CTTM03 - Quick Guide - Europa

Quick guideUser Access ManagementCTIS Training Programme – Module 03Version 1.3 – April 2022Learning Objectives Remember how to log into CTIS and access the landing page.Understand the basic roles and permissions in CTIS.Understand how the user profile management functionality works.Understand how to search for an organisation and submit a request to create one in CTIS. European Medicines Agency, 2021Reproduction and/or distribution of the content of these training materials for non-commercial orcommercial purposes is authorised, provided the European Medicines Agency is acknowledged asthe source of the materials.The European Medicines Agency developed this training material to enhance public access toinformation on the Clinical Trial Information System (CTIS). This material describes a preliminaryversion of CTIS and may therefore not entirely describe the system as it is at the time of use of thismaterial. The Agency does not warrant or accept any liability in relation to the use (in part or inwhole) or the interpretation of the information contained in this training material by third parties.

User Access ManagementIntroductionCTIS is structured in two restricted and secured workspaces, only accessible to registeredusers, and a website openly accessible to the general public.1To access CTIS restricted workspace, users need to have EMA Accounts. Users of other EMAapplications (e.g. IRIS, EudraVigilance, SPOR) that have already created EMA accounts can usetheir credentials to access CTIS restricted workspaces. If an account is inactive for 6 months, itwill be automatically deleted. If users need to recover their username or password, they canrefer to the ‘Recover your credentials and re-activate your account’ guide on the EMA AccountManagement website.If users do not have EMA Accounts, they can refer to the ‘How to create a new EMA account’guide.This quick guide outlines the steps that a user needs to follow in order to know: How to log into the system and access the landing page. How to access and manage the user profile. The basic roles and permissions available in CTIS.2 How to search for an organisation and submit a request to create organisations viaCTIS.The website is not covered in this module. This module focuses on the user access management functionalities in the tworestricted workspaces in CTIS.2A dedicated module on the roles and permissions is foreseen as part of the CTIS Training Programme.12

User Access ManagementSections of this quick guideThis quick guide is structured in four sections:User profileLog-in andlanding pageThis section outlines the steps thatusers need to follow to log into andlogout from CTIS, in addition to providean introduction to CTIS landing page.This section presents how users canaccess and manage their profile andview their roles.Roles andpermissionsThis section introduces the types of rolesand permissions that users can beassigned in CTIS.OrganisationsThis section presents how users cansearch for an organisation and submita request to create organisations viaCTIS.For simplicity purposes, this quick guide presents the user access management processes ofboth workspaces with screenshots taken mostly from the authority workspace. However, thesame processes apply in the sponsor workspace with a slightly different look and feel.3

User Access ManagementLog-in andlanding pageLog-in and landing pageLog-in and landing pageIn order to log into CTIS, users can access it through two workspaces: Authority: login Sponsor: ginOnce they are in the corresponding workspace, they can enter theusername provided in the Self-service Registration Confirmation Formby the EMA’s Account Management Portal, and the password that theyindicated in the Self-service Registration Form. After populating theusername and password fields, users will click on ‘Log in’.The active tab bydefault in CTISlanding pageallows users tosearch for CTs.Users will be able toAfter clicking on the ‘Log in’ button, users will gain access to CTIS landingaccess also otherpage, which will display the ‘Clinical Trials’ tab by default. Depending ontabs from thewhether the user has accessed the sponsor or the authority workspace,navigation pane ondifferent tabs will be displayed next to this one, as shown below:top of the page.Clinicaltrials tab#CTISinsightsUsers will see differenttabs on the navigationpane depending onClinicaltrials tabLanding page of the authority workspaceLanding page of the sponsor workspaceAll registered users via EMA’s Account Management Portal receive a defaultrole in CTIS that enables them to access the landing page. However, as ageneral rule, to navigate the system or access clinical trialstheir roles anddata/documents, roles and permissions must be given to registered users bypermissions.administrator users (see next section on Roles and Permissions).UserprofileAt the bottom of the landing page, users can access relevant informationsuch as the ‘Help’ page for resolving issues with CTIS; a ‘Sitemap’containing the list of pages of their workspace in CTIS; a ‘Contact’ button toaccess relevant contact details; and a direct link to ‘EMA’s public website’.4

User Access Managementer profileUserprofileUser profileCTIS allows users to manage their user profile information by clickingtheir username button at the top right corner of the CTIS interface.Users can manage their user profile information from the ‘Personalprofile’ sub-tab and have visibility of the roles assigned to them from the‘My roles’ sub-tab (and pro-actively request a role only in the case ofsponsor users). Users can also log out from the system using the ‘Logout’sub-tab that drops down after clicking on the username button. Personal profile My roles LogoutThis functionality allowsusers to manage theirprofile information,have visibility on theirroles and log out fromthe system. It isaccessible at all times onThe ‘Personal profile’ sub-tab allows users to access a page where theycan find their personal information (first and last name, email address, andphone number), as well as information regarding their employerorganisation (name and contact details).top of CTIS.In the sponsorsworkspace, users canUpdate personalinformationrequest a specific rolePassword resetfrom the ‘My roles’ subtab.Update employerinformationIn the ‘Personal profile’ sub-tab, users can perform multiple actionsconcerning their profile information, such as resetting their password,#CTISinsightsupdating their personal information (e.g. first name, last name, email, andphone), and also updating their employer’s information (e.g. employer’sname, contact details, or address), by using data from the OrganisationManagement Service (OMS).When clicking on theThe ‘My roles’ sub-tab enables users to view the role(s) they have been‘Password reset’ link,assigned by a user with administrator permissions in order to performthe user will bespecific actions in the system. Roles can be sorted by alphabetical order,redirected to the EMAuser ID, email, employer, organisation name, organisation ID, role type,Account Managementscope, EU CT number, creation date, assessment date, status, authorisedPortal. The passwordfrom, or authorised to (dates).must be at least 8characters long andcontain 4 differentcharacter types (e.g.Sort by moreitemsP4 w0rd, Americ@54,M3d!cines).Search with EUCT ID and ASR IDAdvanced searchSort byalphabeticorder5

User Access ManagementRoles andpermissionsRoles and permissionsCTIS is a role-based system that enables users to perform differentactions depending on the permissions attached to the roles assigned tothem by a user from their organisation or Member State withadministrator permissions. There are multiple roles in CTIS, which allowusers to execute different actions in the system, in accordance with theirrespective responsibilities regarding a clinical trial.3PermissionsPredefined levels of actions that users can perform on data anddocuments stored in CTIS. These include:a) Business permissions (e.g. Member States creating considerations,sponsors creating responses to RFIs).b) Access level permissions, which are described as follows: CTIS enablesView permissions, which allow users to view and downloadstructured data and documents in different formats.administrator users to assignPrepare permissions which, in addition to the viewingpermissions, allow users to create, edit, save, upload, delete orand revoke rolescancel draft items. These permissions also enable users to copywith attacheddata from an existing CTA to create a new one.permissions to registered users toSubmit permissions which, in addition to the formerpermissions, allow users to share, submit and withdrawbe able to performdata/documents from their respective workspace to the EU CTdifferent actions indatabase, and to update submitted data/documents.the system.c) Other permissions related to user management and taskmanagement.RolesPredefined group of actions that users can perform in CTIS regarding aclinical trial application, or regarding data and documents submittedduring the trial life cycle, in accordance with their responsibilities. Twotypes of roles can be distinguished: Administrator roles, which are able to assign roles to otherusers from their organisation or Member State, e.g. sponsor#CTISinsightsadministrator, Member State administrator, National Organisationadministrator, or CT administrator. Business roles, reflect the responsibilities of users during theThe permission levelslife-cycle of a clinical trial. They are assigned by administratorare structured in ausers and are attached to the permissions described above.cascade system wherethe lowest level isviewing permissions,and the highest levelis submittingpermissions.3Further details on the roles and permissions can be found in Module 7.6

User Access ManagementOrganisationsOrganisationsOn various occasions (e.g. CTA creation, notifications submission, inspectionrecords, employer information, etc.), CTIS users need to populateorganisation details including information related to sponsors, CROs, thirdparties, clinical investigator sites captured in Part II of the CTA, inspectedsites, etc. This information is retrieved from the OrganisationManagement Service (OMS), using dedicated search functionalities.To retrieve organisations from OMS, users need to populate either aminimum of three characters on the ‘Name’ field or at least one characteron the ‘Organisation-ID’ field, to activate the ‘Search organisation’button.The higher number ofthe characters that isused in the searchform, the more thescope is narroweddown, allowing usersmore accurate searchesfor organisations.After performing the organisation search, users can select one of theorganisations listed in the results, using the respective radio button on theleft side of the results. If the organisation is not listed, users can submit achange request to create a new organisation in OMS. This request can besubmitted either via CTIS or via OMS (for more information, refer to theQuick Guide OMS).CTISAfter an organisation search is performed, a ‘ New organisation’ buttonis activated on the organisation search functionality (see image above). By#CTISinsightsclicking on it, users can create and submit a change request to the OMSteam to create a new organisation. A pop-up form opens and users need tofill in all the required fields and add the necessary supporting documentationbefore clicking on the ‘Submit’ button.By using the ‘City’ andthe ‘Country’ fields,users can refine evenfurther yourorganisation search.7