Responsibilities of a sponsor in clinical trials

Top clipped slide. Download Now Download Download to read offline. Dr B Naga Raju Follow. Roles and Responsibilities of sponsor in conducting clinical trials as per GC Introduction to clinical research. Clinical research ppt,. Drug development and clinical trial phases. Monitoring and auditing in clinical trials. Institutional review board by akshdeep sharma.

Related Books Free with a 30 day trial from Scribd. Related Audiobooks Free with a 30 day trial from Scribd. If necessary, outside consultant s may be appointed for this purpose. The sponsor should also ensure that the clinical trial reports in marketing applications meet the standards of the ICH Guideline for Structure and Content of Clinical Study Reports.

For those investigators who are collecting additional data, supplemental CRFs should also be provided that are designed to capture the additional data. Monitoring and audits are intended to increase subject protection and integrity of data, with Quality Risk Management as the new QA approach.

ICH Harmonized Tripartite guideline. Guideline for good clinical practice: E6 R1 ; [online] ; [Cited June 10]. Shruti Iyengar Jan. Amy Watts Dec. I don't have enough time write it by myself. Rahul Kumbar Nov. Bhavana Vuppala Oct. Show More. Total views. You just clipped your first slide!

Clipping is a handy way to collect important slides you want to go back to later. The sponsor should determine the appropriate extent and nature of monitoring. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial.

Statistically controlled sampling may be an acceptable method for selecting the data to be verified. The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials.

The flexibility in the extent and nature of monitoring described in this section is intended to permit varied approaches that improve the effectiveness and efficiency of monitoring. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring.

The sponsor should document the rationale for the chosen monitoring strategy e. On-site monitoring is performed at the sites at which the clinical trial is being conducted. Centralized monitoring is a remote evaluation of accumulating data, performed in a timely manner, supported by appropriately qualified and trained persons e. Review, that may include statistical analyses, of accumulating data from centralized monitoring can be used to:. Acting as the main line of communication between the sponsor and the investigator.

Verifying that the investigator has adequate qualifications and resources see 4. Verifying, for the investigational product s :.

That storage times and conditions are acceptable, and that supplies are sufficient throughout the trial. That the investigational product s are supplied only to subjects who are eligible to receive it and at the protocol specified dose s. That subjects are provided with necessary instruction on properly using, handling, storing, and returning the investigational product s.

That the receipt, use, and return of the investigational product s at the trial sites are controlled and documented adequately. That the disposition of unused investigational product s at the trial sites complies with applicable regulatory requirement s and is in accordance with the sponsor.

Verifying that the investigator follows the approved protocol and all approved amendment s , if any. Verifying that written informed consent was obtained before each subject's participation in the trial.

Ensuring that the investigator receives the current Investigator's Brochure, all documents, and all trial supplies needed to conduct the trial properly and to comply with the applicable regulatory requirement s. Ensuring that the investigator and the investigator's trial staff are adequately informed about the trial. Verifying that the investigator is enroling only eligible subjects.

Reporting the subject recruitment rate. Verifying that source documents and other trial records are accurate, complete, kept up-to-date and maintained. Verifying that the investigator provides all the required reports, notifications, applications, and submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the trial.

Checking the accuracy and completeness of the CRF entries, source documents and other trial-related records against each other. The monitor specifically should verify that:. The data required by the protocol are reported accurately on the CRFs and are consistent with the source documents.

Adverse events, concomitant medications and intercurrent illnesses are reported in accordance with the protocol on the CRFs. Visits that the subjects fail to make, tests that are not conducted, and examinations that are not performed are clearly reported as such on the CRFs.

All withdrawals and dropouts of enrolled subjects from the trial are reported and explained on the CRFs. The sponsor should develop a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.

The plan should describe the monitoring strategy, the monitoring responsibilities of all the parties involved, the various monitoring methods to be used, and the rationale for their use. The plan should also emphasize the monitoring of critical data and processes. Particular attention should be given to those aspects that are not routine clinical practice and that require additional training. The monitoring plan should reference the applicable policies and procedures.

If or when sponsors perform audits, as part of implementing quality assurance, they should consider:. The purpose of a sponsor's audit, which is independent of and separate from routine monitoring or quality control functions, should be to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements. If noncompliance that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results is discovered, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions.

For those investigators who are collecting additional data, supplemental CRFs should also be provided that are designed to capture the additional data. Allow cookies Manage Settings. Please choose all settings. Allow cookies Save Settings.

The quality management system should use a risk-based approach as described below. ADDENDUM The sponsor should base their approach to validation of such systems on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results.

Review, that may include statistical analyses, of accumulating data from centralized monitoring can be used to: identify missing data, inconsistent data, data outliers, unexpected lack of variability and protocol deviations. Verifying, for the investigational product s : That storage times and conditions are acceptable, and that supplies are sufficient throughout the trial. The monitor specifically should verify that: The data required by the protocol are reported accurately on the CRFs and are consistent with the source documents.

Informing the investigator of any CRF entry error, omission, or illegibility. The monitor should ensure that appropriate corrections, additions, or deletions are made, dated, explained if necessary , and initialled by the investigator or by a member of the investigator's trial staff who is authorized to initial CRF changes for the investigator.

This authorization should be documented. Determining whether the investigator is maintaining the essential documents see 8. Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations. Reports should include the date, site, name of the monitor, and name of the investigator or other individual s contacted.

Results of monitoring activities should be documented in sufficient detail to allow verification of compliance with the monitoring plan.