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SOP on Investigator Delegation of Authority

Title: Investigator Delegation of Authority

Introduction and Purpose:

This Standard Operating Procedure (SOP) outlines the process by which the Principal Investigator (PI) delegates the authority to conduct clinical study procedures and tasks to sub-investigators and other study personnel. It also details the maintenance of documentation related to staff and investigator signatures and handwriting samples.

Scope:

  • The PI conducting a clinical trial must adhere to regulations governing informed consent (21 CFR 50) and regulations regarding Institutional Review Board (IRB) review and approval (21 CFR 56). If the study involves an investigational drug or device, additional regulations in 21 CFR 312 or 21 CFR 812 apply. Furthermore, all clinical study investigators should follow the International Council on Harmonization (ICH) guidelines for Good Clinical Practice (GCP).
  • While these responsibilities are primarily held by the PI, they can be delegated to qualified sub-investigators and other study personnel under the PI's oversight.

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 Delegation of Tasks:

When the PI delegates study tasks or duties, they are responsible for ensuring:

  • Delegation aligns with the individual's education, training, and experience, including any necessary state licensure.
  • A list of suitably qualified individuals to whom trial-related duties have been assigned is maintained. This list may be kept on a Delegation of Authority log, Research Delegation of Authority Profiles, or another appropriate mechanism.

Clinical or medical tasks are delegated to sub-investigators or study staff with the appropriate education, experience, and necessary licenses or credentials. Commonly delegated tasks include:

  • Obtaining informed consent.
  • Conducting screening evaluations, assessing eligibility criteria, and randomizing participants.
  • Performing physical exams and recording vital signs.
  • Evaluating adverse events.
  • Prescribing study treatment or making medical determinations for treatment adjustments.
  • Reviewing and interpreting lab results and other study assessments.
  • Assessing primary and secondary endpoints.
  • Managing investigational product maintenance, dispensing, and accountability.
  • Tasks such as obtaining informed consent, conducting screening evaluations, assessing eligibility criteria, randomizing participants, obtaining medical history, completing case report forms, and handling IRB submissions may be delegated to clinical research coordinators or other study staff.
  • The PI may use a Delegation of Authority log provided by the study sponsor or another departmental or divisional form to document the delegation of duties.
  • The Delegation of Authority log should be initiated at the start of the study (e.g., during a site initiation visit) and should be continuously updated to reflect changes in study personnel and turnover.
  • Individuals without a dedicated or permanent role and those performing routine tasks as part of their daily job (e.g., clinical staff, including nurses, medical assistants, radiology staff, residents, pharmacy technicians, ECG techs, phlebotomists, etc.) do not need to be individually listed on the Delegation of Authority log. Their qualifications, training, and job performance are monitored by their respective department heads.
  • Individuals working outside the clinical site are also not listed on the Delegation of Authority log, as their training and oversight are the responsibility of their employer.
  • The names of sub-investigators assisting the investigator in the study should be listed on FDA Form 1572 for clinical trials involving investigational drugs. Typically, only physician and mid-level (Nurse Practitioners, Physician Assistants, etc.) sub-investigators who have a permanent and specific role in the clinical trial and are directly involved in the treatment or evaluation of research participants should be included on the FDA 1572.
  • The Delegation of Authority record is an official study "essential document" and should be created and maintained with care. If the document is lost or damaged during the study, it should be reconstructed as fully and promptly as possible.
  • Any corrections made to the Delegation of Authority record should follow standard "good clinical practice" procedures: a single line-through of the incorrect entry, followed by the entry of appropriate information, and then the initialing and dating of the correction. White-out or other methods to obliterate the original entry should not be used. Only delegated members of the study can make revisions to the log when necessary.
  • The Delegation of Authority record may be created and maintained electronically in a system that complies with the requirements of 21 CFR Part 11 for electronic records and electronic signatures.
  • Upon completion of the clinical trial, the original Delegation of Authority log will be retained with the other essential study documents. A copy of the log may be provided to the Sponsor upon request, but the original will remain at the study site.

Principal Investigator Change:

There are two options for updating the delegation log when there is a change in the PI, depending on departmental guidance and the preferences of the PI and study team:

  • Option A: The departing PI assigns an end date to their entry on the delegation log. The new PI creates a new entry with their start date, which should be the same date or the day following the departing PI's end date. The new PI must confirm, either in the comments section or through a Note to File, that they have reviewed all delegated tasks and agree with the delegations made by the departing PI.
  • Option B: An end date is listed for all personnel on the delegation log. The departing PI signs off on all end dates, effectively "closing" the delegation log. The new PI then creates a completely new delegation log.

Roles or Key Study Tasks Changes:

  • If the role of a staff member changes during the trial, an end date should be entered when the individual is no longer performing that role (e.g., a Sub-Investigator who becomes the new PI).
  • If there are any changes to study tasks for an individual, the current delegation entry should be updated with an end date, and a new entry should be created with the updated delegated study tasks. End dates should be assigned, and the new study tasks entered on the new entry. The PI is required to initial and date changes to confirm and acknowledge any additional or deleted tasks.

Materials Required:

  • Delegation of Authority log.
  • Protocol Training Log or other documentation of protocol-specific training.
  • GCP Essential Documents.
  • FDA Form 1572 if applicable.

References:

  • 21 CFR Part 312 Subpart D: Responsibilities of Sponsors and Investigators.
  • 21 CFR Part 50: Protection of Human Subjects research.
  • 21CFR Part 56: Institutional Review Boards.
  • ICH Guidance for Industry E6(R2): Good Clinical Practice.
  • FDA Guidance for Industry – Investigator Responsibilities (October 2009).

Document Approval:




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