Conducting Clinical Trial Monitoring

Clinical trial monitoring includes those activities that ensure that the study is being conducted according to the protocol. Monitoring permits an in-process assessment of the quality of the data being collected. The first alert to safety issues is often revealed during the process of monitoring the clinical trial.

Monitoring clinical studies involves the act of overseeing the progress of a clinical trial. Monitors ensure that the study is conducted, recorded and reported in accordance with the protocol. This is accomplished by the review of CRFs on-site for possible errors, inconsistencies, and omissions. The monitor identifies errors and discrepancies that require discussion with the investigator or staff and any safety questions or issues. The monitor compares CRFs with source documents, confirming that source data are consistent with CRF entries, identifies all serious adverse events, resolves previous and current CRF queries, and confirms completeness of investigator records and files.

To be a successful monitor, the sponsor representative should know: how to interpret hospital/ clinic records/charts, laboratory tests, and interpretations; has to query resolution procedures; protocol and CRF data requirements; medical nomenclature; Serious adverse event (SAE) procedures; and health authority requirements. In addition, a monitor needs to have excellent interpersonal communication and problem-solving skills.

Clinical monitoring requires clinical, interpretive, and administrative skills. The monitor needs to confirm subject selection and patient enrollment compliance. Quality monitoring will always include and confirm the following activities:

• Properly obtained informed consent.

• Adherence to the protocol procedures and inclusion/exclusion criteria.

• Transcription of data from source documents to the CRF that is both consistent and logical.

• Identification of any safety issues, including serious adverse events.

• Proper accountability and reconciliation of drug supplies.

• Continued adequacy of facilities and staffing.

The frequency of clinical monitoring depends on the actual accrual rate of the patients. Complex studies may need to be visited more frequently, depending on the accrual rate of subjects, the amount of data, and the number of visits. Generally, most investigators should be monitored every 4-6 weeks. Sufficient time for good monitoring practices should be anticipated by the monitors. Following a monitoring visit, the monitor will prepare a monitoring report for sponsor records and follow-up correspondence to the trial site. The monitor may need to plan intervention and possible replacement of non-performing or non-compliant trial centers.

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