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Responsibilities

Core responsibility related to GLP Study Director

• Approve the study plan and any amendments to the study plan by dated signature.
• Make the study plan available to RQA for verifying that it contains all information required for compliance with the GLP Principles.
• Ensure that the RQA have a copy of the study plan and any amendments in a timely manner and communicate effectively with the RQA as required during the conduct of the study.
• Ensure that study plans, amendments (if any) and Standard Operating Procedures are available to study personnel during conduct of study.
• Ensure that the final study plan and report for a multi-site study identify and define the role of any Principal Investigator(s) and test facility including test sites involved in the conduct of the study.
• Ensure that the procedures specified in the study plan are followed, and document the impact of any deviations from the study plan on the quality and integrity of the study, and take appropriate corrective action if necessary; acknowledge deviations from SOPs during the conduct of the study.
• Ensure that all raw data generated are fully documented and recorded.
• Ensure that computerized systems used in the study have been validated.
• Sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with Principles of GLP.
• Ensure that after completion (including termination) of the study; the study plan, the final report, raw data and supporting materials are archived.
• Standardisation / validation of new toxicity study - Administrative : Requesting and coordinating resources provided by Management
• Personnel, Equipment and Facilities to ensure they are adequate and available as scheduled for the proper conduct of the study. Allied responsibility :
• Co-ordination with IAEC members.
• General material procurement.
• To help in facility maintenance.
• Communication with finance team, purchase team and suppliers.
• Communication with sponsor’s, if specified in study allotment letter. Any additional responsibility / activity as and when assigned by management which would not arise any conflict of interest.
• Conducting various Pre-Clinical efficacy studies
• Record maintenance related to Pre-Clinical efficacy study
• Development of various animal models and its standardization / validation

Qualifications