UUSOP-04: Investigator Responsibilities
Version Date: March 11, 2021
- Introduction and Purpose
- Definitions and Acronyms
- Investigator Responsibilities
- Investigator Delegation of Tasks
- Investigator Supervision and Oversight
- Investigator Training
- Materials Required
- Document Approval
- Revision History
The scope and purpose of this SOP is to set forth requirements for the conduct of
interventional clinical trials within the University of Utah. This SOP may be used to guide the conduct of other
types of clinical research studies to promote quality and to meet Good Clinical Practice
Introduction and Purpose
The Principal Investigator (PI) of a clinical trial has responsibilities and obligations
for the conduct and oversight of the trial detailed in the Code of Federal Regulations
(CFR) and in the Good Clinical Practice (GCP) guidelines, to ensure protection of
the rights, safety and welfare of study participants, and to ensure the integrity
of study results.
The PI of a clinical trial is required to follow the regulations for the protection
of human subjects, including obtaining informed consent from study participants and
ensuring review and approval by the Institutional Review Board (IRB), as found in
the U.S. Food and Drug Administration (FDA) regulations (21 CFR §50, and 21 CFR §56).
Additionally, clinical trial investigators should adhere to the International Council
on Harmonization (ICH) GCP guidelines, which provides assurance that the rights, safety,
and well-being of trial subjects are protected, consistent with the principles that
have their origin in the Declaration of Helsinki, and that the clinical trial data
The PI is specifically responsible for compliance with the IRB approved protocol,
GCP guidelines, and the applicable federal regulations above. The PI may delegate
authority to conduct study tasks to sub-investigators, coordinators, and other qualified
study personnel; however, the investigator retains ultimate responsibility of overall
Definitions and Acronyms
Clinical Research: Clinical research includes all research involving human participants. It does not
include secondary studies using existing biological specimens or data collected without
identifiers or data that are publicly available.
Clinical Trial: Clinical trials are clinical research studies involving human participants assigned
to an intervention in which the study is designed to evaluate the effect(s) of the
intervention on the participant and the effect being evaluated is a health-related
biomedical or behavioral outcome.
|Code of Federal Regulations
|United States Food and Drug Administration
|Good Clinical Practice
|International Council on Harmonization
|Institutional Review Board
|Standard Operating Procedure
- Investigator Responsibilities: In conducting clinical trials in compliance with federal regulations and GCP, the
PI commits to personally conducting or supervising the trial, including:
- Ensuring the clinical trial is conducted according to the signed investigational plan
(protocol), investigator statement (form FDA 1572, or Investigator Agreement for device
studies), applicable regulations, and ICH guidelines on GCP.
- Protecting the rights, safety, and welfare of subjects under the investigator’s care
through obtaining informed consent and ensuring initial and ongoing IRB review and
approval of the study.
- Providing or ensuring adequate medical care for subjects during and following their
participation on the trial.
- Controlling, maintaining, and accounting for drugs, biologics, or devices under investigation.
- Maintaining adequate and accurate study records, and reporting study data, including
safety data to the sponsor and/or regulatory agency in a timely manner.
- Investigator Delegation of Tasks: When study tasks or duties are delegated by the principal investigator, the investigator
is responsible for providing adequate training and supervision to all delegates (see
UUSOP#: 05 Delegation of Authority)
- Investigator Supervision and Oversight: The PI should develop a plan for the supervision and oversight of the clinical trial.
This plan should include training of study personnel, and ensuring compliance to the
study protocol, SOPs, and study-specific processes.
- The investigator should ensure that all staff participating in the conduct of the
study, including any new staff, have adequate training. To provide adequate training,
investigators should ensure that study staff:
- Are familiar with the purpose of the study and the general objectives of the protocol.
- Have an adequate understanding of the specific details of the protocol and attributes
of the investigational product to perform their assigned tasks.
- Are knowledgeable of the GCPs and applicable regulatory requirements.
- Are competent to perform or have been trained to perform the tasks they are delegated.
- Are informed of any pertinent changes during the conduct of the trial and receive
additional training as appropriate.
- The PI should hold routine meetings throughout the clinical trial with study personnel
to review study status and progress. These meetings should include sub-investigators,
study coordinators, and any other individuals actively supporting the conduct of the
clinical trial, and should accomplish the following:
- Review of enrollment status, and progress and condition of current study participants.
- Review of the performance of delegated study tasks and duties. Tasks should be reassigned
as needed for personnel turnover.
- Ensure the informed consent process is being conducted and documented appropriately,
that IRB approval is maintained, and that conduct of the clinical trial is in compliance
with the protocol.
- Ensure appropriate use, storage and accountability of investigational product(s).
- Verify that clinical trial source data are complete and accurate, that data captured
in the case report form or study database are consistent with source data, and that
data queries and discrepancies identified by the study monitor are handled and corrected
- Review of external safety reports, and assessment for IRB reporting criteria.
- Assessment of deviations or adverse trends, and developing corrective and preventative
action when appropriate.
- Tracking the trends of adverse events (AEs) and deviations may require the use of “master” logs, as opposed to participant-specific logs. PIs should take
stock of available resources for collecting aggregate AE and deviation data, such
as Electronic Data Capture (EDC) systems and/or resources provide by study sponsors.
If no other resource is available, the use of master logs is recommended.
- Address medical and ethical issues that may arise during the course of the clinical
- It is also important to document these investigator/study staff meetings, including
the agenda, additional topics covered, and attendance. This documentation should be
maintained with the study records and made available for review if requested.
- If the study is an investigator-initiated trial being conducted at multiple clinical
sites, the PI should contribute to effective communication with investigators and
study staff at other participating sites to provide direction, training, support,
or corrective action as appropriate.
- Investigator Training: Clinical investigators should receive appropriate instruction and training prior
to conducting or being involved in clinical research.
- Investigators may receive training in the conduct of clinical research through working
with a more experienced investigator mentor, professional courses or seminars, completing
sponsor-required training programs, attending University of Utah clinical investigator
training courses, etc.
- Investigators should maintain documentation of training and attendance at clinical
research training events.
- Clinical research investigator training should include the following topics:
- Informed consent process
- FDA regulations for clinical research
- ICH guidelines for Good Clinical Practice
- IRB submissions, communications, and approval requirements
- CITI (Collaborative Institutional Training Initiative) program on human subjects research
- Detection, evaluation, and reporting of adverse events
- Accountability of investigational products
- The role of auditing and monitoring in clinical trials
- Delegation of Authority log
- Protocol Training Log or other documentation of protocol-specific training
- GCP Essential Documents
- 21 CFR Part 312 Subpart D: Responsibilities of Sponsors and Investigators
- ICH Guidance for Industry E6(R2): Good Clinical Practice
- FDA Guidance for Industry – Investigator Responsibilities (October 2009)
Andrew Weyrich, Ph.D.
Interim Vice President for Research, University of Utah
Printed or photocopied versions are considered unofficial copies unless it is the
original signed document.