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SOP Investigator Responsibilities for Clinical Trial

 Title: Investigator Responsibilities

Introduction and Purpose:

The purpose of this Standard Operating Procedure (SOP) is to outline the requirements for conducting interventional clinical trials at the clinical site. This SOP can also serve as a guide for other types of clinical research studies, emphasizing the importance of quality and adherence to Good Clinical Practice (GCP) standards.


Scope:

The Principal Investigator (PI) of a clinical trial holds crucial responsibilities and obligations outlined in the Code of Federal Regulations (CFR) and Good Clinical Practice (GCP) guidelines. These responsibilities are essential to safeguard the rights, safety, and welfare of study participants and to ensure the credibility of study results.

The PI of a clinical trial is mandated to adhere to regulations governing human subject protection, including obtaining informed consent from participants and obtaining Institutional Review Board (IRB) review and approval, as specified in United States Food and Drug Administration (FDA) regulations (21 CFR §50 and 21 CFR §56).

Additionally, clinical trial investigators should follow the International Council on Harmonization (ICH) GCP guidelines, which guarantee the protection of trial subjects' rights, safety, and well-being. These guidelines align with principles rooted in the Declaration of Helsinki and ensure the credibility of clinical trial data.

The PI holds specific responsibilities, including compliance with the IRB-approved protocol, GCP guidelines, and relevant federal regulations. While the PI can delegate certain study tasks to sub-investigators, coordinators, and qualified study personnel, ultimate responsibility for overall study conduct remains with the investigator.

Definitions and Acronyms:

  • Clinical Research: Encompasses all research involving human participants, excluding secondary studies using existing biological specimens or publicly available data.
  • Clinical Trial: Refers to clinical research studies involving human participants assigned to an intervention designed to assess its impact on health-related biomedical or behavioral outcomes.
  • CFR: Code of Federal Regulations
  • FDA: United States Food and Drug Administration
  • GCP: Good Clinical Practice
  • ICH: International Council on Harmonization
  • IRB: Institutional Review Board
  • PI: Principal Investigator
  • SOP: Standard Operating Procedure

Procedure:

Investigator Responsibilities:

In compliance with federal regulations and GCP, the PI assumes the responsibility of personally conducting or supervising the clinical trial. This includes:

  • Ensuring the clinical trial adheres to the signed investigational plan (protocol), investigator statement (Form FDA 1572 or Investigator Agreement for device studies), applicable regulations, and ICH GCP guidelines.
  • Safeguarding the rights, safety, and welfare of study subjects by obtaining informed consent and ensuring ongoing IRB review and approval.
  • Providing or ensuring adequate medical care for subjects during and after their participation in the trial.
  • Managing, maintaining, and accounting for investigational drugs, biologics, or devices.
  • Maintaining accurate study records and promptly reporting study data, including safety data, to the sponsor and/or regulatory agency.

Investigator Delegation of Tasks:

  • When the PI delegates study tasks or duties, they are responsible for offering comprehensive training and supervision to all delegates (see UUSOP#: 05 Delegation of Authority).

Investigator Supervision and Oversight:

The PI should establish a plan for supervising and overseeing the clinical trial, which includes:

  • Training study personnel and ensuring compliance with the study protocol, SOPs, and study-specific processes.

Ensuring that all staff involved in the study, including new personnel, receive adequate training. This includes:

  • Familiarity with the study's purpose and general protocol objectives.
  • A deep understanding of specific protocol details and attributes of the investigational product to perform assigned tasks.
  • Knowledge of GCPs and relevant regulatory requirements.
  • Competence to perform delegated tasks or appropriate training to do so.
  • Awareness of pertinent changes during the trial and additional training as needed.

Holding routine meetings with study personnel throughout the clinical trial to:

  • Review enrollment status, progress, and the condition of current study participants.
  • Assess the performance of delegated study tasks and duties, with reassignment as needed due to personnel turnover.
  • Ensure the appropriate conduct of the informed consent process, maintenance of IRB approval, and protocol compliance.
  • Verify the correct use, storage, and accountability of investigational products.
  • Confirm that clinical trial source data are complete and accurate, that data captured in case report forms or study databases align with source data, and that data queries and discrepancies identified by study monitors are handled and corrected correctly.
  • Review external safety reports and assess them against IRB reporting criteria.
  • Evaluate deviations or adverse trends and develop corrective and preventive actions when necessary.
  • Tracking trends in adverse events (AEs) and deviations may require the use of "master" logs rather than participant-specific logs. PIs should assess available resources for collecting aggregate AE and deviation data, such as Electronic Data Capture (EDC) systems and/or resources provided 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 trial.

  • It is crucial to document these investigator/study staff meetings, including the agenda, additional topics covered, and attendance. This documentation should be retained with the study records and made available for review upon request.
  • For investigator-initiated trials conducted at multiple clinical sites, the PI should facilitate effective communication with investigators and study staff at other participating sites, providing guidance, training, support, or corrective action as needed.


Investigator Training:

Clinical investigators should receive appropriate instruction and training before participating in clinical research. Training methods may include:

  • Mentorship with an experienced investigator.
  • Professional courses or seminars.
  • Completion of sponsor-required training programs.
  • Attendance at University of Utah clinical investigator training courses.

Investigators should maintain records of training and attendance at clinical research training events. Training topics should include:

  • The 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 and GCP.
  • Detection, evaluation, and reporting of adverse events.
  • Accountability of investigational products.
  • The role of auditing and monitoring in clinical trials.

Materials Required:

  • Delegation of Authority log.
  • Protocol Training Log or other documentation of protocol-specific training.
  • GCP Essential Documents.

References:

  • 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).

Document Approval:


Revision History:






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