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Title: | The Sri Lanka Clinical Trials Registry - a 5 year audit |
Authors: | de Abrew, K.A.G. Ranawaka, U.K. Wanigatunge, C.A. Wimalachandra, M. Goonaratna, C. |
Keywords: | Clinical Trials |
Issue Date: | 2012 |
Publisher: | Sri Lanka Medical Association |
Citation: | Sri Lanka Medical Association, 125th International Medical Congress. 2012;57 Suppliment1: 51 |
Abstract: | INTRODUCTION: Prospective registration is mandatory for the conduct and publication of clinical trials. The Sri Lanka Clinical Trials Registry (SLCTRJ was established in November 2006. It is a Primary Registry of the International Clinical Trials Registry Network of the WHO. AIMS: To audit the process of trial registration at the SLCTR during the 5 year period from the first trial registration (February 2007-January 2012). Methods: An internal audit of the online registry and the functioning of the SLCTR was carried out. We evaluated- (1J all trial applications, including those rejected, for accuracy and completeness of the Trial Registration Data Set (TRDS), (2) all registered trials for maintenance of records and (3) in-house procedures related to trial registration. RESULTS: Seventy trials were registered; 14 were rejected. Over half (n=37) were prospective registrations. All registrations since July 2010 (n=21) were prospective. Four were international multi-centre trials; 13 were industry sponsored. Median time from submission of all relevant documentation to registration was 7 days. All applications from 2010 were registered within 7 working days. Majority (n=41J were drug trials, including herbal preparations (n=7), while 19 were for procedures. 39 trials have been completed, 8 have published their findings and 7 reported protocol changes. Eight trials (11.4%) do not have current progress reports. CONCLUSIONS: The SLCTR has provided a platform for registration of clinical trials in Sri Lanka. In-house registration processes have improved with time. There is a need to improve awareness among trial registrants regarding maintenance of trial records. |
Description: | Oral Presentation Abstract (OP 75), 125th Anniversary Scientific Medical Congress, Sri Lanka Medical Association, June 2012 Colombo, Sri Lanka |
URI: | http://repository.kln.ac.lk/handle/123456789/12376 |
ISSN: | 0009-0895 |
Appears in Collections: | Conference Papers |
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