Can non-regulators audit Independent Ethic Committees (IEC), and if so, how?

A number of guidelines and directives have reinforced the need for a more formalised approach to Independent Ethic Committees (IECs) and support the need to audit IECs. The key elements of an audit of an IEC are reviewed within the context of the European Guidelines for Auditing Independent Ethics Committees published by the European Forum for Good Clinical Practice (EFGCP). Auditing requirements in these recent guidelines and the EU Clinical Trial Directive are discussed as well as the methodology and type of documentation and SOPs that should be present at an audit. It is argued that both inspectorates and independent auditors need to conduct such audits to improve the overall global standard.

Is ICH exportable outside the European Union?

This article sets out to explore whether or not the International Conference on Harmonisation (ICH) Good Clinical Practices (GCP) Guidelines are exportable outside the European Union (EU). It is not a question of whether the Guidelines per se are exportable but rather can studies outside the EU be performed to the same, or a better standard? It is well known that the ICH Guidelines are accepted worldwide in the countries where International Clinical Trials are carried out. Likewise with the signatories to the Step 5 document being the major players--the USA, Japan, and Europe--the guidelines are already enshrined in national legislation. The author therefore sets out to address whether clinical trials can be conducted to the ICH GCP standard outside Western Europe. The facts and opinions presented here are based on a 16 centre (of which eight of the centres were required to be audited by the Sponsor) clinical study that was carried out in both the Czech Republic and Poland for nonseasonal rhinitis. The recruitment of patients was required to take place in a short period of time and had strict inclusion and exclusion criteria. The overall concept of the study and the compliance with internationally accepted ICH GCPs was found to be of a very high standard. In addition, several other studies from totally different therapeutic areas, clearly show that the standard in non-EU countries is equally high and in most cases of a higher standard than is seen at the principal investigators sites within the EU. In what Western Europeans like to call "developing countries," an understanding of the international GCPs has already been grasped and extremely high quality clinical trials are being carried out. To demonstrate this, attention is drawn to a large head and neck cancer study that was part device and part pharmaceutical product and was conducted in conjunction with photodynamic therapy (PDT), carried out in several countries, but of note in India.

Essentials of quality in "the gold standard veterinary clinical trial".

Quality Assurance (QA) has played a pivotal role within Good Laboratory Practice (GLP) since its inception in 1976. GLP is now recognized as a quality standard, as can be seen from the introductory statement of the recently issued OECD Principles of GLP (revised in 1997) that clearly state "GLP is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported". We can, therefore, see a close comparison between GLP compliance and the ISO/EN accreditation systems that have been adopted by other institutes on a worldwide basis.

The changing role of quality assurance: an international industry perspective.

As a Scientific Consultant in the area of Good Laboratory Practice and Good Clinical Practice the author has been involved with Quality Assurance (QA) for 18 years and fells the time has come for Industry to explore a better way to utilize the many talents that the QA professional has achieved. They have a wealth of expertise and should become more involved in the integration of "science" with the many "GXPs" to ensure that compliance is arrived at on a cost benefit basis for the company.

The inspection of drug metabolism and pharmacokinetic studies.

Areas in which the regulations apply must be discussed to ensure that an overall standard of "good practice" is applied to Absorption Distribution Metabolism Excretion (ADME) as an integral part of the safety testing program. There are specific problems in adapting the toxicology regulations for drug metabolism and pharmacokinetic studies. In reviewing the laboratories and their experimental procedures, an attempt to identify, through an auditing approach, how a drug metabolism laboratory can comply with regulations is presented. It must be regarded as of paramount importance that all work be carried out to the highest standards to allow the largest margin of safety. With these experiences, ADME Laboratories "new" to Good Laboratory Practice can proceed along the compliance pathway with minimum trauma to man, animal, and machine.

European Good Laboratory and Clinical Practices: their relevance to clinical pathology laboratories.

The requirements for Good Laboratory (GLP) and Good Clinical Practices (CGP) were established as a matter of urgency by the United States in the early 1970s. These were in response to gross misconduct and, in many instances, fraud. Over the next 15 years, a plethora of regulatory principles, guidelines, and regulations was produced by many countries of the world, culminating in single standards for European, Japanese, and United States authorities. Although with regard to GLP this has basically become a worldwide recognized standard within the preclinical (toxicology) studies, in the veterinary, chemical, agrochemical, and pharmaceutical industries, the GCPs are now seeing a rebirth. Within a clinical trials environment, there is most certainly a requirement for compliance with GCP, especially with regard to the harmonization of data within the European Community. The goal of this article is to cover the following aspects: Why should we have good practices? Why should laboratory data be audited? Why is there a need for a QA unit or function? What is the QA operational approach? How does a laboratory audit take place within laboratories? In discussing the laboratories and their subsequent data audits, the pitfalls and benefits are addressed and an examination of the data from the sponsor's viewpoint is compared with that produced by the laboratory. The types of laboratories present in a clinical environment are examined. They obviously comprise clinical pathology, microbiology, and analytical as well as ancillary hospital areas such as X-ray and cardiology. These laboratories may also be in the private sector, the National Health Service, contract laboratories, universities, or the general practitioner population.(ABSTRACT TRUNCATED AT 250 WORDS)

Recommendations for standards of sedation and patient monitoring during gastrointestinal endoscopy.

(1) Safety and monitoring should be part of a quality assurance programme for endoscopy units. (2) Resuscitation equipment and drugs must be available in the endoscopy and recovery areas. (3) Staff of all grades and disciplines should be familiar with resuscitation methods and undergo periodic retraining. (4) Equipment and drugs necessary for the maintenance of airway, breathing, and circulation should be present in the endoscopy unit and recovery area (if outside the unit) and checked regularly. (5) A qualified nurse, trained in endoscopic techniques and adequately trained in resuscitation techniques, should monitor the patient's condition during procedures. (6) Before endoscopy, adverse risk factors should be identified. This may be aided by the use of a check list. (7) The dosage of all drugs should be kept to the minimum necessary. There is evidence that benzodiazepine/opioid mixtures are hazardous. (8) Specific antagonists for benzodiazepines and opioids exist and should be available in the event of emergency. (9) A cannula should be placed in a vein during endoscopy on 'at risk' patients. (10) Oxygen enriched air should be given to 'at risk' patients undergoing endoscopic procedures. (11) The endoscopist should ensure the well being and clinical observation of the patient undergoing endoscopy in conjunction with another individual. This individual should be a qualified nurse trained in endoscopic techniques or another medically qualified practitioner. (12) Monitoring techniques such as pulse oximetry are recommended. (13) Clinical monitoring of the patient must be continued into the recovery area. (14) Records of management and outcome should be collected and will provide data for appropriate audit.

Future needs for ERCP: incidence of conditions leading to bile duct obstruction and requirements for diagnostic and therapeutic biliary procedures.

Although the development of endoscopic methods of treatment for biliary obstruction has proceeded rapidly in recent years, endoscopic retrograde cholangiopancreatographic (ERCP) services are patchily distributed. A recent survey by the British Society of Gastroenterology has shown that almost half the district general hospitals questioned did not have a sphincterotomy service available locally. To assess the level of provision required, two investigations have been undertaken. Firstly, an epidemiological study of bile duct obstruction has been carried out in the South Western Region. Secondly, the actual surgical and endoscopic workload in treating obstructive jaundice has been analysed in two health districts. Using present incidence and treatment rates at least 50 ERCPs per 100,000 of the population per year are estimated to be required in the future. Surgical treatment rates can be expected to fall as the number of therapeutic ERCPs increases. The implications of this estimate in equipment and staffing terms are discussed.