Monitor Responsibilities - ICH

Question 1

Purposes of Trial Monitoring

Answer 1

1) Rights and wellbeing of human subjects are protected
2) The reported trial data is accurate, complete, and verifable from source documents
3) The conduct of the trial is in compliance with the currently approved protocol/amendments, with GCP, and with applicable regulatory requirements

Question 2

Who appoints monitors?

Answer 2

Sponsors

Question 3

Monitor’s Responsibilities

Answer 3

1. Main line of communication between the sponsor and investigator
2. Verifying for the investigational product:
   -that storage times and conditions are acceptable
   -that products are supplied only to those who are eligible to recieve it
   -that subjects are provided with necessary instruction on proprly sing, handling, storing, and returning the IP
   -that the receipt, use, and return of the IP at trial sites are controlled and documented
   -Disposition of unused IP at the trial sites complies with applicable regulatory requirements
3. Verifying the investigator follors approved protocol
4. Verifying written consent was obtained before each subjects participation in the trial
5. Ensuring investigator recives IB and all documents, trial supplies needed to conduct the study properly
6. Ensuring investigator and the investigator’s trial staff are afequately informed about the trial
7. Verifying the investigator and it’s staff are performing the specified trial functions in ccordsnce with the protocol
8. Verifying the investigator is only enrolling elgiible subjects
9. Reporting subject recruitment rate
10. Verifying source documents are accurate, complete, up to date, and maintained
11. Verifying the investigator provides al reports, applications, submissions, etc
12. Checking the accuracy and completeness of the CRF entires, source documents, and other trial related documents
13. informing the investigator of any CRF entry error, omission, or illegibility
14. Determining whether all AEs are appropriately reported within time periods required by GCP, the protocol, the IRB/IEC, the sponsor, and the applicable regulatory requirements
15. Determining whether the investigator is maintaing the essential documents
16. Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator

Question 4

When should a Monitoring Report be submitted?

Answer 4

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

Question 5

Who is responsible for developing a monitoring Plan?

Answer 5

Sponsor should develop monitoring plan

Question 6

Types of Monitoring

Answer 6

1. On site (occurs before, during, and after a trial)
2. Central (can aid with on site)

Question 7

Who is the main line of communication between a sponsor and investigator?

Answer 7

a monitor

Question 8

What are a monitor’s qualifications

Answer 8

Trained by scientic AND/OR clinical knowledge