Prepared for NCT07027735

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Operations analysis report

Study title

Study of the Implementation of Telehealth-Supported LARC Provision in School-Based Health Centers

NCT#

NCT04840836

Last updated

Jun 22, 2025

10 recommendations found

Clinical Research Coordinator Analysis

Investigational Product Handling and Blinding Integrity

Finding: The protocol (Section 7.5, Investigational Product Blinding and Unblinding) mandates that an unblinded pharmacist or qualified designee, not otherwise involved in study conduct, will be responsible for dispensing/preparing the Investigational Product (IP). It also states, "The site should have a plan in place to ensure that the blind is maintained." For sites, particularly those with integrated clinical and pharmacy research teams or limited dedicated research pharmacy staff, developing and consistently implementing a robust operational plan to ensure this strict segregation of unblinded personnel and prevent any inadvertent unblinding of blinded site staff or influence on assessments can be a significant logistical challenge. Recommendation: Prior to enrolling the first participant, the site should develop, document, and implement a detailed "Site-Specific Blinding Maintenance and Unblinded IP Management Plan." This plan should explicitly:

  • Identify by name and role the designated unblinded personnel (and their trained backups).

  • Describe the physical location(s) for unblinded activities (e.g., IP storage, preparation, randomization access) and outline measures to secure these areas and separate them from blinded study areas and participant interaction zones.

  • Detail the precise workflow for IP ordering, receipt, accountability, preparation (if applicable for maintaining the blind, e.g., over-labeling, identical syringes), and dispensing, ensuring no treatment allocation information is accessible to or observable by blinded staff.

  • Establish clear communication protocols between unblinded and blinded staff to prevent disclosure of treatment allocation (e.g., using standardized, non-revealing language or forms for IP requests and confirmations).

  • Outline procedures for managing and documenting emergency unblinding, should it become necessary, ensuring it's done per protocol.

  • Include training logs confirming that all involved personnel (both blinded and unblinded) have been trained on these specific site procedures and their roles in maintaining the blind.

This plan should be reviewed by the Principal Investigator and relevant research leadership, and readily available for monitoring or audit purposes.

Rationale: This proactive and detailed planning ensures robust protection of the study blind, which is paramount for the scientific integrity and validity of the trial results. It minimizes the risk of unintentional unblinding, associated protocol deviations, and potential biases in assessments, thereby strengthening overall site compliance, operational efficiency, and readiness for audits or inspections.

Operations analysis report

Clinical Research Coordinator Analysis

Investigational Product Handling and Blinding Integrity

Finding: The protocol (Section 7.5, Investigational Product Blinding and Unblinding) mandates that an unblinded pharmacist or qualified designee, not otherwise involved in study conduct, will be responsible for dispensing/preparing the Investigational Product (IP). It also states, "The site should have a plan in place to ensure that the blind is maintained." For sites, particularly those with integrated clinical and pharmacy research teams or limited dedicated research pharmacy staff, developing and consistently implementing a robust operational plan to ensure this strict segregation of unblinded personnel and prevent any inadvertent unblinding of blinded site staff or influence on assessments can be a significant logistical challenge. Recommendation: Prior to enrolling the first participant, the site should develop, document, and implement a detailed "Site-Specific Blinding Maintenance and Unblinded IP Management Plan." This plan should explicitly:

  • Identify by name and role the designated unblinded personnel (and their trained backups).

  • Describe the physical location(s) for unblinded activities (e.g., IP storage, preparation, randomization access) and outline measures to secure these areas and separate them from blinded study areas and participant interaction zones.

  • Detail the precise workflow for IP ordering, receipt, accountability, preparation (if applicable for maintaining the blind, e.g., over-labeling, identical syringes), and dispensing, ensuring no treatment allocation information is accessible to or observable by blinded staff.

  • Establish clear communication protocols between unblinded and blinded staff to prevent disclosure of treatment allocation (e.g., using standardized, non-revealing language or forms for IP requests and confirmations).

  • Outline procedures for managing and documenting emergency unblinding, should it become necessary, ensuring it's done per protocol.

  • Include training logs confirming that all involved personnel (both blinded and unblinded) have been trained on these specific site procedures and their roles in maintaining the blind.

This plan should be reviewed by the Principal Investigator and relevant research leadership, and readily available for monitoring or audit purposes.

Rationale: This proactive and detailed planning ensures robust protection of the study blind, which is paramount for the scientific integrity and validity of the trial results. It minimizes the risk of unintentional unblinding, associated protocol deviations, and potential biases in assessments, thereby strengthening overall site compliance, operational efficiency, and readiness for audits or inspections.

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© 2024 Polytrial Corp.

Find & fix bottlenecks in minutes

© 2024 Polytrial Corp.