relevant functions while creating a therapeutic area exit saving single are common navigation menu IP of common navigation buttons which are there on every form so navigation buttons will also vary from form to form like here I have programs and projects form open up and it shows me projects and compound the sign navigation button but if I exit out of this form and open another form for example easy study design it will show me a completely different set of navigation buttons here it’s got intervals events treatments patient positions so there are completely different set of navigation buttons on this form so navigation buttons allow you to move to different levels of the form and allow you to perform relevant functions on that given form okay Alstom when a form is opened up you will have a so till now we’ve discussed for the informed menu is what a toolbar is then key definitions navigation buttons other user interface elements with an Oracle clinical are the windows title bar so this right here is the windows title bar the dot the windows title bar allows you to see who is the user who is logged into ArcheAge medical what is the symbolic username what is the database is logged into and what is the date of login this information is recorded within the audit trail based based on any activities that are conducted by the user so this is called the window slightly part gives you more information about the user logs in the date he is logged in under symbolic use any of the user logged in then there is the inform menu so for every form that opens up you will see the main you see a title that is present for every form in this case it’s maintain programs and projects so every form will have a title which displays what that particular form is used to do and this is called the form title bar so you’ve got window stratify the top and four if you form you put the form Vagabond then you’ve got a message line so if my cursor is placed on the code field it tells me a unique code for the program so if my cursor is placed on the description field it tells me this is a unique description for the program so this is called the message line it tells it gives you more information about where your cursor is placed so if you’d like to if you like to enter a value for a particular field and you’re not really sure about what value needs to go in there you can refer to the message line which because it will give you some information as to what information needs to go in there right below that is the status line the status line tells you of which record you are working on and how many records that they within that form since the here Thins record one out of four because I’m working on the first record and there are four records within this form if I start working on the fourth record it will change and say record four over four so this is very important in discrepancy management where you really need to be sure about which record you’re actually working on and at that stage the status for the status line will come into use it tells you which record you working on over there wherever there is a list of values for a particular field it will tell you there is a list of values for it so this is the user interface of Oracle clinical now each of these subsystems is used to perform various functions in a in a future sessions we’ll be talking about what subsists what function is performed by each subsystem I will not be doing the administration subsystem because this is used by the Oracle clinical and ministry at mints traitor and it’s a technical function in sync with the actual Oracle clinical Mac in the database so this is generally a role

which is not which is limit to limit it to the IP and the admins administration department you do not have access to it because that’s not involved in the process of planning and designing a clinical study the lab subsystem is not required here oh because laboratory information management systems are used specifically for the management of our area so the subsystems that we’ll be talking about or the plan design global library definition conduct and here a entry open all the administration subsystem helps in the helps in the process of creating new users changing user passwords and maintaining the report queues of various reports that actually run there are several reports also that you can create using the administration subsystem for example you could create administration reports for knowing what are what are the users that are existing within the application so if you’d like to know all the users that are existing within the application you can run a report for groups and users and it will give you a report as to how many users as a written application as such it also is used to set data entry configuration settings for various or data entry behaviors of while performing data entry from Kate report forms so this is mostly to deal with administrative functions of Oracle is going to be the plan subsystem allows you to plan a clinical study by defining the therapeutic area or the disease and the investigation your drug that’s being used for for your specific study the design subsystem is used to design a clinical study by defining the time periods or into which the study is divided it is here that you will also decide how many visits are there within your clinical study and what are the patient identifiers by which you will refer the patients who will enroll in this clinical study in the design subsystem we also define what will be the various treatment arms into which the study into which the patient will be divided during the process of conducting the clinical trial because in any every clinical trial you need to have at least two treatment arms one being the investigation your drug and the other treatment arm or being the one who is going to receive the visible or a control to the investigational drug so you will need to divide your patient IDs into either one of those treatment arms in such a way that there is no bias in the clinical trial okay and you use the design subsystem to do that as well the Kuban library in the definition subsystem are actually used to create your data entry screens so your case report form is used to actually enter the data within the clinical database during data entry but you cannot enter the data from a CRF into the database till you have data entry screens designed which look exactly like your CRF and to create those data entry screens from each report forms you use the global library subsystem and the definition subsystem the definition subsystem is also used to create validation procedures which are programs used to identify invent system data so then there would be several different discrepancies that will be generated as a part of your data collection process some of those discrepancies are due to inconsistencies in the data we’re in for response to one of the questions entre Dex cute the response to another question that is asked answered on same CRF for example the patient the investigator might mark the gender of the subject to be mailed whereas one of the tests one of the largest that is conducted for the same patient might have pregnancy test mark is positive so it could be possible that the investigator has may has actually made a mistake or the laboratory has actually mixed up the samples so you know those cases you will have to actually query back within together and asked the investigator what exactly is the issue why that inconsistency has actually been has actually occurred so in those cases you will need to create automated programs which can run on your data to identify inconsistent scenarios in the data entry and we will be discussing the process of how we create these validation procedures and how we write boolean expressions for them to identify inconsistent data the convex subsystem is used to manage discrepancies that are generated during the data entry process so once the data is actually entered by the data entry operator using the data entry subsystem the conduct subsystem is then used to actually manage discrepancies for incomplete missing and inconsistent data the conduct subsystem is also used to create data clarification forms which actually allow you to send across your discrepancies to the investigator of via the data clarification form through which you can actually query the investigator for clarification as to why that discrepancy exists and what is the resolution to it

okay so as a part of this Oracle clinical training you get a hands-on training exposure to all the subsystems of Oracle clinical with respect to planning designing clinical study creating kidster code forms performing data entry and managing discrepancies when you work in the industry you will not work on all of these subsystems so you might just work as a database designer where you have access only to the plan and design subsystem you might work as a CRF designer when you only have access to the global library subsystem or you might be a you might be working as a or analytic programmer where you only have access to the definition subsystem because you need to design validation procedures or you’ll be working as a clinical data coordinator which will involve the process of using the connect subsystem to manage the discrepancies and send the discrepancies and data clarification forms so this completes the overview of Oracle clinical or under user interface elements of Oracle clinical now for those of you who are using critical operating systems I would advise you to go please go to the link that that you can see on your screen at this time I’ll also be sending you this link when I send you your user names and passwords a short while from now and you can use that link to get to this login page and click on downloads and download JD sugar but please try and download and install this genius sugar before the next session begins because once the next session begins I will be demonstrating the process of planning and designing a clinical study and you have to perform their assignments yourself so please get set up with the Janie shader plugin and make sure that you’re able to login into the application once a send your user names and passwords if you’re not sure if there’s some question that you’d like to ask you can always send me an email I’m driving my email into the chat window here so you can send me an email here and I’ll help you with any doubts that you’re facing but please make sure that before you try installing genius shader and trying to get to the login page you should be able to do it only if you have a 32-bit operating system running on the laptop are you working on so that’s pretty much it from this session if you have any questions that you that you’d like to ask or you can ask your questions now and then we close the session for today and I will send you across your usernames and passwords to the application I have any questions okay so that completes a session for today on Oracle clinical overview and navigation I’ll be sending your user names and passwords to the application shortly thanks for joining the session and I will see you in the next session if you have any doubts along the way please send me an email on the email id director said type into the chat window and I’ll help you with any questions that you have with respect to this error thanks for joining this session I’m good Oh Oh the organizer has ended this