The application form can be obtained from University web site: www.jfn.ac.lk\faculties\medicine\earf\ERAF- Jaffna.doc

The application form should be handed over along with five hard copies of all documents: the project proposal (which have been submitted to graduate studies or any other funding agency), questionnaires and consent forms. Questionnaires, Patient Information Sheet and Consent Form should be provided in the languages to be used with English translation. (One hard copy is enough for student projects)

A soft copy (Microsoft word) of the application form to be forwarded to the Secretary / Ethical Review Committee by hand or via e-mail to: secyerc@jfn.ac.lk

Retrospective approval will not be given for projects already started or completed.

All proposals which are submitted for post graduate degrees should have the signature of the supervisor in the application form.

The principal investigator has to provide yearly progress reports of experimental study which has been granted ethical clearance.

Any amendment to the Protocol, Questionnaires, Patient Information Sheets or Consent forms should be submitted for ethical clearance [5 hard copies].

Please use the reference number given to you with the ethical clearance letter for all future correspondence.

Reference to clinical trial which is indicated in application form in 8.2 of part I

a.

Phase I trials are the first stage of testing in human subjects. Normally, a small (20-80) group of healthy volunteers will be selected. This phase includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in an inpatient clinic, where the subject can be observed by full-time staff. The subject who receives the drug is usually observed until several half-lives of the drug have passed.

b.

Phase II Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials areperformed on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects.

c.

Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions.

d.

Phase IV trial is also known as Post Marketing Surveillance Trial. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold.10. If the application needs detail on specific issues, the applicant would be invited to ERC meeting to discuss the proposal.