Notes: The course is suitable for CTC or external staff in the following roles: Clinical Research Coordinators, e.g. Site Data Manager/Study Nurse

Transcription

1 This course provides an introduction to OpenClinica version 3.1, including key terminology and concepts, as well as basic skills such as navigation. The course is suitable for CTC or external staff in the following roles: Clinical Research Coordinators, e.g. Site Data Manager/Study Nurse Prerequisites Basic knowledge of Clinical Trials and Randomisation processes. Competence in using web-based software applications. 1

2 This course is divided into sections as listed on the slide 2

3 This section will give you an overview of the terminology and important concepts used in OpenClinica, and introduce you to the look and feel of the application. Throughout this course we will use screen pictures and exercises from an example clinical trial. Nothing in the course is specific to any particular study, and the variety of screens is deliberate to reinforce this point. The trainer will provide you with examples to use for practical exercises that do not rely on prior knowledge of any particular study protocol. 3

4 These are the key terms used in OpenClinica. A study is the clinical trial or clinical research study as modelled in OpenClinica. Note that all OpenClinica studies are stored in one database not separated into discrete databases. A hospital or clinic is referred to as a site. A participant in the study is referred to as a subject. Subjects should be associated with a site, and can be reassigned to another site. A visit of a subject at a site is called a study event, where a certain activity is expected to take place such as randomisation, baseline, tumour assessment, drug dispensing etc. One study event can contain one or more ecrfs. An ecrf is an Electronic Case Report Form, and is equivalent to a paper CRF. You need to access an Event to view an ecrf. The complete series of Study Events for a given subject is known as the Subject Case Book. An item is a question on a form. A discrepancy note is a data validation query or a comment associated with the item s data value. 4

5 These are the key software functions in OpenClinica that you will have access to: Subject Matrix allows you to view all the subjects at your site in one table and access a variety of functions, including viewing a patient record, editing data, and scheduling an event. View/enter data to view or enter data in an event. Schedule/ Schedule Event is used to create a new event for data entry. Add Subject/ Add New Subject allows you to add patients to the study DO NOT USE THIS FUNCTION Subjects must be enrolled using Flexetrials. See the Study Manual for details. Notes & Discrepancies allows you to view any notes & discrepancies assigned to you and to manage them. View Events allows you to filter events by date and data entry status Import Data is not used for this study please do not use this function. Update Profile is where you can change your password and update your user profile. 5

6 These following functions may be accessed from the Tasks menu shown at the top menu bar of OpenClinica. Subject Matrix allows you to view all the subjects at your site in one table and access a variety of functions, including viewing a patient record, editing data, and scheduling an event. Schedule Event is used to create a new event for data entry. Add Subject allows you to add patients to the study DO NOT USE THIS FUNCTION Subjects must be enrolled using Flexetrials. See the Study Manual for details. Notes & Discrepancies allows you to view any notes & discrepancies assigned to you and to manage them. View Events allows you to filter events by date and data entry status Import Data is not used for this study please do not use this function. Update Profile is where you can change your password and update your user profile. Log Out is to log out of OpenClinica 6

7 OpenClinica is a typical web-based application and runs within Internet Explorer and Firefox. You do not need to install any special software on your PC. 7

8 8

9 This screen shows the OpenClinica login page. To access OpenClinica, an authorised user must provide a correct combination of user name and password. Otherwise, the system will prompt an error message indicating no such combination exists. Both your User Name and Password are case sensitive. OpenClinica will prompt you to change your password the first time you login using the username and password provided to you by the CTC. After a successful first login, you will be required dto reset your password dfor the first time. To reset your password, you will: 1. Specify the original password provided by the CTC 2. Enter the desired new password (remember passwords are case sensitive) 3. Re-enter the desired new password 4. Choose a password challenge question 5. Specify the answer to the password challenge question Please remember both the password challenge question and answer as they will be used if you forget your password. Password tips: Passwords in a web-based system are equivalent to your written signature. Passwords are generated by OpenClinica when your user account is created or if you need your password reset. These generated passwords are a random sequence of letters and numbers. Passwords must be at least 8 characters in length. Passwords must never be shared. 10

10 You can always reset your password anytime by selecting the "Forgot Password" link from the login page. You will then be prompted to the "Request Password Form" page. In order to reset your password: 1. Enter your user name 2. Enter your used for the OpenClinica account 3. Select password challenge question. This is the password challenge question that you selected when resetting your password upon logging in the first time 4. Enter the answer to the password challenge. This is the answer that you specified when resetting your password upon logging in the first time 5. Click "Submit Password Request" 6. The system will send a new password only if a correct combination of password challenge and answer are specified. Otherwise, the system will prompt an error message indicating that the password challenge could not be verified. 7. Once a correct password challenge question and answer are provided, the system will send a message to the associated containing the new password. You will use this information to login to OpenClinica. After logging in using the new password, you will be prompted to choose a new password. 11

11 The OpenClinica home page consists of the following key areas Top level of Page Consists of the Name of Study, Change Study or Site, User Name and Role and Log out. Navigation Bar Contains the key functions accessible to your role, and the Tasks menu. The Navigation bar consists of Home, Subject Matrix, Notes & Discrepancies, Tasks, Report Issue, Support, a search box and a GO button. Please do not use the Report Issue or Support links please contact the CTC trial coordinator if you require support. The Home button on the Navigation Bar takes you directly to the Subject Matrix. Sidebar Contains four context sensitive sections providing information about the study and activity you are using: Alerts and Messages notifications and information Instructions general guidance and tips relating to the current function Other Info summary of the current study Icon Key a visual guide to the symbols used on screen e.g. to show the status of subject data Body The main workspace of OpenClinica, where you browse, enter and clean subject data. 12

12 When working in OpenClinica, you are always working in reference to a specific study/site. All studies are accessible through h the same URL, however, you will only be able to view those which h you have been given access to. Most Clinical Research Coordinators will only have access to one study/site, so will not need to use the change study/site link. If you have access to more than one study/site, as per the example shown, you must first change your current study/site before you can proceed. This task is accomplished by clicking the Change Study/Site link and then selecting the site you d like to change to. Studies are indicated in bold with sites in regular font. 13

13 User Name and Role - Shows the user who is currently logged in to the application and the User Role assigned e.g. SiteDM (Clinicali l Research Coordinator) Click on this link at any time to access and change your User Profile including changing your password. This can also be accessed from User Profile in the Tasks menu Log out When logging g out of the system, it is important that you use the logout button. Please don t use the red X, as this leaves your session open in cyberspace, and can lead to network congestion. 14

14 Alerts and Messages - This section of the sidebar will present you with messages and alerts based on the actions you are performing in OpenClinica. i One such example is when you log in to OpenClinica i a welcome message will appear in the sidebar along with date of your last login. Instructions The sidebar Instructions panel will give you a set of brief directions or a summary of the task that can be performed as well as guiding you to the Help icon for more detailed information on that module in OpenClinica. Other Information- Information displayed in this section of the sidebar will depend on where you are in the application and the actions you are performing. An example of some information that might display includes the name of the Study, the start and end date of the Study, and the name of the Study principal investigator (as opposed to Site PI) Icon Key- The Icon Key panel is divided into two sections: Status icons and Action icons. 15

15 16

16 The Subject Matrix shows one row of information per Study Subject, with a column for Study Subject ID and columns that trepresents each hstudy Event. For each cell in the table, coloured icons identify the status of a Study Event for that subject. If there are more subjects in the study than can be listed on the page, then you will see at the top of the table green arrows that allow you to scroll backwards and forwards through the pages of subjects. If all the subjects fit on one page these arrows will be grey and not clickable. By selecting the drop-down box next to these arrows to choose the number of subjects viewed on a page (15, 25, or 50 at a time). A popup balloon appears when you hover your mouse over each icon. Click on the icon to get a list of actions that you are allowed to perform on that particular event, which may include (depending on your Role and the status of the Event) Schedule, View/Enter Data, Edit, or Add Another Occurrence (in the case of a repeating event). Many columns (though not all) may be sorted by clicking on the column header. If the column header is clickable it can be sorted. Clicking on the column header once will sort in ascending order, and clicking a second time will sort in descending order. Underneath each column header, you will see a grey field where, depending on the column, you can either select from a drop-down list or enter search text to filter the contents of the table. To Apply the filter, select the link on the far right-hand corner within the table. Select the Clear filter link when the filter needs to be reset. To view a more detailed page for an individual subject, select the View icon on the right hand side of the matrix under the Actions column. Select Show More to expand the Subject Matrix to reveal additional i columns - shown on the next slide. You can also view the matrix by the event using the event selector at the top of the matrix. 17

17 Here is a list of the status icons that you might see on the Subject Matrix. Not started means that the event has not been scheduled. Scheduled means it has been scheduled and data entry is ready to commence. Data Entry Started means that some fields have been completed but the CRF has not been marked as complete. Stopped and Skipped are statuses which are set manually by the user by going into the edit event function. Stopped means that the event was not completed for some reason, even though it did start. Skipped means the subject is skipping that event entirely and will not be participating in the event. Completed means that the CRF has been completed and has been marked as complete. Signed means that the event or the case record book is ready to be signed by the investigator, so you might see this icon on only one event, or for all events. Locked means the CRF data can t be changed. Contact the CTC if you wish to change any data in a locked event. Invalid means there is a problem with the event record and data entry cannot proceed. NOTE: Subject Matrix status icons do not show whether there is missing data or queries this is managed separately from the Subject Matrix, in the Notes and Discrepancies page. 18

18 This view is of the subject matrix when an event is selected, by choosing Select an Event from the drop-down. In this case, the event selected di is Baseline/preop. This page is organised similarly to the default Subject Matrix, but the columns represent the CRFs included in the chosen Study Event instead one column per Study Event. You will see an Event Status icon to the right of the Study Subject ID column showing the overall status of the Event for each subject. For each CRF column in the table, coloured icons identify the status of the CRF for that subject. A popup balloon appears when you hover your mouse over each icon. Click on the icon to get a list of actions that you are allowed to perform on that particular CRF, which may include (depending on your Role and the status of the CRF) View, Print, Edit, Remove, and Delete. 19

19 To view detailed information about a subject, select the View icon on the right hand side of the matrix under the Actions column. This page is divided id d into the following sections: Subject Record Events Groups Global Subject Record...and a link at the bottom of the page allowing you to return to the subjects list. By clicking the plus or minus next to each section you can expand or contract the sections of the Subject page you wish to view. By default the Events section is expanded. d The Study Subject Record section, when expanded, provides information on the Study Subject ID ( Patient Number ) and Study Name. The Events section shows a list of all the events assigned to that particular study subject, and the ecrfs within each Event. You can see the number of pages associated with your Study Subject Record. In the example shown, the subject is associated with two events. One is scheduled, and data entry has started for the other event. There is also a search box that can be used to search on Event names and the Schedule New Event link that when selected brings you to the Schedule Event page. 20

20 When you click on View/Enter Data for an event, the list of ecrfs associated with that event are listed. (You can get to this screen either by clicking on View icon from the View Subject screen, or by clicking on the event in the Subject Matrix then choosing View / Enter Data.) The first time you open an event, the ecrfs are listed in the order they are meant to be completed*. The Status column shows the status of data entry for that form. In this example, all forms have a status of not started. To view the data of any ecrf, click on the View icon ( magnifying glass ) under the Actions column. * Note that as data entry proceeds, the ecrfs are reordered to show the next ecrf at the top of the list. 21

21 OpenClinica Release 3.1: Data Entry When you click on Edit you are brought to the data entry page for the selected CRF. The page shows the subject study number at the top right, and the CRF name with the status icon of the CRF next to it. The CRF Header info is a collapsible box which is hidden by default. It contains information about the CRF, including summary information about discrepancies on the ecrf. The CRF itself is divided into Sections, or tabs. The screen shows at most three tabs at a time, but there may be more sections which can be viewed by clicking on CRF section selector. The number in each tab indicates how many fields are yet to be completed, for example, 10 out of 10 fields in the LATEAE tab have been completed The CRF section selector is a pull-down list: Select to Jump, which can be used to navigate to any section in that CRF. 22

22 23

23 OpenClinica has a print function, which is accessed through viewing a subject, or viewing an event. When you click on the print icon, a window pops up with the CRF and the entered information for that subject. Sometimes the fields don t fit into one page and will be cut off when you print it, so you will need to manipulate the view to get all the data printed. 24

24 You can access the OpenClinica Reference Guide by clicking on the question mark icons which appear next to the headings on various pages, or the help link at the bottom of each page. The reference guide is a generic instruction manual for OpenClinica, and is not study specific. If generic instructions are different to guidelines in this training material, the guidelines in this training material should be followed. The icon at the bottom of the page will always take you to the start of the reference guide. The question mark icons link to the appropriate section of the manual, for example, the question mark on the Subject Matrix page will take you to section 2.1 of the reference guide which gives details on the Subject Matrix. For any further assistance, please refer to the Study Manual or contact your CTC Trial Coordinator. 25

25 OpenClinica Release 3.1: Data Entry The safest way to log out is to click on the Logout link Then close your browser window Try and avoid just closing the Browser window this leaves your session open in cyberspace and can clog the network 26