Frequently Asked Questions

• What is the Sri Lanka Clinical Trials Registry?

• The Sri Lanka Clinical Trials Registry (SLCTR) is a Registry for clinical trials involving human subjects, conducted in Sri Lanka or overseas. It is a not-for-profit Registry, with free and open access to researchers, clinicians, and the general public.

• What is a Clinical Trial?

• A clinical trial is any research that prospectively assigns human subjects (patients or healthy volunteers) to one or more healthcare interventions. A 'health care intervention' can be a drug, vaccine, surgical treatment, device, behavioural modification, preventive measure or a process of care change, that would lead to a change in a health-related outcome. All clinical trials neeed prospective registration in a Clinical Trials Registry (i.e before the recruitment of the first participant)

• What is a Clinical Trials Registry?

• A Clinical Trials Registry is a central repository of key information about clinical trials.

• Why register clinical trials?

• Prospective trial registration certainly has many benefits to scientists, clinicians, health care planners and the general public. It would, hopefully, lead to publication of all trials conducted, and minimise non-publication of trials with negative results or inconclusive results. Dissemination of the results of all trials is important, as the scientific community needs to be aware of findings from clinical trials, and patients and volunteers participating in trials need to be reassured that their participation would lead to advancement of scientific knowledge. Awareness of planned or on-going trials among the research community would certainly help avoid duplication of trials, minimising wastage of research effort and funds. Prospective registration would also facilitate multi-centre participation in clinical trials.
        Prospective registration of all clinical trials involving human subjects is now a requirement for trial publication in International Biomedical Journals.

• Who manages the SLCTR?

• The SLCTR is a joint initiative of the Sri Lanka Medical Association (SLMA) and the Ceylon Medical Journal (CMJ). The SLMA is the premier professional medical association in Sri Lanka, which brings together medical practitioners of all branches of medicine. It is the oldest medical organization in Ausralasia, with a proud history dating back to 1887. The CMJ is the official quarterly journal of the SLMA. The SLCTR is managed by an advisory group appointed by the Sri Lanka Medical Association (The SLCTR Committee).
   

• Does the SLCTR meet international requirements for a Trial Registry?

• Yes, the SLCTR complies with all the requirements specified by the International Clinical Trials Registry Platform (ICTRP) of the World Health Organisation and the International Committee of Medical Journal Editors (ICMJE).

• Who can access the SLCTR?

• The SLCTR is an internet-based registry, with worldwide free and open access to researchers, clinicians, and the general public.

• How can I register a trial with the SLCTR?

• Trial registration can be done by completing the Application Form on-line. All data fields must be completed by the investigator. It is assumed that all trials would have obtained approval from a recognized ethics review committee before enrolment of subjects. For clinical trials that are recruiting patients in Sri Lanka, ethics approval should be obtained from one of the ethics review committees given below, as per the regulations laid down by the Subcommitte on Clinical Trials, Ministry of Health, Sri Lanka.

   

  Ethics Review Committee of the Sri Lanka Medical Association.

  Ethics Review Committee of the Faculty of Medicine, University of Colombo.

  Ethics Review Committee of the Faculty of Medicine, University of Peradeniya.

  Ethics Review Committee of the Faculty of Medical Sciences, University of Sri Jayawardanepura.

  Ethics Review Committee of the Faculty of Medicine, University of Kelaniya.

  Ethics Review Committee of the Faculty of Medicine, University of Jaffna.

  Ethics Review Committee of the Faculty of Medicine, University of Ruhuna.

  Ethics Review Committee of the Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka.

  Ethics Review Committee of the Medical Research Institute, Sri Lanka.

   

  The investigator will be notified by an e-mail when the application has been approved for registration, and a unique trial identifier number will be issued.

• Who can register a clinical trial with the SLCTR?

• Any investigator, from Sri Lanka or overseas, can register a clinical trial with the SLCTR. The responsibility for registering a trial lies with the principal investigator or principal sponsor of the trial. For multi-centre trials, the lead principal investigator or lead sponsor should take responsibility for registration.

• What Types of research studies can be registered with the slctr?

• The SLCTR accepts for registration only prospective clinical trials, before the first patient recruitment.

  The SLCTR does NOT register retrospective or observational studies.

• Is there a trial registration fee?

• An application processing fee for trial registration is levied by the Sri Lanka Clinical Trials Registry to meet administrative costs.

  Category of application	Fee
  Investigator funded trials	Rs. 5,000/-
  Grant funded trials (Government or Research Grants)	Rs. 10,000/-
  Pharmaceutical Industry Sponsored Trials	Rs. 25,000/-
  International investigator funded trials	USD 100
  International Pharmaceutical Industry Sponsored trials	USD 250

   

  Fees can be paid to the SLMA Office by cash, or by cheque in favour of the “Sri Lanka Medical Association”. Processing fee for trials conducted overseas is payable by bank draft to the “Sri Lanka Medical Association”.

• Who is responsible for the accuracy of the data regarding a clinical trial?

• The responsibility for the accuracy of the data regarding any clinical trial lies with the principal investigator or the principal sponsor who provides the trial data.

• Will I need to update trial information?

• All investigators are expected to update trial information at regular intervals. They are required to provide a brief progress report at six months, one year, and every year thereafter until trial completion.

  Investigators are expected to inform the SLCTR Office of any changes to the trial protocol. These will be displayed in the trial registration data set via a separate link. The template to submit your progress reports can be viewed by clicking on the "Related Articles" tab on the home page.

• How can I find more details about the SLCTR?

• You can contact us by e-mail (slctr@sltnet.lk), by phone (+94 112690212), or by writing to us at the Sri Lanka Clinical Trials Registry, Sri Lanka Medical Association, No 6, Wijerama Mawatha, Colombo 7.