Periodic reports to CTEC

The CTEC may require the holder of a “Letter of Authorization” during a clinical trial to provide any information or report at such times and in such manner as the CTEC may require.

Reports of Serious Adverse Events
Any clinical trial related adverse reaction shall be reported immediately to the CTRD of NMRA and to the relevant ERC.

(Refer guideline for the submission of serious adverse events – GL 029 Guideline on safety reporting)

Progress and Final reports.

The holder of a Letter of Authorization should submit to the CTEC a notification of trial initiation, progress reports during the conduct of trial within six (06) months as well as final report of the clinical trial after the completion of the trial or such longer period as the CTEC may allow.

(Refer more details GL-019- Guideline for the conduct of Clinical Trials in Sri Lanka)