Discovery & Approval
DRUG
FDA
ICH documents
Click any arrow to see their document requirement
Every single trial should conducted in accordance with GCP (Good Clinical Practice) If not, the trial is considered invalid and non-compliant. (Ng.R, 2003)
GCP
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Orlando, L (2014) "Clinical Trials-LO-140819.pdf, slide 6. Retrieved from: http://moodle.vle.monash.edu/pluginfile.php/3147562/mod_resource/content/0/2014-%20Clinical%20trials-LO-140819.pdf
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MeduMaze. Supplemental Information and Alphabetical Glossary of Terms, Drug Development & Approval Game (pp 14)
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Ng, R. (2003) Clinical Trials, in Drugs: From Discovery to Approval, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/0471722804.ch6
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NHMRC, 2009 ‘Effective Design Principles of Case Report Forms’ clinical trials centre, University of Sydney supported by the National Health and Medical Research Council, 22 Sep, available from http://www.ctc.usyd.edu.au/media/600620/ctc-effective-design-for-crfs.pdf
Reference
The process to start clinical trial.
Every countries have different clinical trials requirements. However, most clinical trilas are carried out based on 2 main documents from FDA and ICH. (Ng.R, 2003)
Q & A
The medical reviewer wants to receive electronic copies of all the Case Report Forms for patients who withdrew from 3 clinical studies that were completed 5 years ago. They are only available in paper.
According to ICH, E(6) Good Clinical Practise, Case Report Forms, CRF is defined as “a printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject”. The aims of CRF are to gather all the data that answering the study question from the patients and to ensure the safety and efficacy. The idea of the CRF is clear, well organized, provides clear direction and facilities data collection and easy data entry. (NHMRC, 2009) In this question, CRF of the patients are only available in paper form. Hence, all the papers needed to be scanned, indexed and submitted to the medical reviewer.