An agency of the European Union

User Management

Presented by: Ana Rodriguez, Head Clinical and Non-clinical Compliance

Content

1

• What is User Management

• Key Principles

• Self-Registration

• The Gateway

• Clinical Trial Centric approach

• Non- Admin MS User- further access to the CT system

• Administration of Users

• MS Role Hierarchy

• Mock up- Examples

• Role Matrix (MS and EU Commission- excluding administrator role)

User Management

What is User Management

2

• User management are a set of features and capabilities that enable member states (MS) to manage user access to CT that belong to their respective member states within the Clinical trial portal.

• User Management allows users to request access to CT’s that they want to participate in

• Sponsor administrators and CT administrators retain the ability to authorise access. The User Management dashboard will enable the following:

• Approve/Amend/Reject for Role/Scope/CT Access

• Invite to assign roles

• Assign CT

• Revoke Access from CT

User Management

Key Principles

3

• All users will need to be self-registered in the EMA systems before they can access the EU Portal & EU Database.

• A sponsor administrator will have access to all clinical trials that the sponsor organisation is responsible for.

• Sponsor administrators shall be able to validate whether they would like users to perform actions on behalf of their organisation, thus allowing the user to be affiliated with their organisation.

• The user who creates a clinical trial application will automatically become the CT admin for that application

• The CT administrator, with exception of “Organization specific-centric approach ”, will only have administrator rights to the clinical trials for which is an administrator

• The sponsor and CT Administrator can administer their users (approve/amend requests, invite or revoke user access from any trial that they are responsible for)

• The users of the EU Portal will have access to the portal functions according to their role, so the system will display the appropriate data and also the appropriate activities for them.

User Management

User Management – Self Registration

User Management 4

• This is the first activity that a user is required to perform before they can gain access to the CT portal.

• A user will be required to provide their first name, last name and phone number(optional).

• The user will also be prompted to provide a password and security questions

• Once all the relevant information has been provided, a confirmation message will be sent to the email that the user provided

User Management – Self Registration

User Management 5

Sponsors

Organisation-centric • Sponsor administrator required

• Users become affiliated to the sponsor organization

• CTA creation requires authorization by sponsor admin

User management overview (Sponsors)

• Management of clinical trials by the CT administrators

• No required an Sponsor administrator

• No required users to be affiliated to an organization

Trial-centric Sponsors

6 User Management

ALL CTs stream: allows sponsors to approve global access to their CT’s

CT specific stream: allows sponsors to approve access to a subset of trials before the user is assigned to the concerned trial(s)

User Management - Gateway

• Automatically routes a user to an appropriate approach depending on the selection made

• There are two approaches:

User Management - Gateway

User Management 7

Trial-centric Approach

8 User Management

• Management of the trial and users by a CT Administrator

• User becomes a CT admin by creating a CTA

• User will have to seek authorization to work on trials on an individual basis

• CT admin will be responsible for authorizing specific CT access requests from users

• CT admin can manage the users (authorize/change requests, invite users, revoke access etc.)

Trial-centric Approach

9 User Management

• Sponsor admin will authorise the affiliation of user to the organization

• The user can request a role within the sponsor admin organization for all trials (organization specific) or for a subset of trials (CT specific)

• In the “ALL CTs” workstream, once a role is approved by the sponsor admin the user can apply that role for all the CTs in that organization

• In the “CT specific” workstream, once a role is approved, a CT will need to be assigned to the user to apply his/her role in the system

• A sponsor admin will not require CT admin to authorise request access to individual CT but to assign trials to users, unless the CT admin invite users

10 User Management

Organization Centric approach

Organization Centric approach

User Management 11

Administration of Users

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• The Admin roles have the power manage roles within an organisation and at the trial level.

• Sponsor admins are authorised to manage users at both the organisation level and trial level and are responsible for affiliating organisation users

• CT admins are authorised to manage user access for the trials for which they are CT admin.

Request Sponsor Admin role

13 User Management

Sponsor Admin can administer users for the organization

Registered user will become sponsor Admin role for Organization

EMA admin will Approve role

EMA Admin will review documentation

Uploads proof of ID and evidence of appointment

Registered User Request Sponsor Admin role

Request CT Admin role

14 User Management

CT Admin can administer users for that trial

User becomes CT Admin for trial created

User creates CT

Sponsor Admin approves request (Org Centric)

User request role/scope (Org centric)

Administration of Users by the Administrators

User Management 15

User Management

User Management Hierarchy

16

Sponsor Administrator

• Approve CT Admin role

• CT Admin for all trials within the sponsor organization

• Can assign the same level role as a backup to another MS user

Sponsor Administrator/CT

Administrator • Approve/Amend/Reject a role,

scope or Access to CT (CT

• Invite to assign Role

• Assign CT

• Revoke access from specific CT

• Can assign the same level role as a backup to another MS user

MS User

• Request role, scope and for access to all or specific trials

• Carry out actions on CT according to role

• The organisation-based access for sponsors requires a more formal registration process

– creates the opportunity for management of access across trials – Improves security – Leads to better data quality

• The Trial centric approach allows a faster process in case of a first initial application,

– Can lead more easily to duplicate sponsor data – Becomes less convenient if an organisation applies for/runs multiple

trials

User Management 17

Organization Vs CT Centric approach

Request Access - Sponsor dashboard

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Clinical Trial approval

19 User Management

Invite User – User Search

20

class 1014 Search User

User Management

Invite – Add user to CT

21

class 1014 Add User to CT

User Management

Clinical Trial dashboard

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Role matrix- Key principles

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• It is made up of the following elements: - Business role: validator, assessor etc - Roles: WP1, WP2, - Permissions: prepare considerations, prepare AR - Rights: view, prepare and submit. A submitter has all rights, a

preparer has also view rights, a viewer can only view. • The system will know, based on business rules, will permissions

within a role can be performed by the user (e.g. a MSC validator cannot submit validation conclusion)

• For each business role the user will be able to prepare those documents according to its role but also to view those documents required to fulfills that role

• A user can have one or more business roles

Role matrix- Business role

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• Sponsor • MAH • Validator • Assessor:

• Part I • Part II

• Decision Maker • Supervisor • Inspector • Union Controller • Viewer

Role matrix- Roles (WPs) and permissions

25 User Management

• WP1: Part I (without IMPD)/View trial information/fields pulled from IMPD • WP2: Part II • WP3: IMPD • WP4: Responses to RFI, responses to additional info, withdrawal,

notifications, 3rd country IR, Lay summmary, CT summary • WP5: Express willigness, RMS selection, RFI- Vali, comments on RMS

role, comments on RFI response, considerations-Val, consolidated considerations- Val

• WP6: AR (Part I or Part II), RFI- AR, conclusion-AR, considerations-AR, consolidated considerations-AR

• WP7: Corrective measures, additional info request, evaluation add info • WP8: Conclusion- Val, MS decision, disagreement Part I, revert decision • WP9: IR • WP10: Union Control • WP11: Clinical Study Report • WP12: Protocol and IB

Role matrix- Business role Sponsor

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What the user can view, prepare and submit according to its role/permissions (WP5)

What the user needs to view to fulfils its role (WP1, WP2, WP3, WP4)

WP Mapping WP 1a, 1b, 2a, 2b, 4,5, 7 Bussiness Roles Sponsor Roles/Rights V P S WP 1 x x x WP 2 x x x WP 3 x x x WP 4 x x x WP 5 x WP 6 x WP 7 x WP 8 x WP 9 WP 10 WP 11 WP 12

• WP1: Part I (without IMPD)/View trial information/fields pulled from IMPD • WP2: Part II • WP3: IMPD • WP4: Responses to RFI, responses to additional info, withdrawal,

notifications, 3rd country IR, Lay summmary, CT summary

Role matrix- Sponsor- View

27 User Management

• WP1: Part I (without IMPD)/View trial information/fields pulled from IMPD • WP2: Part II • WP3: IMPD • WP4: Responses to RFI, responses to additional info, withdrawal,

notifications, 3rd country IR, Lay summmary, CT summary • WP5: Express willigness, RMS selection, RFI- Vali, comments on RMS

role, comments on RFI response, considerations-Val, consolidated considerations- Val

• WP6: AR (Part I or Part II), RFI- AR, conclusion-AR, considerations-AR, consolidated considerations-AR

• WP7: Corrective measures, additional info request, evaluation add info • WP8: Conclusion- Val, MS decision, disagreement Part I, revert decision

Role matrix- MAH Role

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WP11: Clinical Study Report

WP Mapping WP8 Bussiness Roles MAH (1) Roles/Rights V P S WP 1 WP 2 WP 3 WP 4 WP 5 WP 6 WP 7 WP 8 WP 9 WP 10 WP 11 x x x WP 12