Contract Research Organizations monitoring

Sponsor Monitoring. Another important oversight process to ensure quality, compliance, and subject safety, monitors may be employees of the sponsor s medical staff or a contract research organization, or may be independent contractors. In each... 

Lack of adequate trial monitoring by the sponsor or contract research organization (CRO) ... 

Quantitation of drags and their metabolites in biological matrices currently is one of the most important applications of LC-MS. This can be attributed to the greatly enhanced selectivity and reliability of the analysis, as compared to LC-UV. Selective reaction monitoring (SRM) in tandem mass spectrometry (MS-MS) has become the method-of-choice in quantitative bioanalysis. Ample examples are described in literatnre. Even a larger number of successful examples are hidden in the archives of pharmaceutical companies and contract research organizations. 

Compliance Program 7348.810 - Bioresearch Monitoring - Sponsors, Contract Research Organizations and Monitors, 2001. http // www.fda.gov/ora/compliance ref/bimo/7348 810/default. htm, http //www.fda.gov/ora/ compliance ref/bimo/7348 810/48-810.pdf. 

Forged consent forms are one of the most common types of research fraud. A monitor from a Contract Research Organization (CRO) took the trouble to lay out all the patient consent forms at one site side by side. She noticed that the patients signatures looked similar to each other and some of the letters... 

Contract research organizations (CROs) should be inspected as part of the assessment process to verify that raw data correspond to submitted data, and to assess compliance with standards during the conduct of clinical and bioequivalence studies. Monitoring and requalification should ensure that the principles of good clinical practices (GCP) (20), good practices for quality control laboratories (10) and GLP (19) are adhered to. 

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