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SOP on Clinical Trial Monitoring Procedure

 Title: Clinical Trial Monitoring Procedure

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 It serves as a guide to promote quality and ensure adherence to Good Clinical Practice (GCP) standards. This SOP may also be applied to other types of clinical research studies to maintain high standards of quality.

Scope:

This SOP applies to all personnel involved in the monitoring of ESCTs, including clinical monitors, site coordinators, investigators, and other relevant staff.

Definitions and Acronyms:

  • Clinical Research: Encompasses all research involving human participants, excluding secondary studies using existing biological specimens or data collected without identifiers or publicly available data.
  • Clinical Trial: Refers to clinical research studies involving human participants assigned to an intervention 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.
  • CFR: Code of Federal Regulations
  • CRO: Contract Research Organization
  • EHR: Electronic Health Record
  • ERICA: Electronic Research Integrity and Compliance Administration
  • FDA: United States Food and Drug Administration
  • GCP: Good Clinical Practice
  • ICF: Informed Consent Form
  • ICH: International Council for Harmonization
  • IDS: Investigational Drug Services
  • IRB: Institutional Review Board
  • LAR: Legally Authorized Representative
  • PI: Principal Investigator
  • SOP: Standard Operating Procedure

Procedure:

Monitoring Expectations:

  • Monitoring will be performed as per the sponsor's requirements and should be scheduled based on the trial's complexity and risk.
  • Monitoring may involve on-site and/or central/remote monitoring to ensure the proper conduct and documentation of the trial.
  • The monitor's responsibilities include overseeing the trial, ensuring proper documentation, and facilitating communication between the sponsor and the investigator.

Scheduling On-Site Monitoring Visits:

  • Assigned monitors are expected to schedule monitoring visits with advance notice.
  • Monitors can visit for a mutually agreed-upon number of consecutive days per month for each protocol. The expected duration should be communicated to the study team.
  • Scheduling should consider space availability and potential exceptions for accommodating multiple studies in one visit.

Monitoring Visit Preparation:

  • The study team should identify mutually available dates, reserve necessary space, and schedule meetings with required parties.
  • Notification of the upcoming monitoring visit should be sent to potentially affected individuals.
  • The study team should prepare requested documentation, organize research charts, obtain and file any missing source documentation, and ensure data and case report forms (CRFs) are complete.
  • All essential documents should be filed, and training and delegation logs should be up-to-date.

On-Site Monitoring Visit Expectations:

  • Upon arrival, the monitor should notify the study team and sign in.
  • The study team should familiarize the monitor with their surroundings.
  • Monitors may share space with other site monitors.
  • Monitors should exhibit professional and ethical behavior.
  • Review of study materials should align with the initially requested items during the monitoring site visit setup.
  • Monitors won't have unrestricted access to the Electronic Health Record (EHR) but may have limited access as needed.
  • Monitors should not enter secured areas without authorized personnel.
  • All provided materials for review should be returned at the end of each business day.
  • Monitors are not allowed to duplicate research records.

Monitor Visit Follow-up:

  • The monitor should provide a summary of their review in a monitoring report and/or follow-up letter to the PI.
  • The PI and study team should address findings, data queries, and implement corrective actions.
  • The monitoring visit report should be maintained with other essential study documents.

Centralized/Remote Monitoring:

  • Centralized and remote monitoring can reduce on-site monitoring.
  • Limited remote monitoring may be possible from the clinical site EHR.
  • Regulatory records and IDS records may also be available for remote monitoring.
  • Requests for centralized/remote monitoring must be approved in advance.

Additional Considerations:

  • The monitor should schedule close-out monitoring visits as needed.
  • Any changes to sponsor-assigned monitoring personnel should be communicated to the study team.

Materials Required:

  • Current IRB approved protocol/amendment(s)
  • Current IRB Approved Consent Form(s)
  • Participant research charts
  • Access to electronic data capture (EDC) system
  • Access to essential documents / regulatory binders
  • Access to Vestigo

References:

  • 21 CFR Part 50 Subpart B: Protection of Human Subjects
  • 21 CFR Part 312 Subpart D – Investigational New Drug Application, Responsibilities of Sponsors and Investigators
  • ICH Guidance for Industry E6(R2): Good Clinical Practice

Document Approval:

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