InForm for Primary Investigators Performing esignature Only (v4.6) Narration Page 1: Title Slide No narration Page 2: Welcome Welcome to the InForm for Primary Investigators Performing esignature Only (v4.6) e- learning course. This course will teach you how to sign a subject s case record book in InForm, the electronic data capture tool used for Merck studies. This course should take you approximately 20 minutes to complete. In order to gain access to InForm, you need to pass the assessment at the end of this course. If you are already familiar with InForm, you can use the Menu button to go straight to the assessment. Many pages of this course have narration. You can use the Narration button below to read the narration. You can also click the link on the screen for a printable version of all course narration. Page 3: Course Structure This course includes an introduction to InForm followed by a demonstration that provides you with a quick tour of the InForm system. There is also a demonstration that shows you how to sign a subject s case record book and an interactive exercise where you can practice signing a case record book. The assessment appears after the exercise. Page 4: What Is InForm? InForm is a web-based electronic data capture tool from Oracle that enables site staff to enter subject data into electronic case report forms (ecrfs). Trial data are automatically stored and maintained on a server database via the internet. Therefore, no data are stored locally. The following steps illustrate the typical activities involved in gathering and storing clinical data using InForm: 1. The individual entering the subject data, either a clinical research coordinator (CRC) or primary investigator, logs on to an InForm trial using a web browser. 2. The CRC or primary investigator completes and submits ecrfs over the internet. 3. The InForm system stores the clinical data from the ecrfs in the InForm trial database. 4. The InForm system then evaluates the clinical data entered and automatically generates queries on questionable data. 1
5. The CRC or primary investigator answers the queries. 6. The sponsor reviews the clinical trial data. 7. The sponsor may also create manual queries if there are additional questions on any clinical data items. 8. The CRC or primary investigator answers the sponsor's queries. 9. At the end of the study after sponsor review is complete and all outstanding queries have been closed, the sponsor will freeze the data. 10. The primary investigator signs the case record books for the frozen data and the data are locked. Page 5: A Quick Tour of InForm Click the LAUNCH DEMO button to view a quick tour of the InForm system. Demonstration 1. This demonstration will give you a brief tour of the InForm software. You can use the playback controls at the bottom of the page to pause, play, and rewind this demo, go backwards and forwards, and turn the demo audio on and off. You can also click the cc button to display closed captioning or subtitles of this narration. 2. InForm is a web-based tool that you access through your web browser. Each study is assigned a unique web address which you will receive in an e-mail. When you click on the hyperlink in that e-mail, you will be brought to the InForm logon screen for that study. Instructions for setting up your InForm password will be included in the email. 3. To log in, you enter your user ID and password and click the Log In button. 4. This is an example of an InForm Portal home page for a study. 5. Once you are logged in to the InForm tool, do not use the navigation buttons in your web browser to navigate the system. Only use the links and buttons provided within InForm. 6. To show more of the InForm tool, this demo will now hide the browser buttons and address bar. 7. Clicking on the Study Documents Tab will allow you to access important documents for your study, including the "ecrf Entry Guidelines" which provide detailed instructions on how to enter data on each ecrf. You can also find sample ecrfs, Job Aids, and other useful documents on this tab. 8. This navigation pane is always visible. The study name appears at the top of the navigation pane. 2
9. Buttons on the navigation pane allow you to access various parts of the system. 10. The Enroll button allows you to enroll patients for non-ivrs studies. 11. Once a subject is enrolled, data are entered for that subject by clicking on the Patients button. 12. This is the Case Books for Site page. It displays information about each subject enrolled in the study at your site. If there are more subjects than can be viewed on one page, you can use the page buttons at the bottom of the page to view additional subjects by either selecting a specific page using the drop down list or using the arrow buttons. If you have access to more than one site, you can switch between sites using this drop-down list. There is also a Status filtering option. This option is not useful to Merck studies and should not be used. Traffic light icons are used to indicate the status of each visit for each subject. At this point, you can take the opportunity to print out a reference sheet of InForm icons, which describes the meaning of the traffic lights, as well as other InForm icons. This sheet is also available from the Study Documents tab when you access a live InForm trial. Click the link on the screen to open and print out this reference sheet. Then click the link to continue this demo. 13. Now we will take a closer look at the traffic lights. If a blank traffic light is shown for a visit, it means that data entry for the visit has not been started. A red light means there are open queries for that visit. A green traffic light means that data entry has been completed for a visit. A yellow traffic light on this page means that there are incomplete ecrfs in that visit. However, this may not be an issue since that visit might contain common ecrfs that are accessible across all visits and for which no data need to be entered. For example, if a subject never had an adverse event, no data would be entered on the AE ecrf and the traffic lights on this page would remain yellow. Yellow traffic lights are more useful in pointing out incomplete data on the Time and Events Schedule. We'll examine that page shortly. 3
A snowflake next to a traffic light means that the data for that visit have been frozen and no further additions or changes can be made. After the investigator provides an electronic signature, the sponsor will lock the data and a padlock will appear next to the traffic light. 14. You can use the patient status highlighting feature to highlight the visits in which you are interested. For example, if you want to highlight all the visits that have been both frozen and locked, you can check these boxes. The traffic lights for the visits that do not meet these criteria will be dimmed. Click on the boxes to remove the check marks to return the traffic lights to normal. 15. You can click on a traffic light to access the data for a specific visit. You can also click on a subject's number to access all of that subject's visit data. 16. This is the Time and Events Schedule for this subject. This page shows the status of each electronic case report form for each of this subject's visits. Electronic case report forms are also referred to as ecrfs. Like the Case Books for Site page, traffic light icons are used to indicate statuses, but on the Time and Events Schedule page, each traffic light conveys the status of a specific ecrf in a given visit. Yellow traffic lights on this page alert you to data that are missing on ecrfs. Red traffic lights indicate outstanding queries on that ecrf, and green traffic lights mean the data are complete. You can use the patient status highlighting feature on this page to highlight the traffic lights for ecrfs that meet your selected criteria. To open an ecrf for a specific visit, click on its traffic light. 17. Here is the Date of Visit ecrf for Visit 1. When viewing ecrfs, you can quickly and easily navigate to other ecrfs using the navigation features in the system. The yellow Time & Events Arrow provides quick access to the Time and Events Schedule for this subject. The visit timeline provides access to each visit for this subject. The ecrf tabs provide access to each of the ecrfs within the selected visit. A yellow exclamation mark will appear on tabs for ecrfs that contain missing data or opened queries. The subject's screening number will be displayed until the subject is randomized. Then the subject's randomization number will replace the screening number. To move to another ecrf within this visit, click on its tab. 4
18. Here is the Demographics case report form. Although the content of each ecrf can vary, each ecrf has these common features: An asterisk indicates required data. Icons display next to each data item. See the icon reference chart for a description of each icon. CRF History contains quick links to the last four ecrfs you have accessed. Additional features are also available at the bottom of the page, including a Submit button to save data and a Return button to return to the previous page. 19. The Find Patient option in the navigation pane allows you to quickly search for a particular subject. Prior to randomizing the subject, use the screening number to search. After the subject is randomized, use the randomization number to search for the subject. Once the subject is found, the Time and Events Schedule will be displayed. Clicking the Home link returns you to the InForm Portal home page. 20. When you are finished working in InForm, you can click the Logout link. Do not just click the X button in the top right-hand corner of your browser to close your browser window. By clicking the Logout link, you are ensuring a secure logout. Page 6: Case Book Signature Demonstration Click the LAUNCH DEMO button below to view a demo that will show you how to sign a case record book in the InForm system. Demonstration 1. This demonstration shows you how a subject's data appear once his or her case record book has been frozen, how the primary investigator signs a subject's case record book, and how the subject's data appear once his or her case record book has been locked. 2. The primary investigator will have all of the same data entry rights as the clinical study coordinator or CRC role; however, the investigator, or his or her designee, has the sole responsibility for signing off on the subject data. In this example, the investigator first clicks on the Patients button to view the Case Books for Site page. This is an optional step for the investigator. The blue snowflakes next to the traffic lights for the case record book listed indicate that the case record book has been frozen. The sponsor will freeze the subject's case record book at the end of the study. Site personnel should notify their clinical research associate, or CRA, if a data change is required after a case record book has been frozen. To see if there are any case record books that are ready to be signed, the investigator clicks the Signatures button. 3. The Required Signatures page lists all of the subject case record books that are ready for the investigator's signature. The request to sign case record books will typically be made at the end of the study. The investigator must sign all signature 5
requests in the time specified in their ecrf Entry Guidelines typically within 1 to 2 weeks. If an interim analysis is planned for your study, it is possible that signature requests may also be made at that time. The CRC is also able to view the contents of the Required Signatures page, but the CRC cannot sign off on the subject data. The CRC can, however, alert his or her investigator that a case record book is ready for signature. The subject's Time and Events schedule can also be accessed directly from this screen by clicking on the corresponding traffic light instead of first clicking on the Patients button. To sign a subject's case record book, the investigator clicks the Sign Book hyperlink located in the Signature column. 4. Here the investigator is presented with the Electronic Signature Affidavit. On this page, the investigator will electronically sign the subject's case record book by entering his or her InForm username and password, and then clicking Submit. 5. On the Required Signatures page, the Sign Book hyperlink is now replaced with an icon indicating the investigator has signed that subject's case record book. 6. Within a few days of the investigator having signed a case record book, the data will be locked by the sponsor. Locked data will appear with a padlock next to the traffic light on the Case Books for Sites page and the Time and Events Schedule. 7. In summary, case record books are frozen by the sponsor, then receive the investigator's signature, and finally are locked by the sponsor. Page 7: Case Book Signature Exercise Click the LAUNCH EXERCISE button below to begin an interactive exercise where you will use a simulation of the InForm tool to sign a subject s case record book. Page 8: Assessment No narration Page 9: Certificate No narration 6