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# Incorporate Risk Management in Clinical Research: Imarc
- URL: https://www.fdaweb.com/incorporate-risk-management-in-clinical-research-imarc/
- Published: 2016-07-13T12:00:00.000Z
- Updated: 2026-09-14T21:14:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136165

Imarc Research says in an online [post](http://cdn2.hubspot.net/hub/149400/file-2102327449-pdf/docs/RiskManagementCR.pdf?%5F%5Fhssc=29837664.1.1468426422816&%5F%5Fhstc=29837664.ad62fed4a7a26d422f70a69dfc6105c3.1457558241991.1457558241991.1468426422816.2&%5F%5Fhsfp=2299669380&hsCtaTracking=6e1846a9-0a86-41f7-8f5d-c2242dfb6235%7Cc08358df-3370-4a96-b890-3d11cfd332e9&ref=fdaweb.com) that the release of FDA and European Medicines Agency guidances on incorporating risk management strategies in the clinical research industry, sets an expectation for implementation of quality principles and risk-based decision-making. “It is the responsibility of the industry to incorporate these concepts into existing quality procedures and apply risk management techniques into the clinical research process,” Imarc says.

The post discusses the 8/2013 FDA final guidance “Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring,” and lists focus areas including protocol and case report form design, clinical investigator training and communications, delegation of monitoring responsibilities to a contract research organization, and clinical investigator site selection and initiation.