"Clinical Trial Monitoring refers to the methods used by sponsors of investigational studies or CROs delegated responsibilities for the conduct of IND studies, to oversee the conduct of, and reporting of data from, clinical investigations, including appropriate CI supervision of study site staff and third-party contractors. Monitoring activities include communication with the CI and study site staff; review of the study site’s processes, procedures, and records; and verification of the accuracy of data submitted to the sponsor. " FDA Guidance 2013
Monitoring of clinical trials is necessary to assure that
- rights and safety of patients (i.e. human subjects) are protected
- reported trial data are accurate, complete, and verifiable from the source of documents
- conduct of trails in compliance with the protocol, good clinical practice (GCP), and applicable regulatory requirements
Clinical Trial Visit by Sponsors
- Pre-study Qualification Visit
- Initiation Visit
- Monitoring Visit
-Closeout Visit
Pre-study Qualification Visit
- The purpose of the qualification visit is to assess the site's ability to conduct the clinical trial prior to the initiation of the investigation.
- During this visit the clinical research associate or the sponsor representative
- Visit the site
- Meet with study staff
- Inspect the facilities
- Assess Site Documentation Source & Practice
- Document investigator experience, workload, participation
- Document Patient source, staff allocation, adequacy site, and lab facilities
- 2-3 hours for the visit
Initiation Visit
- The purpose of the initiation visit is to assure that PI and staff understand their obligations of the study conduct, and to identify potential problems and concerns.
- During this visit, the sponsors provide describes the expectation such as
Monitoring of clinical trials is necessary to assure that
- rights and safety of patients (i.e. human subjects) are protected
- reported trial data are accurate, complete, and verifiable from the source of documents
- conduct of trails in compliance with the protocol, good clinical practice (GCP), and applicable regulatory requirements
Clinical Trial Visit by Sponsors
- Pre-study Qualification Visit
- Initiation Visit
- Monitoring Visit
-Closeout Visit
Pre-study Qualification Visit
- The purpose of the qualification visit is to assess the site's ability to conduct the clinical trial prior to the initiation of the investigation.
- During this visit the clinical research associate or the sponsor representative
- Visit the site
- Meet with study staff
- Inspect the facilities
- Assess Site Documentation Source & Practice
- Document investigator experience, workload, participation
- Document Patient source, staff allocation, adequacy site, and lab facilities
- 2-3 hours for the visit
Initiation Visit
- The purpose of the initiation visit is to assure that PI and staff understand their obligations of the study conduct, and to identify potential problems and concerns.
- During this visit, the sponsors provide describes the expectation such as
- Roles and responsibility of PI,
- Protocol procedures,
- CRF completion instruction review,
- Requirement for records management and retention
- Drug handling requirements
- Enrollment and Consent procedures
- Adverse event reporting procedure
- Patient recruitment process
Timing of the visit:
-The visit occurs prior to the patient enrollment, after all the documentation are in place, supplies are received, and IRB approval of the study protocol
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