Version No: 1.0 / Clinical Research Centre / Page 1 of 2
Date: dd/mm/yyyy / Study Monitoring Management / WI-G-3-07-01

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The Director, Clinical Research Centre

STUDY MOITORING MANAGEMENT

  1. Study Monitoring Setup and Study Initiation
  2. Specification of Source Data Verification
  3. Identify study variables to be verified.
  4. Specify sample of data for verification.
  5. Specify source data location.
  6. Prepare SDV specification document.

1.2Preparation of Source Data Verification Documents

1.2.1Prepare a trial specific SDV checklist by using WS-G-3-07-01.

1.2.2Prepare a trial specific source data location list by using TP-G-3-07-01.

  1. Study Monitoring Function During Study Conduct

2.1Communication with Site

2.1.1Maintain on-going contact with study sites by telephone contacts, emails, faxes and/or letters throughout the conduct of the study.

2.2Preparation for on-site monitoring visit

2.2.1Schedule for mutually agreed site visit. Prepare centrally prior to the conduct of on-site visit.

2.3Conduct of on-site monitoring

2.3.1 Accomplish the following tasks:

  1. Review of study staff, facilities and resources
  2. Review of Investigator Study File
  3. Check on informed consent
  4. Check on subject eligibility, enrolment and recruitment
  5. Check on randomization and blinding procedures
  6. Verify CRF against source document
  7. Check on completion of case report forms
  8. Check on safety (AE and SAE) reporting and follow- up
  9. Check on IP handling and accountability
  10. Check on laboratory procedures and specimen handling
  11. Check on study materials and clinical supplies

2.4Preparation of monitoring report

2.4.1Complete Study Monitoring Site Visit Report within one week following the completion of each site visit.

2.5Preparation for on-site monitoring visit

2.5.1 Follow-up with the site by sending a feedback letter within five days after on-site visit.

  1. Study Monitoring Function During Closeout

3.1Archiving and Documentation

3.1.1Prepare all documents, including electronic copy if available, to be archived. This is intended to provide sufficient documentation to permit the reconstruction of study monitoring activities of the original study.

3.1.2 Perform monitoring of archival documents using WS-G-3-07-02. The study monitoring component of the final study archive should include, but are not limited to the following:

  1. Study Monitoring Plan
  2. Study Monitoring Site Visit Report
  3. Study Monitoring Notification Letter
  4. Study Monitoring Feedback Letter
  5. Source Data Verification Checklist
  6. Study Monitoring related correspondence
  7. Study Monitoring Summary Report
  8. Study Monitoring Interim Report
  9. Study Monitoring Final Report
  10. Monitor’s Visit Log
  11. Communication Log

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