European Medicines Agency (EMA) updated the page Clinical Trials Information System: training and support on November 30, 2022, by adding a new version of the CTIS – Sponsor handbook (v3.0).
The below sections were newly added in version 3.0 of the CTIS – Sponsor handbook:
- Section 3.5: Marketing Authorization Holder (MAH) group of users – This section gives a brief idea about the MAH Administrator role and the steps for registration as the MAH Administrator. A link to Module 13 was added for further details.
- Section 4: How to get a clinical trial application started in CTIS – This section gives details about drafting a clinical trial application (CTA) dossier, guidance on the navigation of the evaluation tab in CTIS, and information on the assessment activities once the CTA has been submitted.
- Section 5.3: How to create a transitional trial in CTIS – This section gives details about creating a transitional trial in CTIS. Links to Training Module 23 are provided for further details.
- Section 5.4: How to manage trials transitioned to the Clinical Trial Regulation (CTR) in CTIS – This section gives brief guidance on managing trials once the trial has a recorded authorization in CTIS.
Various sections like Overview of CTA process in CTIS – from submission to decision and reporting (section 1.2), CTIS go-live date (section 1.3), Organisation and Sponsor Administrator registration (section 2.2), Key user management concepts in CTIS (section 3.1), Data, documentation, and processes (section 7), Safety reporting obligations (section 9), Support (section 10), Other references (section 11) were also updated in this version of the handbook.
More information can be found here.
European Medicines Agency updated the event pages Organisation Management System (OMS) Trouble Shooting Session for CTIS users- October 2022 and OMS Trouble Shooting Session for CTIS users- November 2022 on November 29, 2022, with the following information:
- A video recording of the session held on October 2022 was made available.
- A Presentation from the session held on November 2022 was made available. The presentation gives key principles of OMS, discusses the questions raised during and before the event, and provides links to supporting documents.
European Medicines Agency updated the EudraCT homepage by providing the following update over the What’s New section on November 14, 2022:
There are issues reported by the users with uploading clinical trial application (CTA) XML files on EudraCT. This issue is caused by a SPOR malfunction impacting EudraCT and CTIS.
As of November 21, 2022, this issue is now resolved by EudraCT IT.
The below update was posted on the Release notes section of ClinicalTrials.gov PRS Beta test system on November 10, 2022:
Updates have been made to the PRS Test system to include two modules in the Protocol Section. These redesigned modules include on-demand help tips and guidance to make the data elements more understandable.
The key features include:
- Users can create a new record and edit the Study Identification and Study Description modules of the Protocol Section.
- More accessible and understandable help content for protocol data elements have been added.
- Users can now access modules in any order they choose once the record has been created.
Detailed information on the updates can be found at here
European Medicines Agency updated the page Clinical Trials Information System (CTIS): online modular training program on October 28, 2022, by adding new versions for the below documents in Module 13 – Clinical study reports submissions:
- Quick guide: Clinical Study Reports submission (v1.1): Updated by providing information on the process to request the Marketing Authorisation Holder (MAH) admin role in CTIS. Users can request the MAH admin role by raising a service desk ticket to CTIS and by attaching the affiliation letter signed by a representative of the MAH/Marketing Authorisation (MAA) to the ticket. MAH admin users, once appointed by EMA admin after validating the affiliation letter can then assign roles of CTIS Submitter or Viewer to other CTIS users.
- FAQs: Clinical Study Reports submission (v1.1): The questions and answers that are updated in this version are –
- Section 4.2: Details of the CSR-related tasks (view, create, edit, submit, update, and withdraw a CSR) that a MAH admin can perform were added.
- Section 4.3: Information on the process to request the MAH admin role in CTIS has been added.
European Medicines Agency updated the event page Clinical Trials Information System (CTIS) bitesize talk: Notifications – Part 1 over the What’s New Section on October 26, 2022:
The video recording of the CTIS bitesize talk held on September 28, 2022, is now available on the event page. This bitesize talk provided an opportunity for sponsors to learn about the notifications related to trial and recruitment period, e.g. start, end, restart and halt of trial etc.
Also, new version for the below documents were added in Module 08 – Evaluate a clinical trial application: Assessment and decision-making by adding information on uploading the ‘not for publication’ documents in CTIS:
- Quick guide – Part I : How to evaluate a clinical trial application: assessment and decision (v1.4)
- Quick guide – Part II : How to evaluate a clinical trial application: assessment and decision (v1.4)
The eleventh issue of the Clinical Trials Highlights was published on October 21, 2022. Below are the key updates:
- Over 100 clinical trials have now been authorized by the Clinical Trials Information System (CTIS)
- Updated guidance on the protection of personal data and commercially confidential information (CCI) in CTIS will be provided in future issues considering the feedback received during the workshop and the 5-month public consultation period that concluded on 8 September 2022.
- The CTIS Forum including CTIS users and experts from Member States, EU sponsors (Academia, Industry), Clinical Research Organisations (CROs), patients, and from healthcare professionals will meet quarterly to discuss the CTIS functionalities, system use, and development, as well as user support and knowledge acquisition.
- EMA is currently reviewing all the responses received during Survey 3.0 for CTIS Sandbox and will provide eligible participants with access to CTIS Training Environment by the end of October 2022. The web address to CTIS Training Environment has also changed and users have been provided with the new web address through the e-mail account.
- After October 18, 2022, administrators will have to indicate both the user ID and the email address of the user to assign roles to users in their organizations in CTIS.
To know more about the upcoming CTIS events like CTIS walk-in clinics, organization management service (OMS) troubleshooting sessions, CTIS Webinar – 9 months on and going forward, bitesize talks and sponsor end-user training programs that will be held in November and December 2022, please click here.
The World Health Organization (WHO) has released a consultation page to solicit feedback from stakeholders – including researchers, patients, journal editors, funders, industry sponsors, and regulators. The aim is to promote harmonization of minimum data elements for reporting study results in trial registries.
It accommodates the submission of responses on a scale of 1-5 based on the importance of collecting data for various data elements. It includes the following sections – Trial status and dates, Participant flow, Baseline data, Outcome measures and their results including statistical analysis, Adverse events, and public disclosure of study documents.
The deadline for submitting feedback is 11 November 2022.
European Medicines Agency updated the event page Clinical Trials Information System (CTIS): Walk-in clinic over the What’s New Section on October 12, 2022:
The video recording of the CTIS walk-in clinic held on September 20, 2022, is now available on the event page. Walk-in clinics provide a platform for sponsors to receive practical advice on the CTIS system functionalities by asking questions to CTIS experts.
On October 06, 2022, the below update was posted on ClinicalTrials.gov, What’s New section:
Webinar on ClinicalTrials.gov Modernization and Beta Website Progress
The webinar will be held on October 27, 2022, from 1.00 to 2.00 pm Eastern Time. It will provide an update on the progress of the modernization effort and an overview of the Beta ClinicalTrials.gov website and Protocol Registration and Results System (PRS) Beta. Advance registration can be done on the Webinar registration page. A recording of the event will be made available for those who cannot attend the live event.