Regulatory requirements protocol

Name and description of the investigational product(s). A summary of findings from non-clinical sfudies and from clinioal trials that is relevant to the trial. Summary of the known and potential risks and benefits, if any, to human subjects. Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s). A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s). Description of the population to be studied. References to literature and data that are relevant to the trial, and that provide background for the trial... 

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). ... 

A formal written protocol suitable to fill regulatory requirements must be on hand and signed. 

Verify that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCPs, and with applicable regulatory require-ment(s). 

Is there a statement that the clinical trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirements ... 

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. 

Finding 2. Decisions on the end use and identification of the ultimate owner of Johnston Island or other chemical disposal facilities have not been reached in a timely way. For J AC ADS, the need for prompt action on this matter at a high level was pointed out in a letter report of this committee dated May 4, 2000 (NRC, 2000a). Regulatory requirements and analytical procedures/protocols to meet end-state requirements for JAC ADS were not completed as of the writing of this report. 

In many commercial situations and under some regulatory requirements, trade-offs arise between measurement costs and the aim of low uncertainty in measurement. Clear relevant statements associated with the protocol are needed. For example, whereas normally U must be made equal to or smaller than a set tolerance, a protocol may for technical and economic reasons explicitly permit a less stringent requirement (see Fig. 1). 

In fact, method validation is merely the final step in the dynamic process of method development. The emphasis must be placed on the development stage, since any well-developed method can be successfully validated. Initial method development must therefore be undertaken with both the regulatory and technical requirements of validation in mind. While the emphasis is placed on method selection, sufficient development time is provided to ensure that the method meets both its technical and regulatory requirements. Only after this development stage is the testing procedure and validation protocol documentation finalized. 

Relationship of shipping and storage conditions to stability studies Compliance with internal company and regulatory requirements Review, approval, and revision process, especially QA involvement Reason and justification for protocol amendments, especially... 

The appropriate response to this observation would be for the firm to revisit its supplier qualification policy and procedures to ensure that they meet current regulatory requirements as well as internal quality standards. Second, the firm will present the agency with a package of new and improved procedures and an umbrella policy related to a state-of-the-art vendor qualification program. These procedures will ensure that all critical suppliers are audited and monitored appropriately in accordance with predetermined criteria and audit protocols. Audit protocols will be designed to meet the unique aspects of every supplier. 

Select qualified investigators and obtain from them a commitment to conduct the investigation study in accordance with the protocol and all regulatory requirements. 

The above procedures are specified in the site s waste analysis plan and RCRA permit and thus are required by law. For Dow Chemical Company sites that use off-site facilities for treatment and disposal, these same protocols are generally used because of the requirements established by the off-site facilities permits or regulatory requirements for receipt of hazardous wastes. 

The analytical protocols used to characterize hazardous wastes are primarily the EPA-approved methodologies found in their publication Test Methods for the Evaluation of Solid Waste, Physical/Chemical Methods, SW-846. Because these methodologies are a part of the waste analysis plan and the feed-stream analysis plan, they are required by the facility s RCRA permit. In the case of the feedstream analysis plan and the LDRs, adherence is required to meet specific regulatory requirements. Occasionally, DuPont will analyze streams for hazardous constituents or properties other than those required under the permit or regulations in order to address a specific issue (e.g., to determine if the stream can be recycled). Analyses like these should be considered not as an industrial best practice but only as an internal planning aid. 

Because the framework of every clinical research study relies on a number of interdependent disciplines, the development of a clinical study protocol is ideally a multidisciplinary task. Teamwork, coordinated by one experienced person in clinical research with good knowledge of the regulatory requirements for new drug development, is essential. The protocol design team should also include input, recommendations, and review by the following ... 

A validation protocol is a documented, pre-agreed sequence of activities that are to be executed by a nominated team of people who are to review and test the computer system or part thereof. The objective of the protocol is to provide documented evidence that the system is installed correctly and will operate reliably and consistently to meet all user and regulatory requirements. 

The Data Handling and Record Retention section of the protocol will address the requirement to maintain data (whether on a paper CRF or using an electronic data collection tool (DCT)) of each trial subject. It will address expectations of ownership of the completed CRF data, the investigator s responsibility to ensure accuracy and completeness of data recording. This section will also address the requirements for retention of records at the trial site in accordance with relevant guidelines and regulatory requirements. 

QA s task to identify noncompliance with regulatory requirements, the trial protocol and internal procedures such as SOPs is not always an easy job. Communicating deficiencies and highlighting inadequate procedures is certainly a benefit for the company as a whole, but the individual may not appreciate being confronted with audit findings (Winchell, 2004). In order to be efficient and effective in QA, the following should be observed. 

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