The Responsibilities of Sponsor in Clinical

Research

Tarek Gaad

Definition of Sponsor Sponsors initiate and take responsibility for clinical

investigations. A sponsor may be an individual or a

pharmaceutical company, government agency, academic institution, private organization,

or other organization.

Sponsors may transfer to CRO’s obligations such as protocol design, monitoring, report

evaluation, or submission of materials to regulatory authorities.

Sponsor Responsibilities When Working With Contract Research

Organizations

Even if a CRO carries out many trial-related duties, sponsors are always ultimately responsible for the quality and integrity of the research, and investigators are always ultimately responsible for the conduct of the research.

Sponsor Responsibilities for Quality Assurance and Quality Control

Securing written agreements with all involved parties to ensure direct access to all trial-related sites, source documents and reports concerning monitoring, auditing and inspection.

Applying quality control measures to each stage of data handling to ensure that all data are reliable and have been processed correctly.

Sponsors must designate medical personnel—sometimes termed medical monitors—to advise on trial-related medical questions or problems.

Sponsors are responsible for assembling a team of qualified individuals to design the protocol and to participate in all stages of clinical trial development

Sponsor Obligations for Trial Management, Data Handling, Record keeping, and Independent Data Monitoring Committees

Sponsors must allocate and document responsibilities for all trial duties and functions

Selection of qualified investigators is a critical responsibility of sponsors.

Research subjects should understand how reimbursement will be handled for the cost of any possible research injuries they may incur.

All financial details of clinical trials should be documented in agreements between sponsors and investigators.

All approvals from regulatory authorities must be received before clinical trials may begin.

Confirmation and storage of all reviews done by IRB/IEC.

All data about an investigational product should be compiled in an Investigator’s Brochure.

Investigational products must be manufactured in accordance with Good Manufacturing Practice guidelines, and be coded and labeled appropriately.

sponsors must prepare procedures for handling and storage of each investigational product.

Record Access, safety Information and adverse reaction reporting.

Sponsor Responsibilities for Monitoring.

Sponsor Responsibilities for Monitoring Audits. The purpose of a sponsor’s audit is to evaluate trial conduct, compliance with the protocol, SOPs, GCP, and regulatory requirements.

Sponsors should secure compliance if they become aware of non-compliance with the protocol, SOPs, GCP, or applicable regulatory requirements.

If a trial is terminated prematurely or suspended, the sponsor should promptly provide that information to participating sites. This includes the reason for termination or suspension.

Whether a trial is completed or prematurely terminated, sponsors should prepare and submit reports to regulatory authorities.

In multi-centre trials, sponsors and sponsor-investigators must ensure that all investigators conduct trials in accordance with the protocol. Monitoring of clinical trial is required for this purpose.

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