Short introduction. for the

Transcription

1 Short introduction for the secutrial Electronic Data Capture (EDC) system of - productive and training database - last modified: / by CIO CNP

2 CONTENT Browser start... 3 Browser tips... 3 Internet addresses (URL) of the P-PPMI EDC system... 3 Login with test accounts... 4 Notice: Use ONLY the program buttons for navigation!... 4 Your first look? Read the Welcome page... 5 Context sensitive help pages... 5 Enter a new patient... 6 Edit and save data... 6 Document two PSG events... 8 Navigation between forms and overview... 9 PSG file upload... 9 Uploaded PSG file(s): automatic message In case the PSG file is not usable for evaluation: attempt a second upload Please avoid unnecessary message s PSG file download Meaningful icons and symbols in secutrial Scores Form functions: print, comments, queries, audit trail, help Plausibility and completeness checks Symbols for validity warnings and errors Save data without validity check Further work: selecting an existing patient by entering the study ID Reports and statistics Selecting an existing patient record by using a report For documentation: print the patient s file The messaging function The Query system My Account / by CIO CNP

3 Browser start Start your web browser. Browser tips The secutrial EDC system is optimized for an easy use with Mozilla Firefox, SeaMonkey, Opera or Chrome. 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 P-PPMI EDC system If you want to work with the training system to train the EDC system, use: DataCapture.woa/wa/choose?customer=PPPMI If you want to work with the productive system and enter real patient data, use: DataCapture.woa/wa/choose?customer=PPPMI 3 / by CIO CNP

4 Login with test accounts For a first non-individual login at the training system you can use the following test user accounts: For a login with rights of a clinical investigator (may enter new patients, upload PSG files, edit patient forms): Username: gertest1 Password: gertest1 (belongs to Testcenter Germany) Username: usatest1 Password: usatest1 (belongs to Testcenter USA) For a login with rights of PSG evaluation: may not change patient forms or enter new patients, may download PSG files, may enter evaluation form: Username: evaluate Password: evaluate1 For a login with rights of an observer (IND, CTCC or MJFF): may not change or add anything, just have a look): Username: observer Password: observer1 Notice: You will get an individual account (username) and an individual start password for the training system and for the productive system from the principal investigator of the PSG evaluation project. At the first login with your individual account to each of the systems (training or productive) you have to change this start password to your own password (at least 8 digits long, at least 1 digit non-alphabetic). In the pilot state of the project you are enabled to access the training system only. (After pilot phase the productive system will be established and you will be enabled to access both systems.) For your convenience you may save the link as a bookmark. Notice: Use ONLY the program buttons for navigation! IMPORTANT: Only use the program buttons to manage the database. Don t use the browser buttons! 4 / by CIO CNP

5 Your first look? Read the Welcome page If it is your first visit in a secutrial EDC system please read the information on the Welcome page. On the bottom of the welcome page you find the information for download and print out, e.g. the study protocol.. It offers several important Context sensitive help pages Every page of the EDC system offers a special help page. Please click on the HELP button if you want more information. 5 / by CIO CNP

6 Enter a new patient Clicking on the New patient button will open a new page with the form for establishing a new patient. First you are asked for the patient s study ID. Please enter exactly 5 digits. The system uses your centres prefix and these 5 digits to create the study ID (for example: 001-test1 or ). The system takes care for unique IDs. After saving this Study-ID a new patient record will be allocated. With the complete Study-ID of a patient (e.g ) you can access the patient s data in the system. Edit and save data Now you reach the overview form. There are two visits with their electronic case report forms (ecrf). The first visit EDF Transfer 1 should be used to document your first EDF transfer. If you get a message (via ) that your uploaded EDF (you may document two PSGs per visit and upload according EDF file 1 or/and 2) is not usable for evaluation, you can use the second visit EDF Transfer 2 for a second transfer attempt. Open the form you want to fill in by clicking on the respective icon on the overview page. 6 / by CIO CNP

7 .... Please notice: If you choose your site and there is only one collaborating sleep centre, its number will appear at once. If there are two or more collaborating sleep centers, you can choose the name and the system will give you the number. 7 / by CIO CNP

8 Document two PSG events If you want to document two PSG events (two nights), change the numbers of Polysomnography from 1 to 2 in the form top right. Now the event protocol of the polysomnography no. 2 will open. With this accordion function parts of the form are hidden, they only will open if necessary. Normally you will use the same channel configuration for both PSG events. If not, you can document this in the form. Then with the accordion function a second block will open. Here you can enter the channel configuration for the PSG event no. 2: 8 / by CIO CNP

9 Navigation between forms and overview When you have finished the form and saved the data successfully, you will see the following notice: Clicking on will bring you 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 see, that the last edited form changed its color (see meaningful colors below): PSG file upload Open the form PSG file upload EDF-Transfer 1 by clicking on the respective icon on the overview page. If you documented only one PSG event, the form will look like: 9 / by CIO CNP

10 To enter the correct file name please follow the instructions on the form. The system will give you the current date for Date of file transfer (to server). You can change it, if needed. Click on Upload an image, search for and open the file to transfer: Click on the Upload button: Notice: Due to the size of the EDF file and your internet connection speed the upload process can take some time. In case of very large files it can take some hours. The EDC system will show you the upload progress: 10 / by CIO CNP

11 Important: Please be sure to save the form after upload! (Otherwise the connection between file name in the database and uploaded file will be lost and you have to upload and save again.) If you documented two PSG events, please choose which PSG file you want to upload. You can upload PSG file 1, PSG file 2 or both of them. Due to your entry the accordion function will open the question block for upload the PSG file 1, PSG file 2 or both. Uploaded PSG file(s): automatic message When you have uploaded your PSG no.1 file or/and PSG no. 2 file and saved the form, the PSG evaluation team (Prof. Geert Mayer) will get an automatic message via which informs about the new upload(s) from your centre. After checking the file(s) your site investigator will get a message via in the case, the file is usable for evaluation. 11 / by CIO CNP

12 In case the PSG file is not usable for evaluation: attempt a second upload In case the file is not usable for evaluation, your site investigator, the site coordinator(s) and the study coordination team (IND, CTCC) will be informed via . Your site will be asked to attempt a second upload. Please use the visit EDF transfer 2 for this second attempt and documentation. Please avoid unnecessary message s Please notice: Automatic messages will be produced any time, you save the form. If you only want to have a look without any change, please leave the form with BACK or CANCEL to avoid unnecessary s. PSG file download To download a PSG file: Choose the wanted patient (enter subject ID or use a report). Open the PSG file transfer form and click on the image you want. The download window will appear. Then you can choose there to store the image. Please notice that the download of large files can take some time. You can download a file as often as wanted. 12 / by CIO CNP

13 Meaningful icons and symbols in secutrial To support your work with a secutrial EDC 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 right top of the page will lead you to the Help Form overview page. This page provides explanations for all overview, validity check and completeness symbols: Scores Scores are used in the secutrial EDC 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 system, when you save the form. If you want to see the new calculated score, you can tick on the according single the button on the bottom of the form to calculate all included scores of the form. button or use 13 / by CIO CNP

14 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 overview. The PRINT button prints out the current form. The buttons COMMENTS and QUERIES provide access to the comments entered and to all query (open, answered or resolved) entries. 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 the form functions of this special form. Notice: If a single question. button appears on the right side of a question, it provides more details about this Plausibility and completeness checks If you try to save a form with erroneous or missing obligatory entries, the form will open again and you will see error warnings in red colour. The message on top of the form informs you that something is wrong or missing. At the top of each item you will see an individual error warning, which shall help you to understand what to do. This system check can be controlled with the Check data box at the bottom of the form. If the box is ticked (this is the default) the system will check the entered data against plausibility and completeness rules. 14 / by CIO CNP

15 If you untick the Check data box, the system will store your entries without any check, but show a validity warning symbol in the overview. 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 colour. An error shall show you, that obligatory data are missing or a value is definitely wrong (for example: February 30). 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 colour. 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 really are not able to correct an error due to missing values) just remove the tick in the Check data box. You can always come back and correct or enter the rest of data later. Further work: selecting an existing patient by entering the study ID To work with the data of an already existing patient, please enter the patient s study-id 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). 15 / by CIO CNP

16 Reports and statistics Several REPORTS and STATISTICS are available in the secutrial EDC system. Click on REPORTS on the Welcome page to open the list of available reports (and recruitment statistics) for the P-PPMI project. Reports (listed on the left side of the page) always show the data per study centre. If you belong to only one study centre, you will only see the data of your own centre. Reports are created by the secutrial EDC system in just real time. The execution time depends on complexity of the report and the data volume. Statistics show the state of all data of all study centres in the system. They are updated once within 24 hours. While there are some standard reports and statistics for each secutrial project, most of them are customized for the special secutrial project. During the runtime of a project more and more reports can be added due to special interests of the trial management or the participating centres. You can print out each report or statistic by clicking the PRINT button. Most of the customized reports can be directly opened and saved in EXCEL format by clicking the EXCEL button. The report Data completeness check can help you to control the work of your own study centre. It shows the real time completeness status of every visit of every of your centre s patients. Several symbols (see symbol list below) specify the data set state: Selecting an existing patient record by using a report You can use a REPORT to select an existing patient record. A click on a Subject-ID immediately opens the patient s data form overview in a second browser window. 16 / by CIO CNP

17 For documentation: print the patient s file 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. Please take care. In case you choose to include the original image files in the patient file, it can take several time to create due to the size of the EDF files! Notice in addition: if you changed uploaded files (you can delete them and upload another if you want), the patient file will include the old images due to the GCP conform audit trail function of the system. The messaging function The secutrial EDC system is programmed to work very close to legal requirements of data safety, security and individual rights requirements of different countries. Due to this a messaging system is implemented. Certain events you report inside the secutrial EDC system produce automated messages to all whom it may concern, e.g. when a file is not usable. Additionally, the secutrial EDC 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 centres of the project. They will see your message as soon as they login to the P-PPMI project system the next time. 17 / by CIO CNP

18 To send a new message click on the SEND NEW MESSAGE button. Choose one or more recipients, enter the subject and a message text and on Save in order to send the message. All your received and sent messages are stored in a message history. With clicking on Read Messages or Sent Messages you can see them. Notice: If you want to see your new messages directly after login to the system, you have to enable the popup-feature of your internet browser. The Query system If someone of the PSG evaluation team has questions, he can click the QUERY button at the right side of a question and enter a query. 18 / by CIO CNP

19 In the form a question with a Query is marked with a question mark in red color on the left side of the question: By clicking the QUERY button, the Query text can be read. By clicking on the small arrow the Query can be answered. Notice: To minimize clinical investigator s efforts in case of queries the system is configured to answer a Query automatically, if you change one or more values due to monitor query (queries). 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.: 19 / by CIO CNP

20 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 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. 20 / by CIO CNP

21 Notice: The Audit Trail can also be included in the patient file. My Account By clicking on MY ACCOUNT on the Welcome page you can see your own contact data. Please take care for their correctness! Especially your correct address is important, because it is used for the messaging workflow of the P-PPMI project. Please correct your contact data in the case something changed (e.g. your telephone number or address). After SAVE your corrected data are immediately transferred to the P-PPMI user management system. Activate the Auto Tab according to your own preference (see help by clicking the question mark). In addition you can choose your preferred report, if you want (e.g. the Dataset Completeness Check): 21 / by CIO CNP

22 This report will then open immediately after your next login to the system. (You have to activate the popup function of your internet browser). Alternatively you can choose for your preferred report. In this case the report will be shown as additional menu item at the top of each form shown in the system for fast navigation. Last but not least you can change your preferred language for the user interface. Thank you for your attention! Central Information Office Competence Network on Parkinson s disease (CIO CNP), University Marburg, Germany If any questions are left: You can use the messaging function to ask questions about handling the secutrial EDC system. Please address your message to CIO Marburg (EDC system administration). The CIO Marburg will look regularly for new messages. 22 / by CIO CNP