Regulatory Public Disclosure Special Interest Group (RPD SIG)

 

What is ‘Regulatory Public Disclosure’?

‘Public disclosure’ has different meanings for different groups of medical writing professionals:

  • Publication professionals understand it to mean the publication of research findings whether the outcomes are negative or positive; the disclosure of funding; disclosure of involvement of medical writers in publication development; conflict of interest etc.
  • Regulatory professionals understand it to mean the:
    • Registration, status reporting, and results posting of clinical studies in publically accessible internet registries.
    • Upon-request or proactive sharing of clinical regulatory documents (e.g., synopses, clinical study reports, clinical overviews, clinical summaries) and/or individual patient data.
    • Publishing of clinical trial results in journals.

RPD SIG

The RPD SIG was launched at the EMWA Munich Conference in 2016 (view the inaugural video presentation here) and regularly presents new information on regulatory public disclosure updates to members at EMWA conferences. Previous presentations have provided details of the extensive RPD resources that are available to EMWA members and outlined a number of ways members can get involved in supporting the RPD SIG (to view previous slide presentations please click here).

RPD SIG Objective

The RPD SIG objective is to provide a forum for the discussion and sharing of information, best practices, and ideas with EMWA members.

Why is Public Disclosure of ‘Special Interest’ to Regulatory Medical Writers?

The concept of ‘regulatory public disclosure’ is of special interest because of:

  • It's impact on the content and structure of standard regulatory documents.
  • The expectation that the range of regulatory documents impacted will burgeon in the coming years.
  • Public disclosure will create the need for new regulatory documents, which the medical writer will support.

RPD SIG Administration

RPD SIG co-chairs:

Tracy Farrow

Christopher Marshallsay

RPD SIG Committee Members:

Sam Hamilton

Kathy Thomas-Urban

Holly Hanson

Alison McIntosh

RPD SIG Advisor:

Art Gertel 

RPD SIG Activities

  • Members of the RPD SIG co-ordinated and contributed to a special issue of the EMWA journal covering many different topics concerned with regulatory public disclosure (MEW, Volume 27 (2) - Public Disclosure, 2018) and the full issue can be accessed from https://journal.emwa.org/public-disclosure/
  • RPD – related news circulated in the EMWA Newsblast serves as a repository for information resources related to public disclosure, including publications, updates to relevant RPD guidelines and related news items. (See Newsblast link at the bottom of the page)
  • There is a regular RPD SIG section in the EMWA Journal Medical Writing and your suggestions on relevant public disclosure topics of interest to EMWA members are welcome.  We encourage you to share your practical experiences of the regulatory public disclosure arena, and contact us if you have an idea for an article or news item related to RPD.
  • The EMWA Professional Development Programme (EPDP) offers a number of workshops in the area of Regulatory Public Disclosure which run at EMWA conferences; please refer to the EPDP brochure for full details of all the EMWA workshops offered relating to RPD.

Get Involved

  • Please consider becoming involved and supporting the RPD SIG. Contact us by emailing RPDSIG@emwa.org or info@emwa.org (marking your email to the RPD SIG)

RPD SIG Resources

  • Glossary – look here for definitions of key abbreviations and terms
  • Key references – look here for key references (laws, guidance documents, publications) listed together with suitable links
  • Background reading & viewing – look here for some background reading and videos
  • If you have a new question, then email your question to RPDSIG@emwa.org
  • Question & Answer Log – if you have a question, look here first. Perhaps the same question was already raised and answered

CORE Reference

The CORE (Clarity and Openness in Reporting: E3-based) Reference is a user manual to help medical writers navigate relevant guidelines as they create clinical study reports. CORE Reference recommends data and text presentations that conform to current standards for de-identifying data and that help minimise the need for later piecemeal redaction in a CSR when it is publicly disclosed. This approach brings efficiencies to the wider preparation of disclosure-ready documents.

Download Core Reference and other public disclosure resources, or sign up to receive CORE Reference and related updates (https://www.core-reference.org/)