The IRB shall be required to maintain the following records for a period of at least five years (or as the quorum deems it necessary). The member secretary shall be responsible for the same.
• Curriculum Vitae (CV) of all members of IRB.
• Copy of all study protocols with enclosed documents, progress reports, reports on serious adverse events, protocol deviations and any further documents/ reports that the IRB may require the researcher to provide.
• Each application will be provided with a unique ID number which will be maintained for all documents related to that particular project/ application. All documents related to a particular project will be saved in hard as well as soft copy in a designated folder on the Sangath server. The folder will be password protected and accessible only to IRB members. (Example of id: VP_2011_01 that is initial alphabet of First and Last Name of principal investigator _year of submission of application_ serial number of application received in that year.). All hard copies will be kept under lock and key.
• Minutes of all meetings duly signed by the chairperson of the IRB. The minutes shall be noted down by the personal secretary and consequently typed. It is the duty of the member secretary to duly maintain the minutes.
• A copy of all existing relevant national and international guidelines/ updates/ amendments on research ethics and laws amendments.
• A copy of correspondence with members, researchers and other regulatory bodies.
• Annual and final report(s) of all the approved projects.
• All publications related to a particular proposal should be submitted to the IRB for record purposes. Ethics approval should be acknowledged in all research manuscripts arising from the approved study.
