de Abrew, K.A.G.Ranawaka, U.K.Wanigatunge, C.A.Wimalachandra, M.Goonaratna, C.2016-03-282016-03-282012Sri Lanka Medical Association, 125th International Medical Congress. 2012;57 Suppliment1: 510009-0895http://repository.kln.ac.lk/handle/123456789/12376Oral Presentation Abstract (OP 75), 125th Anniversary Scientific Medical Congress, Sri Lanka Medical Association, June 2012 Colombo, Sri LankaINTRODUCTION: 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.en-USClinical TrialsArticle