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European Pharmaceutical Contractor

Patient Diaries: A Possible Source of Data Inconsistency?

Patient diaries constitute one of the most relevant sources of direct information in clinical research. They contain information provided directly by the most important participant in the clinical trial: the patient. This fact makes the diaries a key element when retrieving and analysing data, but also means that the quality and relevance of these data differs considerably from those recorded in the investigators' standard CRF.

When using patient diaries, it is the patient who fills out the diary forms with the information they consider to be accurate. Therefore, this information cannot be evaluated with the same confidence level as those provided by clinical research or health care professionals.

One of the most relevant problems raised from the use of patient diaries in clinical studies is the fact that inconsistencies are sometimes found between the data introduced in the diaries by the patients and those entered in the CRF by the investigator or the study co-ordinator. This problem is even more serious when patient diaries are used in the scope of multicentre, multinational and multilingual studies, when an additional possible bias can be introduced by the use of the various translated versions of the diaries.


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By Sebastián Pacios Merino, Vice President of Operations, Countries Group, PRA International

Sebastián Pacios Merino is Vice President of Operations, Countries Group at PRA International. Beginning his career as a GP in the Spanish national health service, Sebasti‡n has since moved into clinical research. His roles have included Medical Translator/Advisor for SANED, EDICOMPLET, Project Manager at ITEM-PHARMA and Clinical Research Manager at Verum ITEM-PHARMA/Phoenix International Espa–a, where he later became Director. He has experience in a broad range of therapeutic areas including CNS neurology, gastroenterology, dermatology, cardiology and infectious diseases such as HIV. Sebastián has a degree in Medicine from the Facultad de Medicina, Universidad Aut—noma de Madrid, Spain.

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Sebastián Pacios Merino
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