Clinical Trial Sponsor

A clinical trial sponsor is the individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.

A sponsor can transfer any or all of its trial-related duties to a contract research organization or CRO, but the ultimate responsibility for the quality and integrity of trial data always resides with the sponsor.

Sponsors' responsibilities

According to GCP guidelines, the sponsor is generally responsible the following:

  • Select Investigators
  • Monitor progress of clinical trial
  • Ensure trial is conducted in accordance with protocol
  • Monitor safety
  • Drug disposition and reconciliation
  • Maintain required records and reports
  • Transfer of obligations to a CRO

The clinical trial sponsor also has the following additional responsibilities:

  • Inform Investigators of information important to study conduct, e.g., provide Investigator's Brochure/report of prior investigations, investigational plan, updates during study as new information becomes available, in particular, safety/adverse effects
  • Obtain required information from Investigator
    • Signed Form FDA 1572 and/or Investigator Agreement
    • Curriculum vitae
    • Financial disclosure information
    • Clinical Protocol
  • Shipment of investigational product only to Investigators participating in the investigation
  • Submission of Protocol Amendments describing any "change in a Phase I protocol that significantly affects the safety of subjects or any change in a Phase 2 or 3 Protocol that significantly affects the safety of subjects, the scope of the investigation, or the scientific quality of the study"
  • Annual Report to FDA on progress of the IND or IDE
  • Permitting FDA access to records during inspection
ComplianceOnline training for clinical trial sponsors

Clinical Trials Process: Study Sponsor's and Investigator's Responsibilities

FDA Regulations and Good Clinical Practice Guidelines will be discussed with an emphasis on data integrity and the protection of study subject's welfare/rights.

Clinical Trials and Good Clinical Practice

This Clinical Trials and GCP session describes the principles of Good Clinical Practice including drug development process and Specifics of GCP and quality as related to central laboratory work.

How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies observed during FDA clinical audits

This Clinical Trial training provides a detailed review of the FDA regulations for Clinical Trials Process.

Fundamentals of Clinical Research - Key players and roles for a successful and compliant research team

This training on a compliant clinical research team focuses on how Clinical Research Coordinators should work in a research team to ensure success of the clinical trial at your site.

CROs (Clinical Research Organizations) - Identification, Selection, and Management for Maximum Results & Value

This CRO training provides all the specific methodology and management techniques to successfully outsource pharmaceutical programs completed on time, within budget, most importantly completed with high level of quality and performance.

Preparing for FDA GCP Inspections - Essentials for Sponsor Companies

This webinar on FDA GCP inspections provides practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.

Utilizing ICH Guidelines for GCP Regulatory Compliance

This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections.

Implementing a GCP Vendor Qualification Program: Ensuring your vendors are in compliance with FDA requirements

The presentation covers the requirements of the Code of Federal Regulations for drugs, biologics, and medical devices, as well as key FDA Guidance Documents including the International Conference on Harmonization (ICH) E6.