Category: Belgium

European Medicines Agency updated the page, Clinical Trials Regulation: progress on implementation by adding ‘Key performance indicators (KPIs) to monitor the European clinical trials environment (1 – 31 May 2022, edition 2)‘ document over the What’s New Section on June 27, 2022:

KPIs to monitor the European clinical trials environment: It is the second report posted for the period May 01, 2022, to May 31, 2022, consisting of the metrics for the submitted and authorized clinical trial applications along with the non-authorized clinical trials. The data is reported from the two EU clinical-trial databases (Clinical Trials Information System (CTIS)  and European Union Drug Regulating Authorities Clinical Trials (EudraCT)). The data is divided into sponsor type, mono-national or multi-national, clinical trial phase, and therapeutic area. A cumulative data from January 31, 2022, is also available for all the below parameters:

1. Clinical trials submitted under the Clinical Trials Regulation (CTR)
2. Clinical Trial Applications submitted under the Clinical Trials Directive (CTD)
3. Ongoing clinical trials in CTR and CTD
4. Clinical trials with a decision issued with/without deferrals under CTR and CTD
5. Submitted, validated, authorized, rejected, lapsed, and withdrawn Substantial Modification (SM) applications
6. Average time from submission to reporting date, and to first decision for initial applications and Substantial Modifications (Part I or Part I and II): It provides a calculated average number of days required to get a decision on the submitted initial clinical trial application (CTAs) using the dates of 8 authorized initial CTAs.

European Medicines Agency updated about the upcoming events of Organisation Management System (OMS) Trouble Shooting Session for CTIS users to the What’s New Section on June 27, 2022:

EMA will be hosting several OMS trouble shooting sessions on the following dates:

• July 21, 2022: 14.00 to 15.00 (CEST)
• September 22, 2022: 14.00 to 15.00 (CEST)
• October 19, 2022: 14.00 to 15.00 (CEST)
• November 24, 2022: 14.00 to 15.00 (CEST)

It notifies that these trouble shooting sessions will be held for clarifying the questions reported by clinical trial users and sites. It mentions that the questions related to registering the organization and/or location data in the OMS will be addressed in this event. It also mentions that a video recording will be made available after the event.

European Medicines Agency updated about the upcoming Clinical Trials Information System (CTIS) bitesize talks over the What’s New Section on June 27, 2022:

EMA will host two bitesize talks, CTIS bitesize talks: Notifications – Part 1 and Notifications – Part 2 on September 28, 2022, and October 20, 2022, respectively. The sponsors will get an opportunity to learn about the notifications related to the trial and recruitment period, e.g. start, end, restart and halt of trial, etc., in Part 1 and unexpected event notification; urgent safety measures; serious breach, etc., in Part 2.

These events will be open to all sponsor organizations, including pharmaceutical companies, contract research organizations, small and medium-sized enterprises (SMEs), and academic organizations. A video recording will be made available after the events.

European Medicines Agency updated about the events ‘Clinical Trials Information System (CTIS) sponsor end-user training program’ over the What’s New Section on June 27, 2022:

It notifies that EMA will host two sponsor end-user training programs:

1. CTIS sponsor end user training programme – September 2022: It will be held from September 20 to September 23, 2022. The event page provides the agenda and a registration link
2. CTIS sponsor end user training programme – November 2022: It will be held from November 07 to November 10, 2022. The event page provides the agenda and a registration link

These training programs provides sponsor users the guidelines to prepare for the new way of submitting clinical trial application and managing the clinical trial lifecycle on CTIS. The event page also highlights the key topics that will be covered during the training programs.

European Medicines Agency updated about the upcoming event, Clinical Trials Information System (CTIS) webinar: Six months of CTIS and looking forward over the What’s New Section on June 16, 2022:

It notifies that EMA will host a webinar on July 01, 2022 that will cover topics related to system usage metrics, member state and sponsor experience and reflections, user support feedback, and training environment. The event will be open to all sponsor organizations, including pharmaceutical companies, contract research organizations, small and medium-sized enterprises (SMEs), and academic organizations.

It also encourages interested participants to submit their questions in advance relating to sponsor preparedness by June 24, 2022. Most popular questions will be answered by the speakers during the event. No registration is required for this event. A video recording will be made available after the event.

European Medicines Agency updated about the upcoming event, Clinical Trials Information System (CTIS) bitesize talk: Deferral rules and Public website over the What’s New Section on June 10, 2022:

It notifies that CTIS bitesize talk for deferral rules and public website event will be held on July 20, 2022. The sponsors will get an opportunity to learn about the deferral mechanism and it’s affects on publication of clinical trial data and documents. Sponsors will also be able to ask questions during the event. The event will be open to all sponsor organizations, including pharmaceutical companies, contract research organizations, small and medium-sized enterprises (SMEs), and academic organizations. A video recording will be made available after the event.

Also available on the event page is the Speaker bios for this event.

European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on June 06, 2022, by adding new versions for the below documents in Module 08- Evaluate a clinical trial application: Assessment and decision-making and Module 19- CTIS for SMEs and academia:

1.  Quick guide – Part II: How to evaluate an Initial Clinical Trial Application: Assessment and Decision – Module 08 (v1.3): The section for roles and permission was updated by updating the functionalities of the Assessor Part II preparer
2.  Quick guide – Introduction: How to evaluate an Initial Clinical Trial Application: Assessment and Decision – Module 08 (v1.3): It was updated with some minor grammatical changes and by adding more information on how to use the quick guide
3.  Quick guide – Introduction: CTIS for SMEs and Academia – Module 19 (v1.3): It provides links for CTIS demonstration video recordings to issue notifications, and respond to ad hoc assessments and sponsors’ opinion requests. These recording also guides on submission of clinical trial application (CTA), non-substantial modifications, annual safety reports (ASR), results in summary, clinical study report (CSR), along with how to respond to the request for information (RFIs), and CTA RFIs.

European Medicines Agency (EMA) updated the page Clinical Trials in Human Medicines on June 03, 2022, by providing information on complex clinical trials and adding the below document:

Complex clinical trials – questions and answers: It provides answers to the questions related to planning, designing, and conducting complex clinical trials and master protocols. It also guides on transparency requirements and reporting clinical trial information to regulatory authorities.

It explains in detail the definition of ‘end of trial’, requirements of end of trial date, end of sub-protocol date, and/or premature end of sub-protocol date for submitting the complex clinical trial at all three levels (member state, European Union [EU] level, and global level) in Clinical Trials Information System (CTIS). It mentions that a protocol should include a plan for smooth communication between the relevant stakeholders (e.g. investigators, CROs, regulatory authorities, ethics committees, trial participants, and sponsors when there are more than one) to maintain the integrity of the trial. It also mentions that if there are any changes in the communication plan, a substantial protocol should be created.

All documents should be identified either with a common identifier or a specific identifier. It enlists the documents required to gain access to personal data or commercially confidential information, if more than one sponsor is involved in the trial, and while submitting the master and sub-protocols. There should be a section of publication policy in either of the protocols (master or sub-protocol) at the time when data needs to be published that includes the following:

1. Sponsor’s commitment to notify the actual study dates along with the dates of sub-protocols to fulfill EU CTR transparency requirements
2. Sponsor’s commitment to submit the summary results within a year following the end of the sub-protocol date, or a reason for delay if not submitted within the timeline.
3. A valid justification to defer the publication of sub-protocol results

It also mentions if the complex trial has several study phases, the highest phase should be applied. If there are any restrictive changes in the publication policy, a substantial modification will be triggered.

European Medicines Agency updated the page Clinical Trials Information System (CTIS): online modular training programme, on June 01, 2022, by adding the below document:

CTIS Training materials – Latest updates (v1.0): It provides information to users on all the newly developed and updated training modules over the EMA website. This report includes the study materials that were added and updated from January 31, 2022, to May 15, 2022, along with the details for the updates made. It guides the users on how to search for updated documents using the filters available on the EMA website along with screenshots for better understanding.