CGIRB Connexus Tips. Version 1.1 July 2013 Copernicus Group IRB

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1 CGIRB Connexus Tips Version 1.1 July 2013 Copernicus Group IRB

2 Study-Level Management in Connexus Thank you for selecting CGIRB Connexus as your shipment method for receiving copies of site approval documents and/or sites receiving their approval documents. Below are some helpful tips and tricks to assist you in managing your study effectively. Tip #1: Inform sites that this is a Connexus study If Connexus is selected as the primary shipment method for sites to retrieve their approval documents, please let the site know that an invitation from connexusadmin@cgirb.com will be sent to the individual specified as the site contact listed on the CGIRB Investigator Site Questionnaire. Please remind sites that they must register for Connexus first before they can access their workspace. Sites that are already registered will have access after receiving notice that the user has been added to the site s workspace (Site will only be permissioned to access its own workspace). Tip #2: Manage Access (Invite Users to Participate) If you are listed as Study Contact on the CGIRB Study Application Form you will automatically be given Manager-level access to the study s workspace. This enables you to add other collaborating participants at the study and site level. You also have the ability to remove users no longer associated with the study. There can be an unlimited number of managers on a study, so feel free to invite others with this access level also. To add Study Level users (Other Sponsor/CRO/SMO level users): 1. Navigate to the Study Workspace. Inviting someone to the Study Workspace will also grant them access to all sites. 2. Click the button on the right side of the page. 3. Enter the , select who they represent and select access level. To add Site Level users (Users who represent specific sites): 1. Navigate to the Site Workspace. Inviting someone to the Site Workspace will only grant them access to that specific site. 2. Click the button on the right side of the page. 3. Enter the , select who they represent and select access level. Version 1.1 July 2013

3 Study-Level Management in Connexus Tip #3: Notification of New Documents ( Alerts) When a submission that had outcome documents generated reaches Completed status, all Manager and Submit level users of the workspace will be notified via . Site Level Users- receive 1 listing site specific document links. Study Level receive 1 listing document links for all sites who received approval. Tip #4: View All Documents (Your electronic file room ) As a study level user, you have 2 separate View all Documents sections: Study Level View All Documents - Accessed from the Study Workspaces, sites do not have access to this section. Contains study level documents like amendments, brochures, INDs, General Approval Letters, etc. Site Level View All Documents - Accessed from Site Workspace, accessible to all who have access to the site and contains site specific documents like Approval Letters and informed consents. Stamped approved items like Ads and Protocol Support documents can also be found here. To access this section, navigate to the workspace level you want to view documents for (Study vs Site level) and then select the View All Documents button located on the right side of the page. You will then see a list of all documents you have access to. The items in this View All Documents section are displayed with the most recently approved items listed first. Note that you may have several pages of documents depending on how active the trial is.

4 Study-Level Management in Connexus To filter for a specific document, type the name in the search box (see screenshot below) and select the Contains function from the dropdown. This filter will display all Informed Consents: You can remove the filter by selecting No Filter from the drop down. An alternate to Filter is the Sort function. You can sort any of the columns by clicking on the column name, 1st click will sort Ascending, 2 nd click will sort Descending, and the 3 rd click will go back to the initial sort. Tip #5: Informed Consent Form (ICF) Templates To access ICF Templates, click on View All Documents from the Study Workspace. Click on the word Document in the table header; this will sort all the documents alphabetically. Type SICF Template in the Document search box as described in Tip #4. This will display the most current Main and CA ICF templates. Make sure you always use the latest Template version when submitting items to CGIRB that will require a revision. When a revised ICF is processed, the documents viewable in the Connexus submission are only drafts of the revised site-specific ICF. CGIRB uses version control for study templates; only the most current version is made available in Connexus. Because of this versioning, ICFs will always be tied to the initial submission of the ICF (i.e., New Protocol Submission for English and Translation or Translated Document for Spanish).

5 Study-Level Management in Connexus Tip #6: Connexus Training We are pleased to offer weekly web based training sessions. These group sessions last 1 hour and cover every aspect of the site. To sign up for one of these regularly scheduled group training sessions click here: If you would like to schedule a training class specifically geared for your site, please let us know by ing ConnexusTraining@cgirb.com Tip #7: Study Contacts via Connexus In the top left corner of each workspace, you will see a list of Study Specific contacts. You can click these contacts names to send an directly to them. The first two contacts listed are the POCs (Point of Contact) for your study here at Copernicus Group IRB. They can assist in any study specific question that you need answered by the IRB. The Sponsor/CRO contact name listed is the main contact at the Sponsor/CRO for this study. Tip #8: Connexus Newsletter Each quarter our Connexus newsletter is distributed via to all active study and site contacts. In each newsletter we provide additional tips to help you in your use of Connexus. This is also available on our website (

6 Study-Level Management in Connexus Tip #9: CGIRB Connexus Helpdesk Copernicus Group IRB is proud to offer a dedicated Connexus helpdesk team. This helpdesk is available during normal business hours (8:30AM 5:00PM EST) to assist with any technical issues you may be running into on our site. To request support go to There you can submit a support ticket or Live Chat instantly with one of our support staff. To initiate a live chat session, click the Live Support icon located on the top of all CGIRB Connexus pages.

7 Site-Level Management in Connexus CGIRB Connexus has been selected as the shipment method by which you will receive approval documents for your study. Below are some helpful tips and tricks to assist you in effectively managing your study. Tip #1: Gaining Access to Site Workspace As a site, whoever is listed as the Primary Contact on the Investigator Site Questionnaire will automatically be granted access to your Site workspace. This automatic linking occurs once the New Principal Investigator submission is received and information is entered into our internal database. Please look for an from connexusadmin@cgirb.com which indicates you have been added to your workspace. Click the Accept link within the . Registration for CGIRB Connexus is free of charge and there is no limit to the number of users your site can register. If you need to register, please go to to do so. If you log in to Connexus and do not see your study listed please send us a Workspace Request by going to the Contact Us dropdown and selecting Request Access to Additional Workspace Tip #2: Managing Site Access The Primary Contact Person listed on the CGIRB Investigator Site Questionnaire is given Manager-level access. Manager level access allows you to invite others to collaborate with you on the Site Workspace. To add a collaborating user to your workspace, navigate to the site workspace, and then select the Site Participants button located on the right side of the page. This will give you the ability to view who already has access, add new users and change the access level of current users. Version 1.1 July 2013

8 Site-Level Management in Connexus Tip #3: View All Documents (Your electronic file room ) The View All Documents section of your Site Workspace contains all regulatory documents for your site. This includes documents that you have submitted to the IRB as well as outcome documents like Approval Letters, Informed Consents and stamped approved Ads that CGIRB has sent to you. To access this section, navigate to the site workspace, and then select the View All Documents button located on the right side of the page. You will then see a list of all documents you have access to: The items in this View All Documents section are displayed with the most recently approved items listed first. Note that you may have several pages of documents depending on how active the trial is COPERNICUS GROUP IRB. All Rights Reserved.

9 Site-Level Management in Connexus To filter for a specific document, type the name in the search box (see screenshot below) and select the Contains function from the dropdown. This filter, for example, will display all Informed Consents: You can remove the filter by selecting No Filter from the drop down. An alternate to Filter is the Sort function. You can sort any of the columns by clicking on the column name, 1st click will sort Ascending, 2 nd click will sort Descending, and the 3 rd click will go back to the initial sort. Tip #4: Study Contacts via Connexus In the top left corner of each workspace, you will see a list of Study Specific contacts. You can click these contacts names to send an directly to them. The first two contacts listed are the POCs (Point of Contact) for your study here at Copernicus Group IRB. They can assist in any study specific question that you need answered by the IRB. The Sponsor/CRO contact name listed is the main contact at the Sponsor/CRO for this study COPERNICUS GROUP IRB. All Rights Reserved.

10 Site-Level Management in Connexus Tip #5: Connexus Training We are pleased to offer weekly web based training sessions. These group sessions last 1 hour and cover every aspect of the site. To sign up for one of these regularly scheduled group training sessions click here: If you would like to schedule a training class specifically geared for your site, please let us know by ing ConnexusTraining@cgirb.com Tip #6: Connexus Newsletter Each quarter our Connexus newsletter is distributed via to all active study and site contacts. In each newsletter we provide additional tips to help you in your use of Connexus. This is also available on our website ( Tip #7: CGIRB Connexus Helpdesk Copernicus Group IRB is proud to offer a dedicated Connexus helpdesk team. This helpdesk is available during normal business hours (8:30AM 5:00PM EST) to assist with any technical issues you may be running into on our site. To request support go to There you can submit a support ticket or Live Chat instantly with one of our support staff. To initiate a live chat session, click the Live Support icon located on the top of all CGIRB Connexus pages COPERNICUS GROUP IRB. All Rights Reserved.