January 2021

1 - EMA “CTIS Highlights” Issue 02; CTIS Training; CTIS Rollout Dec 2021

CTIS Highlights Issue 02 (December 2020) is out now. As a reminder, CTIS is the paperless integrated system supporting the Clinical Trials Regulation (EU) No 536/2014. It covers the full life cycle of a clinical trial application, from initial submission to authorisation, conduct, corrective measures, inspection information, and publication of relevant documents for the general public as well as substantial modifications over time. Read all about recent developments.

There will be CTIS training with online materials rolled out for Sponsors and CROs in 2021, starting with a 2-day Webinar, 22 Feb 2021 and 04 Mar 2021. Participation is free for all non-commercial trial sponsors (universities, hospitals, charities and public bodies) and for small enterprises. In addition, a more extensive “CTIS Master Trainers Programme” primarily aimed at commercial sponsors is currently being prepared by EMA in collaboration with the Drug Information Association as the training provider).

EMA Management Board highlights from Dec 2020 show that EMA CTIS User testing has revealed important issues on the system quality, that need to be addressed. Development is now focused on improving the quality and stability of the CTIS system. The go-live date is Dec 2021.

2 - PHUSE COVID-19 Impact on May 2020 Clinical Trial Transparency Update

In a follow-up to a previous blog post on 06-May-2020, "The Impacts of COVID-19 on Clinical Trial Transparency and Document Disclosure PHUSE CTT Project”, this December 2020 update explains some of the initiatives that have changed since the initial discussion.

3 - Final FDA Guidance: Research Participant Confidentiality

On 16 November 2020 the FDA issued final guidance on Certificates of Confidentiality. The 7-page document explains how the agency will implement revised provisions on Certificates of Confidentiality for federally funded and independent research. A Certificate of Confidentiality protects the privacy of clinical trial participants from whom identifiable sensitive information is being collected. With a Certificate of Confidentiality in place, researchers are prohibited from disclosing information unless a specified exception applies. The final guidance (which replaces the November 2019 draft) explains how a commercial sponsor may request a discretionary Certificate of Confidentiality for commercially sponsored research involving human participants. New text notes that an institutional review board (IRB) may request that a Certificate of Confidentiality is obtained as a condition of IRB approval.
(Credit to www.brookwood-global.com for this nice summary text).

4 - PHUSE Data Transparency Meeting

PHUSE hosted a Data Transparency Winter Meeting from 19 to 21 Jan 2021. Presentations joint panel discussion/Q&A sessions based on the content from the day included: ‘New Challenges for Data Sharing’, ‘Regulatory Submissions’ and ‘Explore Technologies’.

5 - EPA Rule - transparency in developing regulatory guidances

In September 2020, the EPA finalised its first ever rule to promote transparency in developing regulatory guidance documents. Read the Press Release here and access the portal here.

6 - 14th ISCR Annual Conference 2021: Virtual Medical Writing Workshop

The ISCR is holding its conference virtually in 2021. This opens the event to a much wider audience than might attend face-to-face, and presents an ideal opportunity to make the most of the current global circumstances.

Sam Hamilton (Chair: www.core-reference.org) will present the Keynote Address for the Medical Writing Workshop. Come and join Sam and the distinguished Scientific Committee as we help you navigate... "Effective authoring of clinical study reports (CSRs) in the evolving landscape of data transparency — a competency building workshop"
Date & Time: Friday 12 March 2021, 12:00 to 20:00 (India time).
Details here; Registration here.

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