April 2021: Clinical Trial Information System Portal Update

Clinical Trials Information System Reaches Major Milestone Towards Go-Live

As per the latest update posted on 21 April 2021, EMA’s Management confirmed that the clinical trial EU Portal and Database, one of the main deliverables of the Clinical Trial Regulation and the key component of the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 2022.

The Board confirmed that it has verified that the system meets the agreed requirements during an extraordinary meeting held on 21 April following an independent audit of the new IT system.

April 2021: Spain Regulatory Updates

Publication of Observational Studies with drugs in the Spanish Registry of Clinical Studies

AEMPS posted an update regarding the new platform for the publication of observational studies with drugs in the Spanish Registry of Clinical Studies on April 14, 2021. The trial registration and results posting activities for these will be carried out through GESTO platform, launched on 14th April 2021.

Additionally, as informed earlier by the authority, a document Instructions for conducting observational studies with drugs: Procedures, terms and data format that will be included in the Spanish Registry of clinical studies (REec) has also been made available. The document provides details in compliance with the provisions of Article 3.1 and 6.2 of Royal Decree 957/2020, of November 3. The points are summarized as below:

User account and login information:

  • Account requests and related incidents can be raised through https://servicedesk.aemps.es/servicedesk/customer/portal/2
  • The promotor (individual, company, institution or organization responsible for initiating, managing and organizing the financing study) or representative of a promotor [who will be the sole point of contact for the study promoter (applicant) from registration of trial] can register

Requirements:

  • Publication of information is mandatory for observational studies with prospective follow-up drugs and voluntary for the rest of the studies

Timelines:

  • Registration: Maximum 15 working days from the start date of the study
  • Maintenance: The updating of the data must be carried out within 15 days working from the date the CEIm has issued a favorable opinion to the substantial modification
  • Results: Results will need to be submitted within 12 months from study completion or within 30 working days from the date of publication of the same in scientific journals or other media, whichever is earlier
  • For early terminated trials, information will need to be updated within 3 months from the trial termination date

Trial registration and results posting (Data entry):

  • Details regarding the registration fields, fields that will be made public and other fields that will not be displayed publicly are available on below link, https://www.aemps.gob.es/investigacionClinica/medicamentos/docs/estudios-PA/Instrucciones-GESTO-REEC.pdf?x74012
  • Information for the below-mentioned fields will be submitted to GESTO, however, these fields will not be published on REec:
    Promoter ID, Contact for scientific inquiries, Identification of the principal investigator/coordinator, Contact information, CEIm that approved the study, Meeting date CEIm Opinion, Study status (started, finished), End date, Summary of Results, Post link, Date of the last modification of the record in the REec
  • Results will be submitted either in the form of a summary of trial results or bibliographic reference of the published scientific article
  • The AEMPS will check the consistency of the information provided and will proceed to transfer the information to the REec

April 2021: What’s New on EudraCT

The below update was posted on EudraCT What’s New section, on April 16, 2021:

A new version of the Frequently Asked Questions is now available for users and more detailed instructions are now provided in the tutorials on posting results.

Changes:

  • Q. 30: Provides more information regarding a third country trial
  • Q. 55: Provides an additional reference for contents of results information to be included in a summary attachment
  • Q. 67: Question updated to add ‘user or delegated preparer
  • Q. 70: Provides information for a sponsor to directly upload a PDF document; previously, the NCA was to be contacted who would then upload the document
  • Q. 78: Statement added ‘A link to the old version will remain published in the EU CTR to keep track of the changes and for transparency reason.
  • Q. 81: Addition of statement about errors and warning
  • Minor grammatical and typographical corrections

February 2021: European Regulatory Update

TranspariMed published an article How will national regulators in Europe impose fines for missing clinical trial results?

In this article, TranspariMED’s legal analyst Muhammad Dwistaraifa Rasendriya explains the legal context and how the process will work. As a summary, even though national medicines regulators will get clear legal powers to impose fines and other sanctions on European companies and institutions that fail to make the results of their drug trials public, there will be variation in the amount/type/applicability of the penalty depending on what act/law is passed in each EU country.

Click here for the original article.

March 2021: EMA Medical Terms Simplifier

EMA published a document “EMA Medical Terms Simplifier” on March 19, 2021.

This compilation gives plain-language descriptions of medical terms commonly used in information about medicines.  The list includes side effects and similar terms in summaries of product characteristics and
public assessments of medicines but does not extend to the terms that are used only rarely.

EMA will update the document periodically.

March 2021: Clinical Trials Information System (CTIS) Training Update

European Medical Agency updated the page Clinical Trails Information System: training programme, on March 10th, 2021, by adding the below training materials in PDF format for Module 8 :

  1. Quick guide – Introduction: How to evaluate an Initial Clinical Trial Application: Assessment and Decision – CTIS Training Programme – Module 08
  2. Quick guide – Decision: How to evaluate an Initial Clinical Trial Application: Assessment and Decision – CTIS Training Programme – Module 08
  3. Quick guide – Part I: How to evaluate an Initial Clinical Trial Application: Assessment and Decision – CTIS Training Programme – Module 08
  4. Quick guide – Part II: How to evaluate an Initial Clinical Trial Application: Assessment and Decision – CTIS Training Programme – Module 08

 

March 2021: CTIS Training Webinars Update

Day 2 of the SME and academia Clinical Trials Information System (CTIS) two-part training webinar arranged by EMA took place on March 04, 2021. EMA has made available the presentations from Day 2 of this CTIS training webinar on March 03, 2021.

February 2021: CTIS Training Webinars Update

Clinical Trials Information System (CTIS) Training: Day 1 Webinar Presentations 

SME and academia Clinical Trials Information System (CTIS) two-part training webinar was announced on 19/01/2020. Day 1 of the webinar was held on 22 February 2021. Presentations were provided by EMA system experts, European Commission, and presenters from SME and academic institutions during the webinar. The presentations from the Day 1 of the CTIS training webinar were made available by EMA on 26 February 2021.

February 2021: Clinical Trials Information System (CTIS) Update

Clinical Trials Information System (CTIS): training programme

European Medical Agency (EMA) made available a page, Clinical Trials Information System (CTIS): training programme, for a variety of online training modules, on February 09, 2021.

Each module contains a summary of the topics it covers and learning materials. These consist of e-Learning courses, quick guides, infographics, videos, frequently asked questions (FAQs) and instructor guides. The learning materials are accessible via links unless they are not yet available.

EMA will add new modules and materials throughout 2021.

February 2021: CTIS Training Webinars

EMA published a document Clinical Trials Information System (CTIS) Training – Information update on progress, on February 01, 2021.

The document provides a summary of training webinars planned by EMA for using CTIS, throughout the year. The details of the master training for sponsors and training for SMEs (micro, small and medium-sized enterprises) and academia and other non-commercial clinical trial sponsors are already published.

There will be two additional events:

  • A third training for the end-users from all sponsor groups to provide training in their role-specific functionalities (e.g. administrator, preparer, submitter). This stream will be initiated closer to CTIS Go-live in Q4 of 2021.
  • A survey to collect information from commercial industry sponsors, SMEs and non-commercial sponsors interested in the CTIS training programme. The survey is open for completion until 8 February 2021 at 12 CET to obtain input on clinical trials sponsors (end-user organisations) interest for CTIS sponsor training events. EMA has provided the link to the survey: Link.