Category Archives: Compliance

GCP Records Management – How Are We Doing in Canada?

Posted on April 20, 2012 by

Health Canada has recently released a publication summarising the results of GCP inspections carried out between April 2004 and March 2011. It makes for interesting reading compared to a similar document released by the MHRA three years ago. At 24.5% … Continue reading →

Posted in Compliance, e-records, Regulations, TMF | Leave a comment

Ensure Your Informed Consent Forms Comply With New Requirements

Posted on February 10, 2012 by

For those sponsors conducting clinical trials that need to comply with FDA regulations, remember that from 7th March 2012 your informed consent documentation must comply with the new 21 CFR § 50.25(c) requirement. This requires the informed consent form to … Continue reading →

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GMP Directive (2003/94/EC) to cover active substances?

Posted on January 24, 2012 by

The European Commission are proposing to extend the scope of Directive 2003/94/EC to cover active substances, including the manufacture of active substances. The intent is to bring cohesion of requirements for active substances and medicinal products. However, since all of … Continue reading →

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Is it OK to “manipulate” PDFs to improve records management?

Posted on January 23, 2012 by

This is a question that I hear posed fairly frequently, I guess as a result of organisations managing electronic records rather than – or in addition to – traditional paper records. A typical scenario is an electronic document received into the … Continue reading →

Posted in Compliance, e-records, Litigation, Records management practice, Regulations | 1 Comment

Are Copies as Acceptable as Original Documents?

Posted on November 25, 2011 by

This is a question that I seem to be hearing with increasing frequency! I think the reason for this is that an increasing number of companies and organizations are introducing electronic document management systems (EDMS). Where there are hard-copy records … Continue reading →

Posted in Compliance, e-records, Litigation, Records management practice, TMF | 2 Comments

Documentation Risk Adaptations in Clinical Trials

Posted on October 30, 2011 by

A paper has recently been published under the joint auspices of the UK Department of Health (DH), the Medicines and Healthcare products Regulatory Agency (MHRA) and Medical Research Council (MRC) describing risk-adapted approaches to the management of clinical trials of … Continue reading →

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Questions a Sponsor Should Ask a CRO

Posted on July 27, 2011 by

While I was browsing through my website analytics, I came across the above question that was entered into a search engine which in turn directed somebody to the website. It got me thinking what a great question it was! So, from … Continue reading →

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Search FDA Warning Letters

Posted on June 8, 2011 by

Did you know that the FDA have recently (26th May 2011) provided an advanced search capability on their Warning Letters web pages? The advanced search page now gives you the ability to search for company name (including wildcard), date range … Continue reading →

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