Velos ecompliance. Researcher User Manual

Transcription

1 Velos ecompliance Researcher User Manual

2 Table of Contents Disclaimer... 4 ecompliance Overview... 5 Contacts... 6 Administrator... 6 Super Users... 6 IT/Technical Support... 6 Quick Help... 7 Getting Started... 8 Requesting Access... 8 Logging In... 8 Accessing Velos ecompliance through the Staff Portal... 8 Accessing Velos ecompliance through citrix... 9 Epworth employees and affiliates External researchers Homepage Accessing a Project through the Homepage Quick Links Landing Page New Applications Initial Details Study Personnel Adding a Study Team Member Complete Forms The Epworth Address Book The Epworth HealthCare Ethics Form The Epworth HealthCare Governance Form Completing Forms Upload Documents Uploading Documents Check and Submit Post Submission Administrative Review Correspondence Page 2 of 30

3 Post Review Correspondence Responding to Review Correspondence Checking on the status of your submission Post Approval Submissions Post Approval Forms Completing Forms Add New Document or Document Version Uploading Documents Post Submission Administrative Review Correspondence Post Review Correspondence Responding to Review Correspondence Reports Page 3 of 30

4 Disclaimer Portions of this manual were obtained from the Velos ecompliance User Manual with permission from Velos, Inc. Velos assumes no responsibility or liability for the accuracy or completeness of information in this manual or that this manual includes the most current information available from Velos. Use, duplication or disclosure of those portions is subject to the terms and conditions of the Velos license agreement. Page 4 of 30

5 ecompliance Overview Velos ecompliance is a secure web-based platform, configured to the needs of Epworth HealthCare, which will operate as a complete research review management system. The Velos ecompliance management system incorporates all areas of research project review and will ensure that all review information regarding a study will be available in the one spot. ecompliance revolves around specifically designed, intuitive Epworth HealthCare submission forms that will be completed and submitted within the ecompliance environment. This User Manual covers all aspects of research project submission and review, including easy-to-follow sections on getting started, completing and submitting a new application, uploading documents, post approval submissions and running reports on your research project. Page 5 of 30

6 Contacts Administrator Victoria McMorran Research Advancement Officer Research Development & Governance Phone: (03) Super Users Gerlinda Amor Research Governance Officer Research Development & Governance Phone: (03) David Phillips Group Manager Research Development & Governance Phone: (03) IT/Technical Support Matthew Pullen Applications Support Specialist IT Department Phone: (03) Page 6 of 30

7 Quick Help Logging in When logging into Velos please ensure that your Username is entered in lowercase. esignature Your esignature is a unique 4 digit code (similar to your bank PIN) that will be required to save any entries or changes and identifies you as the user. After the initial log in, you can configure the esignature to your own preferred number. Mandatory Field * Marks fields that are mandatory. You will not be able to submit if these fields are not complete. Submissions Through Velos All Research Ethics and Governance new applications, amendments, reports and correspondence for projects being conducted at Epworth HealthCare must be submitted through Velos ecompliance. Draft Forms To save a draft or incomplete form change the Form Status* at the bottom of the page to Incomplete. This will save your draft Initial Submissions in the Researcher Area, Saved Items and your draft post approval submission in the applicable study post approval tab. Sorting lists Any lists in Velos, including document lists, project lists, and final outcomes can be sorted by the available Table Headings. Simply click on the Table Heading you wish to sort by and the list will be rearranged based on that field. Lockdown form status Do not use the lockdown status when completing and submitting a form. Lockdown will not allow any further updates to the form resulting in a new form needing to be completed and submitted should updates be required. The Research Ethics Coordinator will lockdown your submission form only once that submission is approved. Registration of Clinical Trials The Velos ecompliance platform is not a public-facing registry and therefore would not replace the role of publicly accessible registries such as the ANZCTR or ClinicalTrials.gov for the registration of clinical trials.. Page 7 of 30

8 Getting Started Requesting Access Visit the Research page on the Epworth website to complete the Velos User Access request Form. Send the completed form to If you wish to access Velos ecompliance remotely please ensure that you provide a mobile phone number on your request form. The Research Development and Governance team will contact you via once your User login is available. Please allow 5-10 working days for requests to be verified and an account to be set up. Logging In Once your account has been created, Velos ecompliance can be accessed through the Velos icon on your Epworth desktop, through Citrix or through the Epworth HealthCare website staff portal. Accessing Velos ecompliance through the Staff Portal 1. Open a browser and enter the URL into the search bar. 2. Enter your Epworth Username and password. Page 8 of 30

9 3. Enter the passcode that has been sent to your mobile phone via SMS. 4. Select the Velos eresearch hyperlink. Accessing Velos ecompliance through citrix 1. Open a browser and enter the URL into the search bar. 2. Enter your Epworth Username and password. Page 9 of 30

10 3. Click on the Epworth Desktop icon. 5. Then click on the Velos icon on your virtual desktop. Epworth employees and affiliates Your User name and password will be the same as your Epworth network login and password. Your temporary e-signature (similar to your bank PIN) will be forwarded to you via once your Velos User Access request Form has been processed. Your temporary e-signature can be updated/altered through the Password/e-Sign option in the Personalize menu. External researchers Your User name, temporary password and temporary e-signature (similar to your bank PIN) will be forwarded to you via once your Velos User Access request Form has been processed. Your temporary password and temporary e-signature can be updated/altered through the Password/e-Sign option in the Personalize menu. Page 10 of 30

11 Homepage Once logged in you will enter Velos ecompliance via the Homepage. Accessing a Project through the Homepage The Homepage by default will list the last 5 studies that have been updated. However, you can search for any study through the Search a Study field. Once you have identified the project you are searching for, click on the following study information; icon to access the 1. Summary Quick reference information for the research project. 2. Versions Repository of all uploaded documents for the research project. 3. Study Status Allows you to record various milestones in the life of the research project. 4. Reports Allows you to design, display and print reports regarding your research project. 5. Study Team List of all Velos Users who have access to this research project. Alternatively you can search for submitted or approved studies using the Manage tab, studies search option. By clicking on this menu a list of all studies that you have access to will appear. You can search this list by using the search a study or advanced search option. Page 11 of 30

12 Quick Links Reference document, templates and useful websites can be accessed through the Quick Links section on the Homepage. You can also add your own reference websites through the My Links area on the Homepage. To add a link or document to the My Links area click on the LINKS. button, then click on ADD NEW From the Homepage you are able to access the landing page by clicking on the ecompliance tab on the page menu then select Landing Page from the sub-menu. Page 12 of 30

13 Landing Page The Landing Page has been designed to provide you with a starting point for new and existing study submissions as well as a quick link to saved submissions and information regarding the review of your submission. Page 13 of 30

14 New Applications To create a New Study Application either click on the ecompliance tab on the page menu then select New Application from the sub-menu. Alternatively, click on the New Application for Human Research Participants link on the Landing Page. There are 5 stages to a new research project submission that are set out in the following menu tabs: These tabs guide you through the creation of a new application for submission to the Human Research Ethics Committee, the Low Risk (LR) sub Committee and Research Governance. The tabs should be completed in sequential order from left to right. Initial Details This page allows you to create the study submission in Velos ecompliance by entering a small set of study data. The fields with the * are mandatory fields. Page 14 of 30

15 Fields on this page are: Principal Investigator (PI): Click the Select User link to add the PI to the field. This field is read only and does not allow text to be typed in. The Principal Investigator must have a Velos account to be listed in this look up field. If the PI for the study does not have a Velos user account refer to page 8 of this document for information on obtaining a User Account. Study Contact: Click the Select User link to add a Study Contact to the field. This field is read only and does not allow text to be typed in. The Study Contact must have a Velos account to be listed in this look up field. If the Study Contact for this study does not have a Velos user account refer to page 8 of this document for information on obtaining a User Account. These fields are read only and do not allow text to be typed in. You must use the Select User link to complete the field. The users listed in the Principal Investigator and/or Study Contact fields will be carried over to the Study Personnel tab. Study Number: A unique study number will automatically be generated by Velos. Title: Enter the title for the research project. Division: Select the Division that the Study belongs to. Therapeutic Area: Select the relevant Therapeutic Area for the study. The available options in the Therapeutic Area will vary depending on the selected Division. Once the required fields have been completed enter your e-signature and click the button. The project will then be saved. Continue on to the Study Personnel tab. Study Personnel The Study Personnel page determines who has access to this project in Velos ecompliance. Any member of the study team requiring access to the study through ecompliance must be added to the Study Personnel tab. Only study personnel who have a Velos account can be added to this tab. Refer to page 8 of this document for information on obtaining a User Account. By default, the Study Personnel tab will display the name of the Principal Investigator and Study Contact as completed on the Initial Details tab. Page 15 of 30

16 The Role listed for specified users has pre-defined study access rights which will be important for users with Velos eresearch access. Adding a Study Team Member Click the Add/Edit Study Team Member link. This page will display the current study team members and their role which can also be modified through this page. Enter any or all search parameters to look for a user or just click Search to select from a list of existing user. From the search results, check the Select box to the right of the User s name to add them to the Study Team and define the user s Role by selecting from the drop down menu. You can add multiple users as study personnel at one time. Enter your 4 digit e-signature and click. The user(s) have now been added to your Study Team and will have access to the project through Velos ecompliance. Continue on to Complete Forms tab. Complete Forms The Complete Forms tab includes the Epworth Address Book, Epworth Ethics Form and the Epworth Governance Form. Page 16 of 30

17 The Epworth Address Book When the Epworth Address Book is selected from the drop down list, there will be a button to the right of the Form Name drop down. Click the button to open the form. This option allows for the form to be completed and saved multiple times and each response is editable. The Epworth Address Book stores the researcher/study personnel and their details in your Velos address book. This address book can be used to pre-populate fields throughout the form completion process. An Epworth Address Book Form should be completed for any personnel who may be involved in this project before the Epworth Ethics Form and the Epworth Governance Form are completed. The researchers/study personnel included in the Epworth Address Book do not need to be Velos Users; they can simply be investigators working on the project who will never need to access the study through Velos ecompliance. Previously completed entries into the Epworth Address Book are stored within Velos for future use and can be edited at any time. The Epworth HealthCare Ethics Form The Epworth Ethics Form will be displayed when the form is selected from the drop down. The Epworth Ethics Form is an intuitive form designed to provide relevant information for ethics committee reviews and must be completed for all projects. The Epworth HealthCare Governance Form The Epworth Governance Form will be displayed when the form is selected from the drop down. The Epworth Governance Form is an intuitive form designed to provide relevant information to Research Governance and must be completed for all projects. Although it is not mandatory to complete the Epworth Governance Form by the ethics submission deadline it is recommended. Completing Forms Enter details regarding the study as prompted. Continue to work through the form until all mandatory fields (marked with an *) are complete. To save a draft or incomplete form change the Form Status* at the bottom of the page to Incomplete, enter your 4 digit e-signature and click. This will save your draft submission in the Researcher Area, Saved Items or the Saved Items link on the Landing Page. Page 17 of 30

18 To submit a complete form change the Form Status* at the bottom of the page to Complete, enter your 4 digit e-signature and click. Please note that your application has not been submitted for review at this stage. Continue on to the Upload Documents tab. Upload Documents The Upload Documents page allows you to attach the required document(s) for submitting a new application to the HREC or LR sub-committee. Documents should be uploaded in a PDF format wherever possible. Uploading Documents Click on the ADD NEW VERSION/DOCUMENT link. Page 18 of 30

19 Enter the details for each document in the relevant fields and upload the document through the button. There cannot be more than one document with the same Version Number, Category, Type and Description. For documents such as Patient Information and Consent Forms (PICFs) where there may be more than one type for a submission, ensure that the type of consent form is included in the Description field. Enter your 4 digit e-signature and click. To view the uploaded documents click on the corresponding Attachments link. To change the version status click on the link and update the status, enter the date the status was changed and submit by entering your 4 digit e-signature and clicking. Continue on to the Check and Submit tab. Check and Submit The Check and Submit page allows the user to check if all the submission requirements have been met: The appropriate Study Personnel have been specified; All required forms have been completed; The appropriate documents have been uploaded. Page 19 of 30

20 To submit a new project application to the HREC or LR sub-committee, click the button to confirm all the requirements have been met. The Check and Submit page will refresh indicating if the application is complete or incomplete. = Submission requirements have been met and the project is ready for submission. = Submission requirements have not been met. Velos ecompliance will indicate which submission requirement has not been met, allowing you to go back to the applicable submission area and amend where necessary. A study team member can complete the submission up until this point however only the Principal Investigator can accept the certification and submit the application by clicking the button. Post Submission Once the new application has been submitted through the Check and Submit tab, the application will be forwarded to the HREC coordinator. The HREC coordinator will conduct an administrative review of the submission before assigning the submission to an ethics meeting or review process. Administrative Review Correspondence If the HREC coordinator identifies an issue that should be addressed before the ethics committee reviews the application, this will be brought to your attention via the Researcher Area, Action Required tab or the Action Required link on the Landing Page. You will need to routinely access your Velos ecompliance account throughout the submission process as all correspondence regarding the review of your project will be communicated through the system. Once in the Action Required tab, click on the View Notes link, the notes from the HREC coordinator will appear in a separate pop-up. Page 20 of 30

21 To send the submission back to the HREC coordinator once the comment/issue has been addressed, click on the button in the Action Required area. A reply pop-up will appear allowing you to send a comment and the updated submission back to the HREC coordinator by entering your e-signature and clicking. Alternatively, you can resubmit the application through the Check and Submit tab as per the initial submission. Post Review Correspondence Once the submission has been reviewed by the Ethics Committee and/or by Research Governance, post review correspondence will be available through the Final Outcome tab within the Researcher Area or the Final Outcome link on the Landing Page. Page 21 of 30

22 You can access your review outcome letter via the button. The final outcome letter for your Ethics or Governance submission will be one of the following: Approval/Acknowledgement/Authorisation letter; Further Action Required letter; Not Approved letter. You will need to routinely access your Velos ecompliance account throughout the submission process as all correspondence regarding the review of your project will be communicated through the system. Responding to Review Correspondence To resubmit an application in response to queries raised by the ethics committee or Research Governance, click on the relevant study number link in the Final Outcomes tab. Clicking on the study number link will take you back to the Initial Details tab for the study. You can then work through the tabs updating the forms as required and attach any updated or requested documents. Once the updates are complete resubmit the project through the Check and Submit tab as per the initial submission. Once the new application has received ethics approval and governance authorisation, the project will be available in the Ongoing Studies option in the ecompliance menu. Checking on the status of your submission At any time post submission you can check the progress of your study review by visiting the Items Pending Review/Approval tab in the Researcher Area or by clicking on the Items Page 22 of 30

23 Pending Review/Approval link on the Landing Page. From this page you can see all of your submissions that have not yet been approved, the status of the review, what review process they will undergo and the date of the meeting your submission has been assigned to. Page 23 of 30

24 Post Approval Submissions To create a new post approval submission for an approved project, either click on the ecompliance tab on the page menu, then select Ongoing Studies from the sub-menu, or click on the Ongoing Studies link on the Landing Page. Post Approval Forms There are 4 different categories of post approval submission with 7 different submission forms: Amendments o Epworth Amendment form Safety Reports o Epworth Protocol Deviation and Violation Report form o Epworth Safety Line Listing Report form o Epworth Safety Report form Continuing Review o Epworth Correspondence form o Epworth Progress (Annual) Report form Study Closure o Epworth Progress (Final) Report form Page 24 of 30

25 To begin a post approval submission, click on the corresponding submission icon for the appropriate study. If you have a large number of studies listed over several pages, you can search for the required study by Study Number or Title, through the Search a Study option at the top of the screen. A new pop-up will be displayed once a submission icon has been selected. For the post approval categories that contain more than one form, the drop down box at the top of the pop-up can be used to select the required submission form. Once the correct Post Approval Form has been selected from the drop down box click on the button. All previously complete (submitted) and incomplete (draft) post approval submissions for that specific form and study will be listed. To access one of these submitted or incomplete post approval forms, click on the date link. To create a new submission click on the New link. Page 25 of 30

26 All of the Post Approval Forms are intuitive forms designed to provide relevant information to the ethics committee or delegate reviewing the submission. Completing Forms Enter details regarding the submission as prompted. Continue to work through the form until all mandatory fields (marked with an *) are complete. To save a draft or incomplete form change the Form Status* at the bottom of the page to Incomplete, enter your 4 digit e-signature and click submission.. This will save your draft To submit the post approval submission package change the Form Status* at the bottom of the page to Complete, enter your 4 digit e-signature and click. The Complete option has an action that submits the post approval notification review process. Add New Document or Document Version To include a new version of a document or to add a new document, click the Attach Documents link at the top of the form. This link will open a new window. Uploading Documents Page 26 of 30

27 Documents should be uploaded in a PDF format wherever possible. Enter the details for each document in the relevant fields and upload the document through the button. There cannot be more than one document with the same Version Number, Category, Type and Description. For documents such as PICFs where there may be more than one, ensure that the type of consent form is included in the Description field. Enter your 4 digit e-signature and click. To view the uploaded documents click on the correlating Study Number link and access the tab. To change the version status click on the link and update the status, enter the date the status was changed and submit by entering your 4 digit e-signature and clicking. Post Submission Page 27 of 30

28 Once the post approval application has been submitted the HREC coordinator will conduct an administrative review of the submission before assigning the submission to an ethics meeting or review process. Administrative Review Correspondence If the HREC coordinator identifies an issue that should be addressed before the ethics committee reviews the application, this will be brought to your attention via the Researcher Area, Action Required tab or the Action Required link on the Landing Page. You will need to routinely access your Velos ecompliance account throughout the submission process as all correspondence regarding the review of your project will be communicated through the system. Once in the Action Required tab, click on the View Notes link, the notes from the HREC coordinator will appear in a separate pop-up. To send the submission back to the HREC coordinator once the comment/issue has been addressed, click on the button in the Action Required area. A reply pop-up will appear allowing you to send a comment and the updated submission back to the HREC coordinator by entering your 4 digit e-signature and clicking. Post Review Correspondence Once the post approval submission has been reviewed by the Ethics Committee, Research Governance or delegate, post review correspondence will be available through the Final Outcome tab within the Researcher Area or the Final Outcome link on the Landing Page. Page 28 of 30

29 You will be able to access your outcome letter via the button. The final outcome letter for your Post Approval submission will be one of the following: Approval/Acknowledgement/Authorisation letter; Further Action Required letter; Not Approved letter. You will need to routinely access your Velos ecompliance account throughout the submission process as all correspondence regarding the review of your project will be communicated through the system. Responding to Review Correspondence To resubmit an application in response to queries raised by the ethics committee or Research Governance, click on the relevant study number link in the Final Outcomes tab. Clicking on the ecompliance tab on the page menu, then select Ongoing Studies from the submenu or click on the Ongoing Studies link on the Landing Page. Select the required study and the relevant post approval submission. Change the form status to incomplete and make the updates to the form as necessary. Once the updates are complete and/or additional documents have been uploaded change the form status to complete your 4 digit e-signature and clicking Coordinator. to resubmit to the HREC Page 29 of 30

30 Reports The Reports area allows you to design, display and print reports regarding your research project. All default reports are stored in Report Central. However, some of the report types are available only to users with the appropriate access rights. From the Reports Central page, select the report type from the drop down menu. Once the type is selected, a list of report options for that specific Report Type is displayed. From the list, select the desired report and filter. Some filters are required and will be indicated when you move the mouse over the report name. Once all report filters have been applied, click on the button. The report will be generated in another window, which can then be printed or transposed into a word or an excel document, at which point the report can be manipulated as required. Page 30 of 30