Communications clarifications

The Superfund Amendments and Reauthorization Act of 1986 reauthorized CERCLA to continue cleanup activities around the country. Several site-specific amendments, definitions, clarifications, and technical requirements were added to the legislation, including additional enforcement authorities. Title HI of SARA also authorized the Emergency Planning and Community Right-to-Know Act (EPCRA). 

ECHA points out that some materials currently considered as waste might in future be considered to have ceased to be waste [15]. These materials will then be out of the scope of waste legislation, and - if not covered by an exemption - will potentially fall under REACH. Clarification of end-of-waste criteria is a matter for waste legislation. In accordance with the general principle of subsidiarity of the European Union law, and following the revised Waste Framework Directive, Member States may decide case by case whether certain waste has ceased to be waste, where end-of-waste criteria have not been set at Community level. Member States have already worked for use of this regulation, like, e.g., the Waste Quality Protocol in England, Wales, and Northern Ireland [16]. 

By day 100, rapporteur, co-rapporteur, CHMP members and EMEA receive comments from all other members of the CHMP. A consolidated draft list of questions is prepared by the rapporteur and circulated to the members by day 115. A final consolidated list of questions is agreed by the CHMP on day 120 and communicated to the applicant, and the clock of the procedure is stopped (usually up to 6 months maximum). This consolidated list includes any major public health concerns, points for clarification and changes to the SPC, raised by all Committee members. 

Errors can result when ambiguous orders are interpreted in a manner other than what the prescriber intended. Proper expression of doses is vital in a drug order. Pharmacists should be able to recognize improper expressions of doses, and the potential for error, when they see them. When the order is not clear, the pharmacist must contact the prescriber for clarification. Pharmacists and technicians should avoid using dangerous expressions of doses as they process orders, type labels, and communicate with others. The following examples include several improperly expressed orders that were reported to the Institute for Safe Medication Practices (ISMP) ... 

Once the acceptability of the application is established, the primary review begins. Reviewers communicate with other reviewers and with the applicant regarding issues or questions that arise during the review. During the review process, the FDA reviewer may contact the application sponsor to discuss issues and obtain clarifications. Interactions between the review team and the applicant team can range from telephone calls to letters. If the reviewer requests assistance in finding information, it is important to respond quickly. A submission response team that is familiar with the information in the submission and its organization should be available to address questions as they are received. 

Clarification of the FDA s role in gathering and communicating additional information on marketed products risks and benefits. 

Usually one individual in the CRO and one in the sponsor company are given project management responsibilities for the contract activities. However, this should not be interpreted narrowly to mean that all communication must go through these two individuals. Other individuals in each organization should have direct access to their counterparts in the other company for clarification of... 

Entman, R.M. (1993) Framing towards clarification of a fractured paradigm. Journal of Communication 43(4) 51-58. 

The U.S. Pubhc Health Service undertook a comprehensive survey of water supplies in the United States, known as the Community Water Supply Study (CWSS). Released in 1970, the study found that 41% of the systems surveyed did not meet the 1962 standards. Many systems were deficient with respect to various aspects of source protection, disinfection, clarification, and pressure in the distribution system. The study also showed that, although the water served to the majority of the U.S. population was safe, about 360,000 people were being supphed with potentially dangerous drinking water. 

Discrepancy reports are prepared for investigator review and correction. The sponsor translates the computer output into user-friendly reports. There is direct communication between the investigational site coordinator and the data manager for any error messages that may need clarification. 

On the other hcmd, the need to provide the reimbursement system with greater transparency cis far as the reimbursable drugs are concerned also implies clarification of the decision-making process, particulcirly where drugs are excluded from the reimbursement scheme in accordance with the Community rules on the matter. 

QA auditors are often consulted for advice in GCP because of their broad and profound expertise in the regulations. As they acquire knowledge in many areas and oversee a variety of different clinical trials, QA auditors are often requested for information and clarification. This way of interaction with employees and auditees is an opportunity for preventing errors before they occur and for fostering communication between operational staff and QA. Auditors remain aware of day-to-day challenges in clinical research and learn early on about potential misinterpretations. 

Assessing costs and consequences—the value of a pharmaceutical product or service—depends heavily on the perspective of the evaluation. Common perspectives include those of the patient, provider, payer, and society. A pharmacoeconomic evaluation can assess the value of a product or service from single or multiple perspectives. However, clarification of the perspective is critical because the results of a pharmacoeconomic evaluation depend heavily on the perspective taken. For example, if comparing the value of alteplase (tissue plasminogen activator, or tPA) with that of streptokinase from a patient or societal perspective, tPA may be the best-value alternative because a 1% reduction in mortality rates is observed in this large population. Yet, from a small community hospital s perspective, streptokinase may represent a better value because it provides similar outcomes for less money. Once the perspective is clear, a full evaluation of the relevant costs and consequences can begin. Again, perspective is critical because the value placed on a treatment alternative will be dependent heavily on the point of view taken. 

---