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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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Participant 002 has been a staff member of the department since 2000. Her role in the department is to ensure regulatory compliance, assist Investigators in preparation of audits, and serve as a liaison between the department regulatory committees, and the IRB.

Participant 003 was a part of the department for about five years before moving on to a different AHC. Along with numerous other tasks (clinical and research), he was charged with maintaining a senior leadership role within the IND core.

Participant 004 supports the IND core by writing the Chemistry, Manufacturing, and Control (CMC) sections of the IND application, supplies drug accountability, and manufactures the IND related Radio-pharmaceuticals.

Participant 005 has been with the University for nearly twenty-five years and is responsible for overseeing research within the department. He assumed the role of Sponsor at the start of 2011.

I decided not to interview two groups of individuals from the background interview process: past Sponsor-Investigators, and personnel from OHR. The first group includes four previous Sponsor-Investigators. I decided not to interview these four individuals because I did not believe they would be able to provide me with the specific reasons for centralizing INDs nor insight into the current operational structure of the core.

While their input and perspectives of the core is valuable, I did not believe it was relevant to this capstone. The data I am attempting to collect is to determine the operational effectiveness within the current centralized core.

The other group I will not interview personnel of OHR. The previous Director, who was involved with the development of the centralized office, is no longer an employee of the organization, and I did not have a way to contact this individual. The remaining individuals of OHR had limited involvement with the development and implementation of the core. In addition, one individual was not employed with the organization at the time of implementation. I made the decision to exclude these individuals based on the above noted factors.

Interview protocol I will use a seven-question structured interview process (Appendix A). There are six structured questions and one open-ended question which allow the participants to provide additional information about the history of the IND core. The purpose of the background interviews is to gain an understanding of the history behind the development and implementation of the centralization. The content of the questions focuses on the following: the structure of INDs prior to centralization, when the idea was born, what the rationale was, who led the redesign, the vision of the centralized core, and the communication mechanisms used to inform Investigators of the change.

Question one: Can you provide information on the operational structure of the IND core prior to the implementation of the centralized model? I framed the first question to learn about the operational structure of IND related research within the department prior to centralization. I wanted to hear from the core members how they perceived the way in which decentralization was operating. My hope with these responses is to determine how the IND related protocols were managed prior to centralization.

Question two: When did the idea of a centralized IND core come about? This question is designed to learn when the idea was first born. I want to learn of the time period for this thought process.

Question three: What was the rationale for creating a centralized IND core? The third question is designed to learn what caused the department to change to a centralized structure.

Question four: Who led the re-design of the IND core? The fourth question is designed to gain insight as to whether the leader of the redesign was an individual or group.

Question five: How did you envision the operational structure of the centralized IND core? The fifth question is designed to learn the intended structure of the centralization. I would like to understand how the leader (and those selected to be members of the core) planned to manage the associated responsibilities of a centralized service.

Question six: What mechanism(s) did you use to inform Investigators throughout the University of the Re-design of the IND core? The sixth question is designed to learn what mechanism was used to inform previous (and future) Sponsor-Investigators of the planned centralized core. With these responses, I intend to gain an understanding of how individuals were informed of the new process.

Question seven: Is there additional information about the background development of the IND core that has not been discussed so far in this interview? The seventh question is designed to be open-ended and allow the participant to provide additional information about the background of the core.

I will contact each participant via email requesting their participation in the interview. After agreement to participate, I plan to schedule private individual interviews with the five participants. I will meet with three of the participants in person, and two on the telephone due to distance. At the beginning of each interview, I will remind each participant that their participation is voluntary and the interview will be stopped at any time if they feel uncomfortable.

I will take extensive hand-written notes during the interviews. These notes will include documentation of responses, observation of tone, and body language. At the conclusion of each interview I will write some field notes which will include my thoughts and feelings about the interview.

Current state interviews In order to fully evaluate the effectiveness of the centralized IND core, I will conduct in-depth interviews with three current staff members of the IND core as well as one external member. I selected the administrative manager, the sponsor's authorizedrepresentative and the cyclotron production manager for participation in these interviews.

I selected these individuals as their roles keep the core functioning.

There are three groups that will not be interviewed for this capstone: Radiologists, Investigators using the core, and administrative staff of OHR. I decided to exclude these groups for a variety of reasons, but mainly because their involvement with the core is limited. The Radiologists are called upon to provide scientific input for drugs that are new to the core. A new IND has not been written or submitted within the last two years therefore, their expertise has not been needed often. They are responsible for collaborating with non-departmental Investigators on the conduct of the radiopharmaceutical component of the protocol, as well as for administering the radiopharmaceutical. I selectively excluded this group; they are indirectly involved with the aspects of the core.

The second group I decided not to interview for this capstone is Investigators and research staff who utilize the IND core services. These individuals are valuable to our core as they request our services and keep the core running. To my knowledge, there has only been one complaint about the effectiveness of the centralized core. The complaint was duplicate efforts were occurring. The Investigator held an IND for a separate drug (one not produced by this department). Since this was the only complaint I am aware of, I did not believe interviewing Investigators would provide much useful information for the purposes of my data collection. Their opinions and comments are valuable however; the focus of my data collection is on the internal infrastructure of the core.

Administrative personnel from OHR were not interviewed as well. I decided to exclude these individuals because their expertise is needed if the members of our core need assistance with regulatory guidelines. These individuals are not a part of the daily operations or infrastructure of the core. Due to their limited involvement I will not include this group in the interview process.

Interview protocol There are ten questions included in this current state interview protocol (Appendix B). Of the ten, seven questions are open-ended as I want to investigate my underlying assumptions. The remaining three questions are close-ended questions. If I feel additional information is needed at the time of the interview, I will ask the participant to elaborate on their response. The content of the questions is centered on the current operational structure of the core. Because the purpose of these interviews is to hear from each key member their perspective on the current state and learn if they are aware of a future plan for growth, the questions are framed to facilitate my understanding of each participant’s perception.

Question one: can you give me an example of what is working well about the IND core? This question uses an appreciative inquiry type format. I would like to hear from each key member their view about the strength of the core.

Question two: How would you describe your role within the IND core? This question is designed to ask each participant their role in the core. I want to understand how they view their role in the core, as well as their role with the other core members.

The purpose of the question is to confirm or disprove my hypothesis that the core is not operating in the way it was structured to operate.

Question three: Can you provide information on the current operational structure of the IND core? This question is designed to learn from each participant the current operational structure of the core. My intention with this question is to learn more of the daily operations from the perspective of each participant.

Question four: What is the mission of the IND core? This question is designed to learn how each participant views the mission of the core. The purpose of this question is to determine if the perceived mission is viewed similarly among all participants.

Question five: Is the IND core satisfying all responsibilities associated with the role of Sponsor? This question is designed to learn if the core is satisfying all responsibilities. The intent with this question is to determine if each participant is aware of unfulfilled responsibilities.

Question six is: What are the number of INDs currently active under the core?

What are the number of protocols currently active under the core? This is designed to determine if each member is aware of the number of IND's and protocols being held within the core. The purpose of this question is to determine if each participant is aware of how the core has grown over the past few years.

Questions seven: Do you have a limit on the number of INDs and/or protocols your core will support? and question eight: How do you plan to handle management of additional INDs/protocols? These questions are designed to learn about the projected future of the core. My goal with these two questions is to determine two things: if the core has set a limit on the number of INDs and/or protocols it will manage, and if plans are being developed for the future of the core.

Question nine: What mechanism(s) are currently in place to inform potential Investigators of your core? This question is designed to learn about the communication mechanisms (or lack of) in place to notify potential Investigators of the services. I want to know if there is an effective process in place to inform Investigators of the core services.

The purpose of this question is to learn more from each participant of the structure.

Question ten: Is there additional information about the IND core that has not been discussed so far in this interview that you would like to add? The purpose of question ten is to allow the participant to provide additional information that was not covered in the above structured interview questions.

I will contact each participant via email informing them of the purpose of this capstone and requesting their participation in the interview process. I plan to conduct inperson interviews in a private office within the department. All participants are employees of the organization and should be available to meet in person.

At the beginning of the interview, I will remind each participant of their right as a participant and the plan for maintaining confidentiality. I plan to record each interview with a tape recorder and document the responses to each question on paper, and include observations of tone, and body language. At the conclusion of each interview, I will document my thoughts and feelings from the interview.

Confidentiality In order to maintain privacy of the participants involved in the interviews, all identifiable information (organization name and location, participant names, and titles) has been removed from this capstone. The organization has been assigned a fictional name, and each participant has been assigned a unique participant ID number.

The documented notes and tape records will be stored in a secure cabinet outside of the office. The purpose for securing these documents is to maximize the participant’s privacy. At the completion of this capstone (November 2012), the notes and tape recordings will be destroyed.

Other information In addition to conducting interviews, I examined multiple documents relevant to the IND core (Appendix D). I reviewed and compared audit reports pre and post centralization. In addition, job descriptions of the IND core manager, and correspondences with the FDA of the change in Sponsorship were reviewed.

My role My role within this capstone is two-fold: participant and observer. I have been a member of the organization for ten years and spent the past two years as an active participant in the IND core. My role within the core is to oversee and assist with building the operational structure and supervise one of the staff members. My direct supervisor is one of the interviewees and the others are colleagues that I have worked with for the past ten years.

Due to my leadership role within the core, I am involved in the daily operations and responsible for promoting the mission of the core, as well as finding ways to remove barriers for my staff and other members of the core.

Throughout my two years leading this core, I have often observed ways in which the structure of the core is flawed. I stepped into the position without fully understanding the level of complexity involved with the role of a Sponsor and did not have a clear understanding of each individual's role within the core. Soon after my involvement began, I hired the IND manager with a narrow understanding of the number of tasks associated with the role of core manager.

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