Management of quality assurance in clinical trials

Good Clinical Practices (GCP) were first established by the FDA and are now actively implemented by different countries. This becomes necessary as multinational large clinical programs are more complex, involving a large diversity of personnel and locations, with different practices of medicine and local regulatory requirements.

The responsibility of an independent Quality Assurance (QA) organization is to oversee the quality and integrity of research activities, and to assure compliance with company's regulatory requirements, and ethical considerations in order to facilitate worldwide registration of new compounds. The goal of a Clinical QA group is to provide continuous assistance to monitoring teams and investigators to ascertain authentic and reliable clinical trials. The Clinical QA programs must be flexible, calling for active communication and good understanding of quality requirements.

Clinical auditing is one of the instruments of Clinical QA. Study audit activities begin with the protocol, encompass all facets of the clinical trial and end with the final study report.

The focus of the presentation is geared towards auditing activities at investigator's site, purpose of which is to ensure that data gathered in the final clinical study report reflects the raw data collected at the source.     

Post-Welfare Reform, Low-Income Families and the Dissolution of the Safety Net

There has been a great deal of discussion around the fact that lifting individuals and families out of poverty was not a goal of the 1996 welfare reform legislation. The implementation of welfare reform since 1996 has demonstrated the consequences of caseload reduction as a primary goal. This paper addresses the hardships that can result when lifting people out of poverty is not addressed.     

Issues in Multigenerational Families: Adolescents’ Perceptions of Grandparents’ Declining Health

The impact of declining health in grandparents on grandchildren is largely overlooked in the literature. Similar to their parents, grandchildren may feel pressured between their responsibilities to grandparents while also negotiating their own social and psychological needs (Baranowski (1982). Adolescents 25(67), 575–584). Limited attention is paid to the impact on children’s development when grandparents’ health declines (Baranowski (1982). Adolescents 25(67), 575–584; Mead (1970). Grandparents as educators. In Leichter H. J. (Ed.), The family as educators. Teacher College Press: New York). Narrative themes of adolescents reveal multi-determined reactions to grandparents’ illness through identifications with family members, cultural roles, and individual development. The authors will identify these relevant themes and discuss new interventions with multigenerational families who provide care for older adults in declining health.Marcia Spira and Jack Wall are affiliated with School of Social Work, Loyola University Chicago, Chicago     

Mothers and their adolescent daughters: Transitions and transformations

Throughout adolescence the mother-daughter relationship reflects the tension between the tasks of separation and the need to renegotiate connection. This dilemma may be at the source of frustration in the mother-daughter relationship during adolescence. Theoretical perspectives, with emphasis on feminist theories, and clinical vignettes will be highlighted to illustrate the interface between individual development and the transformations in the mother-daughter pair.is on the faculty of the Institute of Clinical Social Work, Chicago and in private practice in Evanston, Illinois. Marcia Kornfeld Spirais on the faculty of the Institute of Clinical Social Work, the faculty of Loyola University and in private practice in Wilmette, Illinois.     

Cancer as a Life Transition: A Relational Approach to Cancer Wellness in Women

Receiving a diagnosis of cancer is a traumatic event and changes one's life forever. The period of initial diagnosis and treatment is indeed a life transition, regardless of the prognosis. It precipitates a change in self-perception, physically, emotionally, and interpersonally. It changes how a woman sees herself, her family, and her world. Simultaneously the woman is confronted with many decisions to make regarding treatment options and the management of personal, familial, and work related responsibilities. People have the opportunity to reflect on old decisions and to make new decisions. Inevitably one is confronted by mortality. The management of this illness is done in the context of a complex network of relationships with family, friends, coworkers, doctors, other medical personnel, and clergy. Often it is the clinical social worker who is in the position of facilitating access to and participation in resources for care. Many women join healing communities or wellness centers to find a model of care and achieve a state of well-being that utilizes and encourages the support of these relationships. Understanding the importance and impact of these relationships can help clinical social workers facilitate cancer wellness in their clients and advocate better on their behalf. The intent of this paper is to understand the concept of cancer wellness as a relational approach and to promote its place in integrative clinical social work practice.     

The Impact of the Past on the Care and Education of Deprived Children

SUMMARY. In the previous issue of Children & Society, Marcia Newsome reported on her study of the historical development of care and education of poor children. That paper revealed ideas and attitudes which not only informed the past, but surprisingly, can be seen to underpin many aspects of present day policy and assumptions. The study highlighted the interactions of individuals and groups, showing how personal, religious, political and economic interests affected the development and organisation of institutions caring for children, some influences obvious, others concealed and unintended. Such interests inevitably led to practices far removed from the best interests of the children themselves. This second paper indicates that the lessons which the past provides have not necessarily been learned, and that similar motives and influences are still at work today.     

The future in anti-poverty strategies

The uneven distribution of income and assets in the United States continues to have negative effects on the personal, social, and economic well-being of adults and children. Poverty affects the entire family and is often associated with household instability, school dropouts, teen pregnancies, and intergenerational poverty. Although income-based anti-poverty policy initiatives have helped individuals with children meet their basic consumptive needs, they have done little to help families lay a foundation for their futures. The implementation of asset-building programs that provide Individual Development Accounts (IDAs) to both adults and children reflects an approach to reducing the incidence and impact of poverty in the United States. Current state and federal policy initiatives that are designed to help economically vulnerable individuals build assets are also described in this paper. Implications of asset-building program and policy initiatives on the well-being of low-income children and adults, households, and communities are discussed to demonstrate the impact that resources and opportunities have on the social and economic growth of the entire family.     

A profile of support group use and need among middle-aged and older adults with multiple sclerosis

This study compared middle-aged and older adults with multiple sclerosis (MS, N = 1,275) according to their use of support groups and identified factors associated with perceived need. Over 64.6% (n = 824) of participants had attended a MS support group meeting at least once. Individuals who had never attended a group were more likely to reside in urban or suburban communities, report lower symptom interference, and fewer activity limitations. Women, individuals without a helper, and people with greater symptom interference were more likely to perceive a need for a support group. Findings raise questions for professionals involved in developing and implementing multiple sclerosis support groups.