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Shared Scientific Resource Core aids drug, alcohol studies It was a good idea that Angelica Thevos, Ph.D., knew would work.  But she had to meet with a myriad of people and establish trusting alliances so that researchers in the Department of Psychiatry and Behavioral Sciences would allow the creation of a Shared Scientific Resource Core to maximize resources and centralize some of the duties common to most of the Charleston Alcohol Research Center and the Center for Drug and Alcohol Program's  research studies. “It took a lot of coalition building and plenty of feedback,” she said, “to gain their confidence in our abilities to help.” Thevos’ core now has the track record for dependability that the division's researchers and clinicians were looking for. They weren’t about to relinquish important tasks like subject recruitment and data collection to someone outside of their control or close supervision. Not until the core demonstrated it could do it better than they could. Funded by the National Institute on Alcohol Abuse and Alcoholism, the Charleston Alcohol Research Center, of which the Shared Scientific Resource Core is a fundamental component, has sought to achieve efficiency and quality control by identifying and performing those important tasks that serve the needs of researchers throughout the Charleston Alcohol Research Center and the Center for Drug and Alcohol Programs. As more services are added, it has become an indispensable part of most research and clinical activity which is rapidly growing in this prominent and successful division of the Department of Psychiatry and Behavioral Sciences. “We had lots of studies that were getting funded, and each project had its own staff recruiting patients for their particular study,” Thevos said. She said it was not unusual for individual patients to be approached by research staff from a number of studies to be screened for eligibility for study participation. Thevos asked, “Why can't we have a centralized screening place where one person screens everybody, where the patient has to speak to only one person? That way the patient has an advocate, the chances of an inappropriate assignment to a study are lessened, time is saved for both the research staff and the patient, and efficiency for all parties involved is maximized and the carefully trained intake coordinators know the eligibility requirements for each study. Patients appreciate having a single resource person to contact to ask questions and help them understand procedures. In this way the patients are more at ease and the system becomes much easier to negotiate. Ultimately, of course, this improves the quality of care and patient satisfaction.” So the first thing Thevos established was a centralized intake system for recruitment and screening of all individuals who call or access the department’s other services seeking information about treatment options. If the caller is interested in research, he or she initially only needs to speak to one, very knowledgeable intake coordinator. If research studies are not of interest to the person, or he or she is not eligible to participate, clinical referrals are provided and facilitated. The entire system is organized and professional. Additionally, it improves research efficiency, maximizes resources, provides quality control and is standardized. “The next thing we did is centralize pharmacy services. Any medication study we have has a doctoral-level pharmacist and a pharmacy technician, who supervise the medication aspects of any research protocol. This can include packaging the medications, providing a randomization schedule, maintaining the study blind, and even compounding the drugs and making matching placebos if required. Principal investigators utilize the pharmacist to inquire about possible drug interactions and to keep abreast of new pharmacological information pertinent to their work.” The shared core also provides medical and laboratory services to research participants. Through a contract with nurse practitioners in the Institute of Psychiatry, it becomes a matter of just scheduling routine research-related physicals through a centralized scheduling mechanism. Every evening, the nurse practitioners check the schedule for the next day and are ready for the patients when they arrive. The entire process is smooth and delays are avoided. Since the nurses are on contract with the shared core, MUSC resources remain within MUSC and help them to be maximally utilized, Thevos said.  “The nurse practitioners are very valuable to the research operation. They perform routine physicals including EKGs, order associated laboratory tests, receive the reports and review them, and then complete the research-related paperwork which is necessary to document the patient’s eligibility to participate in a certain study,” Thevos said. “Importantly, the nurses provide the essential function of alerting project medical staff and/or the principal investigators of any clinical concerns immediately so that these may be reviewed by them, discussed with the patient, and a plan determined that suits the patient's needs.” Another service of the shared core is that of providing statistical and data-base management services to research projects related to the Charleston Alcohol Research Center and the Center for Drug and Alcohol Programs. The Office of Statistics and Data Management (OSDM) is staffed with a Ph.D. statistician and a full-time masters level statistician. Through this office, quarterly quality assurance activities are conducted and reports are generated. This enables research staff to discover missing or discrepant information in a timely fashion so that corrections and explanations can be recorded. Data entry and data “cleaning” are an ongoing and critical part of this activity. Documentation accompanies any corrected data points and full reports are sent to the principal investigators for review. The OSDM is central in providing vital statistical analyses on existing data as well as helps to plan data management strategies, provides sample size estimates and lends significant assistance in grant submissions, and manuscript and scientific presentation preparation. “You can see where we are going with this,” Thevos said. “These are shared services. Without the core, everybody would go out and hire a statistician for a small percentage of time commitment on each separate grant. The Charleston Alcohol Research Center gave us an important as well as prestigious umbrella under which to provide these vital services while also synergistically helping the entire division.”  Another service—providing centralized research assistant training and training of new hires for project coordinator positions—received approval as an enhancement to the core in the recent renewal from the National Institute on Alcoholism and Alcohol Abuse. This training includes research ethics, confidentiality regulations, administrative and information technology services for all staff. The clinical staff receive specialized training in areas such as safety issues for patients and staff, IRB regulations and compliance, interviewing skills, data management and integrity, and specific clinical assessment instruments. The basic laboratory research staff also receive specialized training related to their duties and responsibilities such as radiation safety, handling of hazardous chemicals, and policies of the FDA and the SC DHEC.  “These are all things that will help them do their jobs better,” Thevos said. “It assists them with procedural information that everybody should know, but until the shared core came along, received irregularly and with no standardization. Now we have excellent trained staff that are receiving consistent, standardized and, most importantly, correct information, so that they, their patients, and the functioning of their laboratories will benefit. The research projects and the results that they generate can only improve as a result of this kind of intensive and careful effort.” Thevos said that the shared core was her idea 20 years ago when she was a research assistant for former department chair James Ballenger, Ph.D. “My goal is to have a research staff of project coordinators and research assistants that have the highest quality and integrity possible, this translates to superb research efforts and results that are fitting to the caliber of a national research center,” Thevos said. “In substance use disorder research, many of the instruments are standard. We train on the valid and reliable measures as well as the research methods in general which are expected from distinctive research endeavors.” Thevos said that as the core's superior services and reputation became known it not only became easier to gain the confidence of principal investigators in the Alcohol Research Center and the Department of Psychiatry, but her shared core has sparked national interest as well.  “They want to know how we managed to be successful at such a difficult task to finesse.”