Frequently Asked Questions ACCESS AND NAVIGATION 1. Can I change my password? 2. What are the guidelines for a new password? 3. What types of information will I get in RDC news? 4. I closed RDC Onsite by clicking the in the upper right corner. Is that Ok? 5. How do I get help with RDC Onsite? PATIENT DATA ENTRY 1. What do the different patient icons mean? 2. What is the difference between an unplanned Visit and Other page? 3. What are the shortcuts for entering dates? 4. When I click the Next CRF link, why does RDC Onsite ask me to save the ecrf page? 5. What happens when I delete an ecrf page? 6. How can I quickly see the list of all ecrfs for a specific patient? DISCREPANCY MANAGEMENT 1. When I see the listing of completed ecrfs, what is the most important icon to me? 2. Why do some red ecrfs turn white after I respond to the discrepancy? 3. What is the quickest way to find my Active discrepancies? 4. Why do some on-line discrepancies occur when I enter data and other when I save a page? 5. What do I do with yellow pages? 6. I entered my data yesterday and all ecrfs were white. When I logged into RDC Onsite today there were several red ecrfs. Why? 7. Why do I have to route Manual discrepancies back to the CRA or Data Manager? 8. When I respond to a discrepancy, there is a Comment field. Do I need to enter anything there? 9. I saw a red icon and opened the ecrf page, but I don t understand what is wrong with the date. How do I handle this? 10. Why is there a red field on the ecrf but the ecrf icon is white? REVIEW AND APPROVAL 1. How can I quickly see the list of ecrfs that are ready to be approved at my site? 2. What is the best way to review ecrfs? 3. Why do I need to re-enter my username and password to approve ecrfs? 4. Should I approve my ecrfs as soon as the CRA has been here?
Access and Navigation LOGGING INTO RDC ONSITE 1. To login to the application navigate to https://rdc.umcg.nl and click the Launch button A new window opens with the Login page. 2. Enter the RDC Onsite User Name and Password that were provided to you. 3. Click The Reset Expired Password page displays the first time you log in. Enter your old password and then enter a new password twice. Then, click the button. A message displays indicating the password was changed. Close the window and log in using this new password. The Home page then displays. 4. Password and login guidelines Your password must be between at least 6 characters and contain at least one letter and one number. Do not share you username or password with anyone. Please store your password so that it is NOT accessible by others Do not perform any activities in RDC Onsite unless you are logged in under your own credentials. If you want to access RDC Onsite and someone else is already logged in at the same computer, log out of that session and then log in as yourself After 30 minutes of inactivety, you will automatically logged out of RDC Onsite. If you enter your password three (3) times incorrectly, you will be locked out of RDC Onsite. In this case you must contact your CRA or Site manager to request a password reset. Your password will then be reset to the one that was handed out to you originally. NAVIGATION AND TERMINOLOGY 1. There are four tabs: The Home page is a portal for RDC Onsite activities, news and general information concerning the study. From this page, you can begin and/or access patient casebooks and perform specific activities. The Casebooks page is where you will find the records and electronic Case Report Forms (ecrfs) for each site patient. It is the only page from which you can initiate data entry for an ecrf. The Review page is where you can search for and access ecrfs to review and edit. The Reports page is where you can create and run the Patient Data Report and Blank Casebook Report. N.B: The Reports do not work when RDC Onsite is accessed from outside the UMCG. 2. On the right side of the Home page is the information about the current session (the period in which you are logged in to RDC Onsite). The Study and Site link displays summaries about your study and your site. 3. Alerts about upcoming system down-time or studyspecific information will be found in the News section. 4. The Activities section is where you will find links to the most common activities performed in RDC Onsite. The links that are displayed depend on your responsibilities, the data in the system and the activities that can be performed on that data.
Access and Navigation 5. Below the Activities section is the Links section. Links to related Internet addresses will be added here by the TCC. Clicking a link opens the website in a new browser window. 6. In the centre of the page is the Patient Search section and the Patients list. Patient Search section: Click the plus symbol next to the title to expand this section so you can see the search fields. Enter the criteria and then click the Go button to perform the search. The results display in the Patients list. Patients List: All patient numbers assigned to your site will be visible in the Patients list. Each patient is represented by one of the following patient icons. The patient number has not yet been used. ecrfs have not been started for the patient. One or more ecrfs have been started for the patient. The patient has at least one Active discrepancy in one or more ecrfs. The patient has at least one Other discrepancy in one or more ecrfs. CHANGING YOUR RDC ONSITE PASSWORD 1. Click the Change Password link in the topright corner of any RDC Onsite page. The Change Password page displays 2. In the Old Password field, enter your current password. 3. In the New Password field, and Confirm Password field, enter your new password. 4. Click See logging into RDC Onsite on the previous page for password guidelines A message displays indicating the password was changed. You must log in again using this new password
Access and Navigation USING RDC ONSITE HELP 1. Click the Help link in the top-right corner of any RDC Onsite page. A new window opens. The RDC Onsite Help program is context-sensitive, which means the Help topic that displays depends on where you are in the program when you clicked the Help link. 2. To go to the next topic, click. 3. To go to the previous topic, click. 4. To see a Table of Contents listing every topic in the Help window, click next to the arrows. Clicking Clicking expands the topics in that book. displays that page on the right side of the window. 5. 5. To close the Help window, click in the upper-right corner of the window. LOGGING OU T OF RDC ONSITE 1. To properly close and log out of RDC Onsite, click the Logout link in the upper-right corner of the page. 2. To close the Login page, click in the upper-right corner of the window
Patient Data Entry ENTERING DATA FOR A NEW PATIENT 1. On the Home page, click the checkbox next to an unassigned patient number icon. Select the patient number that your site received by calling the (IVRS) System when the patient was randomized. 2. Click the Go button next to Open Patient Casebooks. The Casebooks page will display with the BASELINE 1 visit ecrfs in the Casebook spreadsheet. OR 1. Click the Casebooks tab. 2. Perform a search for all unassigned patient numbers. From the Show field in the Search section, select Patients with no data entered Click the Go button in the bottom-right corner of the Search section. The BASELINE 1 visit ecrfs for the patients will display in the Casebook spreadsheet 3. Select the patient number that your site received by calling the IVRS system when the patient was randomized ENTERING DATA FOR EXISTING PATIENTS 1. On the Home page, click the checkbox in the Select column next to the patient whose ecrf you want to complete.
Patient Data Entry 2. Click the Go button next to Open Patient Casebooks (circled on the previous page). The Casebooks page will display with the BASELINE 1 visit ecrfs for the patient listed in the spreadsheet 3. From the visit field (arrow above), select the visit that contains the ecrfs you want to complete 4. Click on the applicable ecrf icon (circle above) for the patient OR 1. Click the Casebooks tab. 2. Click the Go button in the Search section without entering any criteria in the Search fields. The BASELINE 1 visit ecrfs for all patients will display in the Casebook spreadsheet. 3. From the Visit field, select the visit that contains the ecrfs you want to complete 4. Click the applicable ecrf icon for the patient. OR 1. Click in the Casebooks tab. 2. In the Range field in the Search section, enter the patient number. 3. Click the Go button in the Search section. The BASELINE 1 visit ecrfs for all patients will display in the Casebook spreadsheet. From the Visit field, select the visit that contains the ecrfs you want to complete 4. Click the applicable ecrf icon for the patient.
Patient Data Entry WORKING WITH ecrfs 1. To open and complete any ecrf, click the icon in the appropriate ecrf name column. The ecrf opens in a new window. An example of an ecrf is show below: 2. If necessary, scroll down using the scroll bar on the right side of the page to see more of the ecrf 3. The field is an example of a date field For all date fields, you can type the date directly in the field OR select the date form a calendar by clicking the date icon next to the field OR Use one of the following shortcuts: T = today s date Y = yesterday s date L = Last date entered 4. The sex field in the in the ecrf is an example of a LOV (List of Value) field A LOV field is also known as a drop-down field. This is a field in which pre-determined values must be entered. You can type the value in the field or select the value from a list 5. Click in the field and a magnifying glass icon appears 6. Click the magnifying glass icon OR Alt-L A dialog box displays with the list of value that can be inserted in this field. The value column indicates the accepted values
Patient Data Entry 7. To select a value, click the radio button in the Select column of the desired row in the dialog box. 8. Click the Ok button to insert the value 9. The cursor moves to the next field. You can move to another field by pressing the TAB key on you keyboard or clicking in the field 10. Another type of field is a checkbox: Clicking in this type of field adds a check, or tick Click again removes the mark 11. The final field is free-text, meaning you must enter the information directly in the field Some are numeric only, such as Weight entry. Some, such as a Comments field, may contain text and/or numbers. 12. Scroll down to the bottom of the page to make sure you fill in all fields. 13. Once the ecrf is complete, you have three options Save button. Saves the ecrf and leaves it displayed on the screen Next CRF link. Prompts you to save the ecrf if it hasn t yet been saved. Then the next ecrf for that visits opens. Close button: Closes the ecrf. If you have not saved the ecrf, you are prompted to save or discard the changes before it closes. Next CRF link Save button Close button If this is the last ecrf for this visit, you can click the visit. to go to the previous ecrf for 14. Once the data are entered in an ecrf, the following occurs: The ecrf icon changes to the Entry Complete icon The patient icon changes to
ecrf Status DISPLAY ALL ecrfs FOR A PATIENT 1. Click the Review tab 2. In the Range field in the Search section at the top of the page, enter the patient number. 3. Click the Go button in the Search option All ecrfs for the specific patient will display below the Search section IDENTIFYING ecrf STATUS The following table describes the ecrf icons you will see in RDC Onsite: Icon Name Description Placeholder Entry complete Batch-Loaded Active discrepancy Other discrepancy Verified Re-verification required Approved Re-approval required Locked No data have been entered At least one response has been entered and there are no discrepancies The ecrf s data were batch loaded. There is at least one Active discrepancy in the CRF, to be addressed by you There is at least one discrepancy that must be addressed by a user in a role other than yours. The CRF has been verified At least one data point in the verified CRF has been modified since verification. The CRF must be re-verified. The CRF has been approved At least one data point in the approved CRF has been modified since approval. The CRF must be re-approved. The ecrf is locked. Only users with special privileges can update the data It is possible for an ecrf to have multiple statuses at the same time. This will be reflected in the icon representation.
Advanced Data Entry EDITING AN ecrf 1. Identify the field in the ecrf that requires a data change and make that change. 2. Click the Save button. The Reason for change dialog box will display. 3. From the reason field, select the applicable reason. The comment field is optional 4. Click the Ok button to save the reason 5. Click the Ok button in the Saved Dialog box. 6. Click the link Or the Close button The Casebook page will display. 7. Click to update the ecrf icon (never use F5 to refresh the page, the connection will be lost) ADDING AN UNPLANNED VISIT 1. Access the patient s Casebook. 2. From the Visit field in the Casebook spreadsheet, select the scheduled visit that occurred prior to the unplanned one. Add Visit Page button Visit field 3. Select the patient by clicking the checkbox in the Select column next to the patient icon (circle above) 4. Click (labelled above) The Add Visit Page dialog box will display with a list of the planned ecrfs that can be added for this specific visit. 5. Select the desired ecrf by clicking the radio
Advanced Data Entry button in the Select column. 6. Click to confirm you want to add the visit. You are then prompted to select a sub-visit, which is a system-assigned identifier for unplanned visits 7. To accept the default, click A new ecrf will be added in the Casebook spreadsheet with the letter U next to the icon, indicating the ecrf is unplanned. The name of the ecrf appears in the column heading with a.1,.2, etc. at the end. These numbers indicate the sub-visit sequence. 8. Enter the data in the ecrf and then save and close it. ADDING AN OTHER PAGE 1. Access the patient s Casebook. 2. From the Visit field in the Casebook spreadsheet, select the visit to which you want to add the Other page Add Other Page button Visit field 3. Select the patient by clicking the checkbox in the Select column next to the patient icon (circle above) 4. Click (labelled above) The Add Other Page dialog box will display with a list of the available unplanned ecrfs that can be added to an existing visit. If you do not see the ecrf you need, contact your CRA for assistance. 5. Select the desired ecrf by clicking the radio button in the Select column. 6. Click A new ecrf is added in the Casebook spreadsheet with the letter U next to the icon. The name of the ecrf appears in the column heading 7. Enter the data in the ecrf and then save and close it.
Advanced Data Entry DELETING AN ecrf 1. Open the ecrf you wish to delete. 2. Click the Delete button on the toolbar. The Delete CRF dialog box will display. 3. From the Reason field, select the reason you are deleting the ecrf. The Change Comment field is optional 4. Click the Delete button in the dialog box 5. In the confirmation box, click the OK button The Casebooks page will display 6. Click to update the ecrf icon The ecrf icon will change back to a blank piece of paper with a green arrow indicating there are no data.
Discprepancy Management IDENTIFYING DISCREPANCIES Active discrepancies are discrepancies for which you are responsible for addressing and correcting. There are two types of active discrepancies: Online: Generated by RDC onsite and automatically closed when resolved Manaul: Generated by another user and must be routed to another person to be closed. Other discrepancies are discrepancies for which another person is responsible. RESPONDING TO AN IMMEDIATE ONLINE DISCREPANCY 1. When you enter unallowable characters in a field (e.g. letters in a numbers only field) and then attempt to leave the field, the Validation Error dialog box will immediately display The Reason and Description fields identify the error and the reason that the validation error occurred. 2. To change your entry, click the Cancel button in the dialog box. 3. Change the applicable field 4. Click the Save button. 5. Click the OK button in the Saved dialog box. 6. Click the link OR the Close button. ROUTING AN ONLINE DISCREPANCY If a validation error appears but you do not know what is wrong because you have entered the data as you believe it to be, you can leave the data as is, enter a comment and route the discrepancy to your CRA or to the Data Manager for review. 1. Click any where in the ecrf except the discrepant field The Validation Error dialog box will display (see above). The Reason and Description fields identify the error and the reason that the validation error occurred. 2. Enter a comment in the Comment field (optional) 3. From the Action field select Send to CRA or Sent to Data Management. 4. To save the changes click the OK button. 5. The value that you entered in the field remains but the field is now yellow (e.g. ) indicating that this is an Other discrepancy and must be fixed by someone else. 6. Click the Save button 7. Click the OK button in the Saved dialog box. 8. Click the link OR the Close button. The ecrf icon and patient icon become yellow, indicating there is an Other discrepancy.
Discprepancy Management RESPONDING TO AN ONLINE DISCREPANCY THAT DISPLAYS WHEN AN ecrf IS SAVED 1. Save the ecrf The fields immediately become red indicating that there is a discrepancy. (In the picture below as and example, the Start Date is later then the End Date). If you recognize the problem, you can simply change the data 2. If you do not know why the discrepancy is flagged, click the left arrow on the right side of the page to open the Discrepancy Navigator. The arrow is between the scroll bars. The Discrepancy Navigator pane will display with a List section and Details section 3. Click the name of the discrepancy in the List section A description will display in the Details section. 4. Make all the necessary edits. For each field you change, you have to select a reason for doing so. Therefore, the Reason for Change dialog box will display as described in Editing an ecrf topic. 5. Click the Save button. 6. Click the OK button in the Saved dialog box. The fields become white again indicating that the data are valid. The discrepancy is no longer listed in the Discrepancy Navigator. 7. To close the Discrepancy Navigator pane, click the right arrow on the right side of the page. 8. Click the link OR the Close button. RESPONDING TO A MANUAL DISCREPANCY AND ROUTING IT TO THE AUTHOR WHO ISSUED THE DISCREPANCY 1. On the Home page, click the Review Active Discrepancies link. The Discrepancies page of the Review tab will display with a list of the discrepancies to be addressed by you. The ecrf icon(s) are red. The Description column contains the comment that the author who issued the discrepancy entered during his or her review. 2. Open the discrepant ecrf. 3. Make all necessary edits. For each field you change, you have to select a reason for doing so. Therefore, the Reason for Change dialog box will display as described in Editing an ecrf topic. 4. To route the discrepancy, open the Discrepancy Navigator pane by clicking the Left Arrow on the right side of the page. 5. Click the name of the discrepancy in the List section. A description will display in the Details section.
Discprepancy Management 6. From the Action field, select Send to (the author who issued the discrepancy, e.g. Send to CRA). 7. Click the Go button next to the Action field The discrepancy Action dialog box will display. 8. In the comment field, enter the details about the change(s) you made to the ecrf data. 9. Click the OK button The field will become yellow indicating the discrepancy must now be addressed by the CRA. 10. Click the Save button. 11. Click the Ok button in the Saved dialog box. 12. Click the Close button. 1. The ecrf icon and patient icon will be yellow indicating there is a discrepancy to be addressed by someone besides yourself.
Discprepancy Management ACTIVE DISCREPANCIES ON A WHITE ecrf PAGE On the casebook screen you open a white ecrf page (e.g. VIS SCR). When opened a question is red, indicating that there is an active discrepancy (only when the highlight option is All, Active or Active and Other discrepancies). Open the discrepancy navigator panel. Click on the red discrepancy named Multi. In the detail window the description of the discrepancy is displayed. Click on Related Values. The related values window will open The related values window shows which Questions/Variables were involved in creating the discrepancy, the values and on which ecrf page the values these are located. In this case the discrepancy is created using the visit date from the VIS SCR ecrf page in the SCREENING visit and the biopsy date form the BIOPSY ecrf page in the SCREENING visit. The reason why the ecrf icon of the VIS SCR page was white is that the discprancy originated from the BIOPSY ecrf page instead of the VIS SCR page. When you close the ecrf you can see that the BIOPSY ecrf page is red. How to resolve this type of discrepancy There are several scenarios how to solve this discrepancy: 1. The values of visit date and biopsy date are correct
Discprepancy Management Route the discrepancy to data management or CRA from either ecrf page the same way as described earlies in the section ROUTING AN ONLINE DISCREPANCY 2. The visit date is incorrect Open the VIS SCR ecrf containing the visit date and correct the value. The discrepancy disappears. Close and save the ecrf page Select the patient and from the Select Patient and drop down list select validate and press go When the correction of the visit date value resolves the discrepancy the BIOPSY ecrf page will return to white (if there are no other active discrepancies on the biopsy page). If the new visit date still is not correct the BIOPSY ecrf page will stay red and when you open the VIS SCR the visit date question will be red again. 3. The biopsy date is incorrect Open the BIOPSY ecrf and correct the biopsy date. Close and save the ecrf page. Press the button. If the discrepancy is solved the BIOPSY ecrf page will turn white (if there are no other active discrepancies on the ecrf page). Also when the VIS SCR ecrf page is opened the visit date field will no longer have a discrepancy associated with it (color is white again).
Review And Approval Of ecrfs REVIEW AND APPROVAL PROCESS FLOW ecrfs are completed CRA verifies the ecrfs (even the ones with discrepancies) and re-verifies the ecrfs that were already verified but had a data change. Investigator approves the ecrfs that do not have discrepancies and that have been verified by the CRA To see all ecrfs for a site: 1. Click the Review tab. 2. Click the Go button in the search section without entering any criteria in the fields 3. The ecrfs display below in the Search section REVIEW AND APPROVAL PROCESS 1. An investigator has the ability to open and review ecrfs at any time regardless of their status. 2. In order to approve and ecrf, though, the ecrf must not have any discrepancies and it must be verified by the CRA (referred to as clean and verified in RDC Onsite). 3. Approving ecrfs in RDC Onsite requires entry of your Username and Password which serves as the equivalent of your physical signature. You must not share your username or password with others for ecrf approvals Currently, there is an outstanding functionality issue with the Electronic Signature in RDC Onsite. The RDC Onsite system does not yet have the capability to record and report the user if there are failed signature approvals. Therefore, we advise that you lock your screen if you leave you computer for any period of time. (To lock your screen, press CTRL-ALT-DELETE and then choose lock computer. To unlock it, press CTRL-ALT-DELETE and enter your windows password.) This process is recommended so that no unauthorized user can access the application in an attempt to falsify your electronic signature APPROVING ecrfs 1. Click the link in the Activities section of the Home page to display the ecrfs which are ready for approval. The CRF page of the Review tab will display. The ecrfs are clean, meaning there are no discrepancies and they have been verified by the CRA. The ecrf icons have checkmarks which indicate they have been verified. You can approve a single ecrf, a specific group of ecrfs or all the ecrfs on this page at once. 2. Choose one of the following: To approve a single ecrf or a group of specific ecrfs, you must first select the ecrf or ecrfs by clicking the checkbox in the Select column for each one. To approve all ecrfs in the list, click the Select All link above the Select column. All the checkboxes in the Select column now have checkmarks. 3. To approve the selected ecrfs in this list, click the Go button next to the word Approve. The Approve CRFs dialog box will display which summarizes the action you are about to
Review And Approval Of ecrfs perform. The Total Selected CRFs field indicates the number of ecrfs to be approved. 4. By entering your Username and Password in the applicable fields you will apply an electronic signature to the ecrfs. The two fields at the bottom of the page are checked by default and should not be changed. ecrfs that have discrepancies or have not been verified will be skipped. 5. Click 6. On the warning page that displays asking you if you are sure you want to approve the ecrf, click 7. On the confirmation page, click 8. The selected ecrfs have been approved. The icons will now have a checkmark and a signature UNAPPROVE AN ecrf 1. To see all approved ecrfs: Click the Review tab From the Approval field in the Search section, select Approved Click the Go button 2. Select the ecrf to un-approve by clicking the checkbox in the Select column. 3. Click the down arrow in the Select CRFs and field and select UnApprove
Review And Approval Of ecrfs 4. Click the Go button The Undo Approval of CRFs windows will display. If you have not logged out since approving ecrfs, you do not have to enter you user name, but you have to enter your Password. If you have logged out and then logged back in, you have to enter your user name too. 5. Click 6. On the warning page that displays asking you if you are sure you want to un-approve the ecrf, click 7. On the confirmation page, click The selected ecrfs have been un-approved. The icons will now have a checkmark and no signature