RBQM

RACT stands for

• Risk Assessment in Clinical Trial

• Risk Adoption Clinical Tool

• Risk adoption categorisation Tool

• Risk Assessment Categorisation Tool

Reorder the following steps based on the ICH GCP E6 R2 Guidelines Section 5.0-Sponsor on

Risk-Based approach.

• 1.Identify the Critical Process and Data

  2.Identify risk

  3.Evaluate risk

  4.Control Risk

  5.Communicate risk

  6.Review Risk

  7.Report Risk

• 1.Identify the Critical Process and Data

  2.Identify risk

  3.Evaluate risk

  4.Control Risk

  5.Review Risk

  6.Communicate risk

  7.Report Risk

• 1.Identify the Critical Process and Data

  2.Identify risk

  3.Evaluate risk

  4.Review Risk

  5.Control Risk

  6.Communicate risk

  7.Report Risk

• 1.Identify the Critical Process and Data

  2.Identify risk

  3.Evaluate risk

  4.Review Risk

  5.Control Risk

  6.Report Risk

  7.Communicate risk

Identify if this statement is true or false

"To be meet the requirement of expectation on Risk Communication-

The sponsor should document quality management activities.

The sponsor should communicate quality management activities to those who are involved in or affected by such activities, to facilitate risk review and continual improvement during clinical trial execution."

• TRUE

• FALSE

Answer explanation

GUIDELINE FOR GOOD CLINICAL PRACTICE (ich.org)

5.0.5 Risk Communication The sponsor should document quality management activities. The sponsor should communicate quality management activities to those who are involved in or affected by such activities, to facilitate risk review and continual improvement during clinical trial execution.

Identify which of the below statement is true with respect to the monitor responsibilities as per ICH GCP E6

• Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations.

• Communicate deviations to only the critical process, from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and take appropriate action designed to prevent recurrence of the detected deviations.

• Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and take appropriate action designed to prevent recurrence of the detected deviations related to critical process and critical data."

• Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements using a risk-based approach, to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations related to critical process in a study protocol.

Answer explanation

5.18.4 Monitor's Responsibilities

(q) Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations.

Which of the following statements on " Monitoring Report " are true as per the ICH GCP E6 R2

• Results of monitoring activities should be documented in sufficient detail to allow verification of compliance with the monitoring plan.

• Reports should include a summary of what the monitor reviewed and the monitor's statements concerning the significant findings/facts, deviations and deficiencies, conclusions, actions taken or to be taken and/or actions recommended to secure compliance.

• The review and follow-up of the monitoring report with the sponsor should be documented by the sponsor’s designated representative.

• Reports of on-site ...should be provided to the sponsor ...in a timely manner for review and follow up.

• Reporting of centralized monitoring activities should be regular and should be before every planned onsite monitoring site visit.

Answer explanation

5.18.6 Monitoring Report

(a) The monitor should submit a written report to the sponsor after each trial-site visit or trial-related communication.

(b) Reports should include the date, site, name of the monitor, and name of the investigator or other individual(s) contacted.

(c) Reports should include a summary of what the monitor reviewed and the monitor's statements concerning the significant findings/facts, deviations and deficiencies, conclusions, actions taken or to be taken and/or actions recommended to secure compliance.

(d) The review and follow-up of the monitoring report with the sponsor should be documented by the sponsor’s designated representative.

ADDENDUM

(e) Reports of on-site and/or centralized monitoring should be provided to the sponsor (including appropriate management and staff responsible for trial and site oversight) in a timely manner for review and follow up. Results of monitoring activities should be documented in sufficient detail to allow verification of compliance with the monitoring plan. Reporting of centralized monitoring activities should be regular and may be independent from site visits.