The roles of clinical research coordinators (CRCs) are described in numerous

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1 Peer Reviewed Presenting findings from a pilot survey concerning the kinds of work being performed by unsupervised, nonnurse clinical research coordinators, and whether they should be engaged in such activities without supervision. Carolynn Thomas Jones, MSPH, DNP, RN Lynda Law Wilson, PhD, RN, FAAN Clinical Research Nurse Perspectives on Unsupervised, Non-Nurse Clinical Research Coordinators The roles of clinical research coordinators (CRCs) are described in numerous publications, although few differentiate the roles based on the initial educational or professional preparation of the CRC. 1 7 However, several recent publications have described the competencies required by nurses who assume roles as CRCs or as clinical research nurses (CRNs) Other publications have described the roles of CRNs who work on research related to specific health problems (such as oncology, diabetes, and lung transplantation) Poston and Buescher described the importance of nursing in clinical research coordination, and opined that a lack of pharmacologic and pathophysiologic knowledge was a roadblock for non-nurse study coordinator job performance. 17 The complexity and intensity of clinical research trials have increased in the last decade, and study coordinators may work on five to seven study protocols at one time and manage as many as 80 clinical trial participants annually. 18,19 At highly active sites, principal investigators (PIs) may rely on both nurse and non-nurse personnel to coordinate trials. This article presents findings from a pilot survey administered to CRNs attending a meeting of the International Association of Clinical Research Nurses, asking them to identify activities that unsupervised, non-nurse CRCs (NNCRCs) were conducting at their work sites. The CRN respondents also identified whether they perceived that NNCRCs should be performing those activities without supervision. Background Job titles for individuals managing aspects of clinical studies are generally not standardized within or between academic or private research sites. Furthermore, levels of education and training for CRCs vary substantially from individual to individual, with most new coordinators being trained on the job and evolving in their careers, based on study grant funding and research site infrastructure. 20 Certification for CRCs is available through examinations offered by professional organizations such as the Association of Clinical Research Professionals (ACRP) 21 and the Society of Clinical Research Associates. 22 However, although there are minimum education requirements, there is no clinical research related coursework required for those exams. The coordination of clinical research encompasses the day-to-day management of medical, pharmacologic, administrative, informatics, and ethical elements of clinical research. Legal regulations stipulate that those activities The Complexity of Clinical Trial Management 2014 ACRP Peer Reviewed x 1

2 are subject to supervision by the PI, who is the person with overall responsibility for the conduct of a particular trial. 23 Despite Food and Drug Administration (FDA) guidelines that require PIs to provide direct oversight and assurance of site personnel training and qualifications, FDA inspections of research sites have frequently revealed problems with inappropriate PI oversight of research activities. 24,25 Delving Into Delegation Indeed, PIs may delegate activities to nurse and non-nurse study coordinators and staff members without clear lines of authority for management of activities. 26 The delegation of clinical research activities to research staff, specifically to non-nurses, may increase the risk burden of a trial due to insufficient knowledge, skill, or supervision, and this delegation may be subject to professional licensure and scope of practice regulations at the state level. 12 Such regulations may limit delegation of such tasks as dispensing research medications, assessments of participants health histories (including signs and symptoms of adverse events), obtaining informed consent, and providing patient education during clinical trial visits. 12 Many investigators and nurse clinical research coordinators (NCRCs) may be unaware that such delegation and supervisory restrictions apply to clinical trial activities. PIs may delegate activities to nurse and non-nurse study coordinators and staff members without clear lines of authority for management of activities. Olson et al. recently published one of the few papers to examine the activities, scope of practice, and training needs of NCRCs and NNCRCs within a high-volume cardiovascular research site. Institutional administrators, compliance officers, and legal staff at the site evaluated the job descriptions, job performance roles, and associated licensing and research regulations to determine delegation best practices for clinical research site compliance. 27 The results revealed that a number of activities delegated were being performed outside of scope of practice by NNCRCs. The authors suggested that a lack of institutional policies on job descriptions and research roles could lead to a compromise of appropriate oversight of clinical research activities by PIs. Consequently, the institution changed a number of policies in response to the study findings, including development of guidelines for research delegation based on job title. The findings from this study support the need for clinical research sites to clarify the scope of practice of clinical research staff based on educational and professional background. Scope of Practice in Theory and Practice Scope of practice has been defined as follows: 28 Definition of the rules, the regulations, [and] the boundaries within which a fully qualified practitioner with substantial and appropriate training, knowledge and experience may practice in a field of medicine or surgery, or other specifically defined field. Such practice is also governed by requirements for continuing education and professional accountability. The Federation of State Medical Boards also acknowledged that some professions have overlapping scope-of-practice activities. A search of clinical research scopeof-practice policies revealed several that are available on the Internet and that specify study activity restrictions by personnel role, or that require the PI to request approval to delegate specific activities per protocol. For example, the San Francisco VA Medical Center (VAMC) has a policy and associated form that requires both employee and PI signatures delineating (and restricting) specific activities in clinical research. 29 The policies developed by the cardiovascular research practice described by Olson et al. and the San Francisco VAMC restricted NNCRCs from conducting the following activities independently: protocol assessments (without competency certification), writing medical orders in hospital records, conducting physical exams, taking a medical history, assessing and verifying adverse events, and administering drugs. These same policies restricted nurse counterparts from certain activities, such as: conducting physical exams, making certain assessments, and verifying adverse event causality. 27,29 The policies further stipulated the required documentation of specific competencies in order for NCRCs to implement specific study-related patient activities. For instance, a clinical trial evaluating carotid stenosis would require NCRCs to be trained and tested on the ability to administer a protocol-required stroke scale assessment. The delegation of this activity would require training, certification, PI oversight, and institutional approval. To guide the development of competencies and scope-of-practice statements for NCRCs and NNCRCs, current practice must be defined related to delegation of research coordination responsibilities to licensed and nonlicensed study personnel. With the rising complexity of clinical trials, the primary concern is the protection of human participants, quality data, and compliance with research regulations. 30 A Joint Task Force on Clinical Trial Competence has recently convened leaders from numerous research-related organizations to discuss clinical research competencies for the purpose of harmonizing the efforts of individual groups 2 x Monitor February ACRP

3 in defining roles and clinical research competencies for professionals and PIs. Such evolving collaborative initiatives will offer needed guidance on clinical research competencies, training, education, role definition, job descriptions, and career ladders to stakeholders. Participating organizations include key members of ACRP, the Academy of Physicians in Clinical Research, Harvard s Multi-Regional Clinical Trial Center, the Consortium of Academic Programs in Clinical Research, the Clinical Trials Transformation Initiative, TransCelerate BioPharma, the Alliance for Clinical Research Excellence and Safety, the Collaborative Institutional Training Initiative, Mission Model Agreements & Guidelines International, the Global Health Technologies Coalition, Innovative Medicines Initiative/PharmaTrain, and the Drug Information Association. The remainder of this article focuses on the aforementioned survey of CRNs regarding the activities of unsupervised NNCRCs. In addition to questions about NNCRCs, the survey asked the CRNs to describe activities NCRCs performed and should perform; those findings are reported elsewhere. 31 Participants and Methods The University of Alabama at Birmingham Institutional Review Board provided expedited approval of this study. The study methods have been described elsewhere (Jones & Wilson, in press), but are also summarized here. Surveys were given to all 229 attendees at the 2011 annual meeting of the International Association of Clinical Research Nurses, held in Bethesda, Md. During each day of the three-day meeting, the researcher presented the cover letter invitation and survey to participants as they registered for the meeting. Participants were asked to place completed surveys in a designated box on the registration table prior to the end of the meeting. Return of completed surveys indicated participants consents to participate in the study. Data Collection Instrument The 59-item survey instrument was derived from the CRN role delineation instrument used by Bevans et al. (with permission from the author). 1 Initial work of defining role competencies for nurses based on findings from a Delphi survey resulted in the development of a taxonomy for nursing in clinical research that consisted of five To guide the development of competencies and scopeof-practice statements for NCRCs and NNCRCs, current practice must be defined related to delegation of research coordination responsibilities to licensed and nonlicensed study personnel. domains of practice with 52 associated activities. 11 The original list of activities was derived from a synthesis of literature on CRN roles; 11 Castro et al. subsequently validated the CRN taxonomy by conducting three sequential surveys with a cohort of expert nurses working in clinical research, also resulting in a list of 52 CRN activities. 10 Because some items actually included more than one activity, a later tool evolved that had 59 total activities. 1 Bevans et al. compared perceptions of the frequency and importance of these activities in a survey of 288 CRNs, and 74 research nurse coordinators (RNCs). They defined CRNs as nurses caring for research participants who are in a hospital or clinic setting. They defined RNCs as nurses who were hired by an institution or PI to coordinate one or more studies, including the care of research participants, in a large Internet survey open to research nurses working in the National Institutes of Health (NIH) Intramural Research Program. There were many differences in the responses of the CRNs and RNCs, suggesting that the two roles are different. The list of activities was found to be reliable, based on a Cronbach alpha reliability of 0.95 for the frequency, and 0.96 for the importance of the activities. 1 In the study reported here, respondents were asked to respond to two questions for each of the 59 activities derived from Bevans et al. 1 Question A asked: Do unsupervised NNCRCs perform this activity at your site? Question B asked: Should unsupervised NNCRCs perform this activity at your site? Results Sixty-one surveys (27%) were returned by respondents who indicated that their highest level of education was either a baccalaureate degree in nursing (50.8%) or a graduate degree, indicated as a masters or doctoral degree (49.2%). They further reported a range of one to 39 years of clinical research experience (mean = years; SD = 8.7). Fiftythree distinct job titles were listed by 59 of the 61 respondents. The frequencies of job categories for the respondents are shown in Table 1. The Cronbach alpha reliability coefficient for the perform scale was 0.971, and the reliability for the should Table 1 Frequency of Job Categories of Respondents Job Title Category N % Administrative/ nurse manager Research nurse Clinical research coordinator Staff RN research unit CNS research Senior research nurse Nurse consultant Clinical director Nurse educator Nurse practitioner Not specified Total ACRP Peer Reviewed x 3

4 perform scale was Data were analyzed using SPSS (version 21.0; SPSS Inc., Chicago, Ill.) and Microsoft Excel. Table 2 presents findings that addressed the percentage of respondents who indicated whether NNCRCs perform and/or should perform each of the 59 activities without supervision at their sites. The percentage of respondents reporting that NNCRCs perform the activities without supervision ranged from 1.6% to 57.8%; the percentage of respondents who reported that the NNCRCs should perform the activities without supervision ranged from zero to 52.5%. For 50 of 59 activities, the percentage responding that NNCRCs perform the Table 2 Percentage of Respondents Reporting That Unsupervised, Non-Nurse Study Coordinators Perform and Should Perform Selected Research Activities NNCRC Without Direct Supervision Should Activity Performs Perform Domain: Care Coordination and Continuity Coordinate research participant study visits Facilitate scheduling of study procedures Coordinate interdisciplinary meetings and activities in the context of a study Facilitate research participant inquiries and concerns Provide indirect nursing care in the context of research participation Facilitate the education of the interdisciplinary team on study requirements Communicate the impact of study procedures on the research participants 29.5* 14.8* Collaborate with the interdisciplinary team to create and communicate a plan of care that allows for safe and effective collection of clinical research data Coordinate referrals to appropriate interdisciplinary services outside the immediate research team Provide nursing expertise to community-based healthcare personnel (e.g., referring physician or center) related to study participation Provide nursing leadership within the interdisciplinary team Domain: Clinical Practice Record research data in approved source document 39.3* 24.6* Report potential adverse events to a member of the research team Provide teaching to research participants and family regarding study participation, participant s current clinical 36.1* 14.8* condition, and/or disease process Monitor the research participant for potential adverse events 27.9* 4.9* Provide direct nursing care to research participants Domain: Contributing to the Science Participate in the query of research data to prepare for analysis 42.6* 31.1* Serve as a resource to new investigators Perform secondary data analysis to contribute to the development of new ideas Mentor junior staff and students participating as members of the research team Participate in the analysis of research data Collaborate with the interdisciplinary team to develop innovations in care delivery that have the potential to improve patient outcomes and accuracy of data collection Serve as an expert in a specialty area (e.g., grant reviewer, editorial board, presenter, etc.) Generate practice questions as a result of a new study procedure or intervention Disseminate clinical expertise and best practices related to clinical research through presentations, publications, and/or interactions with nursing colleagues Identify questions appropriate for clinical nursing research as a result of study team participation x Monitor February ACRP

5 Table 2 Percentage of Respondents Reporting That Unsupervised, Non-Nurse Study Coordinators Perform and Should Perform Selected Research Activities (continued) NNCRC Without Direct Supervision Should Activity Performs Perform Domain: Human Subject Protections Facilitate the initial informed consent/assent process 41* 24.6* Manage potential ethical and financial conflicts of interest for self** Support research participant in defining his/her reasons and goals for participating in a study 34.4* 21.3* Coordinate research activities to minimize subject risk Facilitate the ongoing informed consent/assent process Collaborate with the interdisciplinary team to address ethical conflicts** Serve as IRB member** Domain: Study Management Protect research participant data in accordance with regulatory requirements Participate in screening potential research participants for eligibility 54.1* 31.1* Comply with International Conference on Harmonization (ICH) Good Clinical Practice guidelines** Coordinate the collection of research specimens 49.2* 36.1* Facilitate processing of research specimens Record data on official study documents Collect data on research participant based on study endpoints 47.5* 34.4* Participate in research participant recruitment Facilitate communication within the research team** Facilitate the handling (storage and shipping) of research specimens** Contribute to the development of case report forms 39.3* 27.9* Participate in the setup of a study specific database Participate in the preparation of reports for appropriate regulatory and monitoring bodies/boards Support study budget development Participate in site visits and/or audits Facilitate accurate communication among research sites (for multisite studies) Support study grant development Oversee human resources (people) related to research process Perform quality assurance activities to assure data integrity** Develop study specific materials for research participant education Participate in study development Participate in the identification of research trends Participate in the reporting of research trends** Identify clinical care implications during study development (e.g., staff competencies and resources, equipment, etc.) Provide nursing expertise to the research team during study implementation Provide nursing expertise to the research team during study development** *More than a 10% point difference in scores, indicating perceptions of what non-nurse study coordinators perform and should perform without supervision. **Those activities that have equal to or higher percentages in the should perform category than in the perform category for activities ACRP Peer Reviewed x 5

6 activities was higher than the percentage responding that NNCRCs should perform the activity. This finding suggests that NNCRCs may be engaging in many activities that NCRCs believe they should not perform without supervision. However, for nine of the 59 activities (three activities in the Human Subject Protection domain, and six in the Study Management domain), the percentage responding that NNCRCs perform the activities was equal or lower than the percentage responding that NNCRCs should perform the activity. For 50 of 59 activities, the percentage responding that NNCRCs perform the activities was higher than the percentage responding that NNCRCs should perform the activity. A chi-square analysis was performed to compare the distribution of the perform to the should perform responses. There was a statistically significant difference in the distribution for 58 of the 59 activities (p <.05). In order to distinguish those activities that had the largest discrepancy between the two criteria, the researchers identified the 11 activities with more than a 10% difference between them (marked with asterisks in Table 2): Four of the activities were related to the Study Management domain collect data on research participant based on study endpoints; contribute to the development of case report forms; coordinate the collection of research specimens; participate in screening potential research participants for eligibility. Three of the activities were related to the Clinical Practice domain monitor the research participant for potential adverse events; record research data in approved source document; provide teaching to research participants and family regarding study participation, participant s current clinical condition, and/or disease process. Two of the activities were related to the Human Subject Protection domain facilitate the initial informed consent/assent process and support the research participant in defining his/her reasons and goals for participating in a study. One activity was related to the Care Coordination and Continuity domain communicate the impact of study procedures on the research participants. Finally, one activity was related to the Contributing to the Science domain participate in the query of research data to prepare for analysis. Discussion The findings indicate that many of the 59 clinical nursing research activities included on the Bevans et al. 1 tool are being performed by NNCRCs without supervision, and that respondents feel some activities currently being performed by NNCRCs should not be done unsupervised. These findings are consistent with the findings reported by Olson et al, 27 which indicated that many research activities were being conducted outside the scope of practice of the CRCs, and that there was a need for clearer policies outlining guidelines for delegation of researchrelated responsibilities. Issues related to care coordination and continuity, human participant protections, and safety should be carefully considered as study personnel are assigned to study activities, and especially when investigator involvement in daily activities is limited. In keeping with the FDA draft guidance on supervisory responsibilities of investigators, The investigator should ensure that any individual to whom a task is delegated is qualified by education, training, and experience to perform the delegated task. 32 Strategies described by Olson et al. and the San Francisco VAMC might be used as models to develop policies to clarify the scope of practice for NCRCs and NNCRCs. 27,29 Limitations Because this study had a convenience sample of a specialized group of NCRCs, the findings cannot be generalized to reflect perceptions of all NCRCs. Another limitation is that the sample did not include non-nurse participants, and thus their perspectives were not assessed. Issues related to care coordination and continuity, human participant protections, and safety should be carefully considered as study personnel are assigned to study activities, and especially when investigator involvement in daily activities is limited. The study was further limited because the tool used was developed specifically to describe clinical nursing research activities, and has not been validated as a tool to differentiate research activities of nurse and nonnurse study coordinators. The wording of some of the items in the tool may have been confusing to participants when they were asked to determine whether non-nurse study coordinators should perform the activity. For example, one activity in the clinical practice domain reads provides direct nursing care to research participants. A more appropriate phrase may have been provides direct clinical care. 6 x Monitor February ACRP

7 Finally, the selection of more than a 10% difference was an arbitrary selection for the purpose of identifying a cutpoint for stimulating further discussion and research. Further research is needed to develop a valid and reliable measure for assessing and differentiating the activities of nurse and non-nurse study coordinators. Moreover, there is a need for research on the distinct contributions of nurses to the interdisciplinary clinical research enterprise to distinguish this group of research professionals as offering unique nursing leadership. Conclusion Despite the limitations, the findings from this study provide initial data about perceptions of nurses concerning the role of non-nurses in clinical research activities, and can serve as a platform for further discussions and explorations about clinical research competencies and roles. Moreover, as policies evolve to distinguish or limit the delegation of clinical research activities, it is important to clarify restrictions within the framework of scopes of practice and considering the complexity of the study using a riskbased approach. Table 3, adapted from Olson et al, provides a suggested template for distinguishing those activities requiring further clarification. 27 Defining job descriptions by competencies and scope of practice will ensure site compliance with guidelines set forth by the FDA. 32 The clinical research enterprise is expanding to include roles that might be filled by nonclinical personnel, including data managers, protocol navigators, regulatory professionals, study assistants, institutional review board personnel, research administrators, program coordinators, and contract research organization personnel. Indeed, a recent report published by the Institute of Medicine 33 predicted that a significant clinical research workforce will be needed meet the needs of the expanding research enterprise. In light of this, it will become increasingly important that researchers clarify the roles of all research personnel and Table 3 Delegation of Activities to Nurse and Non-Nurse Clinical Research Staff Clinical Study Activity NCRC Staff Perform? NNCRC Staff Perform? Screening medical records Yes Maybe* Informed consenting Yes Maybe* Protocol testing Yes Maybe* Protocol assessments Yes No Patient orders (research orders only) Maybe* No Physical exam Maybe* No Medical history Maybe* No Adverse event (AE) intake and documentation Yes Maybe* Transcribing AE information Yes Yes Assessment of AE causality No No Assessment of AE expectedness No No Assessment of AE relationship to test article No No Serious adverse event (SAE) determination Yes Yes Report SAE to sponsor Yes Yes Test article receipt and storage Yes Yes Test article accountability Yes Maybe* Assign study product (randomization) Yes Maybe* Drug administration Yes No Test article destruction (per sponsor requirements) Yes Yes Test article return Yes Yes Entries into participant s medical and research record Yes Yes Entries into participant s hospital record or EMR Yes No Writing verbal orders in the hospital record (for the Yes No study) Regulatory binder accountability Yes Yes Maintaining study manual Yes Yes Case report form (CRF) completion (paper and electronic) Yes Yes Answering CRF queries Yes Maybe* Designing CRFs Yes Maybe* Communication with sponsors Yes Yes Completing IRB submission materials Maybe* Maybe* IRB submissions Yes Yes Source: Adapted from Olson et al.27 *Clarify who and when can be performed. ensure site compliance with regulations related to scope of practice, delegation, and meaningful oversight of clinical studies. 34,35 As core competencies for clinical research personnel are harmonized and defined, issues in job descriptions, career ladders, professional development opportunities, and scope-of-practice policies will naturally evolve to improve clinical research site operations to ensure the public health. For the sake of public health, an institution s scope of practice expectations and state requirements for licensure must be linked with adherence to clinical research regulations, quality 2014 ACRP Peer Reviewed x 7

8 data, and human participant protections as the clinical research profession looks forward to the next stage of evolution in the complexity of clinical trial management. Acknowledgments The authors would like to thank Clare Hastings, RN, PhD, FAAN, of the NIH Clinical Center, for her valuable comments in preparing this survey study, and Jennifer Cunningham, a University of Alabama at Birmingham doctoral student in health education, for her assistance with data entry and quality checks. References 1. Bevans M, Hastings C, Wehrlen L, Cusack G, Matlock AM, Miller-Davis C, Tondreau L, Walsh D, Wallen GR Defining clinical research nurse practice: results of a role delineation study. Clinical and Translational Science 4(6): Anderson DL A Guide to Patient Recruitment and Retention. Boston, Mass.: Thomson CenterWatch. 3. Habermann B, Broome M, Pryor ER, Ziner KW Research coordinators experiences with scientific misconduct and research integrity. Nursing Research. 59(1): Davis AM, Hull SC, Grady C, Wilfond BS, Henderson GE The invisible hand in clinical research: the study coordinator s critical role in human subjects protection. Journal of Law, Medicine, & Ethics 30(3): Duane CG, Granda SE, Munz DC, Cannon JC Study coordinators perceptions of their work experiences. The Monitor 21(5): Fedor C, Cola PA The coordinator s forum: preliminary results of the clinical researcher coordinators survey. Clinical Researcher 3(4): Gwede CK, Johnson DJ, Roberts C, Cantor AB Burnout in clinical research coordinators in the United States. Oncology Nursing Forum. 32(6): Bell J Towards clarification of the role of research nurses in New Zealand: a literature review. Nursing Praxis in New Zealand 25(1): Ehrenberger H, Lillington L Development of a measure to delineate the clinical trials nursing role. Oncology Nursing Forum 31(3): E Castro K, Bevans M, Miller-Davis C, Cusack G, Loscalzo F, Matlock A, Hastings C Validating the clinical research nursing domain of practice. Oncology Nursing Forum 38(2): E72 E CRN2010 Clinical Research Nurse Domain of Practice Committee Building the foundation for clinical research nursing: domain of practice for the specialty of clinical research nurse. Bethesda, Md.: National Institutes of Health Clinical Center. 12. Hastings C, Fisher CA, McCabe MA, The National Clinical Research Nursing Consortium Clinical research nursing: a critical resource in the national research enterprise. Nursing Outlook 60(3): Ahern J, Grove N, Strand T, et al The impact of the trial coordinator in the Diabetes Control and Complications Trial (DCCT). The DCCT Research Group. Diabetes Educator 19(6): Lindquist R, VanWormer A, Lindgren B, MacMahon K, Robiner W, Finkelstein S Time-motion analysis of research nurse activities in a lung transplant home monitoring study. Progress in Transplantation 21(3): Roche K, Paul N, Smuck B, Whitehead M, Zee B, Pater J, Hiatt MA, Walker H Factors affecting workload of cancer clinical trials: results of a multicenter study of the national cancer institute of Canada clinical trials group. Journal of Clinical Oncology 20(2): Scott K, White K, Johnson C, Roydhouse JK Knowledge and skills of cancer clinical trials nurses in Australia. Journal of Advanced Nursing 68(5): Poston RD, Buescher CR The essential role of the clinical research nurse (CRN). Urologic Nursing 30(1): Getz KA Assessing the downstream impact of protocol design complexity. Touch Briefings Available at ophthalmology.com/sites/ -getz.pdf. Accessed March 5, Getz K Has the study coordinator landscape reached a tipping point? Available at &utm_medium=social&utm_content=9c27 ae0c-b8c1-470b d d Carter SC, Jones CT, Jester PM Issues in clinical research manager education and training. Research Practitioner 8: Association of Clinical Research Professionals CRC Certification Guide. Available at Accessed June 2, Society of Clinical Research Associates Certification for CCRP. Available at www. socra.org/html/certific.htm. Accessed July 7, DeMarinis AJ Supervisory responsibilities of investigators. Research Practitioner 8(4): U.S. Food and Drug Administration. FDA Form 1572, Statement of Investigator, 21 CFR (c) In: U.S. Food and Drug Administration, ed. Office of Management and Budget. 25. IMARC Research I Top ten 2011 FDA warning letter findings for clinical investigators. Available at Accessed April 13, Ross JS PI: Principal investigator or practically invisible. The Monitor 23(5): Olson RE, Boisjolie C, Goldman JA, Jorgenson B, Pink V, Williams KA, Henry TD, Cosico JN Scope of practice in clinical research: a cardiovascular research institute s approach. The Monitor 26(6): Federation of State Medical Boards of the United States I Assessing Scope of Practice in Health Care Delivery: Critical Questions in Assuring Public Access and Safety. Available at _scope_of_practice.pdf. Accessed July 3, San Francisco VA Medical Center. Scope of Practice for Clinical Research Employees. Available at /Scope.doc. Accessed July 3, Thomasell J Collaborative Opportunities ACRP/CoAPCR. Paper presented at 10th Annual Meeting of Consortium of Academic Programs in Clinical Research, Boston, Mass. 31. Jones CTW. Role perceptions of nurse clinical research coordinators. Nursing: Research and Reviews, in press. 32. Food and Drug Administration Guidance for Industry: Protecting the Rights, Safety, and Welfare of Study Subjects Supervisory Responsibilities of Investigators. Draft Guidance. Available at /RegulatoryInformation/Guidances/ucm pdf. Accessed July 3, Institute of Medicine Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for Washington, D.C.: The National Academies Press. 34. American Society of Clinical Oncology Quality assurance and educational standards for clinical trial sites. Journal of Oncology Practice 4(6): PR Newswire Collaborative Initiative to Develop Standards for Clinical Research Sites Underway. Available at -to-develop-standards-for-clinical-research -sites-underway html. Accessed April 13, 2013, Carolynn Thomas Jones, MSPH, DNP, RN, is faculty instructor at the University of Alabama at Birmingham (UAB), where she is coordinator of the Clinical Research Management program and a senior scholar for the Pan American Health Organization/World Health Organization (PAHO/ WHO) Collaborating Center for International Nursing. She has more than 25 years of experience working in clinical research as a clinical research nurse coordinator and administrator of an NIH-funded Coordinating Center, and has managed clinical trials across multiple disciplines, primarily in cardiovascular diseases and infectious diseases/mycology. She is also president of the Consortium of Academic Programs in Clinical Research. She can be reached at cjthomas@uab.edu. Lynda Law Wilson, PhD, RN, FAAC, is a professor, assistant dean for international affairs, deputy director of the PAHO/WHO Collaborating Center for International Nursing, and associate director for nursing programs with the Sparkman Center for Global Health at UAB. She served as principal investigator of an NIH Challenge Grant providing distance education for study coordinators working in low-resource sites, and organizes onsite leadership courses for global health leaders at UAB. She can be reached at lyndawilson@uab.edu. 8 x Monitor February ACRP