Regulatory requirements sponsors

The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs [standard operating procedures] to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s). ... 

The use of an alert card is not a specific regulatory requirement. However, in many clinical trials, it is appropriate that an alert card is given to subjects, particularly if they are outpatients. In an emergency, the alert card will identify that the subject is in a clinical trial and provide information on the nature of the clinical trial and whom to contact for information. The alert card should contain the sponsor s name and address (if appropriate), investigator s name, address and telephone number, with a 24-h contact number (the contact should have knowledge of the study and not just be an on-calT physician), the protocol number, the indication (perhaps modified to be more acceptable to the subject) and the subject s name and address and identification number. 

The new European Directive (2001/20/EC) has reinforced the need for European agencies, as well as those of the United States and Japan, to conduct inspections of clinical trials. Sponsors, mindful of the implications of failed inspections, are carrying out audits by their QA units to try to ensure that standards at a particular site meet the regulatory requirements of GCP, and of any future regulatory inspection. Frequently, the inspections will occur 2 or more years after the end of the study. 

There are many regulatory requirements for new drug development and approval. Before a sponsor submits a request for a drug to be registered for human use, a tremendous amount of highly specified laboratory testing, nonclinical work, and clinical trials need to be performed. In all cases, the procedures and results must be documented appropriately. From a regulatory perspective, if the research is not documented, for all intents and purposes, it has not been done. 

To prepare an IB, the sponsor s representative must understand the fundamental purpose and uses of the IB, the basic format and content of sponsor IBs, the clinical pharmacology and toxicology findings, the investigational product-disease relationships, the international regulatory requirements governing IBs and the indications and safety profile of the investigational product. 

According to ICH GCP guideline 4.9.5, records are to be retained until at least two years after the last approval of a marketing application. Records may be retained for even longer periods if required by applicable regulatory requirements or if required by the sponsor. 

ICH GCP (1995) defines an audit as A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor s SOPs, GCP and the applicable regulatory requirements). ... 

Analytical methods must be adequately validated following regulatory requirements and adequate validation documents should exist. Computerized systems must be validated and the reporting of laboratory results to investigator sites, CROs, monitors and sponsors should be clearly described. 

The FDA plays a major part in the prevention and detection of research fraud and misconduct. The FDA carries out two different types of reviews. Study-orientated audits are conducted on clinical trial data itself, in order to ensure patient eligibility, and investigator-orientated inspections can be carried out either routinely or because a sponsor has concerns. If the inspectors have reason to believe that a site has not complied with regulatory requirements or has engaged in fraudulent activity - for which the definition in the Federal Code is very similar to that of the Wellcome Trust - they have the power to disqualify the investigator from taking part in further research, or severely restrict his activities. Such findings are widely publicized both within and outside the United States on the so-called Black List . 

The FDA requires each PI to comply with GCP and other applicable regulatory requirements, permit monitoring and audits by the sponsor and the FDA, and maintain a... 

Going out of business is often a sudden and unplanned event for a laboratory. Under such circumstances, personnel from the lab ceasing operations may not show proper concern for complying with regulatory requirements. The party with the greatest stake in preserving the records of a study, namely the sponsor, may therefore have to assume responsibility for the preservation and transfer of the records to the sponsor s location and for notifying the FDA of the transfer. 

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