These are the clinical research core competencies from Sonstein et al., 2014. Below is how I fulfilled the clinical research core competencies through my classes and internship.
Scientific Concepts and Research Design
This clinical research core competency integrates scientific concepts such as the study of pharmacology, toxicology, and pathophysiology trying to answer clinical research hypotheses. To do so there needs to be an understanding of research design through statistics, epidemiology, and operational concepts. Research design also involves how to design a clinical trial and analyzing study results to understand efficacy.
Since I was a clinical pharmacology specialization student, I took many science classes such as pathophysiology and many pharmacology classes including a toxicology class. I also took a research design and methods class taught by Dr. Chipps and a biostatistics class. All these classes gave me the ability to understand research design and the science behind clinical research.
The Clinical Research Unit (CRU) I was interning at had numerous oncology studies and also bionutrition studies. I do not recall what other types of studies there were. However, my internship experience involved the evaluation of protocols heavily. I had to attend protocol improvement process taskforce meetings. This is where the administrative manager and her team discussed how to improve their CRU.
Ethical and Participant Safety Considerations
This core competency is in regarding the ethical treatment of human research subjects. Because clinical research involves testing of drugs and devices on patients, it needs to be heavily regulated. Just general clinical research which are not based off drugs and devices on human research subjects applies as well. There is considerable risk in testing on humans especially with drugs and devices. The human research subjects are taking a risk when they choose to participate in clinical research. As a result, there are many guidelines in place regarding the ethical treatment of human research subjects. These include getting informed consent from the subjects, specific inclusion and exclusion criteria to make the study design sound, ethical considerations in dealing with vulnerable populations, and understanding risk/benefit considerations.
I took a class specifically for this competency which was called Responsible Conduct of Research and I also had another class that overlapped called Management of Clinical and Preclinical Research. I designed an informed consent document being sure to keep the terms simplistic and at an eighth grade reading level. But also not using coercive language. For Responsible Conduct of Research class, I read and l listened to lectures regarding ethics of vulnerable population, and understanding risk versus benefit and trying to determine if the benefits outweigh the risks. In Research Design and Methods class I designed a full research proposal and I had to understand and include inclusion and exclusion criteria.
Considering this was an internship and I had no IRB approval, I had no contact with human research subjects. This is because it would probably violate confidentiality issues. The Standard Operating Procedures (SOPs) I wrote were also confidential and I could not include them in my final capstone project report. Though it would have been more interesting and fun to see actual subjects, it would jeopardize the CRU.
Medicines Development and Regulation
Since pharmaceutical drugs are a possible danger to human health especially if not tested thoroughly, there are very tight regulations concerning the testing for the safety, quality, and efficacy of pharmaceuticals. There were significant events in history which led to these tight regulations of drugs and devices. An example would be the thalidomide incident where an anti-nausea drug was given to pregnant women which caused significant structural malformations in the appendages of the children who were born to those mothers.
The major class that helped me with this clinical research competency is Dr. Jones’ class Medical Product Regulatory Affairs. I learned all about the regulatory laws that affect medicines development and afterwards. I had assignments designed with medicines development in mind. Examples include IND submission planning, device labeling paper, and a group project called risk mitigation.
The entire CRU was based off of a Clinical and Translational Science Collaborative between Case Western Reserve University and University Hospitals. As a result, the clinical research studies were pretty much all Phase I clinical trials. Since many of the studies were oncology-based, there were many chemotherapy treatments and other anti-cancer treatments being tested.
Clinical Trials Operations
This competency is related to the conduct and management of clinical trials and also the roles and responsibilities of the clinical research team as related by good clinical practices. Clinical Trials Operations also includes the regulations and guidelines in place to guide the operation.
There were a few classes designed for this competency in mind including Medical Product Regulatory Affairs, Management of Clinical and Preclinical Studies, and Responsible Conduct of Research. All three classes described the roles and responsibilities of the clinical research team as related by good clinical practices very well. The regulatory aspects were covered by Medical Product Regulatory Affairs. The conduct and management of clinical trials were covered in Management of Clinical and Preclinical Studies.
The entire CRU was very hierarchical. There was a medical director at the top then administrative manager then all the other staff members. This includes protocol nurse, functional team leaders, clinical research coordinators and so on. As a State Tested Nursing Assistant, I know to only perform tasks within my scope of practice and tasks that are not usually in my scope of practice may be delegated to me by someone in a higher position than me such as a nurse. I am pretty sure clinical research is the same.
Study and Site Management
The competency of study and site management involves the financial and planning aspects of clinical research sites. Site management and planning includes how to manage risk, improve quality, how to manage patient recruitment, complete procedures, track progress, and understanding the legal aspects of accountability at a clinical research site. It also includes the specific procedural documentation for the clinical research site.
Management of Clinical and Preclinical Studies and Medical Product Regulatory Affairs were the classes that helped me master this competency. Management of Clinical and Preclinical Studies was all about study and site management. I had experience in creating and balancing a budget, listened to a thought lecture on patient recruitment. The thought lecture on patient recruitment was very interesting and I felt the speaker was really creative in how she managed recruitment. Examples include writing down notes regarding special dates in the human subjects life like anniversaries and birthdays of close relatives. Medical Product Regulatory Affairs taught by Dr. Jones taught me how to manage risk. We had a large group paper all about on how to manage risk in a clinical research setting. My section was on training of clinical research employees. The same class definitely made me understand the legal aspects of accountability at a clinical research site.
My internship mentor introduced the concept of change management to me. This is a business administration technique which incorporates how to handle change in the workforce. Many people, myself included, are terrified of change. It is unknown and puts us out of our comfort zone. However, due to this, change management is such an important business administration technique. You really have to go at the employee’s own pace, understand their personality and psychological makeup, and know how to motivate them.
Data Management and Informatics
Data management and informatics involves the study of Biostatistics, electronic data capturing programs such as REDCap, the regulations involving data correction and queries, and how SOPs are involved in quality assurance. Basically this competency aims to ensure data is managed correctly and Biostatistics are needed to analyze the data correctly. Data is managed correctly through rigorous data correction and queries and the employees who do that are data management coordinators.
The two classes that helped me master this competency is Biostatistics and management of clinical and preclinical studies. Biostatistics was very fun, my last Statistics class prior to this one was a very basic one. Since I love the clinical research setting, it was very fun to learn all about Biostatistics. Biostatistics is highly important because it analyzes the data and provides the evidence for the results of the clinical research study. Management of Clinical and Preclinical Studies helped me understand data management. We had an assignment called a data management plan utilizing a NIH template and it also involved the process of data correction and queries. We also built REDCap and Balsamiq databases creating case report forms. I felt this was a very good experience because REDCap is widely used everywhere. I also typed up a SOP on adverse drug reactions for my management of clinical and preclinical studies class.
I helped my internship mentor brainstorm clinical research fields for writing SOPs in REDCap. There was not much I could do in helping design a REDCap database because I did not even have volunteer status. However, it was a still a good experience in brainstorming clinical research fields for my internship mentor. This is because it would be highly useful in my future job as a clinical research employee. I definitely would like more experience in that regard and am excited to learn more about REDCap. My class in data management helped me design a REDCap database which was very interesting.
Leadership and Professionalism
Leadership and Professionalism is the competency which involves the ethical considerations involving the professional conduct of the clinical research investigators and the conduct of the clinical research study itself. It also involves sensitivity to the cultural background of the human research subjects. Leadership and professionalism also involves the leadership, mentorship, and management of the clinical research setting.
Responsible Conduct of Research and Management of Clinical and Preclinical Studies are the classes that fulfilled this clinical research competency. Responsible Conduct of Research taught me how to be ethical in my professional conduct and how to conduct a clinical research study itself ethically. It also allowed me to understand and be sensitive to the cultural backgrounds of the human research subjects. Management of clinical and preclinical studies allowed me to understand the dynamics between leadership, mentorship, and the management of the clinical research setting.
I am very articulate, I know how to express myself both orally and through written communication. I know how to get along with other people and work as a team. This has been shown time and time again in my work as a STNA. I remember having a dilemma with a coworker and to resolve it I brought it up to a supervisor who talked with both of us together. Then the coworker and I talked to each other and we came to a mutual understanding. We are actually good friends now but I believe he has quit to become a RN. I know to always be polite and be compassionate especially from my time as a STNA.
Communication and Teamwork
This competency involves the relationship and communication between the sponsor, CRO, and clinical research site. It also involves understanding and analyzing the components of a scientific publication and presenting the findings to the scientific and non-scientific community. Communication and teamwork is heavily involved in the relationship between the multidisciplinary and interprofessional research teams.
Research Applications in Clinical Pharmacology definitely allowed me to understand and analyze the components of a scientific publication. I also presented the findings of what I researched through voice thread for various classes including Responsible Conduct of Research, Pharmacogenomics, and Research Applications in Clinical Pharmacology. Several classes had group projects where communication and teamwork were vital. We communicated through texting, video chat, and meeting in person.
I was able to see how the CRU was able to work as a team to improve their clinical research. One of the employees is a specialist in REDCap and I could see how vital she was. Many people do not have much experience in computer databases and having someone who is an expert is priceless. I for one do not know much about REDCap but I hope I become an expert some day. It seems like a really important subject in clinical research. At the protocol improvement taskforce meetings, I saw the administrative manager and her team brainstorm ideas to improve the CRU. One example is implementing organization in place to improve the process of writing SOPs.