<![CDATA[http://rammell-consulting.co.uk - News]]>http://rammell-consulting.co.uk/News.aspxTue, 07 Sep 2010 18:05:20 GMTMicrosoft Office Live Small Business RSS120list<![CDATA[Serious breaches notifiable]]>Title: Serious breaches notifiable
Body:
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.
Created: 29/06/2010
]]>Serious breaches notifiable<div class=ExternalClass4EDCDA79586B42F89F1B72420DD335D5><div><font size=2 face=Arial>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.</font></div> <div><font size=2 face=Arial></font> </div> <div><font size=2 face=Arial>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.</font></div> <div><font size=2 face=Arial></font> </div> <div><font size=3><font size=2 face=Arial>The full guidance document can be found at the following </font><a href="http://www.ico.gov.uk/upload/documents/library/data_protection/practical_application/breach_reporting.pdf"><font size=2 face=Arial>link</font></a><font size=2 face=Arial>.</font></div></font></div>29/06/2010<![CDATA[eTMF Tutorial available at DIA Electronic Document Management Conference]]>Title: eTMF Tutorial available at DIA Electronic Document Management Conference
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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.
Created: 08/06/2010
]]>eTMF Tutorial available at DIA Electronic Document Management Conference<div class=ExternalClass4C2702DB51584451AA0CEE37F65050BB> <div><font size=2 face=Arial>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 <strong>Eldin Rammell</strong>, Managing Director at Rammell Consulting Limited and <strong>Karen Redding</strong>, 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.</font></div> <div><font size=2 face=Arial></font> </div> <p style="margin:0cm 0cm 0pt" class=MsoNormal><font size=2 face=Arial>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:</font></p> <ul> <li> <div style="margin:0cm 0cm 0pt" class=MsoNormal><font face=Arial><font size=2>what do the regulations say about eTMFs</font></font></div></li> <li> <div style="margin:0cm 0cm 0pt" class=MsoNormal><font face=Arial><font size=2>how should documents be filed in an eTMF</font></font></div></li> <li> <div style="margin:0cm 0cm 0pt" class=MsoNormal><font face=Arial><font size=2>metadata and naming conventions</font></font></div></li> <li> <div style="margin:0cm 0cm 0pt" class=MsoNormal><font face=Arial><font size=2>what formats are acceptable</font></font></div></li> <li> <div style="margin:0cm 0cm 0pt" class=MsoNormal><font face=Arial><font size=2>how can the eTMF be reviewed by end-users, auditors and inspectors</font></font></div></li> <li> <div style="margin:0cm 0cm 0pt" class=MsoNormal><font face=Arial><font size=2>how can an eTMF support global clinical trials</font></font></div></li> <li> <div style="margin:0cm 0cm 0pt" class=MsoNormal><font face=Arial><font size=2>how is the eTMF populated and maintained</font></font></div></li> <li> <div style="margin:0cm 0cm 0pt" class=MsoNormal><font face=Arial><font size=2>what are the validation requirements</font></font></div></li> <li> <div style="margin:0cm 0cm 0pt" class=MsoNormal><font size=2 face=Arial>does an eTMF need electronic signatures</font></div></li></ul> <div><font size=2 face=Arial>Click on this <a href="http://rammell-consulting.co.uk/Documents/edm_cfa_200110.pdf">link </a>to download the conference program.</font></div></div>08/06/2010