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The three powerpoint slide sets on the right hand side of the screen have been kindly shared by Laurie Ben-Yair of QA Data, South Africa. Each provides a comprehensive overview of some issues surrounding data management: the first is an overview of data management, the second explains the issue of coding, and the third focusses on regulations and guidelines. Laurie has also provided a brief explanation of the issues below.
You may also be interested in the overview data management article provided here by the editorial team (includes CRF tracking template and sample SOPs), and here by Lesley Workman from the University of Cape Town, South Africa. There are also numerous discussions about data management, including an 'Ask the Expert' panel, available in the discussion group. Please feel free to get involved!
Data Management – Basics
Data management is an integral part of the Clinical Trial process. It encompasses the entry, verification, validation and quality control of data gathered during the conduct of a clinical trial.
The attached presentation gives you an overview of the Data Management process, I hope you find it useful.
Data Management – Medical Coding
Medical Coding is the process of ‘grouping’ and ‘classifying’ Medical terms or drugs. It is important that medical terms captured in a clinical trial are reported consistently so that they can be analysed/reviewed properly.
When clinical trials are conducted across multiple sites with different investigators, uniformity becomes a big challenge!
The task of the statistician to count and report on ae/disease/drug terms becomes impossible, never mind the regulators trying to review the data. Take the below example: ‘Site 01′ reports 1 patient with ‘headache’ whereas ‘Site 02′ recorded 1 patient with ‘sore head’, or another example: ‘Site 01′ recording ‘hypertension’ whereas ‘Site 02′ reports ‘high blood pressure’……When the time comes to perform the analysis, these events would not be counted as the same event, which could have significant implications for the sponsor and patients safety too.
I attach a Coding training document, I hope you may find useful. Enjoy!
Data Management – ‘Guidelines governing us’
There are so many different guidelines in Clinical Research, we hear names like ICH, GCP, CFR Part 11... being thrown around and then even more in Data Management. To try make things clearer, I have attached a short presentation giving a brief overview and description of each of the guidelines, that we in data management need to be aware (and more importantly) follow.
NEW ADDITIONS AUGUST 2013: Code of Federal Regulations part 11 - Guidelines on how to implement