Good Clinical Practice standard operation procedures

Statisticians in the Pharmaceutical Industry (PSI), at http //www.psiweb.org. They have published the excellent Guidelines for Standard Operating Procedures for Good Statistical Practice in Clinical Research, at http //psiweb.org/pdf/gsop.pdf. 

Provision of adequate competent medical staff is essential for the safe and ethical conduct of studies in humans. Decisions about whether a volunteer fulfils the entry criteria for a healthy subject or should be withdrawn from a study, how to respond to an unexpected adverse event and when to discontinue a study can prove challenging to the most experienced physician. Similarly, research nurses need many organisational and other skills over and above those that they acquired during their basic clinical training. Scientific staff must be competent in the techniques that will provide the essential data. All must be properly briefed about what will be required of them during the course of a study, and must be fully familiar with local standard operating procedures (SOPs) in compliance with good clinical practice (GCP). 

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. 

Based on Step 4 of the ICH Good Clinical Practice (GCP) guideline of May 1996, the Japanese Ministry of Health and Welfare (MHW) prepared an amendment to the previous GCP guideline and on 27 March 1997 this was issued as MHW Ordinance of the Standards for Good Clinical Practice . This new GCP became effective as of 1 April 1997 with some moratoria (preparation of standard operating procedures (SOP) at medical institutes, source data verification, etc.), and full implementation was from 1 April 1998. Unlike the previous GCP guidelines, the new GCP is based on the revised Pharmaceutical Affairs Law of June 1996, which requires... 

If the bioanaiyticai method is performed according to good laboratory practice (CLP), the method is described in a standard operating procedure (SOP) and the validation method is reported accordingly. In general, validated methods are used in preclinical development for toxicokinetic studies and in clinical development for all studies in which pharmacokinetics is evaluated. 

Current good manufacturing practices (cGMPs) Practices or procedures that the regulatory agencies currently consider to be the standard, accepted manner of operation for products made for human consumption either in a clinical or commercial venue. 

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