Maintaining Adequate Resources: o Ensure that required number of suitable subjects is recruited within the agreed recruitment period. o Provide sufficient time to properly conduct and complete the study within the agreed study period. o Ensure availability of adequate number of qualified staff and adequate facilities for the conduct the study properly and safely. 2 Protocol, Informed Consent Form (ICF), Case Report Form (CRF), SOP Preparation: o Coordinate with the clinical research personnel for preparation of the SOP. o Coordinate with the Clinical Research personnel for preparation of Protocol, ICF and CRF. 3 Medical Care of Study Subjects: o Ensuring adequate medical care for the subjects in the study for any adverse events, including clinically significant laboratory values, related to the study 4 Communication with IEC: o To obtain written and dated approval/favorable opinion from the IEC for the study protocol, informed consent form, and any other written information to be provided to subjects. o Incorporate the suggestion given by IEC members in respective documents and take re- approval in case of any changes. o Should provide the IEC with a current copy of the Investigators Brochure. If the Investigators Brochure is updated during the study, the copy of the updated Investigators Brochure should be provided. o Inform any amendment regarding the Protocol, ICF and safety related information, Clinical updates to IEC, Sponsor and applicable regulatory authorities. 5 Compliance with Protocol: Page 2 of 4 o Ensure that the study is conducted in compliance with the protocol agreed by the sponsor and, if required, by the regulatory authority and which was given approval/favorable opinion by the IEC. o Ensure that no deviation from, or changes in the protocol is made without agreement by the sponsor and prior review and documented approval/favorable opinion from the IEC, except where necessary to eliminate an immed
