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.
The following update has been posted on ClinicalTrials.gov PRS test, expected to go live on ClinicalTrials.gov PRS on February 01, 2021:
- Delayed Results and Results Expected Details
Responsible parties may now only submit certifications for delayed submission of results information prior to the date of (i.e., the day before) the standard submission deadline for results information. The standard submission deadline for results information is no later than 1 year after the ACT’s primary completion date. Related details have also been added to Results Expected date.
- Field Length Change
Maximum field length has been increased to 500 for the Results Participant Flow:Period(s):Milestone:Data:Comments field to make it match the allowed length in the Participant Flow:Period(s):Milestone:Comments field.
- Review History Download
For administrators, Review History information for all of an organization’s records can now be downloaded as comma-separated values (CSV) for input to spreadsheet applications such as Excel. This function is accessed via the PRS Home page Records menu.
The following update has been posted on ClinicalTrials.gov What’s New section on January 25, 2021:
- Webinar on ClinicalTrials.gov Modernization: Join us on February 18, 2021, from 3 to 4 p.m. ET for an update on the ClinicalTrials.gov modernization effort. Please register via the ClinicalTrials.gov webinar registration page to learn more about the modernization efforts, the RFI, and ways to share your feedback. A recording of the webinar and slides will be made available for those who cannot attend live.
- New and Updated FAQs to Clarify the Deadline for Submitting Certifications for Delayed Submission of Results Information: The Frequently Asked Questions (FAQs) page has new and updated content under the Results Information and Submission Deadlines section:
IT systems temporarily unavailable from 31 December 2020 to 1 January 2021
Several European Medicines Agency (EMA) information technology (IT) systems will be temporarily unavailable between 08:00 on Thursday 31 December 2020 and 18:00 on Friday 1 January 2021 (Central European Time, CET).
This is due to essential maintenance related to the end of the transition period for Brexit: the United Kingdom’s withdrawal from the European Union. EudraCT, EMA Account Management, Clinical data website are among the systems to get affected due to this maintenance next week.
Click here to go to the original news.
The below update was posted on the What’s New section of ClinicalTrials.gov, on December 22, 2020:
- Race and Ethnicity Reporting for Clinical Trials in ClinicalTrials.gov and Publications: A brief communication, “Race and ethnicity reporting for clinical trials in ClinicalTrials.gov and publications,” was recently published in Contemporary Clinical Trials and is now available in Selected Publications.
- NIH-Funded Basic Experimental Studies with Humans Registration and Results Reporting Webinar Recording Available: The slides and recording are available on the Support Materials page from the December 7, 2020 webinar summarizing findings from NLM’s analysis of challenges in registering and reporting results information for Basic Experimental Studies with Humans (BESH) on ClinicalTrials.gov and issues to consider.
An FAQs document was published by MHRA on 21 December 2020. The guidance document referred to in the FAQs is the guidance document published on September 01, 2020 (LINK).
Section C, questions 3, 4, 5, 7, 8 and 9 deal with disclosure related aspect. Below are the summarized points based on the questions and answers:
- For the UK clinical trials (CTs) approved and entered in EudraCT prior to January 01, 2021, the results posting can still be completed in EudraCT. This will meet the UK publication requirement.
- For CTs approved after January 01, 2021, results can be posted on a public database, where the study is registered.
- Once the results are made public, an email confirmation must be sent to MHRA about the same.
- If a clinical trial is not on a public register (e.g. Phase 1 healthy volunteer), summary results should be submitted to the MHRA.
- The Health Research Authority (HRA) at [email protected] will need to be contacted, in case deferral is required.
- If a Phase 1 healthy volunteer study is approved before December 31, 2020, and entered on the EU Clinical Trials Register (but not visible to the public), then either a copy of the EU Clinical Trials Register upload or a copy of the CSR synopsis has to be submitted to MHRA
EMA Management Board: highlights of December 2020 meeting were published on 18/12/2020. The section Update on the EU IT systems required by the Clinical Trial Regulation summarizes the progress with respect to CTIS.
Additionally, the EMA page for CTIS updates has been updated to include below post, which covers the key points from EMA management board meeting highlights:
In 2021, EMA plans to focus on:
- the findings of a system audit;
- improving usability, quality and stability of the CTIS;
- knowledge transfer to prepare users and their organisations for CTIS.
It is also working towards go-live in line with a plan developed together with the Member States and to deliver a minimum viable product (MVP). The CTIS programme governance is responsible for agreeing what the MVP will consist of.
Go live is planned in December 2021.
The second issue of the Clinical Trials Information System (CTIS) Highlights is published on December 09, 2020.
This issue explains the CTIS benefits, CTIS features including user administrators and roles, member states and sponsor interaction, CTIS training and audit.
Additionally, it also provides the future developments for CTIS as below:
Go-Live is planned for December 2021 and CTIS will be further
developed to include:
- The safety reporting module which will be fully combined with
the CTIS components and other safety reporting features will
- The sponsor workspace with enhanced functionalities;
- Enhanced functionalities available for oversight, cooperation,
supervision and visibility within and among Member States;
- Improved users’ navigation and experience.
After Go-Live more functionalities will be released such as:
- The public register will be enhanced;
- Reporting, cooperation, interoperability functionalities will be
- User experience features will be further strengthened.
The below updates were posted on the What’s New section of ClinicalTrials.gov, on December 08, 2020:
- New Advanced Search Feature: The ability to search for study records with Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801) Violations is available in Advanced Search and an accompanying definition for ‘FDAAA 801 Violations’ is now available in the Glossary. NLM adds FDAAA 801 Violations to study records after this information is provided by the FDA.
- New Study Design Examples: The Training Materials page has two new study design examples for results data entry, Micro-Randomized and Sequential, Multiple Assignment, Randomized Trial (SMART).
The below update is posted on EudraCT What’s New section, on December 07, 2020. The information is not new as such, and all the points that have been published so far regarding the Brexit and the action required therefore, are reported in a summary format. The sponsor is required to make changes to the Clinical Trial Application (CTA) as mentioned below:
From January 1st, 2021, for all clinical trials recorded in EudraCT that are ongoing in the EU/EEA:
- Sponsors established in the United Kingdom prior to 31 Dec 2020, must as of 1 January 2021 be legally established in the EU/EEA or have a Legal representative who is legally established in the EU/EEA.
- Legal representatives established in the United Kingdom prior to 31 December 2020 can no longer act as a legal representative of a UK sponsor as of 1 January 2021.
- Qualified persons established in the United Kingdom other than in Northern Ireland can no longer certify batch-release of an IMP for use in EU/EEA as of 1 January 2021 and must be established either in the EU/EEA or in Northern Ireland.
Sponsors are requested to update these requirements in sections B.1, B.2 and/or D.9.2 of the Clinical Trial Application (CTA) form, as appropriate, using the EudraCT application (click on “EudraCT number, CTA & Login for posting results”, then “load -> EEA CTA”, add the CTA XML file, perform the changes and save the CTA file locally). The amended XML file of the CTA will then need to be submitted to all the relevant National Competent Authorities where the trial is submitted/ongoing.
Please note that it is already possible for sponsors to modify the XML file of their CTAs with the following:
- Update section B.1 with a sponsor based in EU/EEA
- Update section B.2 with a EU/EEA legal representative for third country sponsors having a legal representative based in UK
- Update section D.9 with a Qualified Person based in EU/EEA
In addition, from January 1st, 2021 sponsors will be able to perform the following changes in the CTA:
- Update section B.2 with a EU/EEA legal representative, for trials with sponsors based in UK
- Update section D.188.8.131.52 specifying “Northern Ireland” in the country field
When submitting the updated XML file of the CTA to the National Competent Authority, the sponsor is requested to make a reference to the relevant substantial amendment form already submitted.