Good clinical practice sponsor

Study monitors or clinical research associates (CRAs) can be employed by the study sponsor, CRO, or independently contracted for a specific study and, according to the International Committee on Harmonisation (ICH) and formalized by FDA in the Guidance for Industry Good Clinical Practice (GCP), the purpose of a CRA is to ... 

Corrections are made by the site representative directly onto the CRF page and then faxed back to the sponsor. If fax technology is not used, a copy of the corrected CRF page is made and sent to the sponsor by mail or courier. Good clinical practice requires that all corrections must be dated and initialed by the site representative. 

Clinical Trials, 1994. The rules of good clinical practice (GCP) have been partly incorporated in the Directives. A prominent feature is that it is the investigator rather than the sponsoring company who will be responsible for most aspects of the trial. Following are the main features of the rulings ... 

The second most important criterion is compatibility. Are the CRO s procedures and practices compatible with the sponsor s Is the chemistry between the CRO and sponsor good The sponsor should examine the CRO s standard operating procedures (SOPs) and talk with CRO staff to determine not only whether the CRO is meeting the requirements of good clinical practices (GLP), but also whether its practices closely parallel the sponsor s. CROs sometimes claim they can work according to the sponsor s SOPs , but the results are likely to be disappointing if the two companies have vastly different approaches or use incompatible technologies. 

Note the acronym CRO is used throughout this document to refer not only to a contract research organization (CRO), but also to any organization involved in the conduct or analysis of in vivo bioequivalence studies. As defined in the International Conference on Harmonisation (ICH) Tripartite Harmonised Guidelines, Guidelines for Good Clinical Practice (5), a CRO is a person or an organization (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor s trial-related duties and functions. 

Since finalization in 1996, the International Committee on Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP) underpinned by the ethical principles of the Declaration of Helsinki have been the cornerstones upon which most clinical research has been conducted outside the United States (1,2). However, in such a widely disparate and expanding territory as Europe (EU), the national differences in complying with local national requirements have presented a highly resource-hungry administrative workload for sponsors. 

Good Clinical Practice (GCP) regulations in the United States and the ICH guidelines, which meet safety, ethical and efficacy requirements, are comprehensively covered in the clinical research development chapters. Investigator, sponsor, and monitor obligations are detailed and applied practically. Institutional Review Boards (IRBs), Independent Ethics Committees (IECs), and Informed Consent (IC) will be discussed fully along with the... 

The CBETS asks what tasks the sponsor needs to have done to meet its drug development goals and objectives. The primary tasks of clinical research and good clinical practice can be described rather precisely. Once one knows what the major tasks are and what activities are needed to accomplish these tasks, one can define the knowledge and skills needed by staff to complete the tasks and, finally, what education and training should be provided to imderstand the knowledge and skills. 

The sponsor has to explain how the drug is to be manufactured, tested and stored. The important criterion is to ensure that it is safe for the subjects of the clinical trials. The CMC is a living document it is updated as the clinical trials proceed from Phase I to Phases II and III and eventually to a licensed product. In essence, the CMC describes the adherence to Good Manufacturing Practice (GMP) for the manufacture of the trial drug. The subject of GMP is described in Chapters 9 and 10. 

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