Role & responsibilities

• To be qualified by education, experience and training to assume responsibility for proper conduct of the study.
• Comply with requirements of the GCP, EC/Sponsor agreed protocol and Lotus SOPs applicable regulatory requirements and the ethical principles which have their origin in the declaration Of Helsinki
• Review and timely inputs on the protocol (eg dosing information, contradictions, warnings, precautions, adverse events, drug interaction) CRF, ICD and any other document as required for the study.
• Obtaining ethics committee approval and clarifying the issues / questions raised by the EC.
• Ensure that all study personnel assisting in the trial are aware of their obligations and have been trained on the protocol, study plan and trial related duties and functions respectively to perform duties assigned to them.
• Ensuring that all necessary trial related documents are generated and compliant with the protocol.
• Responsible for all clinical or medical aspects of the study hence should personally conduct or supervise the study.
• Brief the volunteer about the study and the related procedures, encouraging the volunteers to ask questions, answering the questions and then obtaining written informed consent and ensure the same is captured audio-visually.
• Enrolling healthy volunteers as per the inclusion / exclusion requirements of the protocol.
• Supervision of activities like check-in, dosing, blood sampling and separation as applicable.
• To assess the eligibility of the subject for dosing based on ME, AE details, vitals recording any mid study safety reports or any other tests as per protocol.
• Ensure that the diet specifications as per the protocol are met.
• Maximize the trial subjects protection by effective management of medical events, adverse events and SAEs (if any) and ensure that the subjects wellbeing safety is the foremost priority. Timely intimation to the sponsor and ethics committee of any serious adverse event in a study.
• Review all study related documents(CRF, log books and any other documents as required for the study) to ensure that the data generated is complete, legible, internally consistent.
• Provide study updates to the sponsor and review of clinical study data before the start of the analysis.
• Ensure the clinical reports generated are consistent with the clinical raw data and conform to applicable regulatory requirements.
• Ensure that compensation to the subjects is paid to the extent of participation or in case of withdrawal of subjects due to medical reasons the subject is compensated fully.
• Allow and coordinate with the monitoring and auditing activity.
• Report to respective Principal Investigator on all study related activities.
• Report to Centre Head on all activities.
• To perform any other activities as and when assigned by the management.