Clinical Research

Data integrity is critical to good clinical research, and the first step in ensuring data integrity is to involve the best physicians and scientists who have a personal and professional stake in conducting high quality studies. The second step is to put in place a system of checks and balances to ensure that no inconsistencies are unresolved.

Merck Frosst regionally based data monitors travel to every clinical trial site and check that the data are documented appropriately and supported by the official source documents. Merck Frosst conducts a targeted verification of clinical trial data- data points are checked against a source document such as patient records or workbooks.

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Trial data are then entered into a computerized database by biomedical research associates or directly by site personnel. During data entry, computer-generated queries are run and workbooks are checked to ensure consistency from page to page. All inconsistencies and queries are returned to the site for resolution.

Clean data are transmitted to Merck & Co., Inc. in the US, where they are checked again and added to the larger database for the entire international trial. When all the data from the trial have been collected and verified, Merck & Co., Inc. statisticians analyze them and prepare the results.

At any time during the clinical trial, any of the sites may be audited by internal Merck auditors, or by governmental auditors. Auditors review all procedures associated with the conduct of the trial, and ensure that both the Good Clinical Practice standards and the policies and procedures of Merck & Co., Inc. are adhered to. In Canada, the Therapeutic Products Program (TPP), a division of Health Canada, has the authority to conduct audits of Canadian clinical sites and of pharmaceutical companies clinical research files.