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HEALTH SCIENCES
RESEARCH

Amrita health Science
Research

Clinical research has been held sacrosanct in the ethos of Amrita Institute’s development over the years with prolific output by way of research papers, publications, research conclaves and workshops, and patents being seen as key drivers to the high ranking of Amrita University and Amrita hospital in the NIRF and other ratings. A full-fledged research unit oversees all research activities in the institute.
Research is embedded in the routine activities that involve clinical care and education, through focussed research, community programs, outreach and collaborative projects, thesis and dissertations across the medical spectra including medical post-graduate (MD, MS), post-doctoral (DM, MCh), PharmD, MSc Nursing, and PhD courses. Each undergraduate and postgraduate, cutting across different courses, is mandated a short-course in research methodology and statistics in the first month of entry to the Institute. GCP (Good Clinical Practice) and Research workshops are held twice every year, which is also open to external attendees.

Standard Operating
Procedures

Clinical Research (Site SOP)

institutional
review board

Amrita health Science
Research

Flowchart for initiating a research study in AIMS

#1

Submission of Proposal

Read the Policies and Procedures document of the IRB, The ICMR Bioethics Guidelines (2006), Schedule Y of the Drugs and Cosmetics Act, The Indian GCP Guidelines

#2

SRC Review

The investigator/Co-Investigator may make a presentation of the protocol and thus get an opportunity to provide clarifications on the study protocol that he/she has submitted for review to the IEC. Their comments / advisory shall be implemented by the PIs.

#3

IEC

IEC meeting will be held twice on every month. Be present for the meeting at the required time to answer clarifications. It is preferable that the guide be also present for PG dissertations.

#4

Approval

A certificate of approval will be sent to the applicant within 2 weeks. All the approvals will be valid for only for the duration of the project. Investigator has to get his or her project re-approved after validity period, if necessary.

#5

Final report

Progress report and final report to be submitted to the committee (This applies to internally and externally funded proposals).

IRB policies & procedures
Intellectual property policy
Adverse event adjudication committee
DSMB (Data Safety Management Board)

funding
agency

Amrita health Science Research

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