RESPONSIBILITIES OF SPONSOR
- Implementing and maintaining quality and to ensure that the conduct process of clinical trials and data reporting is in compliance with the GCP guidelines.
- A sponsor can always transfer all trial related responsibilities to a CRO (Contract Research Organization) which takes care of GCP compliances and quality assurance; but, every clause has to be mentioned in writing in the contract.
- The sponsor should maintain a follow on with the qualified individuals like clinical pharmacologists, biostatisticians, physicians etc. for trial design.
- The sponsor should utilize appropriate individuals to supervise the overall conduct of the clinical trial and may also establish an independent data monitoring committee (IDMC) for the same.
- While using electronic data handling systems, the sponsor should ensure the authenticity of the data and maintain the list of authorized individuals and a backup for the data.
- If the sponsor wants to close a trial, it becomes the sponsor's responsibility to inform all the investigators and concerned individuals.
- To choose the investigator is also the responsibility of the sponsor; the investigator must be qualified and experienced and the sponsor should notify the investigator for all the protocols and GCP guidelines and obtain an agreement to conduct the trials under defined conditions only.
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The compensation to subjects also comes under the sponsor's responsibilities.
- The sponsor is required to submit all the necessary documents to the drug regulatory authorities and also obtain confirmation of review by IRB/IEC.
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The manufacturing, packaging, labeling and coding of the investigational product.
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Sponsor is also responsible for the safety evaluation of the investigational product.
- Adverse drug reaction reporting.
- Selecting the monitors who act as a bridge between sponsor and the investigators.
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Sponsor's audit is different from routine monitoring but ensures compliance with GCP, SOPs and other regulatory requirements.
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In case of non compliance reports, the sponsor should terminate the trials and inform all the concerned parties.
