Short introduction. for the

Transcription

1 Short introduction for the Secutrial ecrf system of - productive and training database - last modified: Notice: Explaining screenshots can come from other projects, implemented with the Secutrial system of the CIO Marburgi

2 CONTENT Browser start... 3 Browser tips... 3 Internet addresses (URL) of the TransEUro ecrf system... 3 Login... 4 Notice: Use ONLY the program buttons for navigation!... 4 Your first look? Read the welcome page... 4 Context sensual help pages... 5 Enter a new patient... 6 Enter a patient to a part project... 8 ecrf form types and families Edit and save data Meaningful icons and symbols in Secutrial Special entry fields: catalogues, repetition groups and scores Form functions: print, comments, queries, audit trail, help Plausibility and completeness checks Symbols for validity warnings and errors Save data without validity check Verification forms Further work: selecting an existing patient by entering the pseudonym Edit visit plan dates, even if forms are stored Reports and statistics Selecting an existing patient by using a report For documentation: patient s file print The messaging function Reporting Adverse and Serious Adverse Events (AE/SAE) The Monitoring workflow The Query system A special report: Query details Monitor Review Data management review Audit Trail by CIO CNP

3 Browser start Start your web browser. Browser tips The Secutrial ecrf system is optimized for an easy use with Mozilla Firefox, SeaMonkey or Opera. If you want to see new messages or reports directly at database start you only have to enable the popup feature of your browser. If you want to use the Microsoft Internet Explorer: You have to uncheck the option "do not save encrypted pages to disk" in internet options/advanced. You have to check the file download options in the security settings: Internet addresses (URL) of the TransEUro ecrf system If you want to work with the productive database and enter real patient data, use: DataCapture.woa/wa/choose?customer=TREU If you want to work with the training database to train the ecrf system, use: DataCapture.woa/wa/choose?customer=TREU by CIO CNP

4 Login Productive Database For access to the productive database ask Danielle Daft ( from the Cambridge Centre for Brain Repair) for your individual username and start password. Notice: At the first login to the productive database you have to change the start password to an own password (at least 8 digits long, at least 1 digit non-alphabetic). Training Database For access to the training database you can use test user accounts: Username: testuser1 (belongs to Testcenter) Username: testuser2 (belongs to Testcenter) Password: testuser1 Password: testuser2 Notice: Use ONLY the program buttons for navigation! REMEMBER: Only use the programme buttons to manage the database. Don t use the browser buttons! Your first look? Read the welcome page by CIO CNP

5 If it is your first visit in a Secutrial ecrf system please read the information on the Welcome page. On the bottom of the welcome page you find the. It offers several important information for download and print out, e.g. the study protocol and work packages for the study centers. Context sensual help pages Every page of the ecrf system offers a special help page. Please click on the HELP Button if you want more information by CIO CNP

6 Enter a new patient Clicking on the NEW PATIENT button will bring you directly to the form for creating a new patient in the database. First you are asked for the date of the first visit (screening visit). Please enter the date of the screening visit. This date is used by the system to calculate the visit plan. A pseudonym (Pat-ID) will then be allocated to the new patient. The database will contain only the Pat-ID (pseudonym), while the patient s personal core data will neither be stored in the database nor on your local computer. Click continue to get the next screen and fill in the patient s data. Notice that only fields marked with a little red star are mandatory. After completing all mandatory fields click on PRINT AND CREATE PATIENT. A new window will open with a print view of the core data and the generated pseudonym (PID) allocated to the patient. Print out this file or notice the patient s pseudonym! by CIO CNP

7 Remember: these identifying patient data and its relation to the pseudonym (Pat-ID) will be lost after closing the print page. A message will appear confirming that the Pat-ID creation was successful. Please notice: This is the confirmation, that a new database record for the new patient was created. If you interrupt before this confirmation, no database record will be created. Click on to access the patient s visit plan overview by CIO CNP

8 Enter a patient to a part project A new patient has first to be included in the main project observational study. After that the patient can be added in a part project by clicking on the NEW PATIENT button. Clicking on the NEW PATIENT button will open a new page with the form for entering the patient to the part project and centre you want by CIO CNP

9 HINT: You will find the Study-ID that you have to enter in the Patient field in the headline in the left top corner. A patient can be included in as many projects as needed. It is easy to switch between this (part) projects with the lookup table in the right corner under the headline by CIO CNP

10 ecrf form types and families After you have generated a new patient record, the form overview appears: There are three types of forms: The patient s visit plan overview is the central access point for data entry. Visit forms contains all the different forms to be used according to the visit plan in the study protocol. Adverse Events (AE/SAE) contains the forms to report adverse events / serious adverse events. Case forms contains forms used once (for example Study termination ) or continuously in a study (for example Concomitant medication ). In the Visit forms you see the form families listed at the left side. A form family may contain one or more data forms. Click on a form family icon. If a form family contains only one data form, that will open immediately. If a form family contains several data forms, you will get an overview of the included forms for each single visit date listed at the bottom by CIO CNP

11 Clicking on a form icon (for example ) opens the data form. Edit and save data Open the form you want to fill data in by clicking on the respective icon on the overview page. Here is an example of the Pre study evaluation form: When you have edited a form, please make sure to save the data by clicking SAVE on the bottom of the form by CIO CNP

12 If you leave a form by CANCEL or BACK before saving the data, the form data will not be saved. If you do not save, the entered data will be lost. When you have finished the form and saved the data successfully, you will see the following notice. Clicking on will you bring step by step to all forms of this visit. But you can choose to go back to the overview or back to the just saved form as well. Back to the form overview you can see, that the last edited form changed its color (see meaningful symbols below): Meaningful icons and symbols in Secutrial To support your work with a Secutrial ecrf system a sophisticated system of meaningful icons and symbols is implemented. For example: the appearance of the icons will change to darker shades depending on the completeness status of the data forms (empty, partially completed, completed). On a patient s form overview clicking on the Help button on the top right of the page will lead you to the Help Form overview page, where you will find explanations for all overview, validity check and completeness symbols by CIO CNP

13 Special entry fields: catalogues, repetition groups and scores You will know most entry field types of the Secutrial ecrf system from other internet forms: free text fields, radio buttons, check boxes and pull down menus. Secutrial knows three additional types: catalogues, repetition groups and scores. A catalogue and repetition groups are for example used in the form PD and concomitant medication in the form type family Case Forms: by CIO CNP

14 A catalogue normally contains great amounts of entries (e.g. the ATC code for medications with more than entries) hierarchical ordered. In a catalogue you can scroll through the entries or search for a term. In the upper part you can define your search. You can enter a word or a combination of signs. Your search term will be searched in the whole catalogue and will result in every adequate catalogue entry. The findings are shown heavy typed and yellow marked. Alternatively you can scroll through the catalogue with help oft the triangles on the left side. With a click on a triangle you can open and close the different catalogue levels. With a click on the searched entry it will be copied to the form entry field by CIO CNP

15 Catalogue fields allow manual entries, but only if they are contained in the catalogue. At storing the system checks the consistency between catalogue and form entries. If your manual entry is not exactly included in the catalogue, you will get a warning. Repetition groups are groups of entry fields, that can be repeated as often as needed. They are used for entry fields that can be needed once or several times, for example a patient can take one or several concomitant medications. By clicking on the MORE Button you create a new entry group. You can create as many entry groups as needed. By clicking on the DELETE-Button the group can be deleted (but only, if their is no comment or query entered, this is explained later in this manual). Scores are used in the Secutrial ecrf system to calculate for example the total score of a neuropsychological scale or the duration of a disease. Some data forms can contain several scores, for example for subscale calculations. Please notice: if a form is stored once, and you come back and change data entries, the score will not show the new calculation at once. But the new calculated score will be stored in the database, then you save the form. If you want to see the new calculated score, you can tick on the according single the button or use button on the bottom of the form to calculate all included scores of the form. Form functions: print, comments, queries, audit trail, help Additional to the buttons, you already know (HELP, LOGOUT for example), in a data form you have some more available: BACK brings you back to the form overwiew. The PRINT Button prints out the current form in. The buttons COMMENTS and QUERIES provide access to the entered comments and to all entered queries (open, answered or resolved). The AUDIT TRAIL shows the history of all data changes. It does not appear until the form has been saved for the first time The HELP button on the top of the page provides detailed information about all form functions by CIO CNP

16 Notice: If a single question. button appears on the right side of a question, it provides more details about this Plausibility and completeness checks To minimise the likelihood of erroneous entries into the database and increase data quality, more than validity rules (e.g. for completeness, plausibility, ranges, formats) are implemented in the Secutrial ecrf system for TransEUro. They point out any improbable or incorrect data to you at the time you save a form. Checks usually concern formats (e.g. you cannot enter February 30th as a date, neither alphabetical characters in number fields) and logical probabilities (e.g. pregnancy only if gender is female) and limit values (e.g. human pulse is unlikely to be higher than 250). If you try to save a form with erroneous entries, the form will open again and you will see errors or warnings in red color. Symbols for validity warnings and errors A warning shall show you that something seems to be not plausible. Normally you can leave a form with warnings regularly with storing it a second time (click SAVE again). To help the trial management to understand these warnings (and save unnecessary queries) you are asked to enter a short comment for warnings. For example: measure is correct or value confirmed. In the form overview forms with warning(s) are marked with an exclamation mark in grey color. An error shall show you, that obligatory data are missing or a value is definitely wrong (for example: 30 th February). You can save forms with error(s) only by deactivating the Check data function (see below). To avoid queries you should enter a comment for fields, you have to save without corrected error (for example: no patient answer available ). In the form overview forms with error(s) are marked with an exclamation mark in red color. Save data without validity check If you want to save a form without a system validity check (e.g. in case you have to interrupt your entry work or in case you can not correct an error), just remove the tick in the field Check data. You can always come back and correct or enter the rest of data later by CIO CNP

17 Verification forms After you have entered and checked all forms of a visit, you can verify all visit forms. After you have entered and checked all case forms, you are asked to verify at the patient s termination in a case forms verification form. You have to sign with entering your username and password: Further work: selecting an existing patient by entering the pseudonym To work with an already existing patient dataset, please enter the patient s pseudonym in the field on the Welcome page and click the Select-button or press <ENTER>. (Alternatively you can use a REPORT to get access to the data of a patient (see below). Edit visit plan dates, even if forms are stored It sometimes happens, that a wrong date for the screening visit was entered. This date is important, because the Secutrial ecrf system calculates all following visit dates on the basis of this date. If you have to correct visit plan dates, just click on EDIT VISIT FORMS by CIO CNP

18 After you have corrected visit plan date(s), click on to see the new visit plan date calculation: You have to enter a reason for the change. History of changes is visible with Show history. Reports and statistics Several reports and statistics can be offered in a Secutrial ecrf system. To have a look click on Reports on the Welcome page to open the list of available reports (and recruitment statistics) for TransEUro by CIO CNP

19 Reports (listed on the left side of the page) always show the data per study center. If you belong to only one study center, you will only see the data of your own center. Reports are created by the Secutrial ecrf system in real time; they are always actual. Statistics show the state of all data of all study centers in the database. They are updated once a night. While there are some standard reports and statistics for each SecuTrial project, most of them are customized. During the runtime of a database more and more reports can be added due to special interests of the trial management or the participating centers. Notice: You can print out the most reports or statistics by clicking the PRINT button or download report and statistic data by clicking the EXCEL button for a quick Excel analysis by CIO CNP

20 Please notice: Some reports (for example Data Set completeness check or Query Details) would be senseless as download. They are only for print out. The report Data Set completeness check can help you to control the work of your own study center. It shows the real time completeness status of every visit of every of your center s patients. Several symbols (see symbol list below) specify the data set state: Selecting an existing patient by using a report You can use a REPORT to select an existing patient record. A click on a patient s pseudonym (here for example on kjv197 in the Data Set completeness check report) immediately opens the patient s data form overview in a second browser window by CIO CNP

21 For documentation: patient s file print With the function PATIENT FILE (on top of the patient s form overview) you can print out the patient s data for your own documentation. You can choose between single or all patients, single or all visits and single or all forms. In addition you can choose to include queries and comments, the Audit trail or uploaded image files (if this function is used in the project). The messaging function The Secutrial system is programmed to work very close to legal requirements of data safety, security and personal rights requirements of different countries. Due to this a messaging system is implemented. Certain events you report inside the Secutrial ecrf system produce automated messages to all whom it may concern, e.g. when a patient has changed his treatment center or when a patient has withdrawn his consent. Additionally, the SecuTrial ecrf system provides a simple messaging function for individual exchange of information. Clicking on the MESSAGES button on the Welcome page gives you the opportunity to write and send messages to the administrative centers of TransEUro. They will see your message than they login to the database the next time. To send a new message click on the SEND NEW MESSAGE button. Choose the group of recipients, enter the message text and a subject and click on Save in order to send the message. Please notice: If you want to see your new messages directly after login to the database, you have to enable the popup-feature of your internet browser by CIO CNP

22 Reporting Adverse and Serious Adverse Events (AE/SAE) Forms for reporting an Adverse Event (or a Serious Adverse Event) are under the Adverse Event (AE/SAE) tab. To enter data just click on New Adverse Event. AE and SAE report forms have to be confirmed with your e-signature (enter username and password again) by CIO CNP

23 If the adverse event is a serious one, the ecrf system makes two additional forms for detailed reporting available. If available, the ecrf system copies data, already entered in other forms, to the SAE form: Notice: In case of a reported Adverse Event the system send an internal message and an to the principal investigator. In case of a reported Serious Adverse Event the system send additonal a fax to the principal investigator by CIO CNP

24 The Monitoring workflow The Secutrial ecrf system knows several functions for supporting the monitoring workflow in a clinical trial or a medical register. Normally the workflow is established as follows: The Query system After visit forms or case forms are confirmed as verified (verification forms), the monitoring process can start. If the monitor has questions, he can click the QUERY button at the right side of the question and enter a query. In the form a question with a Query is marked with a question mark in red color on the left side of the question:

25 By clicking the QUERY button, the Query text can be read. By clicking on the small arrow at the left side the Query can be answered: Notice: To minimize clinical investigator s efforts in case of queries, the Secutrial ecrf system for TransEUro is configured to answer a Query automatically by writing done, if the clinical investigator changes a value due to a monitor question. In every case you have to enter a short reason for modification. This modification reason is added to all open queries of this form, you have answered with changing values, e.g: Of course additional text can be entered, if wanted by CIO CNP

26 In the form overview there are three different symbols to mark forms including Queries: This form contains at least one open query. All queries in this form have been answered by the clinical investigator. Monitor has resolved all queries in this form. A special report: Query details To answer or resolve queries, the report Query details can be used. In this report all queries are listed: In this sample five queries are listed: four answered and one open. With a click on! or? or #xyz you will get more information about the query text. A click on the patient s study ID will open the form overview of the patient in a second browser window. A click on the following columns (monitor, date or form) will open the form in a second browser window with the marked query by CIO CNP

27 Monitor Review If all entries are correct and plausible (and the source data verification complete), the monitor can mark the single forms (or the complete visit) with clicking REVIEW A at the bottom of the form. Marked with Review A further data entries or changes are not possible. A form family with partly marked Review A forms. A form family with all forms marked Review A. (With Review A marked forms give the signal to the data management, that additional data management checks may be started.) If the clinical investigator wants to add or change data, after the monitor has marked a form with Review A, he can ask the monitor to REVOKE REVIEW A by clicking the button at the bottom of the form. After that the form can be opened again, data can be added or changed. Data management review Please notice: According to the support contract between trial management and data management the workflow can differ: In clinical trials (phase I to III): While monitors normally have a permanent look for the entered data, the data management do regularly data checks in shorter or larger intervals (e.g. every 3 months or every two years). As described in the picture in the Monitoring workflow section, the data management will wait for its final data checks, until the monitor has marked a whole visit (all forms) with Review A. If the system check finds discrepancies, the data management will set additional queries (or ask the monitor to do so). If all data are consistent, warnings, errors and missing data explained with comments,and no further data discrepancies found, the data management will mark the visit with REVIEW B. From this moment the data are finally checked and ready for statistical analysis or publications. The data of this form are marked with Review A and Review B. They are ready for statistical analysis. In medical registers: Due to the longer duration and higher amount of recruited patients the data management normally do only system checks with control samples in larger intervals (e.g. each year). Centers with a high agree of missing data or forms with unexplained warnings or errors are given feedback. Notice: Forms or visits marked with Review B are frozen; further data change is not possible by CIO CNP

28 Audit Trail According to GCP and FDA regulations, the Secutrial ecrf system provide change or complete audit trail functions. The Secutrial ecrf system for TransEUro is configured to store a complete audit trail. Any data entries, modifications, queries and review entries are stored with username, date and time. The Audit Trail can be opened with a click on the AUDIT TRAIL button on the top of each single form. A look in the audit trail can be helpful, if several clinical investigators or monitors work with the data of a single patient. If needed an audit trail can become very large! it can be printed. Thank you for your attention! Central Information Office Competence Network on Parkinson s Disease, Marburg, Germany (CIO CNP) Version: If any questions are left: You can use the messaging function to ask questions about handling the Secutrial ecrf system. The CIO Marburg will look regularly for new messages by CIO CNP