ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

ICH E6(R3) Guideline

storing, using, handling, returning and destroying, or alternative disposition of the investigational product(s);

(v)

That the receipt, storage, use, handling, return and destruction or alternative disposition of the investigational product(s) are controlled and documented adequately; That the disposition of unused investigational product(s) complies with applicable regulatory requirement(s) and is in accordance with the sponsor requirements; Where product available on the market is dispensed and used in accordance with applicable regulatory requirements, some of the previously outlined considerations may not be applicable.

(vi)

(vii)

3.11.4.5.4

Monitoring of Clinical Trial Data

(a)

Verifying that the investigator is enrolling only eligible trial participants.

(b)

Checking the accuracy, completeness and consistency of the reported trial data against the source records and other trial-related records and whether these were reported in a timely manner. This can be done on the basis of using samples and supported by data analytics, as appropriate. The sample size and the types of data or records may need adjustment based on previous monitoring results or other indications of insufficient data quality. Monitoring should: Verify that the data required by the protocol and identified as data of higher criticality in the monitoring plan are consistent with the source; (i)

(ii)

Identify missing data, inconsistent data, data outliers, unexpected lack of variability and protocol deviations;

(iii)

Examine data trends, such as the range, consistency and variability of data within and across sites;

(c)

Identifying significant errors in data collection and reporting at a site or across sites, potential data manipulation and data integrity problems.

3.11.4.6 Monitoring Report

(a) Reports of monitoring activities should include a summary of what was reviewed, a description of significant findings, conclusions and actions required to resolve them and follow-up on their resolution including those not resolved in previous reports. The requirements of monitoring reports (including their content and frequency) should be described in the sponsor’s procedures.

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