Rammell Consulting Limited

Organisational Effectiveness through Records and Information Management
Home     Services     Archive Storage     Sectors     Projects     About Us     Contact Us     Resources     News      
News items will remain on this page for approximately six months. For further information about items, please contact us. To ensure you are alerted to new issues, click on the Subscribe to feed link at the foot of the page.
 
Title Body Created
Serious breaches notifiable  
Colleagues involved in the conduct of clinical trials are now used to regulatory requirements for the reporting of serious breaches of GCP. Well, the UK Information Commissioner has recently released updated guidance on the reporting of data security breaches, including serious breaches.
 
Although there is no legal obligation on data controllers to report breaches of security which result in loss, release or corruption of personal data, the Information Commissioner believes serious breaches should be brought to the attention of his Office. The nature of the breach or loss can then be considered together with whether the data controller is properly meeting his responsibilities under the DPA. The ICO does not define serious breaches but the revised guidance provides useful pointers to circumstances under which it expects voluntary reporting.
 
The full guidance document can be found at the following link.
  		29/06/2010  
eTMF Tutorial available at DIA Electronic Document Management Conference  
The program for the next DIA Electronic Document Management Conference includes a one-day tutorial on migrating to electronic trial master files (eTMFs) to be co-presented by Eldin Rammell, Managing Director at Rammell Consulting Limited and Karen Redding, Business Development Director at Phlexglobal Limited. This was an extremely popular tutorial at last year's conference and has since been updated for the conference in Nice on 1st December 2010.
 

This tutorial will provide a comprehensive overview of the issues involved in implementing an electronic trial master file. In addition to covering foundation principles such as “what is the trial master file”, this interactive session will provide guidance in a wide range of related aspects, including:

  • what do the regulations say about eTMFs
  • how should documents be filed in an eTMF
  • metadata and naming conventions
  • what formats are acceptable
  • how can the eTMF be reviewed by end-users, auditors and inspectors
  • how can an eTMF support global clinical trials
  • how is the eTMF populated and maintained
  • what are the validation requirements
  • does an eTMF need electronic signatures
Click on this link to download the conference program.
  		08/06/2010