Determine the specific problems leading to the need for a rescue study, such as recruitment challenges, data quality issues, or logistical setbacks.

Gather all stakeholders, including sponsors, clinical investigators, and regulatory bodies, to discuss the identified issues and potential solutions.

Develop a detailed rescue plan, including revised protocols, timelines, and budgets. This might involve changes to study design, additional training for staff, or the introduction of new technologies or methodologies.

Submit the revised plan and any protocol amendments to the relevant ethical and regulatory bodies for approval.

Roll out the rescue plan across all sites, ensuring consistent and thorough application of the new protocols and procedures.

Implement a robust data monitoring plan to allow for interim analysis and close tracking of the rescue study progress, ensuring adherence to the revised protocols and identifying any new issues promptly.

Ensure that data management systems are capable of handling changes and that data integrity is maintained throughout the process.

Maintain open and regular communication with all stakeholders, including trial participants, throughout the rescue study to ensure transparency and trust.