ELECTRONIC CASE REPORT FORM

Transcription

1 ELECTRONIC CASE REPORT FORM User Requirements & Settings Version 3.9 User Requirements & Settings v 3.9

2 TABLE OF CONTENT AIM OF THE DOCUMENT... 3 GLOSSARY... 3 REFERENCES INTRODUCTION HARDWARE & SOFTWARE REQUIREMENTS INTERNET EXPLORER SETTINGS ADD TO FAVORITES INTERNET EXPLORER 9 AND PREVIOUS VERSIONS INTERNET EXPLORER 10 AND TROUBLESHOOTING SYSTEM BLOCKED ON CONFIGURING SYSTEM. PLEASE WAIT EMPTY WHITE PAGE AFTER THE LOGIN THE SYSTEM DOES NOT SAVE THE DATA CORRECTIONS User Requirements & Settings v 3.9 Page 2 of 30

3 Aim of the document This document is issued in order to describe as widely as possible, the computer requirements to be compliant with and the computer settings instruction to be followed to allow the use of the QuArk web site for the remote data collection of clinical studies data. Glossary Term Definitions ecrf FDA GCP HW ICH I.E. SW PW Electronic Case Report Form Federal Drug Administration Good Clinical Practice Hardware International Committee for Harmonization Internet Explorer Software Password References 1. QuArk - Manuale Utente MUT01-04-Utente; CM Sistemi Srl, Milano and subsequent up-dates 2. ICH Topic E6, Guidance for Good Clinical Practice, Note for Guidance on Good Clinical Practice (CPMP/ICH135/95) 3. US Guidance for Industry. Computerized Systems Used in Clinical Trials (May 2007). FDA 4. FDA - 21 CFR Part 11: Electronic Records; Electronic Signatures. (August 1997) 5. Guidance For Industry. Part 11, Electronic record; Electronic signature scope and application, August 2003 final version User Requirements & Settings v 3.9 Page 3 of 30

4 1. Introduction The collection of clinical data is of pivotal importance for the management of clinical study aimed to prove the activity, efficacy, tolerability and safety of the study product. During the last years, the collection of clinical data has undergone to more and more pressing controls and the issue of the new Good Clinical Practice guidelines has further focused its importance. The use of computerized systems has greatly grown also in the clinical practice, offering highly specialized solutions, making easier the investigators tasks during their practice. Several industry developed software thought for the collection, the management and archiving of data coming from clinical investigations. To facilitate the Investigator s task of collecting clinical data as well as the job of the study monitor in charge of the study, this system was found which enables both the Investigator to collect the study data directly into an electronic questionnaire - designed ad hoc - and the Sponsor to follow the course of recruitment / treatment in an easier and careful way. This system for on-line data collection is part of a wider application system enabling: 1. the issue of study specific questionnaire, with control rules for data to be input; 2. the management of users especially the Investigators and the relevant staff 3. the electronic data capture directly from the study site by the Investigator and/or the authorized staff; 4. data management by Sponsor at home. This manual only concerns the information about requirements and settings of the personal computer used by all authorized users. This tool was wholly validated to ensure the compliance with international regulations and USA guidelines, especially FDA 21CFR Part 11.(Ref 2, 3, 4, 5) User Requirements & Settings v 3.9 Page 4 of 30

5 2. Hardware & Software Requirements The user, who has access to the website properly set up for the study, is required to have a computer with at least the following characteristics: Hardware 2 GB of RAM Software Operating system: Windows 2000, Windows XP, Windows 7 Browser: Internet Explorer version 7, 8, 9, 10, 11 PC setting Auto-log-off enabled Video settings Suggested resolution: at least 1024x768 pixel DPI setting: normal (96dpi) Internet Explorer settings* Pop-up enabled for the web site: ecrf.ibsa.ch Script enabled Internet connection ADSL * please refer to 3 for the details of Internet Explorer settings Internet Connection The characteristics of internet connection will affect the speed of access to the website and consequently the speed of data entry and saving. The internet address of the study will be disclosed only to people involved in the study and everyone will have an exclusive and private identification (User ID and Password), not to be disclosed to anyone else. User Requirements & Settings v 3.9 Page 5 of 30

6 3. Internet Explorer settings Before having access for the first time to the ecrf, the Internet Explorer (I.E.) browser must be configured. This chapter collects the instruction to perform the configuration of the I.E.. Please, take into consideration that the configuration procedure depends on the version of the browser; then, as the first step, verify the version of the I.E browser as explained hereafter: Open Internet Explorer Click ALT+X or alternatively click on the icon on the upper right corner of the window Choose the option About Internet Explorer. A pop-up shows the browser s version: User Requirements & Settings v 3.9 Page 6 of 30

7 3.1. Add to favorites As first step, it should be useful add the Study Web Site to the favorites sites. There are two ways to perform this. 1. First method Open Internet Explorer Insert the Internet address of the Study Web Site On the menu bar click Favorites and then Add to favorites In the item Name insert a significant name to easily recognize the link (E.g. the string IBSA followed by the protocol name) and then click Add to save the link To open the Study Web Site, click on Favorites menu and then select the link created in the previous steps: User Requirements & Settings v 3.9 Page 7 of 30

8 2. Second method Open Internet Explorer Insert the Internet address of the Study Web Site Click on the star icon on the upper right corner of the window and then Add to favorites In the item Name insert a significant name to easily recognize the link (E.g. the string IBSA followed by the protocol name) and then click Add to save the link To open the Study Web Site, click on Favorites menu and then select the link created in the previous step: User Requirements & Settings v 3.9 Page 8 of 30

9 3.2. Internet Explorer 9 and previous versions This paragraph describes the steps to configure the settings of Internet Explorer 9 and previous versions: a) Security b) Pop-ups TIP: to display the Menu bar, right click on the top of the window, in an empty area and then choose the option Menu bar. a) Security Open the browser and insert study web site: Click on Tools and then on Internet options. User Requirements & Settings v 3.9 Page 9 of 30

10 Select the tab Security and then the icon Trusted sites Click on Sites. Insert the URL in the item Add this website to the zone User Requirements & Settings v 3.9 Page 10 of 30

11 Click Add and deselect the option Require server verification ( for all sits in this zone: Click Close. In the Internet Option window, tab Security, icon Trusted Sites, click on button Default level and move down the vertical bar on the left side until you visualize Low. Click Apply. User Requirements & Settings v 3.9 Page 11 of 30

12 Then click on the button Custom level and look for the section ActiveX controls and plug-ins and verify that the option Allow Scriptlets is Enabled. After that, look for the section Scripting and verify that the following options are Enabled: Active scripting Allow Programmatic clipboard access Scripting of Java applets Click Ok. User Requirements & Settings v 3.9 Page 12 of 30

13 b) Pop-ups Click on Tools and then on Internet options, then click on the tab Privacy Enable the option Turn on Pop-up Blocker, then click on Settings and insert ecrf.ibsa.ch on the item Address of website to allow: User Requirements & Settings v 3.9 Page 13 of 30

14 Click Add: Click Close. Click Ok. User Requirements & Settings v 3.9 Page 14 of 30

15 3.3. Internet Explorer 10 and 11 This paragraph describes the steps to configure the Internet Explorer 10 or 11 settings: a) Security b) Pop-ups c) Advanced d) Compatibility View Settings TIP: to show the Menu bar, right click on the top of the window, in an empty area and then choose the option Menu bar. a) Security Open the browser and insert the study web site: Click on Tools and then on Internet options. User Requirements & Settings v 3.9 Page 15 of 30

16 Select the tab Security and then the icon Trusted sites Click on Sites and insert the URL in the item Add this website to the zone User Requirements & Settings v 3.9 Page 16 of 30

17 Click Add and deselect the option Require server verification ( for all sits in this zone: Click Close. In the Internet Option window, tab Security, icon Trusted Sites, click on button Default level and move down the vertical bar on the left side until you visualize Low. Click Apply. User Requirements & Settings v 3.9 Page 17 of 30

18 Then, click on the button Custom level and look for the section ActiveX controls and plug-ins and verify that the option Allow Scriptlets is Enabled. After that look for the section Scripting and verify that the following options are Enabled: Active scripting Allow Programmatic clipboard access Scripting of Java applets Click Ok. User Requirements & Settings v 3.9 Page 18 of 30

19 b) Pop-ups Click on Tools and then on Internet options, then click on the tab Privacy. Verify that the item Select a setting for the Internet zone is set on Medium. Enable the option Turn on Pop-up Blocker, then click on Settings and insert ecrf.ibsa.ch on the item Address of website to allow: User Requirements & Settings v 3.9 Page 19 of 30

20 Click Add: Click Close. Click Ok. User Requirements & Settings v 3.9 Page 20 of 30

21 c) Advanced Click on Tools and then on Internet options, then click on the tab Advanced. Verify that the option Enable native XMLHTTP support is ticked. User Requirements & Settings v 3.9 Page 21 of 30

22 d) Compatibility View Settings Click on Tools and choose the option Compatibility View Settings Insert the string ibsa.ch on the item Add this website User Requirements & Settings v 3.9 Page 22 of 30

23 Click Add: To be noted: the list of Website you ve added to Compatibility View could be deleted when the Delete browsing history is performed. In this case the Compatibility View settings must be configured again. User Requirements & Settings v 3.9 Page 23 of 30

24 To avoid the deletion of the browsing history at each Internet Explorer closure, it is necessary to perform the following steps: Click on Tools and then on Internet options. Click Delete: User Requirements & Settings v 3.9 Page 24 of 30

25 Deselect the option History and click Delete: Click Apply: User Requirements & Settings v 3.9 Page 25 of 30

26 Alternatively, but only for Internet Explorer 10, it s possible to activate the Compatibility View for the site every time that the Internet Explorer is open, by a click on the icon representing a broken page on the address bar: The button will turn blue to indicate that Compatibility View is turned on: Usually this configuration will be lost after leaving the browser User Requirements & Settings v 3.9 Page 26 of 30

27 4. Troubleshooting 4.1. System blocked on Configuring system. Please wait Symptom: When opening a Patient s ecrf, the system stops and the message Configuring system. Please wait doesn t disappear. Suggestion: verify the Internet Explorer settings. If it is not possible to open an ecrf because the system blocks itself on the following screenshot: Figure 1. System blocked when the user try to open an ecrf There are two possible reasons: 1. the settings of the tab Security of the Internet Options are not correct 2. the Compatibility View settings are not correctly configured (only for Internet Explorer 10 and 11) To solve the problem verify and correct the browser settings. Another indication that the Compatibility View settings are not correctly configured, is the alignment of the button Enter of the main page of the web site (Figures 2 and 3): button Enter aligned on the left: the Compatibility View settings are not correctly set; button Enter aligned on the center: the Compatibility View settings are correct. User Requirements & Settings v 3.9 Page 27 of 30

28 Figure 2. Button Enter aligned on the left: wrong Compatibility View settings Figure 3. Button Enter aligned on the center: correct Compatibility View settings User Requirements & Settings v 3.9 Page 28 of 30

29 4.2. Empty white page after the login Symptom: After the login to the system, only an empty white page appears. Suggestion: Verify that the link saved in the Favorites is correct. If the system shows only an empty white page after the login and the Web Site has been open by the link saved in the Favorites, it is possible that the link saved in the Favorites is wrong. Open the Favorites, right click on the Study Web Site and then click on Properties Verify that the item URL contains the correct link of the Study Web Site If the link is wrong, correct it and then click OK. The link should have these formats: Protocol>/ Protocol>_test/ after the last slash (/) no others chars should appear. For example, the link is wrong. User Requirements & Settings v 3.9 Page 29 of 30

30 4.3. The system does not save the data corrections Symptom: The system does not save the data corrections Suggestion: Verify the popup setting. The modification of data inserted in the ecrf requires the insertion of a reason for the data change by opening a dedicated popup. Figure 4. Popup asking for the reason of the data change If the popups for the web site are not allowed, the system cannot open the popup with the request of the reason for the modification and then the modification cannot be saved. To solve the problem verify and correct the browser settings. User Requirements & Settings v 3.9 Page 30 of 30