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«11-18-2012 An Organizational Diagnosis Of A Centralized Investigational New Drug Core Within A Large Academic Health Center Kathleen M. Thomas ...»

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Over the past two years I have been concerned with the lack of Sponsor responsibilities remaining unmet by the centralized core. The three responsibilities not being fulfilled by the centralized core include: monitoring, drug accountability, and training. In addition to my observations, the lack of fulfillment has been documented on routine audits by OHR. I feel these issues are present because leadership did not clearly define the core's infrastructure prior to implementation.

The second assumption I have is, operating effectively because roles were not clearly identified at the time of implementation. When I was first asked to assist with the core, I was introduced to two people: the core manager and the sponsor-representative.

The other indirect members (regulatory and cyclotron) were not discussed. At the time, I assumed the only two individuals that mattered to the operation of the core were the manager and the sponsor-representative. Presently, the core manager and I meet monthly with the -representative to discuss the operations of the core. Recently, I have noticed the other indirect members are important to the operations. I’m concerned that the absence of these members from monthly meetings is hindering the effectiveness of the core. Each of these individuals has important skills that could contribute to the effectiveness of the core. The regulatory manager is knowledgeable of FDA regulations and could assist in the development of effective processes and the cyclotron manager has the most knowledge of drug production. At this point, it is not clear how involved these individuals should be in the core.

The goals of the core have not been made clear. Initially, I had a very limited understanding of the IND core and the purpose it served within the department. I also had a very limited understanding of the role of sponsors. I read section 312 of the CFR to better acquaint myself with the regulations centered around INDs. Sponsors have specific responsibilities and per FDA regulations must be met. I do not believe leadership clearly identified if the centralized core was going to handle the full responsibilities of a Sponsor.

My goals with this capstone are to learn more about the rationale of developing a centralized core, and understand the reason the IND core is not fully functioning as a full service centralized IND core. In order to fully understand the problem, I will conduct a diagnosis of the organization described above.

In Chapter 2, I review literature pertaining to conducting an organizational diagnosis, the importance of understanding an organization's history, and the historical events leading to clinical research regulations. In Chapter 3, I outline the methods I used to explore my hypotheses. I will explain why I selected structured interview questions, as well as how I plan to carry out the diagnosis. In Chapter 4, I present the data and my interpretation of the data. I will then provide a detailed summary of feedback for the client system. I conclude this thesis in Chapter 5 with a summary of my findings and learning from performing the diagnosis.

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Introduction In this literature review I will discuss three areas of research: organizational diagnosis, organizational history, and the history of clinical research regulations. I will begin by describing the important elements involved in conducting an organizational diagnosis. I review this literature in order to demonstrate the ways in which an organizational diagnosis can contribute to our understanding of why an organization is not functioning effectively. The second area of research which I discuss is organizational history. I reviewed literature centered on the importance of understanding an organization's past and the impact it has on the present and future. The final section of this chapter presents literature evaluating support programs at AHCs.

Organizational diagnosis The focus of this capstone is the diagnosis of a centralized IND core within an AHC. It is critical for me to explain the importance and relevance of conducting an organizational diagnosis because the framework of my capstone is a diagnosis of my current workplace. After searching through literature extensively, I was unable to find literature specific to diagnoses of academic health centers. The lack of literature highlights the importance of this capstone, as it begins to fill the gap within the literature.

I will present the importance of conducting a diagnosis within an organization.

Clayton P. Alderfer describes the methods of organizational diagnosis in his article “The Methodology of Organizational Diagnosis” (Alderfer, 1980) as a process of entering a human system, collecting data, and feeding that information back to the system to increase understanding among the system's members. Based upon what is learned, a determination regarding change can be made. While this may seem like a lengthy task, the performance of an organizational diagnosis is a stepping stone to a successful and productive change management program (if applicable).

"The purpose of organizational diagnosis is to establish a widely shared understanding of a system and, based on that understanding to determine whether change is desirable” (Alderfer, 1980, p.459). Conducting an organizational diagnosis is important for several reasons. The first is a diagnosis can provide data valuable for testing a hypothesis, rather than speculating about the cause of the problem. The second reason for conducting an organizational diagnosis is to focus on determining the root cause of a problem, rather than focusing on the symptoms of the problem. The third reason for conducting a diagnosis is to identify factors that may be causing the problem, but are not visible. These three points emphasize the importance of understanding the overt and covert dynamics of an organization.

Managers are charged with getting an organization to operate effectively. This can be an overwhelming and challenging task, to say the least. “Understanding one individual's behavior is challenging in and of itself; understanding a group that's made up of different individuals and comprehending the many relationships among those individuals is even more complex” (Nadler & Tushman, 1980, p.35). There is a pressing need for a manager to manage organizational behavior. Nadler and Tushman (1980) state the manager can learn to predict and control organizational behavior with tools to fully understand the dynamics at play. One tool is a model. “A model is a theory that indicates which factors are most critical or important” (Nadler & Tushman, 1980, p. 36). There are several different models that can be used when conducting an organizational diagnosis.

Utilizing an organizational model can help diagnosticians understand the problem systemically.

Nadler and Tushman (1980) describe the diagnostic model as a model that describes the system, identifies the problem, and also analyzes the fits. This model is known as the congruence model. “The model also implies that different configurations of the key components can be used to gain outputs. Therefore, the question is not how to find the "one best way" of managing, but how to find effective combinations of components that will lead to congruent fits among them.” (Nadler & Tushman, 1980, p.


Marvin Weisbord (1976) developed the “six box model” as another model for diagnosing organizations. This model consists of six components: purpose, structure, relationships, rewards, leadership and helpful mechanisms. Weisbord (1976) explained the purpose of this model as a model allowing consultants to apply theories they know and to discover new connections.

Weisbord (1976) noted, “There are two main reasons why one might want to diagnose an organization: to find out systemically what its strengths and weaknesses are or to uncover reasons why either the producers or consumers of a particular output are dissatisfied” (p. 435).

Determining the underlying root cause is another reason why conducting an organizational diagnosis is important. There is often confusion between symptoms and root causes. A root cause is the underlying problem often masked by symptoms. Freeman and Zackrison (2001) describe symptoms and root causes with a medical metaphor.

Individuals will experience a high fever as a symptom to an underlying medical condition. In order to fully cure the fever, a medical professional must identify the underlying cause. However, this level of diagnosis may not always occur. As argued by Freedman and Zackrison (2001), “Many people settle for immediate, temporary relief they get by treating their symptoms; If they can endure it and it goes away, they've saved time and money” (p.27). One can argue that the temporary relief of symptoms is not diagnosing or treating the underlying problem. In turn, this could potentially cause more harm in the future.

The above metaphor illustrates the importance of finding and treating the root cause. The same can be applied to diagnosing an organization. Consultants and leaders, who choose to find and treat the underlying cause, can begin the diagnosis process with asking open-ended questions. The purpose of doing this is to gain perceptive from as many avenues as possible.

Alderfer (1980) describes three phases of a diagnosis: entry, data collection and feedback. I want to briefly describe the entry and data collection phases as they were specific to my experience with this capstone. Entry is the first phase of a diagnosis.

Alderfer (1980) theorizes that internal (to the system) people cannot act as consultants to the system.

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I did not experience a definite point of entry with this capstone. I've been a staff member of my organization for ten years and am familiar and comfortable with the operations of the organization. I found my experience to be the opposite. I observed the participants as accepting and supportive of the diagnosis. Due to my personal experience and journey, to an extent, I disagree with Alderfer's perspective on internal consulting.

Internal consulting can be essential for the growth and change of an organization. Internal consultants possess knowledge of background information, the system, and established relationships with people that are a benefit to conducting a diagnosis. Although, I must ask the question, will leadership accept my findings? Or would these be better received from an external consultant?

There are differences between external and internal consulting. For this literature review, I will focus specifically on internal consulting. Miriam Lacey (1976) describes the role of an internal consultant as being unique. These are usually individuals hired to serve as an organizational development professional for a specific organization. I also believe these professionals could be line managers/general managers interested in learning change management techniques to apply within their organization. My relationships with staff members, accessibility to schedules, and personal role within the organization contributed to the ease I experienced with understanding the background of the issues present within the organization.

Interviewing is a method of data collection. This is an opportunity to speak with staff members individually or as a group. “Individual interviews have a relationshipbuilding quality if they are conducted competently and, as a result, are probably the most essential tool of any data collection” (Alderfer, 1980, p. 463). The data provided from individual staff interviews is rich. This point of the diagnosis provides the consultant with individual perspectives, archival documents, and a chance to observe reactions.

The diagnosis process is a way to determine the cause of the problem without focusing on the symptoms. “The aim of an organizational diagnosis is to produce learning about the system for its members” (Alderfer, 1976, p.369). Taking time to really understand what is going on within an organization will produce a common understanding and ability to produce change if applicable.

Underbounded systems As a consultant, it is important to understand the type of system you are entering so you can really navigate through the system and understand the contributing factors to the issues. Specifically for this literature review, I will focus on underbounded systems and how they are perceived. Alderfer (1980) theorizes two system types: overbounded and underbounded. But, the bigger question is, what is a system?

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The systems are designed with boundaries, allowing exchanges to occur internally and externally. Alderfer identified three system categories: optimal, overbounded, and underbounded. The optimal system allows for just the right amount of permeability between the system and the outside. Overbounded and underbounded are the opposite extremes of optimal. Overbounded systems do not allow for much permeability, and underbounded systems allow for too much permeability (Alderfer, 1980). Is a system always bound to be one type versus the other? Based on Alderfer’s definition of a system, I would argue the system type can be altered when there are changes to the units within.

This could include the addition of a unit. How can one distinguish between the systems they are consulting to? Alderfer identified eleven interdependent variables that distinguish the difference between the two system types (see Table 4).

Table. 4. Alderfer’s (1980) system type variables

1. Goals

2. Authority relations

3. Economic conditions

4. Role definitions

5. Communication patterns

6. Human energy

7. Affect distribution

8. Intergroup dynamics

9. Unconscious basic assumptions

10. Time-span

11. Cognitive work The four variables that stood out most for this capstone included: goals, authority relations, role definitions and intergroup dynamics. I will focus specifically on these four variables and how these relate to the organizational diagnosis I conducted.

Goals are highlighted as things that partly define an organization (Alderfer, 1980).

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