Good clinical practice reporting

Clinical trials must be conducted in accordance with the principles of Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Its purpose is twofold ... 

World Health Organization (WHO). Technical Report Series, No. 850. Annex 3 Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products. Geneva, Switzerland World Health Organization, 1995 (Modified 2000). 

The verification of compliance with the standards of good clinical practice and the need to subject data, information and documents to inspection in order to confirm that they have been properly generated, recorded and reported are essential in order to justify the involvement of human subjects in clinical trials. 

All clinical trials, including bioavailability and bioequivalence studies, shall be designed, conducted and reported in accordance with the principles of good clinical practice. 

WHO. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. Geneva World Health Organization 1995 [cited 2008 Jan 13]. (WHO Technical report series no. 850, annex 3). Available from URL http //www.who.int/ medicines/library/par/ggcp/ GGCP.shtml... 

WHO (1995) Guidelines for good clinical practice for trials on pharmaceutical products. Geneva, World Health Organization (WHO Technical Report Series No. 850). 

Good clinical practices govern the approval, conduct, review, and reporting of clinical research intended for submission in an NDA. The U.S. GCPs as enforced by the FDA are delineated in the following documents ... 

Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. For more information on the FDA s GCP program, go to http //... 

Quality Assurance (QA). All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s). 

Good Clinical Practice (GCP) The standard by which clinical trials are designed, implemented and reported so that there is public assurance that the data are credible, and that the rights, integrity, and confidentiality of subjects are protected. [Defined for this book.]... 

Figure 11.5 ICH GCPGuidelinesforSAEandAEreport-ing [Source Safety Reporting Guideline for Good Clinical Practice]...

Premises where clinical studies are to be conducted are open to inspection by the GCP Inspectorate set up by the MHRA in accordance with the EU Directive on good clinical practice. The inspectorate is required to give a preliminary oral report at the conclusion of the inspection and a written report within 30 days. 

The report of a bioequivalence study should give the complete documentation of its protocol, conduct and evaluation complying with good clinical practice rules (4). The relevant ICH guideline (13) can be used in the preparation of the study report. The responsible investigator(s) should sign their respective sections of the report. Names and affiliations of the responsible investigator(s), site of the study and period of its execution should be stated. 

Expert reports are not a promotion platform for the product but an assessment of the data generated, an explanation of the results and an interpretation. An expert report should not normally exceed 25 pages of A4. Reports should also make clear whether or not the preclinical studies submitted have been conducted according to good laboratory practice, and whether the clinical studies have been conducted according to good clinical practice principles and in accord with the Declaration of Helsinki. 

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