compensation in case of injury or death during the study as per the prevailing provisions of Act and rules, regulations. In addition to the written patient information sheet, an informative, audio video CD by the investigator may be prepared, shown and given to participants specially if study is being done on illiterate subjects with a proof of their having seen and received it. 7. Procedure for recruitment of participants/volunteers for the trial should be documented in the SOP. Guidelines for the procedure should be framed with due deliberation and discussion and should be in consonance with ethical guidelines for biomedical research. 8. Investigator should ensure adherence to Medical Council of India code of ethics specially for research as stated in chapter 7 and for Human rights as stated in chapter 6. 9. Participants of the clinical trial should be provided medical care from the time of enrolment in the study, for the duration of study and for the period of follow up as specified in the protocol. How and where it will be available, including close to the participants residence should be specified in the patient information sheet. 10. In the Drug and cosmetics Act and Rules, definition of clinical trial varies in different Rules, schedules and appendices. Notification of 30.1.2013 for compensation is given as rule 122 DAB to be inserted after 122 DAA. It needs to be clarified whether rule 122DAB pertains to only clinical trials of new drugs. As per Drugs and cosmetic Rules 1945, part X-A, import or manufacture of new drug for clinical trials or marketing. 122 DAA : defines clinical trial as systematic study of new drug