E6: Monitoring Report/Plan

Question 1

5.18.6 Monitoring Report

a.

Answer 1

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

Question 2

Monitoring Report

b.

Answer 2

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

Question 3

Monitoring Report

c.

Answer 3

Monitor 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.

Question 4

Monitoring Report

d.

Answer 4

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

Question 5

Monitoring Report

e.

Answer 5

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

Question 6

Monitoring Plan

5.18.7

Answer 6

The sponsor should develop a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial. The plan should describe the monitoring strategy, the monitoring responsibilities of all the parties involved, the various monitoring methods to be used, and the rationale for their use. The plan should also emphasize the monitoring of critical data and processes. Particular attention should be given to those aspects that are not routine clinical practice and that require additional training. The monitoring plan should reference the applicable policies and procedures.