Sponsor Responsibilities in clinical research as per ICH GCP E6

1. Sponsor Responsibilities and GCP
Ashish Singh Parihar

2.  (ICH) E6 Section 5
 The sponsor is often a pharmaceutical company, but
may also be an individual (the investigator), an
academic institution, governmental agency, private
organization, or other organization.
 The type of sponsor can vary from study to study,
depending on who takes overall responsibility for the
conduct of the trial.
Who can be a sponsor?
Sponsor is not synonymous with Funder!

3.  Sponsor: "An individual, company, institution, or
organization which takes responsibility for the initiation,
management, and/or financing of a clinical trial.“
 Sponsor-Investigator: "An individual who both initiates
and conducts, alone or with others, a clinical trial, and
under whose immediate direction the investigational
product is administered to, dispensed to, or used by a
subject. The term does not include any person other than
an individual (e.g., it does not include a corporation or an
agency). The obligations of a sponsor-investigator include
both those of a sponsor and those of an investigator."
Definition of Sponsor

4.  Implementing and maintaining a quality management
system throughout all stages of the trial process. The
quality management system should use a risk-based
approach.
 Implementing and maintaining quality assurance and
quality control systems.
 Those systems include written standard operating
procedures (SOPs) to ensure that the studies are
conducted in accordance with GCP, and are in
compliance with applicable legal, ethical, and
regulatory requirements
Responsibilities
In general, sponsor responsibilities include (but are not limited to):

5.  Designating qualified medical personnel who will
advise on study-related medical questions or
problems.
 Often these qualified medical personnel are
referred to as medical monitors.
 Selecting investigators qualified by training and
experience to properly conduct the study.
 Asking for curriculum vitaes (CVs), medical licenses and
training certificates helps ensure qualified investigators (and
study teams) are selected.
Cont…

6.  Ensuring the research has sound scientific rationale
and principles.
 Preparation of documents (Investigator's Brochure,
protocol, subject information and consent, case
report forms, final report).

7.  Providing investigator(s) with the necessary information to
conduct the study.
 Ensuring investigators are appropriately qualified, are
trained on the protocol, and are committed to providing
medical oversight for study subjects while
understanding their role in relation to specific trial
activities.
 Using unambiguous subject identification codes that
allow identification of all the data reported for each
subject.

8.  Providing the investigational product(s), as well as
information to ensure the safe use of these products.
 Ensuring compliance with labelling, reporting, and
recordkeeping requirements.
 Maintaining a system for the disposition of unused
investigational product(s).

9.  Ensuring all necessary ethics review(s) and
approval(s) are obtained.
 Providing compensation and indemnity in the event
of a study-related injury or death (according to local
laws and regulations).

10.  Safety Management and Reporting of applicable adverse
events.
 Responsible for the ongoing safety evaluation of the
investigational product.
 Setting up a data safety monitoring board (DSMB) as
required.
 Sending reports of all serious and unexpected adverse
reactions to all investigators conducting clinical trials
using the product and applicable regulatory authorities.
 Preparing periodic safety updates (revisions to the
Investigator's Brochure) for review by applicable
regulatory authorities.

11.  Ensuring data management, record retention,
reporting, and generation of study reports.
 Ensuring proper monitoring of the study.
 Selecting a monitor qualified by training and
experience to monitor the progress of the study.
 Preparing and submitting clinical trial application(s)
and amendment(s) to the appropriate regulatory
agencies.

12.  A sponsor can transfer any or all of its study-related
duties to a Contract Research Organization (CRO),
however any such transfer should be documented in
writing.
 The sponsor should ensure oversight of any study-
related duties carried out on its behalf, even those
duties subcontracted to another party by the
sponsor’s CRO.
 Ultimately the responsibility for the quality and
integrity of a study always resides with the sponsor.
Imp. Points

13.  As an investigator acting as a sponsor, the
investigator is held to the same standards and
obligations as any other individual or organization
that takes responsibility for and initiates a clinical
investigation
 Investigator-initiated studies are managed by the
same regulations that apply to the sponsor initiated
studies
Investigator-Initiated Studies Where
the Investigator is also the Sponsor

14.  An investigator, regardless of the study type, is
responsible for the proper and safe conduct of the
study from initiation until the completion of the
study.
 The sponsor-investigator is responsible to ensure
compliance with all applicable regulations, legislation,
and codes of ethics and GCP.

15.  Study design
 Ensuring appropriate institutional, regulatory and
ethics committee approval
 Study conduct, including responsibility for ensuring
appropriate medical safeguards, adequate record
keeping, medical monitoring, adverse event
reporting, and medical supervision
 Analysis and interpretation of the results
 Communication of the results (for example,
publications)
When an investigator initiates a study and develops the
protocol (alone or with others), and acts as the study
sponsor, the investigator assumes responsibility for all
aspects of the research, including:

16.  Regulatory requirements
 Funding and budgeting
 Reporting
 Investigational Product Accountability
 Agreements, Insurance & Liability
 Ongoing safety evaluation of the investigational
product(s)
 Quality Assurance
 Monitoring
 Auditing
 SOPs
 Multi-centre or international studies
Challenges of Taking on the "Sponsor"
Role in Investigator-Initiated Studies
Understanding the additional obligations and resources required in relation to: