Sub: Submission of Internal Assignment as part of Course requirement

The University is pleased to announce, that, for examinations to be held effective, April/May2013, as a prior requirement, students already enrolled with the University in its various Programs, will be required to submit assignments by uploading the same onto the EduNxt portal, for evaluation by the University’s pool of approved evaluators, including SMUDE Central faculty. All students are hereby directed to comply with this change in form of evaluation and upload their Assignments on time as per accompanying Template and Guidelines.

INSTRUCTIONS FOR ASSIGNMENT SUBMISSION 1. Completed assignments must be typed and formatted neatly and soft copies should be uploaded on or before February 15th, 2013. 2. You may download the question paper by clicking on the question paper link provided on EduNxt portal. 3. Ensure that you answer all questions according to the marks allocated (not more than 400 words for a 10-mark question and not more than 200 words for a five-mark question). The total page limit shall not exceed 8 pages of A4 size. Students are advised to check their Assignments thoroughly before uploading the same, as Only ONE submission will be considered and evaluated. Multiple submissions are not allowed. 4. Please restrict the assignment document size to <500 KB. 5. Please avoid inserting images of very high resolution into the document to prevent exceeding the size limit.

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Please ensure you provide a valid email id and mobile number to receive confirmation message on successful submission. Only those assignment copies uploaded on EduNxt will be considered for evaluation.6. 10. No hard copies will be accepted.Content that has been directly copied from the Internet will NOT be accepted. 8. Consult the Helpdesk if you have any problems in submitting the assignments. Uploading should be done on EduNxt portal. Assignment submissions are accepted only in . 12.Late submissions will NOT be accepted. There is no need for any specific nomenclature of the file containing assignment. 2 . 9. Please do not courier hard/soft copies of your assignments either. 7. 11. 13.Assignments that have been copied and shared among students will be automatically rejected and liable for disqualification.Follow assignment format and complete all the details for each assignment individually.doc or .docx formats.

If the IRB disapproves clinical study. can the sponsor approach another IRB? Give reason for your choice.Mention the types of IRBs.Question 1. 3 .

What are the basic elements which must be present in informed consent forms according to ICH-GCP? 4 .Define informed consent.Question 2 .

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