Hedian Records Management Projects:

Hedian Records Management has been involved in the following projects:

To be published
TMF Reference Model TMF Plan Template Working Group 2017 – 2018. TMF Template.

Released on the 12th April 2017 – 11 July 2017.
Contributed to EMA Consultation on the draft ‘Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials’.

Released in July 2016 – 31st October 2016
Contributed to MHRA Consultation on the draft ‘GxP Data Integrity Definitions and Guidance for Industry’.

October 2016 to present
Training co-ordinator for Scientific Archivist Group (SAG).

24th June 2012
Member of the Document and Records Management (DRM) Special Interest Area Community (SIAC) that produced the DIA Framework for the Destruction of Paper Originals v 1.0.

4th June 2010
Worked on the TMF Reference Model v1.0, particularly attending regular teleconferences and contributing to section 11 (Statistics).

30th June 2009
Lead on workstream for GCP-RMA and main author to produce Relevant Communications Policy.

For more information about Hedian Records Management and how our services can help your business or for a free no-obligation initial meeting, please contact us at sarah.curno@hedian.onmicrosoft.com.