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MHRA Guidance Document –What It Means for Central Labs and Why We’re Excited About It
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Posted by
Lorrie Divers, 7/13/2010 11:34:11 PM
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 This past January, our QA Officer in Europe, Elizabeth Atkin and I attended the MHRA conference – GCP for Clinical Laboratories – Clinical Pursuits in York, England – and we were thoroughly impressed with how organized, well run and educational the whole experience was. Sessions throughout the day provided comprehensive overviews of how the clinical trials regulations directly impact central clinical laboratories, and there were practical presentations and discussions on how such laboratories can effectively and efficiently operate in compliance with GCP requirements. Read more >>
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Category:
Quality Assurance
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Notes to File – Problematic or Preventive?
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Posted by
Lorrie Divers, 6/21/2010 09:30:52 AM
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I recently had the privilege of speaking at the Roswell Park Cancer Institute's Education Day for Clinical Research Staff on a topic chosen by the staff: How to prepare for sponsor audits. The topic selection alone was an indication of how engaged their clinical research staff is, and their questions demonstrated their proactive approach to improve overall study quality.
For example, there was a question regarding notes to file (NTF) that led to an interesting discussion. NTF are typically used to explain any discrepancies or missing/incomplete data during the course of a trial and are increasingly requested by sponsor monitoring staff to provide additional information or clarification. This practice has become prevalent, and yet simultaneously problematic.
When used properly, NTF can be valuable source documentation. However, when they simply note a problem and don’t resolve it, these NTF can raise more questions than they answer for auditors and regulatory authority inspectors. For example, issues can arise when NTF are written long after the initial occurrence or corrective action was taken. (Carl Anderson of Biologics Consulting Group wrote a great article Read more >>
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Category:
Quality Assurance
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A QA Perspective on Working with New Clinical Research Sites
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Posted by
Lorrie Divers, 4/12/2010 03:39:01 PM
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How difficult is it to train and set up investigator sites that have never been involved in clinical research
This question was posed to myself and other members of the Clinical Research Professionals group on LinkedIn. Thorough Good Clinical Practices (GCP) training, careful consideration of the site's capabilities, personnel resources, and commitment from the principal investigator (PI) are all important. However, in my opinion there are several other factors also critically important for a successful naive clinical research site.
1) Practical training in managing the routine and non-routine tasks of conducting a clinical trial.
Much the process can be described in SOPs, however, for staff who has never conducted a clinical trial before, many of the things experienced personnel take for granted will be new and unknown. For example, they need to understand not only the importance of using the current, IRB-approved version of the informed consent form, but how to actually control the document to ensure that is done consistently and easily. They need to understand how to keep accurate investigational drug accountability records with periodical review the inventory, compare them to the accountability record and identify and investigate/correct any discrepancies in “real time” rather than 14 months later. Read more >>
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Category:
Quality Assurance
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