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SOP on Protocol Training for Investigators and Study Staff

 Title: Protocol Training for Investigators and Study Staff


Introduction and Purpose:

The purpose of this Standard Operating Procedure (SOP) is to establish the requirements for the conduct of interventional clinical trials within the clinical site. It may also serve as guidance for other types of clinical research studies to ensure adherence to Good Clinical Practice standards and maintain research quality.

Scope:

Before commencing clinical research, the Principal Investigator (PI), sub-investigators, and study staff must undergo training in various aspects, including the protection of human research participants, the handling of personal health information, Good Clinical Practice (GCP) guidelines, Conflict of Interest (COI) principles, and, when applicable, Biosafety Training.

Furthermore, the PI and all study personnel must receive specific study/protocol training to ensure:

  • Compliance with the investigational plan.
  • Protection of the rights, safety, and welfare of study participants.
  • Validity and integrity of study results.

Protocol training is mandatory for interventional clinical trials, encompassing industry-sponsored trials, network trials, institutional trials, and investigator-initiated trials. While the PI holds overall responsibility for clinical trial conduct, certain tasks or responsibilities may be delegated to sub-investigators, clinical research coordinators, study coordinators, data coordinators, or other study personnel. Adequate training must be completed before these individuals participate in the clinical trial.

Definitions and Acronyms:

  • Clinical Research: All research involving human participants, excluding secondary studies using existing biological specimens or publicly available data.
  • Clinical Trial: Clinical research studies involving human participants assigned to an intervention aimed at evaluating its impact on health-related biomedical or behavioral outcomes.
  • CFR: Code of Federal Regulations
  • GCP: Good Clinical Practices
  • HIPAA: Health Insurance Portability and Accountability Act
  • ICH: International Council on Harmonization
  • IDS: Investigational Drug Services
  • IRB: Institutional Review Board
  • PI: Principal Investigator
  • SIV: Site Initiation Visit
  • SOP: Standard Operating Procedure

Procedure:

Initial Protocol Training:

  • Initial protocol-specific training is typically conducted by the sponsor, sponsor representative, or delegated trainer during a Site Initiation Visit (SIV) or initial training meeting, excluding self-training.
  • Training covers the purpose of the research, protocol design, investigational product details, task-specific skills, regulatory requirements, and research conduct standards.
  • For investigator-initiated trials, the PI conducts initial protocol-specific training after IRB approval and before any study-related research procedures commence.
  • Study personnel who miss the SIV or initial training must complete training before conducting study-related research procedures.
  • Protocol training must be documented, with all participating study personnel signing a protocol training log, indicating the trainee and trainer names, training date, and content details including the protocol version.

Investigational Drug Services (IDS):

  • For clinical trials involving investigational drugs and utilizing the IDS pharmacy, the lead pharmacist attends the investigational drug/pharmacy segment of the SIV.
  • The lead pharmacist provides training to other pharmacists and technicians involved in the study.
  • IDS pharmacy personnel maintain separate protocol training records.

Specialized Groups:

  • Specialized groups with study-specific roles and tasks may assign individuals to attend the SIV or protocol training.
  • A representative from the group may receive initial training at the SIV and subsequently train other group members before their participation in the study.
  • For in-patient clinical trials or studies with in-patient components, clinic Nurse Managers or Nurse Educators attend the SIV to ensure clinic nursing staff receive training on the study treatment plan and monitoring parameters.
  • Routine job procedure performers receive training within their department and are not required to undergo study-specific training.

Ongoing and Continuing Protocol Training:

  • The PI and study personnel should hold routine meetings throughout the clinical trial to provide protocol refresher training as needed and review study progress, subject enrollment, adverse events, deviations, monitoring results, and assignment of responsibilities.
  • Meeting summaries should include date, attendance, agenda, and follow-up tasks. Meeting notes must be maintained and made available for review upon request.
  • Protocol amendments may necessitate additional training depending on the extent and nature of the changes.
  • Notification of protocol amendments is sent to the PI and all sub-investigators, coordinators, and study staff listed on the IRB application.
  • Administrative changes in a protocol amendment, such as minor errors or non-operational modifications, do not require re-training.
  • Protocol amendments affecting operational aspects of the study require re-training.
  • Additional protocol training following an amendment may be led by the sponsor or overseen by the PI, either in a formal meeting or through individual protocol review. Documentation of this training should be kept.
  • Electronic confirmation of individual review completion may serve as documentation.

Maintenance of Training Records:

  • Protocol-specific training records for the PI, sub-investigators, and study personnel must be kept with the study records, usually within the Regulatory Binder with other essential documents.
  • Individual training records that are not protocol-specific, such as GCP, HIPAA, CITI, etc., can be maintained separately in an electronic or paper individual training file. These records must be available for review by study monitors or regulatory inspectors upon request.

Materials Required:

  • Protocol Training Log or other protocol-specific training documentation.
  • Current version of the study protocol.
  • Agenda and training materials from the SIV or PI-led training for investigator-initiated clinical trials.
  • Delegation of Authority log.

References:

  • 21 CFR Part 312 Subpart D: Responsibilities of Sponsors and Investigators.
  • ICH Guidance for Industry E6(R2): Good Clinical Practice 1.29, 6.10.
  • FDA Guidance for Industry – Investigator Responsibilities (October 2009).


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