Recommendations for preparation for Reg (EU) 536/2014

Organisation Management System (OMS) Trouble Shooting Sessions for CTIS users

On Thursday, 21 July 2022 from 14:00 to 15:00 CET, EMA will organise an event to support CTIS users with OMS-related questions.

The event will be broadcasted (details of the event page).
 
This event will be the first in a series of 6 monthly events to clarify outstanding questions reported by CTIS users and clinical trial sites. EMA is offering this dedicated support to address issues and questions related to registering the organisation and/or location data in OMS for use in CTIS clinical trial applications.
 
The calendar of the sessions is shown below:

Session     Event DateDue date for questionsEvent page linkTime (one hour)
4th19 October 202212 October 2022Event page14:00 – 15:00
5th24 November 202217 November 2022Event page14:00 – 15:00

In preparation for this session, we will capture questions via Slido, until 14 July 2022.

For sponsor users, please use code: #CTISTSSponsor and for Member States users, please use code: #CTISTSMS.Questions will be answered by speakers during the panel session.

We look forward to hearing from you by the 14 July 2022 COB.

Training material from the European Medicines Agency

The European Medicines Agency (EMA) offers extensive training material to prepare for Regulation (EU) 536/2014 ("Clinical Trials Regulation, CTR") and for working in the Clinical Trials Information System (CTIS).

General information on the Clinical Trials Regulation (CTR)

Training material on the Clinical Trials Information System (CTIS)

Training materials include

  • Online training modules
  • Handbook for clinical trial sponsors
  • Reference materials for clinical trial sponsors
  • Reference materials for authorities
  • Training and information events (including video recordings)
  • Information on master trainers from sponsors, agencies and ethics committees

It is strongly recommended to be familiar with these training materials before submitting a clinical trial via CTIS.

Support of Sponsor Master Trainers in the CTIS Training Environment

The Federal Office offers the following support for Sponsor Master Trainers:

  • The BASG can take over the authority role in workflows to complete workflow steps.
  • The Austrian Ethics Committees are not involved.
  • It is purely a matter of technical completion. There is no regulatory or scientific review foreseen.
  • Only standard workflows for initial submissions and substantial amendments are offered.
  • Procedures are to be identified in the title as training studies (see below).
  • Once a week, a procedural step (e.g. validation deficiencies, validation, substantive deficiencies, decision) is completed by the agency.
  • Parallel correspondence to the procedure is not foreseen. Communication should be through CTIS.

Recommendation for title:

  • Fixed wording that allows the studies in question to be found: 'Sponsor MT test trial for MS involvement'.
  • Mentioning the MS is then optional as this can also be filtered via advanced search.
  • Explanation of the sponsor's expectations in the title (e.g. validation RFI, assessment RFI, type of RFI).

User administration by the EMA

  1. In order to be able to take actions in the Clinical Trials Information System (CTIS) (e.g. submit an application), you have to be registered in the EMA's Account Management System. This is a self-registration which is open to all.
  2. Once you have an EMA account, you can request access to EMA applications such as CTIS, SPOR, IRIS, EudraVigilance and UPD on behalf of your organisation.
  3. If your organisation is not yet registered with EMA, you can do this yourself in EMA's Organisation Management Service (OMS). The prerequisite is that you are authorised to do so by your organisation, which will be checked by the EMA.

Important information for trial sites!

Trial sites also need to be registered as organisations in the EMA's OMS in order to be selected for a clinical trial application. This does not aim at the individual department, but at the organisational unit of the clinical institution.

A potential trial site therefore has to submit its Organisation ID (ORG ID) and the name and department of the Investigator to the Sponsor/Applicant prior to submitting an application in CTIS in order to be selected as a trial site. In CTIS first the organisation for the trial site is to be selected and then the Investigator's name, contact information and department are manually entered.

For complex organisational units it is recommended that the registration of the organisation is coordinated centrally (e.g. by the medical directorate or the rector). The administrator of the organization should be the person responsible for certifying the suitability of the clinical site as a trial site according to Annex I, letter N, of the regulation (although this responsibility can of course be delegated).

Using the example of the Agency for Health and Food Safety (AGES) below, one can see that the AGES Austrian Medicines and Medical Devices Agency (AGES MEA) located in Traisengasse, although it has its own site, is part of the overarching organisation AGES. In the case of a trial site, the AGES MEA would be the department and the AGES the clinic/institution.

National documents and templates

In principle, Austria plans to accept the templates for national documents ("Part II") published by the working groups of the European Commission in Eudralex Vol. 10 in the spirit of European harmonisation.

An exception is the template for the patient information and consent form, for which national templates are already available.

The Federal Office is currently in close consultation with the ethics committees operating under the CTR as to whether the European templates should still be supplemented or whether national templates should be used instead. New information will be published as soon as it is available.

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Further inquiry note