This chapter from Business Administration for Clinical Trials: Managing Research, Strategy, Finance, Regulation, and Quality is about cultivating good relationships with colleagues and research subjects. Authors Cavalieri and Rupp discuss the "people part," one of the most rewarding and challenging parts of research. The chapter explains how to take unique perspectives and needs of colleagues and subjects into consideration to overcome barriers to finding common ground.
The most rewarding and challenging part of research is the “people part.” An intimate understanding of human nature is at the heart of good practices for managing professional research relationships between supervisors and staff. There are, of course, many other factors influencing the research professional’s work relationships, including institution policies, the scope of practice, and state and federal laws, but it’s the “people part” that is meaningful and memorable. This chapter explores ways the research professional can foster relationships with colleagues and research subjects, as well as provides some suggestions on creating firewalls.
Finding common ground and understanding
Working with colleagues and research subjects is required. Doing it well is an art. If you take the unique perspectives and needs of each of your colleagues and subjects into consideration, you have overcome the biggest barrier to finding common ground.
Research subjects have a relationship with research professionals that is similar to their relationship with their medical providers. There is a fundamental similarity between a patient and research subject in the healthcare setting because both are involved in activities and testing within a medical environment. But there are also a host of differences.
Table 4.1 shows these similarities and differences
TABLE 4.1 The Similarities and Differences Between Patients and Research Subjects
Both Groups Are...
Illness and care requirements may be creating stress and disruption of their normal lives.
They may feel too weak or ill to question or comparison-shop for medical services.
They may need to use preferred medical providers due to the requirements of their medical insurance plan.
They may feel stressed by their medical condition and care.
They may be desperate for treatment options.
The subject may not understand the difference between standard of care or optional research activities.
They need professional medical treatment.
They may have exhausted available approved medical therapies.
Interacting With You Over a Period of Time
Outpatient clinical care is usually intermittent and ongoing.
Inpatient care is usually a short-term situation until the patient is medically stable and released from the hospital.
The relationship between research professionals and research subjects is based on the research protocol and last for a day, a week, or years.
Treatment may take place in a medical clinic, hospital ward in an acute care hospital, or a longterm care facility. Medical professionals may provide services in the patient’s home.
The study may take place in a clinic, hospital ward, long-term care facility, or community-based ward, medical office, or in the community.
Simply put, patients need clinical care, but research subjects do not need to participate in research. The importance of establishing rapport and a positive working relationship with research subjects cannot be overstated.
Why do patients agree to participate? Despite strict research regulations to the contrary, some patients may feel pressured to participate. They may want to “please” their physician or feel obligated to go along with their family’s wishes.
What are the direct and indirect benefits a subject may receive from participating in a clinical trial? Directly, they may be receiving access to innovative medications or interventions. It is important for research professionals to clarify the difference between clinical care and research participation. Therapeutic misconception is when a subject believes their research participation is medical therapy with a medical provider following a treatment plan with interventions and medications that have already undergone the scrutiny of the clinical trial process. Sometimes subjects choose to participate and lose sight of the research aspects of the study interactions and consider it a social relationship.
Family members were participating in a research study in which blood samples were collected for genetic analysis. The investigator used a group consent process to thoroughly explain the study and answer questions. Family members had as much time as they needed to consider participation, and those individuals who agreed proceeded from the conference room one by one to the clinic room, where a blood sample was taken.
In the clinic room, one consented subject told the research nurse how much he hated needle sticks and that, although he was perfectly willing to participate in the study, he did not want a phlebotomy procedure. “If I don’t do this, my family will be angry and keep trying to convince me to do it. They are going to know I didn’t do this.” The investigator spoke with the subject privately, supported the subject’s right to privately decline to continue participation, and provided the subject with an “out”—the option of placing a bandage on his arm so that he appeared to have had a blood sample collected.
Because all results were confidential, the family members did not find out that one of them did not participate. Could the investigator have re-explained the optional nature of research to the group? Sure, but some family members might have continued to pressure the person who didn’t want the needle stick.
It is not unusual for us to hear subjects say that they consider their study participation as beneficial from the standpoint of having an extra set of eyes looking over their clinical condition. Some patients and their families, facing teams of medical specialists, may see the investigator and his research team as a stable resource.
A clinical trial for osteoporosis was conducted over a 4-year period. The sponsor, wanting long-term efficacy and safety data, offered the participants the opportunity to continue on in a 2-year extension study. As the primary study neared completion, the subjects were offered information about the extension study, and the informed consent process was conducted. The investigator realized the subjects needed additional reminders and explanations about the research when he saw that the majority of participants had, over time, actually forgotten that they were participating in a clinical research trial and regarded their quarterly study visits as clinical care with a social benefit. They looked forward to their interactions with the research staff just as they looked forward to their aquatic exercise programs and their church activities.
Their decision to participate may be based on a desire for more medical attention. Because research visits can take much longer and happen at more frequent intervals than clinical care appointments, this extra time may mean additional education, reassurance, and encouragement.
These days, when clinicians are so busy, patients may want providers to slow down and explain (and re-explain) medical information in more detail or provide reassurance about symptoms. Time and attention may be the only “carrots” a research professional can provide.
Attaining access to medical caregivers and services in large hospitals and clinic systems can take considerable effort and time waiting for an open appointment time. During a research study, subjects usually have direct access to the investigator and his team because they are responsible for closely monitoring the subjects’ status. Subjects can become very dependent on the research staff to help them navigate the complex healthcare system and get quicker access to help.
Adverse events are assessed quickly, and the research team will intervene when the subject has concerns or symptoms of an adverse event.
When their study participation ends, patients and family members may still want to leverage their relationship with the clinical research team to help them cut through red tape and schedule quicker visits and medical attention. They may call to update the investigator on their medical progress, notify the investigator when they have been admitted, or simply drop by to visit. These actions can stem from a former subject’s normal desire for assistance and attention. We have done many studies and worked with wonderful research subjects, and we’re always sorry to see a study end. We do frequently run into former subjects, and they often ask about study outcomes.
Helping subjects to transition from their active to completed status in the research relationship will need to be handled respectfully and tactfully.
Strategies for working with subjects include:
- Regularly refer to their research participation and obtain and document their verbal assent to continue.
- Use dedicated research telephone numbers and cell phones for all interactions. Never give out your personal cell phone or information about your residence.
- Clearly identify what you can and cannot do for former subjects. For example, say, “I am sorry to hear that (former subject) was admitted to the hospital. The investigator is available if (former subject’s) medical providers have any questions about the research.”
- Consider sending a study closure letter to subjects from the investigator. This provides a final formal thank you to the subject for their involvement in the study, clearly closes the formal study relationship, and gives them a route to contact the investigator and research personnel within the confines of study follow-up.
- Research offices and clinics should maintain controlled access at all times in order to protect the integrity of the research records. Front desk personnel should not grant access to these areas without scheduled appointments or calling the research personnel to the front desk.
Sponsors and their representatives
One of all sponsors’ cardinal priorities is to understand what is happening at their research sites and make sure they are in compliance with GCP and the research protocol (International Conference on Harmonisation, 1996). It is the sponsor’s goal to develop a positive working relationship with the investigator and the investigator’s research staff. The days when they were permitted to bring in refreshments and provide small gifts such as tote bags and office supplies to research personnel are long gone due to federal anti-kickback statutes (Burgess, 2014).
Industry sponsors and their representatives, contract research organizations (CROs), may use standard business practices to provide incentives and reward their own employees by using gifts of products, financial bonuses, and paid expenses, but this is not the case for the research sites. Sponsors and their representatives must build rapport with the investigators and their research personnel without gifts. They rely on establishing a firm connection with site personnel in order to understand how the research site operates and will provide feedback and liberally praise achievements in order to encourage performance.
Sponsors are in the business of developing products. Investigators are in the business of providing medical care, teaching, and publishing, but there is common ground between the two. Sponsors have business goals, and the investigators have professional goals. The common ground is that both want subject safety, to reach study enrollment goals, to maintain protocol compliance, and ultimately to have the research question, the purpose of the study, answered.
Building a positive and productive relationship with the study sponsor makes good business sense, but the integrity of the research data must be maintained and the results must avoid any appearance of influence from the sponsor.
Here are some important strategies you can put into practice:
- Use caution when the sponsor or their CRO offers to provide direct support for site activities.
- Do not allow the sponsor or CRO to prepare local IRB documents. The IRB submission process is the investigator’s responsibility.
- Refrain from releasing any prescreening information about the investigator’s patients because these persons have not signed consent. It would be a Healthcare Insurance Portability and Accountability Act (HIPAA) violation to even report the sex or age of patients who were evaluated for eligibility.
- Providing colleagues’ contact information for the sponsor to use for study communication may seem like a supportive suggestion, but the investigator’s IRB will need to be informed that this is part of the study recruitment plan. Remember, after the contact information is provided to the sponsor or CRO, there is nothing to stop them from sending study-specific information as often as they choose to busy colleagues who may view this as spam at best. In addition, there is nothing to stop the sponsor from using the contact information for their own purposes.
- Use caution when the sponsor or their CRO requests participation in surveys comparing their systems with the systems other sponsors are using. Investigators are required to maintain the confidentiality of their studies.
- Use the dedicated research addresses, telephone numbers, and cell phones provided as a part of the investigator’s institution for all interactions.
- Check your institution’s and IRB’s policies on recruitment bonuses and gifts. Expect them to be prohibited and be thoroughly familiar with the institution and IRB policies. The IRB’s interpretation of bonuses may include more than prohibiting direct payments. It may also prohibit “educational grants” and “finders’ fees” for clinical personnel.
- Keep study documents in secure cabinets and maintain confidentiality with all study information. Monitors know better than to ask for details about other study commitments, but especially those who are industry-sponsored will be keeping their eyes and ears open for evidence of competing commitments at the sites.
- Keep meals and coffee breaks Dutch treat. Make sure the monitors know where the cafeteria and restrooms are located.
- There is no need to establish the expectation of continuously being together during their entire visit. Their goal is to establish rapport, and they will be maintaining a file with notes about the investigator and site staff. Your goal is to establish a positive working relationship. Always remember that you are in control of how much personal information you want to share about yourself.
The support and engagement of clinical stakeholders who oversee the clinical and ancillary areas in the institution are critical to the success of a study. They will likely want to know about the results of the data collection long before the research analysis is complete. Their clinical world moves at breakneck speed, and their priority is the use of the data for their reports and initiatives.
An investigator conducted a clinical trial for an investigational device that evaluated levels of bioburden (essentially dirt, debris, and germs) in patient rooms over a 2-year period. Although the clinical staff was fully informed of the study plan and activities, over time, they made assumptions about the reliability of the device’s data for the cleaning status of the room. The investigator had to explain and re-explain that the study results were not yet available—the study data had not yet been analyzed and could not be used to make clinical decisions (Smith et al., 2014).
Here are some strategies for working with clinical stakeholder:
- Include clinical stakeholders in planning, updating, and sharing results.
- Include support for them in a study budget where appropriate, especially when the research disrupts their workflow or consumes some of their resources such as staff time.
- Let them know that their involvement is appreciated and that long-term success of the organization’s mission depends on their goodwill and support.
Adults are free to choose whether to establish personal relationships with co-workers, when this is going to happen, and how much of their life outside of work they are going to discuss. Colleagues have a natural interest in each other and getting to know new employees. New employees may be anxious to fit in as they start in their new position. Co-workers will almost certainly ask them to talk about themselves and their interests. A proactive strategy is to prepare an “elevator speech” of some very general comments about yourself to use for these early meetings with your new colleagues.
Matters can become very personal if family members are employed at the same institution or research professionals are receiving healthcare services at the institution where they work. Family may work at the same institution; however, there are usually policies that prohibit their working in the same department or supervising relatives.
Research professionals may work and receive healthcare services at academic medical centers. Their privacy is protected by HIPAA privacy laws, and there are strict policies on how and when medical records can be accessed. Surveillance and audits are conducted to ensure every patient’s, employee or not, privacy.
It is not uncommon for clinical personnel to participate in clinical research. Clinical personnel may have a better fundamental understanding and, in general, a greater trust of research. They may be curious and altruistic and see their participation as an avenue to contribute to medical knowledge. Strive to maintain the employee–subject’s confidentiality, especially during testing and study visits.
Expect the employee–subject to experience some role confusion. They may be uncomfortable with the role reversal. Do not assume that the employee–subject already knows anything at all about the disease process under study or the mechanics of daily research activities.
Often investigators and institutions have policies prohibiting family members or direct employees from participating in their clinical trials in order to avoid or avoid the appearance of coercion and breach of privacy. Research protocols may also include enrolling family members or employees as exclusion criteria.
Strategies for working with colleagues include:
- It is important to block potential conflicts of interest or breaches in confidentiality before they happen. Check your institution for policies related to enrolling relatives into trials. Institutional review boards (IRB) and the principal investigator’s research enterprise usually have a standard operating procedure (SOP) and policies in place addressing issues related to members of the research team or their family members participating.
- If such policies do not exist, draft a policy for the research enterprise to address this.
Facing the grim realities of life
The mission of research professionals is to find answers to treat and mitigate the effects of illness, better understand ways to prevent illness, and provide a measure of hope that what we learn can help ease the suffering of others. The passion and compassion of research professionals can lead to the very real effects of sadness, depression, and feeling burned out over time as they face the needs and loss of so many medically ill people.
Because a significant number of waking hours are spent with colleagues, these relationships are important and valuable and can be a source of tremendous joy and pain. The change in relationships with our colleagues due to career moves, retirement, or illness is inevitable. These changes can also lead to feelings of sadness and loss.
Here are some strategies you can use for taking care of yourself:
- Appreciate today. Remind yourself that today, what you are working on now, and the people you are working with are a part of “the good old days” you will look back on in the future.
- Work on the coping skills necessary for facing death and dying. We should recognize the signs of burnout in ourselves and colleagues and take steps to cope.
- A change in research specialty may be in order. Not all clinical trials are working with seriously ill subjects. There are many research roles, and some involve no patient contact.
Be (almost) indispensable
The people within a research enterprise, like people in any business, need to work at building productive working relationships. Productive research relationships are grounded in communication, team effort, and compliance, and this chapter has presented some research-specific ideas to consider. How are productive relationships built? One way to look at working relationships at an academic research site is to recognize that everyone, even the principal investigator, has a boss and is expected to contribute to the success of the research enterprise. Adopting the strategy of becoming (almost) indispensable to your boss and your colleagues benefits everyone on the team.
Why is indispensable status risky? First, you should never be truly indispensable because this can hold you back from developing and taking on new opportunities. People may also ask you to do unreasonable things because you are the supposedly the only one who can do them. Being indispensable is a sign of poor planning on the part of all parties involved. Having indispensable people will backfire when they have an illness or family emergency, as everyone does at some point. Finally, people with “indispensable” labels can get a falsely elevated impression of themselves.
No one is indispensable.
That said, here are some ways to be (almost) indispensable:
- Consider ways to work collaboratively and build a strong study team. Mentoring the less-experienced members of the research team or coaching a colleague through the research certification process helps to reduce the frequency and seriousness of mistakes and improve efficiency. Supporting and advising a peer while they prepare for research certification creates a sense of shared accomplishment and fosters the spirit of teamwork.
Research professionals can contribute to developing orientation processes and tools, create an intranet site for research resources, or hold periodic meetings for education and fellowship.
Helping a new colleague can be as simple as an experienced coordinator taking a new coordinator under her wing and mentoring her through her first weeks and months as a study coordinator. Explaining, identifying references, and listening in these early days can be the difference for successfully acclimating to the new position.
If the principal investigator needs some backup on study activities, having the secondary investigator assume responsibility from beginning to end on the next subject being enrolled is an excellent orientation to the study. It will become much easier for them to step in and out of the process for backing up the study activities going forward.
Recognize that recruitment and retention of subjects is everyone’s job. Subject recruitment and retention are prime examples of the value of teamwork. Each member of the research team has a part to play, from the investigator administering informed consent to the research coordinator handling the logistics and education to the research assistant who efficiently collects and processes specimens. If a subject doesn’t understand what they have consented to, if parking or finding the research office is too frustrating, or they have to return for a repeat blood collection, study retention is in jeopardy.
Consider the impact of a friendly receptionist, a research assistant who provides clear directions to the study visit location, and the value of updates on study progress to clinical personnel in ancillary areas. Your subjects as well as the study coordinator and investigator will have regular interaction with them. Completed subjects and even patients who do not qualify for study participation can become ambassadors. We consider it high praise when qualifying medical professionals choose to participate in our clinical trials.
Thorough pre-study and ongoing targeted education makes a difference in retaining research subjects. Telling a subject that there are 13 study visits as a part of the informed consent discussion may be honest, but he may consider this too much of a commitment. If the information is presented as five study visits and eight telephone study visits over 3 months, the subject may find this less daunting. With so many visits over several months, providing a simple calendar with appointments plotted out or a list of appointments can help the subject stay organized.
At each study visit, be sure to remind the subject of where they are on the study timeline. For example, reference the study visit calendar and tell the subject, for example, that today is study visit three, and that his next study visit is a telephone visit that should be done either Thursday or Friday. Ask if it would be convenient for you to telephone him in the morning on Thursday, for example.
- Go the extra mile. Successful research professionals look for ways around, over, or through obstacles.
Interactive systems (historically called interactive voice-recognition systems or IVRS) are commonly used in research for managing investigational product and supplies. They have been in place for more than a decade and have evolved from telephone and fax to web-based systems. These systems efficiently track inventory and study milestones such as screening visits and may be a tool for implementing the randomization process of subjects for multisite trials. Research professionals receive training on how to use the system, but should be prepared to think and work through logistical glitches.
During the final months in a recent clinical trial, the remaining amount of limited investigational product was being redistributed among sites and several boxes were removed from our site’s stock. Shortly after this transfer, a system error in the IVRS was discovered at an early morning study visit. One of the redistributed boxes of investigational product was still listed as our site’s stock, and the IVRS assigned it to our subject. Our dilemma was to reschedule the subject’s study visit or attempt to work around an automated system.
Rescheduling subjects for study visits is a risk to their compliance. Will the inconvenience cause the subject to consider withdrawing from study? Will the subject return for a repeat study visit within the protocol-mandated schedule? Will the delay result in a delay of the study drug start or a protocol deviation due to the timing of doses?
The study visit was scheduled for 7:00 a.m. Central time because the subject and her parent needed to get to school and work on time. Telephone calls to the IVRS are usually done after a subject arrives for the visit because this centralized system is working with dozens of study sites and is designed to take global and site variables into consideration for study drug assignment.
The study sponsor was based in the Pacific time zone. The investigator was in route and unavailable by telephone. Calls to the IVRS help line and study monitor were unanswered. With minutes left to decide whether this issue could be resolved to salvage the study visit or reschedule the study visit, the research coordinator made a call to the sponsor’s project leader. This person was available and had the authority to provide immediate authorization to assign an alternate investigational product kit, and the study visit was completed.
The take-away message is that technology is great, but clinical trials call for sharp critical-thinking skills to keep subjects engaged and maintain protocol compliance. Technology will keep up with the clinical trial needs, but cannot always anticipate all of the real-life challenges that arise. Several years have gone by, and our latest clinical trial IVRS system has an automated choice for kit replacement to address lost or damaged kits.
Study monitors, the sponsors’ representatives, are responsible for supervision of the overall conduct of the trial. Their visits to the study site are part of these responsibilities. They will send confirmation letters for scheduled study visits and provide a description of what they plan to review. The monitor will interact with the investigator and study coordinator during the visit and works to clarify and resolve any data discrepancies. They may also provide additional protocol and GCP-related education.
Our investigators rely on email or verbal updates on the progress of a site visit from the research coordinator. Emails are a handy documentation tool for the research coordinator to use. Formal meetings with the investigator are customarily done toward the end of the monitor’s visit. By remaining in close contact with their study staff, the investigator can intervene in a more timely manner and as needed.
Monitoring visits are a significant investment of coordinator time. The coordinator will prepare for the visit, making sure that the items listed in the monitor’s confirmation letter are ready for their review.
Action items presented at the final meeting with the investigator and listed in the follow-up monitor letter will need to be addressed.
The dilemma for the research professional is that the monitor’s follow-up letter may be 4 to 6 weeks in coming. The solution for the research coordinator is to use the investigator’s update emails to create a short summary of the activities and create a punch list (a to-do list of items commonly used in construction or project management) so that the needed items are not forgotten. Site personnel should carefully review the monitor’s follow-up letter to make sure all of the noted items are addressed. On the rare occasion that the monitor’s letter does not arrive, is misdirected, or is very tardy, the investigator can rely on their documentation.
It is essential that research professionals understand their study responsibilities and regularly review GCP guidelines to ensure compliance (U.S. Department of Health and Human Services, 1996).
- Understand that research professionals on the front lines often have the best perspective on improving operations.
A clinical trial for a new drug to treat osteopenia (low bone-density) needed participants. Because most women have never had a bone-density measurement (a low-risk radiology procedure), their bone density was usually unknown.
Because the investigator had been conducting these types of trials for many years, the experienced team of research professionals at an academic research site had efficient processes in place for conducting outpatient osteoporosis clinical trials.
Their standard recruitment plan was to inform potential subjects of the study and then filter qualifying subjects from a large pool of interested women. The dedicated recruitment nurse was responsible for managing all outreach efforts, including giving community-based presentations, arranging the advertising and public relations messages, phone triage, and scheduling screening visits. The recruitment nurse frequently used staggered advertising strategies to achieve 50 to 75 telephone calls per week and, of these, an average of 10 screening study visits were scheduled, with the goal of scheduling them within a few days of the telephone call. The research nurse coordinator was responsible for conducting the screening visits, enrollment, and study visits.
As enrollment steadily increased, the research coordinator’s schedule was quickly filled, and the processes needed improvement. The original thinking was that a positive working relationship between the research coordinator and a subject is established at the time of the screening visit. When we analyzed our screen-fail ratio, it became clear that only one to two subjects out of every 10 scheduled visits qualified for the study. The 30-minute screen visits for the other eight screen failures were a poor investment of the research nurse coordinator’s limited time. She needed to spend her time working with the subjects who qualified and chose to continue on in the study.
The recruitment nurse and research nurse coordinator re-examined their usual tasks and formulated a process change to let the recruitment nurse assume responsibility for the conduct of the screening visits. After study eligibility was confirmed, the research nurse coordinator stepped in to complete the visit and move forward with the study activities. The recruitment nurse completed the screen visits for the subjects who, based on their bone-density results, did not qualify to participate. After a brief trial, the investigator agreed to this plan. Subjects were more accepting of this process than we had anticipated.
- Strengthen your research team by understanding your weaknesses and working together to bridge the gaps.
Teaching and sharing educational resources can help make the research team well rounded. Investigators who make an educational investment in their staff by explaining the medical condition and related testing will reap the benefits of personnel who are better equipped to support the screening, recruitment, and study visit processes. They have a better understanding of what to report and can identify options and solutions for process improvements.
Colleagues can use “teaching moments” to explain software programs and share documentation tools and tips. It can be uncomfortable to admit that you aren’t an expert at creating graphs or aren’t familiar with the medical symptoms or tests associated with the study’s disease process. Keeping abreast of dynamic regulations and the latest ethical issues is a challenge every research professional faces. Subject safety is promoted in a work environment where research professionals are encouraged to ask questions and share mistakes.
- Understand that knowledge and information is power.
- Operations can be slowed or halted when key personnel are absent or knowledge is hoarded by insecure members of the team.
All of the members of the research team can contribute to centralized references for resources such as organizational charts listing key contact personnel, detailed standard operating procedures (SOPs), policies, and crisis plans. This is essential for both a small research enterprise and the campus-wide research community.
- Maximize available resources. Research teams may have limited surge capacity, ability to suddenly handle significant increases in the workload such as multiple eligible subjects at the same time, as investigators balance funding and personnel logistics. There are times when redirecting efforts and working as a team can make a significant impact on recruitment efforts and coverage for personnel illness and family events. For example, investigators may work collaboratively with other investigators within their department or other specialties. Their research coordinators may serve as secondary personnel for multiple investigators. It is critical to clarify delegation and define the expectations and SOPs for this collaborative work.
- Set and reach stretch goals. When the question is, “How much effort is enough?” the answer becomes, “Just a little bit more.” Setting a study enrollment goal is a good idea. Setting a stretch goal, one that requires extra effort, is a standard performance practice that supervisors implement. The research professional may be able to enjoy some flexibility with their schedule, which can sometimes translate into a little downtime during an investigator meeting in Miami during January, or coming into the office a little later or leaving a little early to balance out some unavoidably long days.
It is common for a sponsor to designate the date when study enrollment will close. At that point, the priority focuses on a final push to enroll subjects. For a recent study, the final enrollment date was on a Friday. A potentially eligible subject was contacted on Thursday afternoon, and a message was left using the call-back phone number for the dedicated research cell phone instead of the research office phone.
When the potential subject returned the call at 6 p.m., the research coordinator was walking from the office into the parking garage. The potential subject was willing to come in the following morning for a screening visit to learn more about the study, qualified for participation, consented, and was the final subject enrolled in the study.
- Recognize that appreciation, optimism, enthusiasm, and the willingness to take on new challenges can be as infectious as pessimism. We are human and need recognition for our ideas, contributions, and achievements. The best recognition doesn’t have to be a trumpet fanfare.
A handwritten note is a quiet acknowledgement of a job well done or milestone achieved and can go a long way toward building morale. A “wall of fame” in the research offices can display certificates for milestone service anniversaries, the names of certified research professionals, and internal publications. Employee-of-the-month awards may not be appropriate for very small research enterprises and may result in unintended consequences such as resentment and disappointment for those who are not recognized. Customizing ways to recognize and reward team effort makes sense in most settings.
So let’s look at a risk the investigator might identify, which involves a scenario of working with multiple personnel at multiple research sites:
What exists: An experienced investigator has just learned that a federal research proposal has been funded. This multiyear, multisite protocol will involve more than a dozen specialized team members.
The risk: Assuring regulatory compliance and maintaining required documentation across three study sites.
First, the investigator can create some quality objectives to address the risk:
1. Assign study regulatory responsibilities and accountabilities for supporting the approval and reporting processes.Assign study regulatory responsibilities and accountabilities for supporting the approval and reporting processes.
2. Assure compliance with sponsor-mandated progress and financial reports and regulatory approvals from federal and local IRB groups.
3. Create and conduct surveillance and monitoring plans.Create and conduct surveillance and monitoring plans.
Next, fill in the details of how these quality objectives will be measured and the set up the QC processes:
1. Assign study regulatory responsibilities and accountabilities for supporting the approval and reporting processes.
- The regulatory specialist is responsible for daily document and file management. Quality indicators include checking the contents of the files against a standard checklist of “essential file documents,” dated communication demonstrating study activities such as meetings and instructions from the investigator, and evidence that the documents are maintained securely, such as document storage in rooms accessible only to the investigator’s designated personnel.
2. Assure compliance with sponsor-mandated progress and financial reports and regulatory approvals from federal and local IRB groups.
- Under the direction of the principal investigator, the regulatory specialist is to create schedules, report templates, and checklists. Quality indicators include a comparison of the schedule and report submissions.
- The regulatory specialist is responsible for drafting reports and correspondence for the principal investigator. Quality indicators include investigator and sponsor satisfaction with report contents.
3. Create and conduct surveillance and monitoring plans.
- A written monitoring plan will be included in the study-specific manual of procedures (MOP) and the research enterprise’s SOPs. Quality indicators include verification of the presence of the MOP and SOPs.
- Principal investigator oversight will consist of formal and informal contact with all participating research sites on a quarterly, monthly, weekly, and as-needed basis with the hospital and research personnel at each participating research site. Quality indicators include review of the documentation of written, electronic, and notes to file on telephone conversations between the principal investigator and the site personnel.
- The principal investigator will visit each participating research site to conduct a site monitoring visit on a quarterly schedule. Quality indicators may include a review of the monitoring report for each visit.
- The principal investigator will conduct “for cause” visits without prenotification as needed. Quality indicators may include a review of the documentation of the circumstances associated with triggering the visit.
Again, these objectives contain some very general descriptions of the QC activities and quality indicators for a typical clinical trial scenario.
- The research environment is not immune to the dynamics of unprofessional behavior, personal differences, conflict, and ambition.
- General principles of managing people are relevant to the research environment.
- Research professionals can benefit from firewalls
- Quality control and quality assurance activities are directly connected to the work performed by multiple members of the research team. RNL
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