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Year : 2010  |  Volume : 1  |  Issue : 2  |  Page : 64-66

Getting ready for inspection of investigational site at short notice

Vice President, Clinical Operations, SIRO Clinpharm Pvt Ltd

Correspondence Address:
Rajendra Talele
Vice President, Clinical Operations, SIRO Clinpharm Pvt Ltd

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Source of Support: None, Conflict of Interest: None

PMID: 21829785

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India is becoming an attractive destination for drug development and clinical research. This is evidenced by the three fold increment in clinical trial applications in last four years to the office of Drugs Controller General of India (DCGI). This upward trend is collaborative efforts of all stake holders and the quality of Indian data. Therefore to sustain this trend, it is important that stake holders such as Regulators, Sponsor, CRO, Monitor, Investigators and trial subjects required maintaining high standards of data and conduct of clinical trials. Indian regulations and the role of DCGI in quality check for Indian clinical trials is always a topic of discussion in various forums. A recent move by DCGI for conducting random inspections of investigational sites and companies at short notice, checking their compliance in accordance with the guidelines, and taking action against non-complier is welcomed. This will certainly increase over quality of the clinical trials. Quality of clinical trial conduct is measured on essential documents for their appropriateness and its correctness. It is observed that the stakeholders engaged in multitasking often overlook the requirements or appropriateness of the document due to their focused approach on a specific activity which is on priority. This can lead to serious quality problem and issues. Understanding of the process and documents reviewed by auditor is important to maintain such high quality. The proper planning and time management working on essential documents can minimize the quality issues, and we can be always ready for any type of inspection, announced or unannounced, or "short notice".

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