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Working with Applications

Click on the links below for more information.

Create a new Applicationexpand

There are two ways you can create a new application, from scratch or from a copy of an existing application/study. LOGIN to eProtocol utilising the eProtocol button on this website.

Create a new application from scratch

To create a new application, simply click on the CREATE APPLICATION button in the upper right-hand corner of your HOME page or click on CREATE APPLICATION option in the menu. You will need to enter basic information (such as Protocol Title, Personnel Information) before your application form is generated, a Bellberry Reference number assigned, and the initial information that you have entered is saved. TIP: make sure you include the protocol number in the study title.  This will ensure it appears on your page header in the system. Once you have your application number, you may continue to complete the application, or exit the system and return at a later time to complete. PLEASE NOTE: If after entering the title, personnel info, nothing happens when you click CREATE, then you have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, etc. that are blocking your pop-ups. See User Tips/Instructions for allowing pop-ups in your browser.

Multi Centre Applicationsexpand

For multi centre applications each Principal Investigator is required to lodge an application and attach only site specific documentation.  Bellberry requires only one application (the Master) to attach all documentation.  Please specify if there is a lead Investigator who will be responding on behalf of all Investigators and note this in the Study Sites section. Go to Print User Guide to access the comprehensive guide and flow chart.

Filling in an Application Formexpand

  • Enter in the details. Once completed select Create. If the Principal Investigator (PI) is also the Nominated Contact then the PI section only needs to be completed.
  • Navigate using the arrow icons in the upper right corner of page, or jump straight to a particular section using the left-hand menu.
  • Each time you advance a page, the application form will be automatically saved. You can also save by clicking the save icon (image of a diskette) in the upper right-hand corner of the page.NOTE: If you are working on a particular page for a long time, you’ll need to save frequently to avoid losing work. The program will time out after 30 minutes on one page without saving.
  • Some special required fields will have a red asterisk *.
  • Check boxes mean that you may select more than one item from that group.
  • Radio buttons mean that you may select only one item from that group.
  • Tables are used in parts of the application where you may need to add more than one item (for example, Additional Sites).
  • When you click add, a window will open where you enter the details related to the site. To view or edit the detailed information, click the Investigator Name link, in this case Simon, Jones. This will re-open the window where you had first entered the site details. To delete a site, click the check box next to a particular name, then click the DELETE button. To add additional sites, simply click the ADD button again.
  • Principal Investigator Declaration – remember when completing the application form on page 6 of the Application Information the Declarations box must be ticked.
  • Please make sure you enter the Protocol Number correctly. This number alerts Bellberry that a multi-site application has been received. 
  • Attachments Page 7 of Application Information. This section allows you to attach documentation from the list below. Ensure that you save the document under the correct heading and that you save the file as a PDF using a file name that describes the content. e.g. for Protocols save file as ProtocolVersionNoxxDate.
  • Please note that the file names used in the attachment section will be the document names that are listed in the approval letter. If the documents are incorrectly named in the attachment section the Approval Letter will be incorrect therefore it is imperative that you name the documents as you want them to appear in the Approval Letter.
  • Documents requiring signatures eg. CTN/CTX, Indeminities are required to be sent by standard mail.
  • Click on the Check for Completeness left-hand menu option when you believe you have finished entering all of the necessary information. You will see a message that will indicate which sections may be missing information. NOTE: The check for completeness feature cannot check to see if all of the necessary supporting documents have been attached. Be sure to double-check that this has been done before you submit your application.

Clone an Applicationexpand

To create a new application from an existing protocol, click on the CLONE APPLICATION button in the upper right-hand corner of your HOME page and follow the instructions on the page.  This function only works for the one Principal Investigator i.e. you can not clone applications between Investigators.

Submit an application to Bellberryexpand

After completing your application form, you can submit it to Bellberry by clicking on the SUBMIT APPLICATION button in the left-hand menu of the Application Form as shown below. You will need to have the application open in EDIT mode. Select YES and the application will automatically be submitted to Bellberry.  Please be patient after clicking submit. The application will automatically check to make sure that all parts of the application form are complete. If the application is complete, a small window will open thanking you for submitting your application. If the application is not complete, then a window will open indicating the portions of the application that remain to be completed. Navigate to those areas and answer the questions before attempting to submit again. PLEASE NOTE: Once an application is submitted, you will not be able make edits or additions, unless requested as part of the Bellberry HREC review process.

Returned Applicationsexpand

After your application has been submitted, it will undergo an initial check by the Bellberry office staff before it is assigned to a Bellberry Committee for review. The application is checked to make sure it is complete and that it includes all of the necessary attachments, etc. Sometimes it is necessary to Return an application. If you receive an email that your application was returned, go into the application and check the Return Notes section to see why. This releases the application back to you (with full EDIT capability) so that you may make any necessary adjustments. Also the Application Status that displays on your HOME page will be “Submission Returned”. You’ll need to open the application and click the link in the left-hand menu labeled “Return Notes ” as shown below.  This will open a small window with information regarding the reason your application was returned and instructions on how to proceed. When you are ready to re-submit the application, you simply click the SUBMIT APPLICATION button, just as you did for the initial submission. PLEASE NOTE: The HREC Return Notes area is only used for instructions relating to returned applications and is not where you can see comments that were entered as part of the full HREC review.

Application Review Processexpand

Once your protocol has been accepted, it will be assigned to a specific Bellberry Committee A,B or C etc for review and assigned a meeting date. Check your email regularly. You will receive an email for each major event in the review process. You can also see the status by looking at the application listing on your HOME page in the eProtocol Application Event column as above. To view the Event History, select the relevant application and from the menu on the LHS, last option, select Event History. 

Respond to HREC commentsexpand

Once your application has been accepted, it will be assigned to a specific Committee A, B or C for review and assigned a meeting date. Check your email regularly. You will receive an email for each major event in the review process, alerting you to when you need to log into the system and take a particular action. You can also see the status by looking at the application listing on your HOME page in the eProtocol application:  Click on the link in the Application Status column to access the comments page. A sample of what the comments page looks like is shown below:

Use the Show All Comments to list all the comments.  Use the print screen button and then right click on your mouse to copy into a word or email document. You’ll need to:

  • make the adjustments to the application itself (click the GET APPLICATION button to open up a new window with the application)
  • enter a response for each comment (and SAVE)
  • click the SUBMIT TO HREC button to send your responses back to Bellberry.

PLEASE NOTE: SAVE will save your responses to the comments. However, these responses are not “sent to the HREC” until you click the SUBMIT TO HREC button.

Once Application is Approvedexpand

You’ll receive an email notification when your application is approved with instructions on how to access the approval letter on-line. You will be required to print the letter and sign and send the original copy to Bellberry. Please do the same for the CTN/CTX. Once received by Bellberry we will attach the signed copy to your application in the attachments section in eProtocol. Once the application is officially approved in the system, it will no longer appear on the top of your home page in the Applications (In Preparation / Submitted) section, but will be visible at the bottom of your home page under Approved Applications.

Making Amendments and Investigator Brochure Updates to Approved Applications/studiesexpand

If you would like to make changes to a study that has already been approved, you will need to submit an Amendment/Investigator Brochure Form and wait for Bellberry Approval before implementing the change. For studies approved prior to eProtocol, these have been added to the system under the Principal Investigator’s name.  To add additional nominated contacts to these stuides the PI will be required to login and complete an Amendment Form. Before you begin an Amendment, you should consider the date that the current approval will expire. Keep in mind that once an amendment is submitted, you will not be able to start an Ethics Approval Extension (Renewal) application until the amendment has been reviewed and approved. If the expiration date of your study is near, you should start an Ethics Approval Extension (link to instructions) instead. As part of the Ethics Approval Extension application, you may include any proposed changes to the application. To start follow these steps:

  1. On your eProtocol HOME page (the page you see when you first log in), look at your Applications (Approved) listing. You may need to click the at the right-side of the section header to expand this section.
  2. Click on the number of the study you wish to amend, and you will see a small window open.
  3. If the option to “Start Amendment/IB” button (as shown below) is not available ie you cannot click on it, then:
    • You may not have EDIT access to this study. Select “Open in View mode” and click on the left-hand menu option “Personnel Info”. Only those people listed in the first four roles (Principal Investigator, Administration Contact, Co-Investigator, Other Contact) have access to EDIT the application and start amendments.
    • An amendment or extension may have already been started or is in-process for this application. Check on your HOME page in the Applications (In-Preparation/Submitted) section to see if the study is listed there.
  4. Select “Start Amendment/IB” and click OK.PLEASE NOTE: If an Amendment Form does not open when you click OK, then you have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, etc. that are blocking your pop-ups. See instructions for allowing pop-ups in your browser.
  5. Answer all of the questions on the Amendment/IB Form page, depending on whether it is an update to the Investigator Brochure, Protocol or Other. Describe the changes that you wish to make. For all minor correspondence and changes you will need to complete and Amendment Form. You will also need to go to the appropriate sections in the application form and make your updates to reflect those changes. i.e. to add nominated contacts to the Personnel Section.
  6. Click on the Attachments text at the bottom of the page and you will be redirected to the application form, Attachments Page 7.
  7. All attachments are to be attached under the heading “Amendment/IB Attachments Only”.
  8. Submit the amendment form when ready by clicking the SUBMIT APPLICATION option in the left-hand menu.
Progress Report/Ethics Approval Extension (Renewals)expand

To start a Progress Report/Ethics Approval Extension application, follow these steps:

  1. On your eProtocol HOME page (the page you see when you first log in), look at your Applications (Active) listing. You may need to click the at the right-side of the section header to expand this section.
  2. Click on the desired application number. A small window should open as shown below:
  3. If the option to start a Progress Report/Ethics Approval Extension is not available (you cannot click on it) then:You may not have EDIT access to this application. Select “Open in View mode” and click on the left-hand menu option “Personnel Info”. Only those people listed in the first four roles (Principal Investigator, Admin Contact, Co- Investigator, Other Contact) have access to EDIT the application and start a Progresss Report/Ethics Approval Extension. An amendment may have already been started or is in-process for this application. Check on your HOME page in the Applications (In-Preparation/Submitted) section to see if the application is listed there.
  4. Select “Progress Report/Ethics Approval Extension” and click OK.PLEASE NOTE: If a Progress Report/Ethics Approval Extension application form does not open when you click OK, then you have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, etc. that are blocking your pop-ups. See instructions for allowing pop-ups in your browser.
  5. Answer all of the questions on the Progress Report/Ethics Approval Extension Form page.
  6. Ensure that any attachments are attached under the heading “Progress Report/Ethics Approval Extension Only”.
  7. Submit the form when ready by clicking the SUBMIT APPLICATION option in the left-hand menu.

 

Adverse Event Report Formexpand

Repeat the above steps and select ‘Adverse Event Report Form’ from the Approved Application Decision Box. Select either of – Individual Event or Summary Report – and then complete the relevant fields. For Individual Event Select 1 and complete report as required For Summary reporting select 2 and attach relevant documents. using the heading “Adverse Event Attachments Only”. Once completed Submit Form. If you are requiring a summary SAE template go to the bellberry website and select Investigator and then Forms.

Start Violation Reportexpand

Repeat the above steps and select ‘Start Protocol Violation Report’ from the Approved Application Decision Box. Complete required fields and attach any attachments under the heading “ Protocol Violation Report Attachments Only”. Once completed Submit Form.

Start Final Report Formexpand

Ensure that this form is only completed once all sites included in the study sites section of the Application that the PI is responsible for, have been finalised as this report can only be submitted once. Use the heading  “Final Report Attachments Only” when attaching documents to this form. Repeat the above steps and select ‘Final Report Form’ from the Approved Application Decision Box. Complete required fields Once completed Submit Form

Update Study personnelexpand

If there has been a change in the personnel related to a particular protocol, you’ll need to complete an Amendment Form.  The Amendment Form will allow you edit access to update the personnel information.

Print an Applicationexpand

You may generate an Adobe .pdf file of your application form that can be printed or saved on your computer. In the left-hand menu of the application form, click on the Print View option (shown below): A small window will open: Select an option, sections and their orientation, and click OK. The Adobe .pdf file will be created and opened. You may save it to your computer by clicking File, then save as in the upper left-hand corner of the window. Bellberry is currently working on rectifying the issue of being unable to print.  As an interim measure, before you select the print view option, click on the control (CTRL) button on your keyboard and keep this held down while you select your print view choice.  You should then be able to print providing you keep your Ctrl button held.