The New Shape of Workforce Development HOME STUDY TEST Earn 3.0 Continuing Education Credits This test expires on December 31, 2017 (original release date: 12/1/2016)

ACRP EDITORIAL In this issue of Clinical Researcher, the three articles that follow this page have ADVISORY BOARD been selected as the basis for a Home Study test that contains 30 questions. For your Michael . Hamrell, PhD, RAC, FRAPS, RQAP-GCP, CCRA (Chair) convenience, the articles and questions are provided in print as well as online (members only) in the form of a PDF. This activity is anticipated to take three hours. Erika J. Stevens, MA (ABoT Liaison) Suheila Abdul-Karrim, CCRA, CCRT Answers must be submitted using the electronic answer form online (members Victor Chen only, $60). Those who answer 80% of the questions correctly will receive an electronic Gregory Hale, MD, CPI Julie M. Haney, RN, BS, MSL, CCRC statement of credit by e- within 24 hours. Those who do not pass can retake the test Stuart Horowitz, PhD, MBA for no additional fee. Stefanie La Manna, PhD, ARNP, FNP- Jamie Meseke, MSM, CCRA Grannum Sant, MD, BCh, BAO (Hons.), MA, FRCS, FACS ACRP DISCLOSURE STATEMENT CONTINUING EDUCATION Paula Smailes, RN, MSN, CCRC, CCRP As an organization accredited by the Accreditation INFORMATION Naveen Tirkey, PhD, CCRA: Nothing to Disclose Council for Continuing Medical Education (ACCME®), The Association of Clinical Research Professionals Jerry Stein, PhD (Vice Chair): the Association of Clinical Research Professionals (ACRP) is an approved provider of medical, nursing, Consultant to Encore Vision, Contractor (ACRP) requires everyone who is in a position to for various companies and clinical research continuing education credits. control the planning of content of an education activity to disclose all relevant financial relationships Contact Hours ACRP STAFF/ with any commercial interest. Financial relationships The Association of Clinical Research in any amount, occurring within the past 12 months Professionals (ACRP) provides 3.0 VOLUNTEERS contact hours for the completion of this of the activity, including financial relationships of a Gary W. Cramer educational activity. These contact hours Jan Kiszko, MD spouse or life partner, that could create a conflict of can be used to meet the certifications Jo Northcutt interest are requested for disclosure. maintenance requirement. Deepti Patki, MS, CCRC The intent of this policy is not to prevent indi- (ACRP-2016-HMS-012) Barbara van der Schalie viduals with relevant financial relationships from Continuing Nursing Education Christine Streaker participating; it is intended that such relationships Nothing to Disclose The California Board of Registered Nurs- be identified openly so that the audience may form Karen Bachman: ing (Provider Number 11147) approves Alcon speaker’s bureau their own judgments about the presentation and the the Association of Clinical Research James Michael Causey: presence of commercial bias with full disclosure of Professionals (ACRP) as a provider of con- Contributor, AssurX blog the facts. It remains for the audience to determine tinuing nursing education. This activity whether an individual’s outside interests may provides 3.0 nursing education credits. (Program Number 11147-2016-HMS-012) reflect a possible bias in either the exposition or the conclusions presented. Continuing Medical Education The Association of Clinical Research Professionals (ACRP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing The pass rate for the medical education for physicians. The 80% Home Study Test is now Association of Clinical Research Profes- sionals designates this enduring material 80% to be in alignment with ACRP for a maximum of 3.0 AMA PRA Category professional development standards. 1 Credits™. Each physician should claim only the credit commensurate with the extent of their participation in the activity.

Clinical Researcher 11 December 2016  HOME STUDY The New Shape of Workforce Development

Project Managers Influence Parallel Planning and Collaboration Between Sites and Sponsors

PEER REVIEWED | Romiya Barry, MSc | Joe Coffie, CCRA | Catherine Pui Yin Mok, MSc, CCRP, CCRC | Jill Chapman, BHSc, CCRA [DOI: 10.14524/CR-16-0005]

Clinical research is a dynamic field. Changes in regulatory requirements, market demands, and clinical practice can affect clinical project design and study timing. To plan and execute a clinical trial today can take years and cost hundreds of millions of dollars, but what is most at stake is the relevancy of the drug or device to the intended patient or user.

It is critical that studies are conceptualized, great tools for ensuring both parties (sponsor/ initiated, and reported efficiently. Successful trials CRO and site) have the opportunity to review tasks must be both scientifically sound and managed associated with the project. according to best practices, but it has been The project managers at the sponsor and site reported that many clinical trials fail to deliver also are responsible for communicating with because of the lack of a structured, practical, sys- one another about their respective project plans tematic approach to trial management.1 A robust using a pathway that can be documented for each clinical project plan can have a powerful impact study. This communication pathway facilitates the on increased efficiency in all phases of clinical parallel planning approach. In current practice, LEARNING OBJECTIVE trial development and implementation; this can be it is often the case that a sponsor shares its study supported by a strong, collaborative approach in timeline with the site during the investigator After reading this article, project management. meeting or site initiation visits, but regularly fails participants should be able to actually discuss the timeline and plans for to explain what parallel Parallel Planning in Project Management executing the study. planning is in project Use of project management systems can be Many business and project management systems management, provide optimized in a parallel planning approach by are available on the market. However, while the inputting site start-up timelines and enrollment rate examples of how it can be use of tools like SAP Business ByDesign, projections (as two examples). With this information implemented in a clinical SharePoint , ProjectManager.com, ALLEGRO ® in hand, the sponsor can then look at the overall trial, and use it in their CTMS, and others may garner different results for study in a “big picture” view and make informed trials. different users, the importance is having effective decisions that may impact the study. For example, project leadership—whether identified by title or a particular region has one site that can be ready DISCLOSURES delineated based on the responsibilities of a person’s for a site initiation visit early, but is not expected to Romiya Barry, MSc; role—at the sponsor/contract research organization be a high-enrolling site, and the remaining 10 sites (CRO) and clinical site levels. Joe Coffie, CCRA; will be ready three months later. The sponsor may A representative for each entity involved in the Catherine Pui Yin Mok, MSc, decide to delay study launch in that entire region study should be responsible for initiating, plan- CCRP, CCRC: until the time that all sites are expected to be ready. ning, executing, and monitoring the project plan Nothing to disclose In so doing, the personnel resource requirements on his/her respective side of the overall project. would be optimized, and sponsor/CRO resources Jill Chapman, BHSc, CCRA: These project leads (project managers) ensure that would thus be directed to the other regions that are Employee of ACRP the tasks are carried out appropriately and accord- expected to be ready sooner. ing to the plan. Project management systems are

December 2016 12 Clinical Researcher Study Timelines: A Shared TABLE 1: Shared Project Concept Review Responsibility Utilizing a consultative approach by involving all PROJECT MANAGER stakeholders as early in the project development as Sponsor Site possible takes into account the perspectives of the sponsor, the CRO, and the investigative site, thus Is this study Define reasonable eligibility requirements Confirm the site has an adequate targeted Feasible? and sample size for the protocol synopsis. patient population that correlates with the reducing chances of decreased scientific relevance protocol eligibility requirements. resulting from changes in standard-of-care that Clearly state the objectives and required Understand if the study procedures can occur while the clinical project is in development. activities of the protocol, limiting optional be performed appropriately with special Clinical trials guided by strong communication study activities unrelated to the objectives. attention to procedures outside the between sponsors and sites are more successful and standard of care at the site. enjoyable, as they contribute to “pride in ownership.” Specify equipment requirements that may Consider if any special equipment is All stakeholders should prospectively establish not be standard or in routine use at studies needed to perform the study procedures a clear understanding of each party’s responsibil- sites (e.g., research equipment vs. clinical described in the protocol. ities and of the expectations for the conduct of the equipment). project. Often, face-to-face communications about Determine with biostatistics and medical Evaluate the rationale of the study design study data quality are important steps to starting director if the study is similar to previous with respect to clinical practice at the site. on the right foot or for getting a fledgling project on investigations; provide rationale for the right track. repeating the study or modifying the study design based on results of the previous Both sponsor/CRO and site clinical trial project evaluations. managers are challenged to balance project needs, each other’s requests, and the site’s abilities in Is this study Propose a detailed, fair market value Does the protocol include the cost of all Achievable? budget that captures the cost of activities and manpower required to implementing new initiatives for a particular procedures in the protocol. support the protocol? study. One approach to gain efficiency and increase What are the anticipated regulatory What local ethical considerations are power in planning is to use parallel planning challenges for study approval in each study required for this study or were required for rather than a common “authoritative” approach country? similar studies in the past? whereby the sponsor tells the CRO and sites what Are there temporal factors that could needs to happen and when. influence the study conduct, such as In a parallel planning approach, each aspect of seasonal effects? the clinical trial project plan is reviewed simulta- What is the overall timeline and what are neously from the perspectives of the site and the the milestones each stakeholder needs to sponsor. This approach could foster more openness achieve? about the schedule and timeline risks, empower the Identify plans that can be put into place site to positively influence the study schedule, and to mitigate threats and capitalize on promote a collaborative culture of a shared project. opportunities. Ideally, a sample of sites should be used in Is this study How will the results be used? Can the results be used for internal parallel planning from the very beginning of the Believable? institution education, published in trial (from the feasibility stage). When conceptualiz- peer-reviewed literature, or disseminated ing a project and reading the study design synopsis, to study participants? project managers at both the sponsor/CRO and the Are the study endpoints and expected Are results relevant to clinical practice? site may use a checklist to determine if the project is results supported by medical advisors? Could these results advance medicine? “Feasible, Achievable, and Believable” (see Table 1). Do the study endpoints and expected For patient-centered studies, are results The early discussion phase between the sponsor results support the user need relevant to patient needs? and site about study feasibility is ideal for begin- requirements? ning parallel project planning. When planning Are the study endpoints and expected Do the endpoints and expected results the project, research team members from both results comparable to similarly available promote community public health? the site and the sponsor/CRO should understand medical products? the required study coordination activities ranging Do the study endpoints and expected from the project’s conception to site initiation. results meet the expectations of regulatory During this time, leaders from both parties should approvers? discuss and make a go/no-go decision so resources Is the protocol designed to be statistically can be focused where needed. credible? Outlining and following the study-related processes and procedures at each entity could allow for identification of parallel processes and help identify any early roadblocks. By establishing

Clinical Researcher 13 December 2016  HOME STUDY The New Shape of Workforce Development

were still willing to move forward, then a working plan could be put into place. Continued engagement is crucial for mitigating reduced enthusiasm about the trial. Throughout the TABLE 2: Guiding Principles for Sponsor/CRO and Site Collaborations course of the project, the clinical project managers should complete quarterly or biannual reviews of Recommendations for the Sponsor/CRO Recommendations for the Site the final plan. These periodic reviews provide an GET STAKEHOLDERS ON THE SAME PAGE opportunity for discussion on whether changes are • Write a well-summarized project synopsis that • Discuss the protocol with the entire team/staff and required to the parallel plan, based on the status can be distributed to internal and external team obtain feedback of the project and possible future impacts to the members project timeline. DEFINE OBTAINABLE GOALS WITH SPECIFIC TIMELINES Developing and Defining • Create a project plan that includes dates for • Ask for project timelines Meaningful Metrics deliverables from the sponsor, CRO, and site • Request sponsor’s/CRO’s expectations for • Ask the site for timelines to meet the project goals milestones in the phases prior to, during, and after Sponsors and CROs should set expectations, but the study conduct also should ask site personnel how they view their IDENTIFY RESOURCES NEEDED TO ACHIEVE GOALS own current levels of quality and how they feel these levels can and should be measured. This is a conver- • Be specific on the sponsor/CRO responsibilities • Review schedule of events of the protocol and sation worth having up front, and not an item to be confirm that all necessary resources are available • Provide specific examples of support that are buried in an investigator pre-qualification question- available to the site if needed • Ensure study budget accounts for all financial naire or site qualification checklist. According to one • Prepare a detailed, fair market value study budget burdens source, “the quality of our decisions depends at least • Communicate the expectations the sponsor/CRO has for the site in terms of time, personnel, facility, in part on the quality of the information on which we and budget base them,”3 so communicating the standards and metrics for evaluation allows site staff to focus on GET STAKEHOLDER BUY-IN critical elements for study management and adapt • Document agreement on the goals with all • Review tasks and delegation with impacted staff the methods as needed. stakeholders In a survey of Society for Clinical Research Sites • Identify areas of disagreement as potential risks to members, less than 50% of respondents reported the project and create a risk management plan strong agreement that sponsor/CRO teams effec- REASSESS STAKEHOLDER UNDERSTANDING tively communicate their expectations regarding quality to sites.4 In recent years, new initiatives and • Prepare efficient and effective investigator • Ensure all concerns are addressed by sponsor guidance documents have been introduced as a meetings • Ensure all impacted/assigned staff are present • Conduct site initiation visits that include re- at the site initiation visit or investigator meeting method for sponsors and CROs to enhance and eval- training and review of the goals and timelines when possible uate site performance, quality, and sustainability as • Ensure absent staff are trained on their study a means of improving the quality of clinical trials. responsibilities Care should be taken to ensure that site quality and performance metrics are not defined solely from the industry’s perspective. Sponsors should A robust clinical deadlines for completion of critical tasks, the impact of delayed or missed targets on subsequent not create program-level metrics that do not fit project plan can have activities can be minimized. For example, Cheng with a specific project at the risk of inundating the top-performing sites with unnecessary requests and a powerful impact on et al. found that trials that did not have a patient enrolled within the first two months of trial requirements just to meet poorly designed metrics— increased efficiency in activation were significantly less likely to achieve especially ones that are disruptive to research processes at sites that have been proven to work well. all phases of clinical the minimum accrual target, despite the length of time the trial remained open.2 To combat the “metrics mania,” some sites have trial development and By including constraints on when it is acceptable instituted their own metric systems to evaluate to achieve the critical task of “first patient in” for a sponsors. However, similarly, the ability to act on implementation; this study, the risk posed by poor enrollment to a site’s some of the metrics is limited because they are not can be supported by a performance—and to overall study enrollment— associated with actual steps in the project plan may be identified earlier in the initiation phase. upon which the sponsor can improve. strong, collaborative The above-mentioned study found that, as the Overall, metrics should be value-added and approach in project two-month mark in an active trial was approached, meaningful to both the sponsor and the site. A the project managers at the sponsor and site could simpler, more focused initiative may be for project management. review if their collaboration on the study was still managers to identify areas of concern at their own Feasible, Achievable, and Believable. If both parties organizations and at partner organizations.

December 2016 14 Clinical Researcher Co-Managing Study Changes Leading a Collaborative Partnership References 1. Farrell B, Kenyon S, Parallel project planning would also identify any It is critical that the project managers from both Shakur H. 2010. Managing clinical trials. Trials 11:78. flexibility in the project plan for expansion of time, the sponsor and the site provide strong leadership, http://trialsjournal. costs, or scope. Due to the dynamism of the medi- set the tone for shared collaboration in the projects, biomedcentral.com/ cine, new information may be published or learned and resist the urge to show off their authority to articles/10.1186/ 1745-6215-11-78 from clinical practice that could severely impact the one another. With a historic culture of having 2. Cheng SK, Dietrich MS, study endpoints, or even introduce new concerns “sites as customers” and the “customer is always Finnegan S, et al. 2010. about risks to participant safety and data reliability. right” mentality, shifting to the “sites as suppliers” Early indicators of accrual success: Time-to-first- Similarly, regulatory changes can have a huge concept and following the practices of supply patient and accrual impact on project plans. Even changes aimed at management require a focus on finding balance in performance at an improving the efficiencies of clinical trial oper- the relationship. anticipated enrollment milestone—A study of ations, such as the adoption of electronic data A post in response to the recent “Site Empow- NCI-CTEP-sponsored capture or risk-based monitoring, may result in erment Series” of webinars from Forte Research clinical trials. J Clin Oncol undesirable outcomes to the study operations Systems stated that “one of the easiest ways to 28:447s, suppl; abstr 6001. 3. Martens H, Martens M. when inappropriately initiated in the study plan. improve site-sponsor relationships is for sites to 2001. Introduction to 5 Unless experienced at a great frequency, changes take control.” Reading past that bold—and some- multivariate data analysis at a site level (e.g., staff turnover, new contract what aggressive—statement, the content of the for understanding quality. John Wiley & Sons Ltd. negotiation processes, etc.) may have a smaller webinar series supports shared collaboration, by 4. Society for Clinical impact on the overall project timeline. which the clinical project is a partnership between Research Sites. 2014. The Project plans are often inflexible to changes the site and the sponsor that is founded on open Quest for Site Quality or expanded project scopes, yet project amend- and Sustainability: communication and transparency in the planning, Perceptions, Principles ments still occur in response to new information. conduct, and reporting of the study. and Best Practices. http:// These changes affect the work of all stakeholders; myscrs.org/wp-content/ uploads/2014/10/Quest- however, it is often the case that the overall project Conclusion for-Site-Quality-and- plan is only adjusted to reflect the additional work Sustainability-FINAL.pdf Good management at both the sponsor and site required from one group. 5. Schultz A. 2015. Forte level is essential to the delivery of high-quality Since the sponsor usually develops the original Research. How to Set the trials. More specifically, sites that are (or want to Tone for Stronger Site- project timeline, adjustments to the schedule be) known as being committed to providing quality Sponsor Relationships. generally are made only for activities internal to http://forteresearch.com/ data have high-performing clinical project manag- the sponsor’s operations. In some cases, the impact news/beginners-guide- ers, and their counterpart project managers with at to-site-empowerment- of the change comes in terms of extra effort by the turn-insight-into- least equal skills on the sponsor/CRO side likewise site to maintain the expectation for the duration of action/#sthash.05HlZCzB. contribute greatly to the successful delivery of dpuf work. In a parallel planning model, the impact on clinical programs. the amount of effort and the duration of work for Using a few guiding principles for early engage- both the sponsor and the site would be captured in Romiya Barry, MSc, (romiya. ment can lead to a culture of shared collaboration the updated timeline. [email protected]) is manager on the clinical project (see Table 2). Far from being of clinical operations When the details of changes in a study’s scope a “team of one,” successful clinical trial project with AngioDynamics in and operational models are not communicated Marlborough, Mass. managers have the ability to work effectively with prior to implementation, the activities needed to each other and with all of a study’s stakeholders to Joe Coffie, CCRA, is a global support the changes may not be fully accounted define the clinical program requirements, shape the clinical project manager with for in the time, budget, and resource allocation of MacroGenics, Inc. in Rockville, output of projects, and drive successful outcomes. the project plan. Additionally, standard operating Md. procedures (SOPs) often cannot be adapted easily ACKNOWLEDGEMENT AND DISCLAIMER Catherine Pui Yin Mok, to unique situations that may present during the We sincerely thank Jovan Petty, former specialist MSc, CCRP, CCRC, is a clinical researcher with the University course of the project. for committees and interest groups at ACRP, for of British Columbia in Early identification of procedures for co- her support and coordination of this collaborative Vancouver, Canada. managing study changes could minimize such effort. All trademarked products and services Jill Chapman, BHSc, CCRA, barriers to the study’s progress as described here. mentioned in this article are the property of their is based in Toronto, Canada, These procedures may include mechanisms for respective owners. The inclusion of names of tools as a manager of training revising and updating SOPs expeditiously, so they and development with and management systems within this article is for the Association of Clinical can be readily implemented during the conduct of illustrative purposes only, and does not serve as an Research Professionals. the clinical trial. This level of engagement requires endorsement by any of the authors. communication skills and a clear communication plan to ensure information from both parties is being delivered efficiently and conveyed effectively.

Clinical Researcher 15 December 2016  HOME STUDY The New Shape of Workforce Development

Risk-Based Monitoring: Changing Roles, Changing Mindsets

PEER REVIEWED Vipul S. Halbe, MSc, CCRA, CAPM | Jeroze Dalal, PhD [DOI: 10.14524/CR-15-0047]

The adoption of any new concept or technology in organizations is generally slow and usually meets with some resistance from the intended end-users. Some of the issues with adoption of new technologies are the users’ comfort level (mindset), the time needed to make changes, the costs involved, the strength of the proof of value/concept presented to users, the ultimate level of user acceptance, and the performance and reliability of the technology itself, including the factor of whether it will continue to provide value to the organization.1

Risk-based monitoring (RBM) is still a relatively Sponsors new method of performing clinical trial monitor- A sponsor is an individual, company, institution, ing. It uses a combination of modern technology or organization responsible for the initiation, and protocol information to define study risks and management, and/or financing of a clinical analyze the frequency and type of monitoring to be trial.2 Sponsors may be considered the primary conducted for a given trial. stakeholder where the process of conceptualizing, RBM is supposed to provide a more structured implementing, and sustaining RBM is concerned. and proactive approach for monitoring to generate When RBM was still in infancy, its proof of value LEARNING OBJECTIVE higher quality data without compromising subject had yet to be harnessed on a large scale.3 Even now, After reading this article, safety or data integrity. This in turn is expected the sponsor’s return on investment for RBM may participants should be to lead to better acceptance of data by regulatory be slow. For a sponsor, proactive planning of all authorities. able to understand the processes to be followed in the trial is extremely As RBM continues to be promoted as the new different stakeholders and important, as one of the main sources of risk in best practice in monitoring of clinical trial data, their responsibilities in a trial using RBM is associated with insufficient just as with any other new technology it is likely successful implementation consideration of the details surrounding the study to face resistance to its widespread adoption. In of risk-based monitoring. population and investigational product.3 fact, one of the biggest challenges in adopting RBM It is also important to have a system for con- appears to be changing approaches/attitudes on tinuous review, and to fine tune the executed plan DISCLOSURES the part of those who are directly or indirectly for ensuring optimum results. Some operational Vipul S. Halbe, MSc, CCRA, involved in monitoring of clinical trial data. challenges the sponsor may face in implementing CAPM; Let’s have a look at the three prime stakeholder RBM can include the need to review and create a Jeroze Dalal, PhD: groups impacted by the use of RBM—sponsors, robust monitoring plan, standard operating proce- Nothing to disclose investigators/site teams, and regulatory authorities— dures (SOPs) dedicated to RBM, and electronic data and some of their representatives. capture systems (including metrics and reports).4

December 2016 16 Clinical Researcher Although a sponsor may have initial apprehen- PROJECT MANAGER One of the biggest sions about adopting RBM, it is noteworthy that A project manager is an individual whose main some important mortality outcome studies using responsibility is to ensure day-to-day management challenges in adopting RBM have generated credible and valuable results, of the trial at the operational level. RBM appears to be despite having very few onsite monitoring visits.5 Typically, a project manager’s role has been Within the category of sponsors as the main oriented toward study/project management on changing approaches/ entity, four main functions that need to adapt to the basis of information provided by the monitor attitudes on the part of RBM methodologies are in the realms of the data through review of monitoring visit reports. Within manager, project manager, monitor, and auditor. the context of RBM, the project manager needs those who are directly to consider inputs not just from the monitor, but DATA MANAGER also from the data manager (for metrics/hard facts or indirectly involved in The data manager for a sponsor is primarily respon- and figures, such as quality metrics). The project monitoring of clinical sible for providing the framework for how study data manager’s role will also extend to data monitoring should be entered into the case report form (CRF) to ensuring that the monitoring activity plan for trial data. and ensuring that the received data are analyzable. each site is followed efficiently. Historically, a data manager’s work has been essen- Some of the important metrics that a project tially limited to the “back end” of the study (i.e., manager must pay attention to cover type of visit, cleaning the data entered into the CRF as the source number of queries, time onsite, noncompliance, data are verified by the monitor at the site). and monitoring action items open/closed.3 In scenarios using RBM however, data managers Further, project managers play a major role as are among the most important players. As RBM coordinators/mediators between data managers includes use of software technology, data managers and monitors. In fact, owing to there being so must not only learn nuances of new technology, but much overlap in the roles of data manager and also ensure an automated, error-free run during project manager, there is a possibility that these the actual trial conduct. RBM puts data managers roles may be combined into a single staff position on the front line in the quest for high-quality data, in RBM studies. as they are the ones having large amounts of data fed to them (usually in real time) for sorting and MONITOR identifying trends that affect the study. A monitor is an individual who oversees the progress In some , data managers may be of the clinical trial at the investigative site level, and in a position to make the call on deciding how who ensures that the trial is conducted, recorded, monitoring visits for a particular site should be and reported in accordance with the protocol.2 conducted, based on risks that have been identified The monitor’s role in RBM is modified greatly up front and then tracked during the course of the compared to the case if he/she is used to perform- study. This will require them to be more vocal in ing 100% source data verification and making their communications, as well as to spot trends at frequent onsite visits. A traditional monitor often a much faster rate for effective resolution. Thus, verifies 100% of a study’s data, however there is the domain of data monitoring may be integrated no guarantee that this practice improves data with data management over time. In other words, integrity or an investigator’s oversight. As a result, the data manager’s role could evolve to include there is a requirement to fine tune monitoring to responsibilities of a monitor, and even those of an address keys risks associated with the study. auditor. One focal point of RBM is to tackle study-critical Another important, and often overlooked, aspect data first, along with any changes to those data of the data manager’s functions in light of RBM is that may lead to changes in the study’s outcome.6 the responsibility for facilitating effective compe- The monitor needs to adjust to the fact that the tency to ensure minimal data entry errors. Since way data will be monitored will not be solely his/ RBM is a concept based on identifying, assessing, her call, but may come to be influenced more monitoring, and mitigating risks to the quality and than is now common by the data manager, who is safety of studies, strong systems for training and remotely located and generally does not contact other foolproofing methodologies need to be in the site. This may sound like a negative, but should place to minimize chances of error, before remov- actually be considered an added weapon available ing the need for actual monitoring visits. in the monitor’s arsenal.

Clinical Researcher 17 December 2016  HOME STUDY The New Shape of Workforce Development

RBM puts data To further elaborate on this point, a monitor is • Continuous trend analysis is an innate process only exposed to the data generated from his/her within RBM. Thus, RBM also overlaps the managers on the front site; as a result, that monitor is only privy to those domain of the audit function, which may lead line in the quest for limited trends. In RBM, trend analyses covering all an auditor to change his/her processes regard- sites will be carried out at a central level with the ing what to audit, how to audit, and even whom high-quality data, help of computerized systems. Such analyses may to audit. as they are the ones identify issues even before their occurrence; this Given these factors, two main aspects that an can only help the monitor to be better prepared auditor needs to review in an RBM environment having large amounts for mitigating risk or totally preventing risk factors are as follows: of data fed to them from becoming problematic. • An auditor needs to ensure that the RBM The monitor would be required to unlearn processes—especially those followed to mitigate (usually in real time) legacy methods used in the past, and to adopt such risks—are set up adequately at the start of the for sorting and new monitoring practices as using a combination study. of onsite and offsite visits, relying on remote con- • During the active part of the study period, an identifying trends that tacts, and sometimes having no ongoing contact for auditor needs to confirm that all of the planned certain sites. In this environment, communication affect the study. processes are actually working in practice (i.e., skills will play a wider role in RBM, as the monitor are the monitoring activities being conducted is expected to relay information to the site and as per the prescribed monitoring plan). There see to it that the proper outcomes occur without have been instances in which the auditing making frequent face-to-face, onsite visits. team has observed that, despite having the Communication is also key to the process of the availability of centralized/remote monitoring monitor receiving information about the monitor- activities, the monitors have fallen back on ing activity plan from the data manager. A monitor conventional methods of monitoring.7 This becoming familiar with RBM will require not just makes the intentions behind using RBM tech- training, but cooperation and support from the niques counterproductive, since monitors will data manager, study manager, and members of the still be reviewing voluminous amounts of data site team. at reduced efficiency, with little or no impact AUDITOR on data quality. The primary root cause of this An auditor is a sponsor representative who per- issue is again resistance to change in mindset. forms a systematic and independent examination of trial-related activities and associated documents Investigators/Site Teams to ensure that they were recorded, analyzed, and An investigator conducts the clinical trial at a site, reported accurately according to the trial protocol, and is usually supported by a team comprised of the sponsor’s SOPs, and applicable regulatory medical and nonmedical staff. 2 requirements. For the investigator and his/her team, RBM still To improve overall quality and confidence in the means following the study protocol, conducting RBM model, an evolution in the quality manage- the informed consent process, recruiting patients, ment mindset is required. Auditing a study employ- maintaining study drug supplies, attending to ing RBM may be challenging, and will certainly source documentation, making safety reports, require a completely different approach than has updating CRFs, and other tasks. What changes been the case historically. The following list gives for the site team members is how their data are some of the main reasons for this state of affairs: monitored/audited by the sponsor. • Data reviewed during an audit may not match In RBM, more remote/offsite monitoring may be the RBM plan fixed for a particular site/study. undertaken instead of onsite visits made. Hence, To eliminate bias from an audit perspective, it is for RBM to be successfully implemented, it is also vital that the audit plan and RBM plan are essential that sites attend to the aforementioned prepared independently of each other. unchanged activities in a timely manner and • There are multiple overlapping responsibilities without any compromise in quality. among the data manager, study manager, and RBM shifts much of the onus of data integrity monitor roles. Hence, it is necessary to identify and quality back to the investigators and their in advance who will provide corrective and teams. Site staff must consider the offsite visits/ preventive actions (CAPAs) for any given type contacts as seriously as the onsite ones. of observation.

December 2016 18 Clinical Researcher Moreso than a sponsor, the investigator has • Sponsors must accept and invest in the initial References the best opportunity to mitigate risk to the subject cost of setting up the infrastructure of RBM, as 1. www.escribecorporate. 3 com/blog/2013/meeting- and, in turn, to the study. This, in a way, impacts well as define new processes for implementa- management/top-15- sponsors as they identify potential sites for studies tion of the same. barriers-to-adopting-new- technology-adoption in which RBM will be adopted. In RBM, sponsors • Sponsor-based representatives of different 2. International Conference may opt for sites with a track record or reputation functions of clinical trials must step out of their on Harmonization. for compliance with protocols and safety mea- comfort zones and accept the changes implicit Guideline for Good Clinical sures. This may lead to more stringent filtration of Practice E6. https://www. in RBM, update their skills, and let go of some acrpnet.org/resources/ sites for selection, which will in turn challenge the or many of their old routines. gcpartner-app/ best-performing sites to recruit more patients and • Investigators and site staff must ensure that 3. Fay MF, Oleson KW. 2013. simultaneously maintain high standards of quality. A rationale for a risk-based they provide high-quality data without frequent approach to clinical trial intervention from the sponsors, and recognize conduct and monitoring Regulatory Authorities that the data generated from their sites will be practices. The Monitor 27(6):9–14. These are legal governmental agencies whose subject to scrutiny in real time. 4. Christison N, Gilbert members formulate the rules and regulations • Regulatory agencies should perform a lead role KL. 2013. Is risk-based associated with pharmaceutical products in their monitoring a risky in ensuring consistent implementation of RBM business? Industry own countries. All stakeholders are required by methodologies across all stakeholders and perspectives and law to follow these rules while performing clinical across regions. considerations for trials within those countries.2 implementation. The All of these changes to individual roles will Monitor 27(3):19–22. Regulatory agencies such the U.S. Food and be followed with changes in mindsets to create a 5. Heske S. 2013. Risk-based Drug Administration (FDA) and the European beneficial paradigm shift in the way clinical trials monitoring and today’s CRA. The Monitor 27(6):54–6. Medicines Agency (EMA) already have created are conducted. guidance/position papers on the RBM approach8,9 6. Gupta A. 2013. Taking the ‘risk’ out of risk-based that endorse RBM and encourage sponsors to adopt ACKNOWLEDGEMENT monitoring. Perspect Clin it in new studies. Sponsors of multinational trials The authors acknowledge Dr. Saifuddin Kharawala, Res 4:193–5. for which data are expected to be submitted to the Dr. Archana Harshvardhan, and Ms. Zarina Irani 7. Mitchel J, Gittleman D, Markowitz JMS, Suciu L, FDA and EMA are already implementing RBM. for their valuable feedback during the development Hamrell MR. 2013. A 21st Although the FDA and EMA are globally influ- of this article. century approach to QA ential agencies, they surely do not govern countries oversight of clinical trial performance and clinical beyond their jurisdiction. This leaves many countries data integrity. The Monitor around the world where clinical trials are being 27(6):41–6. conducted using the International Conference on 8. U.S. Food and Drug Administration. 2013. Harmonization’s Guideline for Good Clinical Practice Guidance for industry: E62 as guidance on RBM. There remains a need to Oversight of clinical sensitize and educate other regulatory authorities for investigations—A risk-based approach to a globally standardized RBM adoption. monitoring. www.fda. Regulators should make frequent contact with gov/downloads/Drugs/.../ all stakeholders and consider their feedback on Guidances/UCM269919.pdf 9. European Medicines the functioning of RBM and how it can be further Agency. 2013. Reflection evolved for higher success. Regulatory agencies paper on risk based quality that have no guidance on RBM should connect management in clinical trials. www.ema.europa.eu/ with those agencies that do, and update their pro- docs/en_GB/document_ cesses to seamlessly adapt to newer methodologies. library/Scientific_ guideline/2013/11/ WC500155491.pdf Conclusion

With an embrace of RBM, the clinical research Vipul S. Halbe, MSc, CCRA, enterprise is poised to become more effective in CAPM, ([email protected]) an environment geared toward doing more with is expert clinical manager at Novartis Healthcare less. There is no doubt that for RBM to evolve Pvt. Limited based out of successfully, the key stakeholders involved need to Hyderabad, India. adapt and simultaneously improve upon their RBM Jeroze Dalal, PhD, approaches in a variety of ways: ([email protected]) is global clinical operations leader for Novartis Healthcare Pvt. Limited. Clinical Researcher 19 December 2016  HOME STUDY The New Shape of Workforce Development

Workforce Development for Clinical Research Associates: Evolving Paths to Competency

PEER REVIEWED | Nicole Tesar [DOI: 10.14524/CR-16-0021]

One of the greatest challenges facing the clinical research enterprise today is ensuring that a qualified, competent workforce is available to carry out its activities. Those of us already working in clinical research know that the downstream effect of having a highly qualified team is bringing new products to market quicker. The role of the clinical research associate (CRA) or monitor, like so many others in the industry, is challenging to break into, and one reason is the high standards set by employers for job entry.

An innovative approach to hiring new entry- validate that individuals with these credentials are level CRAs needs to be created—an approach that superior to those who do not have them? Con- would fill the business need and give intelligent, versely, how do job seekers find those particular motivated a chance for success in the companies that do value them? industry. Once new staff have gained experience, To help point CROs and sponsors in the right thoughtful measures must also be taken to con- direction, in 2013 the Joint Task Force (JTF) for tinue training and professional development that Clinical Trial Competency was formed to develop ensures ongoing career success. competencies and skill requirements for the clinical research professional. Eight competency LEARNING OBJECTIVE Getting in the Clinical Research Door domains are highlighted in the JTF’s projects, including scientific concepts and research designs, After reading this article, As an independent CRA, I have received LinkedIn ethical and participant safety considerations, participants should be messages, phone calls, and e-mails from many medicines development and regulation, clinical able to understand the individuals looking to break into the clinical trials operations (Good Clinical Practice [GCP]), research industry. Ultimately, what they are importance of having a study and site management, data management looking for is a clear cut formula for getting their workforce development and informatics, leadership and professionalism, foot in the door without having direct experience. program in place for CRAs, and communication and teamwork.2 The goal of recognize some of the There are individuals out there with potential to be valuable assets to an organization, but they need this group was to align both skill and competency related challenges that an opportunity. Possible routes into the clinical requirements for the industry professional. organizations face, and research arena include networking, volunteering, It is not uncommon for companies to want a mix of skills, degrees, and general competencies for describe potential models and internships,1 however, there is no prescribed their CRAs. For the beginner CRA, the challenge for success. route for CRAs. becomes how to demonstrate skills and competen- An arbitrary requirement for CRAs to have cies despite a lack of prior work experience. As an DISCLOSURES at least two years of experience is still in place at industry, we have an obligation to bridge the gap Nicole Tesar: most contract research organizations (CROs) and between the inexperienced and seasoned CRA. sponsor companies. This raises the question: To Nothing to disclose One possible solution to this may be an Appren- what extent are employers valuing clinical research ticeship Program Model. credentials/education, and how do the employers

December 2016 20 Clinical Researcher FIGURE 1: A Career Pathway Model Project or for an Apprentice CRA CRA Manager

Lead CRA

Senior CRA

Apprenticeship Program Model CRA III By utilizing apprenticeship as a workforce devel- opment strategy, an organization can promote CRA II successful outcomes for both its business and job seekers in a manner that helps it find and retain skilled workers with desired traits. Apprenticeship CRA I has been shown to be an effective solution for 3 many federal- and state-regulated industries. Apprenticeship Program (six months) Research shows that, through an apprenticeship program, companies have been successfully able to recruit, train, and retain highly skilled workers.4 The clinical research enterprise has all of the following challenges, which make it ideal for an a decreased site load. Thus, an apprenticeship As an industry, we have program incentivizes a potential employee with apprenticeship model: an obligation to bridge • Jobs for which it is difficult to find workers with the opportunity of a job at the conclusion of a the right skills successful apprenticeship, as well as providing an the gap between the opportunity for the senior CRA to grow and add • Positions with high turnover new leadership skills. inexperienced and • Challenges helping workers keep pace with However, as no training and development seasoned CRA. One industry and technology advances model is perfect, what happens if the apprentice- • Difficulty in attracting new and diverse talent ship program is not successful? What if apprentices possible solution pools decide the CRA role is just not for them? Further- to this may be an An Apprenticeship Program Model for CRAs more, what happens if they are unable to meet the would involve a lower pay rate/salary initially, benchmarked requirements of the role? Apprenticeship on-the-job training, and low-risk task assignment. One important step to reduce such risks is to The lower pay rate/salary at the onset lends ensure that the apprenticeship program is long Program Model. to less financial burden on the organization. If enough. Perhaps the candidates need longer than the apprentice is willing to accept lower pay, the six months to meet the required milestones. In exchange would be the opportunity of a full- the case of the apprenticeship model, it is critical fledged job upon successful completion of the to evaluate learned skills frequently to ensure program. those preset benchmarks are being met. If not, an Meanwhile, the program is comprised of a extension of the program may be required. mix of classroom training, online modules, and Meanwhile, what if candidates decide they one-on-one training with an assigned mentor. no longer wish to pursue the role of a CRA? If an In this program model, the apprentice must pass individual has already invested time in a program, ongoing skills and knowledge testing. and the company has invested in training them, Finally, low-risk tasks would be assigned as one positive outcome may be that while the CRA the would-be CRAs learn more about their future role might not be a good fit, perhaps another role role. Examples of potential low-risk tasks include can be identified as being of more interest. Part taking meeting minutes during a team teleconfer- of a solid apprenticeship program would be the ence or organizing and filing of Trial Master File understanding of cross-functional roles within documents. clinical research. If a candidate feels that his or her An apprenticeship program essentially involves interest has shifted to one of those roles, the CRA “You do the job, and then you get the job.” Candi- apprenticeship may end; however, the potential for dates would begin a six-month clinical research a different development plan could be considered apprenticeship, spending one-half day per week to provide more exposure to the alternate role. on a site visit with a more senior CRA in order to While the Apprenticeship Program Model further develop core skills and observe interaction represents a viable option for the novice CRA, other with site staff. Once hired as a CRA, the former pathways exist to help facilitate this transition. A apprentice should successfully move upward to a multiple-mentor workforce program would allow higher level role over time (see Figure 1). for an apprentice to be exposed to different work The senior CRA position involved in such a styles and personality types. In this model, the program holds mentoring responsibilities and candidate would have mentors who are subject

Clinical Researcher 21 December 2016  HOME STUDY The New Shape of Workforce Development

matter experts in specific cross-functional areas which route is taken, the presence of a formal (e.g., data management, site management, thera- program is essential for success. peutic area training). A learning and personal development model Training and Development treats people as individuals, targets both tradi- for Existing CRAs tional work skills and knowledge, and includes whole-person development—not just transference As a CRA begins to gather experience, an ongoing of skills. This model would have a secondary focus training and development program is necessary. on assisting employees in identifying and achiev- This not only shows that an employer is investing in the CRA’s future, but training ensures that ing their own personal potential.5 Regardless of

TABLE 1: CRA Attributes and JTF Competency Domains/Harmonized Core Competencies

CRA Attributes Objectives JTF Competency Domain(s) Harmonized Core Competencies Attention to Detail Comprehending data completeness and deviations, review Data Management and • Carefully reviewing the importance of data collection, of medical records, study protocols, regulatory documents, Informatics; capture, and management, as well as the ICH GCP and conducting product accountability Study and Site Management requirements for data correction • Assist sites in the management of patient recruitment, completion of required procedures, and progress tracking Organization • Prepared and well-organized for site visits, training Study and Site Management Effectively train site staff during the site initiation visit to sessions, study meetings, or other type of interaction reduce risk and improve quality of the clinical research with sites or sponsor representatives study at the site • Needed to ensure maximum efficiency of a site visit and use of investigator’s/study team’s time • Prioritization (managing most pressing issues first) Communication Skills • Effective interaction with both internal and external Communication and • Act as a liaison between the site and sponsor/CRO; colleagues; critical when writing reports and e-mails, Teamwork; Leadership and effectively communicate the content and relevance of the conducting training sessions, or delivering presentations Professionalism required procedures at study meetings or external events • Demonstrate skill, good judgment, and polite behavior • Corresponding with cross-functional teams within the during all interactions organization Regulatory Knowledge • Excellent working knowledge of Code of Federal Medicines Regulation and • Describe the safety reporting requirements of the site, Regulations, International Conference on Harmonization Development; Clinical Trials and how that contributes to the development of new (ICH) guidance on Good Clinical Practices (GCPs), and Operations; Ethical and Partic- drugs, devices, and biologics other applicable guidances and regulations ipant Safety Considerations • Describe the roles and responsibilities of the site staff as • Base guidance to site personnel on these guidances/ defined by GCP guidelines regulations and be able to direct them to the specific • Explain to sites how inclusion and exclusion criteria are sources when necessary included in a clinical protocol to assure human subject protection Ability to Consume and • May need to review hundreds of pages of medical records Data Management and Understand the typical flow of data throughout a clinical Retain Information Efficiently in order to verify trial data during a site visit Informatics; Study and Site trial and the significance of data quality • Process large numbers of e-mails, site action items, or Management study documents • Must quickly and effectively focus on the important information without losing sight of peripheral matters Educating Teams • Necessary for training physicians, study coordinators, and Leadership and Profession- Effectively train and re-train sites throughout the conduct junior monitors alism; Communication and of a clinical trial to reduce risk and improve quality at the Teamwork site level Interpersonal Skills • Ability to effectively work with all personality types and Leadership and Profession- • Identify and apply the professional guidelines and codes be able to navigate such relationships in a manner that alism; Communication and of ethics that apply to the conduct of clinical research produces results and desired outcomes Teamwork • Understand the principles and practices of leadership, • Work collaboratively and respectfully with the research management, and mentorship, and apply them within coordinator in order to achieve mutual goals and build the working environment rapport

December 2016 22 Clinical Researcher employees are knowledgeable in the ever-changing landscape of the industry while supporting a FIGURE 2: Phases of Ongoing CRA Training career path for them. Training and development of a successful CRA workforce involves a three-step process (see Figure 2). The first step isskilling —the basic teaching of a Skilling Reskilling Upskilling required skill. This initial step typically involves a structured orientation program, including training on company standard operating procedures (SOPs). SOPs standardize the required skills, and are updated frequently as regulations and When considering training and development, References company expectations evolve. SOPs ensure that companies are on a “slippery slope” regarding 1. Frestedt JL, Kablinger A, Smailes P. 2015. How to the CRA is, and remains, properly qualified and consultants/contractors, as they are only to be enter the clinical research trained for job roles for which he or she is made provided training in order to successfully complete field. Clin Res 29(6):52–7. responsible. the job to which they are contracted, and not to [DOI 10.14524/CR-14-0058] 2. Sonstein SA, Seltzer Once skilling is established, the next step is grow outside that role (which could be perceived as J, Li R, Silva H, Jones reskilling, which involves re-teaching the skills development). Developing skills and broadening CT, Daemen E. 2014. that change or evolve. one’s knowledge base for future work is the respon- Moving from compliance to competency: A Lastly, the third step is upskilling—the concept sibility of the individual in this case. harmonized core of teaching and training employees beyond their A good CRA consultant/contractor will want competency framework to continue to grow in the role. By making an for the clinical research current role to position them for the next role. professional. Clin Res investment to keep skills up to par and adding 238(3):17–23. [DOI: Developing Soft Skills self-training to their curricula vitae/resumes (e.g., 10.14524/CR-14-00002R1.1] taking courses to focus on “hot” therapeutic areas 3. Olinsky B, Ayres S. 2013. Beyond the challenge of creating and maintaining Training for success: or novel study designs), such CRAs understand a robust training curriculum, how best to train on A policy to expand that this will increase their marketability for future apprenticeships in the soft skills is a matter to consider. Interpersonal contracts. By doing this, they also show a potential United States. Center for communication and executive functioning are American Progress; 9–15. client that improving and adding to their skills is critical in the role of the CRA. This role involves 4. Collins M. 2015. Why important to them. America has a shortage interaction with both external partners (site staff) of skilled workers. www. and internal partners (in-house team members). industryweek.com/skilled- CRAs often may have the basics of the commu- Revisiting Competency Domains and workers nications skill set, but lack the personality it takes Harmonized Core Competencies 5. Alan Chapman/ Businessballs. 2016. to balance relationships. Maintaining positive Throughout ongoing training and development of Training and Learning relationships is key when it comes to keeping site the CRA, the strengthening of attributes and skills Development. www. businessballs.com/ staff motivated and encouraged to get the work that are essential to the role should be the ultimate traindev.htm done. During the hiring process, employers need to goal. Many of these align with the JTF competency 6. Chittester B. 2015. decide what attributes are required and figure out domains and harmonized core competencies 10 attributes of a how to not only test for aptitude, but also how to 2,6 great monitor. www. (see Table 1). These competencies should yield a imarcresearch.com/ provide ongoing development of these skills. highly proficient CRA. blog/10-attributes-of-a- great-monitor Workforce Development Conclusion in a Volatile Market Creating a workforce development program Nicole Tesar (ntesar@ harmonyclinicalconsulting. The work environment in the pharmaceutical and addresses the challenge of inexperienced CRAs not com) is owner and director biotech industries these days is characterized being able to break into the industry, and main- of clinical operations with tains the skill set of existing professionals. Through Harmony Clinical Consulting by frequent upsizing and downsizing as a direct Corporation in Avon, Ohio. reflection of the ever-changing pace of product continuous support of the CRA’s career path and development. These conditions have led to a ongoing development, organizations can demon- change in the landscape of the industry, from a strate a vested interest in retaining the employee primary dependence on the hiring of full-time and, therefore, in reducing turnover. The ultimate employees to an “on-demand” approach to result is an efficient and agile CRA workforce, and resourcing and the inclusion of consultants and a clinical research industry that produces quality contract workers. products for the healthcare market.

Clinical Researcher 23 December 2016 The New Shape of Workforce Development OPEN BOOK TEST This test expires on December 31, 2017 (original release date: 12/1/2016)

Project Managers Influence Parallel Planning and 5. Guiding principles for sponsor/CRO and site collabora- 9. When details to a change in project scope are not Collaboration Between Sites and Sponsors tions include: well communicated, what are possible impacts to the 1. Selecting the right personnel at the site and sponsor project described in the article? What are examples of how the use of project 1. for the project A. There should be no changes to the project plan. management systems can be optimized in a parallel planning approach? 2. Communicating to internal and external stakeholders B. A new ethics review is required to move forward with about the goals of the project the plan. A. Preparing clinical research forms and data entry systems 3. Documenting agreement on the goals with all C. The clinical trial agreement is void and the project must stakeholders be re-proposed. B. Running lab results and consulting principal investigators 4. Reassessing stakeholder understanding of the goals D. Additional time, money, and resources may be required and timelines to carry out the project within the new scope. C. Inputting site start-up timelines and enrollment rate A. 1, 2, and 3 only projections 10. This article discusses the shifting view of sites toward D. Negotiating contracts and enrolling study subjects B. 1, 2, and 4 only which of the following: C. 2, 3, and 4 only A. Sites as suppliers 2. Why is it important for sites and sponsors/CROs to D. 1, 3, and 4 only collaborate in developing each stage of the clinical B. Sites as demanders trial project plan? 6. Study metrics should be developed: C. Sites as customers 1. Establish achievable timelines A. By study sponsors only D. Sites as consumers 2. Foster openness to identify risks B. By study sites only 3. Sites will determine the project schedule C. By CROs only as a third party Risk-Based Monitoring: Changing Roles, 4. Promote a culture of a shared project D. With input from all parties Changing Mindsets A. 1, 2, and 3 only 7. A suggested way of combating “metrics mania” is 11. Risk-based monitoring (RBM) is a new method of B. 1, 2, and 4 only which of the following? monitoring: C. 2, 3, and 4 only A. Sites implement metrics to evaluate sponsors A. Pharmacovigilance D. 1, 3, and 4 only B. Sponsors implement metrics to evaluate sites B. Clinical trials data 3. When conceptualizing a project and reading the study C. Metrics should be evaluated to ensure they add value C. Drug shipment logistics design synopsis, a checklist may be used by both a and are meaningful to sponsors and sites D. Vendor activities sponsor/CRO project manager and a site project man- D. Metrics should be standardized to ensure they are 12. Who is NOT a main stakeholder in RBM? ager. This checklist helps them better understand the consistent across all studies, sponsors, and sites A. Sponsor project. What are the three criteria being reviewed on the checklist? 8. What is a drawback to the sponsor developing the B. Investigator original project timeline, as suggested by the authors? A. Planning, Executing, and Closing C. Patient 1. Adjustments to the schedule are often only made to D. Regulatory agency B. Unsatisfactory, Pass, and Good consider sponsor’s internal operations. C. Behind, On Track, and Ahead of Schedule 2. Adjustments to the schedule often do not take site 13. The sponsor’s role in RBM is to: D. Feasible, Achievable, and Believable operations into consideration. 1. Create a robust monitoring plan 4. A technique for continual stakeholder engagement 3. Adjustments to the schedule often impact resourcing 2. Establish standard operating procedures described in the article includes: and work load of sites. 3. Train patients on use and implementation of RBM A. Increased onsite monitoring visits from the sponsor 4. Adjustments to the schedule often increase the overall 4. Identify potential risks in the clinical trial or CRO study budget. A. 1, 2, and 3 only B. Regular reporting of project status by the sponsor/CRO A. 1, 2, and 3 only B. 1, 3, and 4 only to the site B. 1, 2, and 4 only C. 1, 2, and 4 only C. Periodic review of the project plan by the sponsor/CRO C. 2, 3, and 4 only D. 2, 3, and 4 only and site project managers D. 1, 3, and 4 only D. Annual investigator meetings 14. State the four roles within the sponsor that will need to adapt to RBM: A. Data manager, project manager, monitor, and auditor B. Study drug supply manager, scientist, monitor, and Trial Master C. Medical writer, marketing manager, sales manager, and company president D. Company president, finance manager, drug supply manager, and data manager

December 2016 24 Clinical Researcher Find the most current online test at www.acrpnet.org/homestudy, including any revisions made after publication of this issue of Clinical Researcher.

15. Historically, what has been the main task of a 22. Some possible routes into the clinical research 26. What is the suggested length of a clinical research data manager? arena are: apprenticeship program? A. Co-monitoring visits to sites with monitor 1. Networking A. Two years B. Providing input on study drug supply 2. Volunteering B. One year C. Cleaning the data entered in the case report form 3. Surveys C. Three months D. Selection of sites for trial 4. Internships D. Six months A. 1, 2, and 4 only 16. Traditionally, what percent of source data verification 27. The following three-step process is included in the is carried out by a monitor? B. 1, 3, and 4 only training and development of a successful CRA: A. 10% C. 1, 2, and 3 only A. Skilling, over skilling, upskilling B. 50% D. 2, 3, and 4 only B. Skilling, upskilling, out skilling C. 85% 23. According to the Joint Task Force (JTF) for Clinical Trial C. Skilling, reskilling, upskilling D. 100% Competency, the eight competency domains include: D. Reskilling, upskilling, over skilling A. Scientific concepts and research designs, ethical and The project manager will play a major role in Beyond a solid training curriculum and skill-based 17. participant safety considerations, federal regulations, 28. coordination between: training, what is the other critical attribute that a CRA clinical trials operations (GCPs), study and site must possess but that organizations have difficulty A. Data manager and monitor management, data management and informatics, training on? B. Data manager and site leadership and professionalism, and ICH Guidelines A. Soft skills: Interpersonal communication and executive C. Site and drug supply manager B. Medicines research and designs, HIPAA law consider- functioning D. Data manager and regulatory authority ations, medicines development and regulation, clinical trials operations (GCPs), study and site management, B. Technical skills: Use of CTMS and web-based programs 18. Which of the following is NOT a challenge in auditing data management and informatics, leadership and C. Organization: Creating e-mail folders and prioritizing an RBM trial? professionalism, and communication and teamwork tasks A. Continuous trend analysis C. Scientific concepts and research designs, ethical and D. Regulatory knowledge: Excellent working knowledge B. Adherence to monitoring plan participant safety considerations, medicines develop- of all applicable regulations C. Correct identification of CAPA owner ment and regulation, clinical trials operations (GCPs), 29. When considering training and development, the D. Selection of a site for audit study and site management, data management and article suggests CRA contractors can do which of the informatics, leadership and professionalism, and following to ensure they continue to grow in the role? 19. RBM shifts a higher onus to the investigator for which communication and teamwork A. Request training from the CRO they are contracted to of the following activities? D. Scientific concepts and research designs, ethical and A. Data integrity and data quality participant safety considerations, medicines devel- B. Read books about clinical research B. Patient recruitment opment and regulation, clinical research operations, C. Work on multiple contracts at one time C. Patient retention study and site management, project management, D. Take courses in a growing therapeutic area or modality D. Ethics committee notification leadership and professionalism, and communication and teamwork 30. Which of the following is one of the objectives of the 20. What efforts should regulatory authorities make for CRA attribute: Organization? successful implementation of RBM? 24. Which are some of the challenges faced by the A. Prioritization—Managing the most pressing issues 1. Take active feedback from all stakeholders clinical research enterprise that make it ideal for an first apprenticeship model? 2. Provide minimum or no oversight B. Correspond with cross-functional teams within the 1. Jobs for which it is difficult to find workers with the 3. Connecting with other regulatory agencies to update organization right skills the process C. Necessary for training physicians, study coordinators, 2. Challenges helping workers keep pace with industry 4. Reject trials not using RBM and junior monitors and technology advances A. 1 and 2 only D. Work collaboratively with the team in order to achieve 3. Difficulty in attracting new and diverse talent pools mutual goals B. 1 and 3 only 4. Candidates without adequate experience C. 2 and 4 only A. 1, 2, and 4 only D. 3 and 4 only B. 1, 3, and 4 only Workforce Development for Clinical Research C. 2, 3, and 4 only D. 1, 2, and 3 only Associates: Evolving Paths to Competency 25. Examples of low-risk tasks assigned to a CRA 21. In clinical research, the downstream effect of having a apprentice are: highly qualified team is: A. Getting coffee and running errands for project A. Identifying new team members managers B. Bringing new products to market quicker B. Taking meeting minutes during a team teleconfer- C. Decreasing training time ence, or organization and filing of Trial Master File D. Requiring less management oversight documents C. Scheduling and booking travel for the CRAs who monitor sites D. Writing CRF/eCRF guidelines and SOPs, or creating source documents for new studies

Clinical Researcher 25 December 2016