{"id":261,"date":"2020-02-13T19:37:24","date_gmt":"2020-02-13T19:37:24","guid":{"rendered":"https:\/\/www.socra.org\/blog\/?p=261"},"modified":"2020-02-13T21:57:56","modified_gmt":"2020-02-13T21:57:56","slug":"developing-effective-study-start-up-processes","status":"publish","type":"post","link":"https:\/\/www.socra.org\/blog\/developing-effective-study-start-up-processes\/","title":{"rendered":"Developing Effective Study Start-up Processes"},"content":{"rendered":"\n<figure class=\"wp-block-image\"><img decoding=\"async\" loading=\"lazy\" width=\"1024\" height=\"683\" src=\"https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/02\/iStock-1188760541-1024x683.jpg\" alt=\"Clinical research start-up study\" class=\"wp-image-263\" srcset=\"https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/02\/iStock-1188760541-1024x683.jpg 1024w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/02\/iStock-1188760541-300x200.jpg 300w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/02\/iStock-1188760541-768x512.jpg 768w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/02\/iStock-1188760541.jpg 1254w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h3 style=\"text-align:center\">Jennifer Goldfarb, CCRP<br>Senior Director, Clinical Research Support Office<br>Children&#8217;s Hospital of Philadelphia&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/h3>\n\n\n\n<h3 style=\"text-align:center\">Grace Wentzel, CCRP<br>Director, Clinical Research Services<br>The Research Institute at Nationwide Children&#8217;s Hospital<\/h3>\n\n\n\n<p><strong><em>Abstract<\/em><\/strong><em>: The study start-up process sets a study up for success or failure.<\/em> <em>This article provides an overview of study start-up, the players on the study team, and the infrastructure required for successful study start-up. Tools for the study feasibility assessment for dissecting and implementing the protocol and for ensuring compliance are described. Challenges to study start-up and solutions to those challenges are provided. <\/em><\/p>\n\n\n\n<!--more-->\n\n\n\n<h2><strong>Introduction<\/strong><\/h2>\n\n\n\n<p>Study start-up is everything that must take place from the first\npoint of contact with the sponsor to the moment that the study team is ready to screen and enroll subjects. Study start-up\ncan be compared to the gestation period in pregnancy. The baby, in this case\nthe study, must be nurtured and developed in a way that will produce a healthy,\ndesired outcome; a successfully executed study.<\/p>\n\n\n\n<p>Many things must happen before\na study can be started:<\/p>\n\n\n\n<ul><li>Conversations with the study team , key stakeholders, ancillary      departments, CRO, and sponsor (to name a few)<\/li><li>Planning for all components of the protocol<\/li><li>Requests for information<\/li><li>Development of study processes to ensure protocol adherence and to      identify gaps<\/li><li>Regulatory submission and approval<\/li><li>Confidentiality Disclosure Agreements (CDAs) and Clinical Trial Agreements (CTAs) <\/li><li>Staffing: planning, reallocating, hiring<\/li><li>Site visits<\/li><li>Budgeting<\/li><li>Creation of the informed consent form and other study documents <\/li><li>Training<\/li><li>Development of collaborations and any needed process development with ancillary departments<\/li><\/ul>\n\n\n\n<p>Even\nthough study start-up tasks are challenging, it is very satisfying when study\nstart-up is done right. Making an informed choice to take on or decline a study\ncan lead to satisfaction as well. The study team does not have to conduct every\nstudy that is offered and should have established criteria to guide them in\ntheir study selection. One approach may be to select the studies that offer the\ngreatest benefit to the populations that they serve, have a high chance of\nenrolling an adequate number of subjects, and perform according to the protocol\nwithout logistical issues at that institution.<\/p>\n\n\n\n<h2><strong>The P<\/strong><strong>layers on the Study Team<\/strong><\/h2>\n\n\n\n<p>At any institution, the players\non the study\nteam include:<\/p>\n\n\n\n<ul><li>Principal investigator<\/li><li>Sub-investigators<\/li><li>Study nurse or study coordinator<\/li><li>Regulatory coordinator<\/li><li>Ancillary resources<\/li><\/ul>\n\n\n\n<p>These key players are\nessential to the success of any study; therefore, the plan for team communication\nshould be established early and continued throughout the lifecycle. Effective\nongoing communication among the study team is essential to the success of a study.\nWithout regular team meetings, for example, issues with study enrollment may go\nunnoticed for extended periods of time, leading to the ultimate failure of the\nsite to enroll the necessary number of participants. &nbsp;<\/p>\n\n\n\n<p>The approach to the study\nstart-up process has been undergoing a culture shift in recent years. While\nprogress has been made, study teams still need to slow down and be more\nmethodical about study start-up. All of the key players must inform study start-up,\nas no single team member has all of the answers. The investigator, for example,\nmay consider the study\u2019s science but not its logistical feasibility. The study\nnurse\/coordinator may find the science interesting but is usually more\nconcerned with study operations.<\/p>\n\n\n\n<p>Other players may be present\nat some institutions, including:<\/p>\n\n\n\n<ul><li>Feasibility coordinator<\/li><li>Study intake team<\/li><li>Site assessment visit<\/li><li>Budget analysis<\/li><li>Sponsored projects office or contract manager<\/li><li>Training\/compliance coordinator<\/li><\/ul>\n\n\n\n<p>Nationwide Children\u2019s\nHospital has an institution-wide mandatory feasibility assessment process that includes\na feasibility coordinator team and a training\/compliance coordinator, which has\nsignificantly improved the feasibility process. <\/p>\n\n\n\n<p>It takes a village to\nsuccessfully conduct a study. If the right people are not involved, the study\nwill not be conducted efficiently and effectively. The study team must think\nbroadly about everything that could possibly be needed by the study and must\nalso plan for costs. Study teams often take on studies that they are not\nequipped to conduct due to limited resources.<\/p>\n\n\n\n<h2><strong>Feasibility Evaluation<\/strong><\/h2>\n\n\n\n<p>Sometimes, study coordinators\nget into a rut of reinventing the wheel every time that they work on a study\nbecause each study is unique. While studies are complex and multi-factorial, a\nstandardized process for feasibility evaluation can be developed. The issue\nalways boils down to whether the clinical research site has the resources\nnecessary to conduct the study. The necessary resources are time, space, access\nto protocol-required tests and procedures, research participants, and staff. <\/p>\n\n\n\n<p>Questions about resources\nmust be answered fairly quickly because the timeline is running. Study\ncoordinators often feel an enormous pressure to move fast and may not stop to\nthink about the questions that must be answered before proceeding. Sometimes, study\ncoordinators may feel external and\/or internal pressure to conduct a study.<\/p>\n\n\n\n<p>Feasibility assessment needs\nto be a priority during the study start-up process. Once the CDA is in place\nand the study team can see the protocol and a draft of the sponsor\u2019s budget,\nthe team must move quickly into the feasibility review of the different aspects\nof the study in order to make an informed decision about whether to\nparticipate. A good review ensures that only feasible studies move forward,\nprotecting the precious institutional resources of staffing related to\ncoordination, contracting, budgeting, institutional review board (IRB) review,\nand other institutional resources. <\/p>\n\n\n\n<p>A feasibility assessment is\nan established standard process to objectively review every study. External\nbiases can color the way that studies are evaluated. Having a standardized process\nfor evaluating studies will minimize bias and facilitate objective study assessment.\n<\/p>\n\n\n\n<p>Feasibility can be conducted\nat the level of the investigator, the department, and\/or the institution. At\nsome institutions, the investigator is the sole decision-maker in selecting new\nstudies. However, there is now more interest in developing processes whereby\nnew study feasibility is assessed in a more formal manner with the involvement\nof key personnel early in the process in order to fully evaluate studies and to\nbest position studies for success. <\/p>\n\n\n\n<p>The interest in conducting a\nstudy should ideally be aligned with the overall goals of the investigator, the\ndepartment, and the institution. This requires answering difficult questions\nsuch as:<\/p>\n\n\n\n<ul><li>Who defines the goals and what are they?<\/li><li>What happens when goals conflict?<\/li><\/ul>\n\n\n\n<p>There are many reasons for\nclinical research sites to assess feasibility (Table 1). Saving time and money is\none reason, although this can be tough for some teams to process since it requires\na shift in effort with more up-front work. Study teams may not think that they\nhave the time to assess feasibility and may not know how to measure cost\nsavings. Ultimately, conducting a thorough feasibility assessment can allow\nsites to focus their time on studies that are both desired by the investigator <em>and<\/em> feasible.<\/p>\n\n\n\n<p>Proactively identifying and\naddressing competing priorities are other added benefits of a formal\nfeasibility assessment. When multiple investigators are working on similar\nstudies, the study team may not know that they are \u201ccompeting\u201d for patients.\nAssessing feasibility enables study teams to fully understand the requirements\nof the study, allowing the team the opportunity to be fully committed and\nknowledgeable in the conduct of the study, potentially reducing errors and\nimproving efficiencies. <\/p>\n\n\n\n<p>In determining feasibility, timelines\nmatters. No matter how feasible the study seems, if the timeline does not work,\nthe study is not feasible. Knowing when the sponsor will close enrollment, the\nnumber of study participants that the clinical research site can enroll, and\nthe amount of time that is likely required for IRB review, for budget\nnegotiations, and for contract execution will all make a huge difference in the\nfeasibility of a study.<\/p>\n\n\n\n<p>The study start-up timeline\ncan range from eight weeks to more than six months. One factor that influences the\nstudy start-up timeline is the ease of budget and contract negotiation and\nfinalization. If there is a sticking point, the study may never move forward.\nUnderstanding the status of contract negotiations is really important, because\nif there is a deal breaker, it may make sense to stop assessing feasibility. <\/p>\n\n\n\n<p>The complexity of the protocol\nand the investigator and sponsor responsiveness will influence the study\nstart-up timeline. At Children\u2019s Hospital of Philadelphia, the Clinical\nResearch Support Office knows that with certain sponsors, study start-up that\nwould normally take 8 to 12 weeks could take about 6 months because of anticipated\nsponsor delays. <\/p>\n\n\n\n<p>Committee review and\ncompeting workloads also impact timelines. Multiple committees may review each\nstudy, and this takes time. Competing workloads of the study coordinator and the\nprincipal investigator are also a concern. Investigators often over-extend\nthemselves. <\/p>\n\n\n\n<p>The feasibility process\nshould have steps that assess workflow at the clinical research site and\nclearly-define responsibilities for various tasks. It is ideal to begin the\nfeasibility process as early as possible in order to avoid wasted efforts on a\nstudy that will not work. An approval process must be in place, whether this is\ndone at the level of the investigator, the department, or the institution.<\/p>\n\n\n\n<p>The protocol feasibility tool\navailable for use at Children\u2019s Hospital of Philadelphia starts with first-line\nquestions (Table 2). These questions enable study teams to conserve the time\ninvestment in a new study by quickly determining if a study is feasible on a\ngrand scale. Study teams only move forward when answers to the first-line\nquestions indicate that a study may be feasible.<\/p>\n\n\n\n<p>The first question, for\nexample, asks when enrollment is scheduled to end. Children\u2019s Hospital of\nPhiladelphia has received requests from sponsors to initiate new studies where\nenrollment ends within a month. It is not possible for Children\u2019s Hospital of\nPhiladelphia to complete study start-up and opening enrollment within a month.\nThus, the feasibility of a study is quickly determined.<\/p>\n\n\n\n<p>Best practice in assessing\nstudy feasibility at Children\u2019s Hospital of Philadelphia includes developing a\nwritten tool to objectively review study feasibility for the required study\npopulation, time, resources, finances, staff, space, and so forth. Conducting feasibility\nmeetings about new studies with key personnel and investigators is another best\npractice. Study teams at Children\u2019s Hospital of Philadelphia are not required\nto conduct feasibility meetings; however, these meetings are encouraged. If a\nstudy team says that they do not have time for a feasibility meeting, it may be\nan indication that the team is not ready to take on a new study. <\/p>\n\n\n\n<p>Developing a defined feasibility\nassessment and approval process with steps to resolve conflicts is another best\npractice. There may be times when the investigator insists on conducting a\nstudy; however, the administration determines that the study will not work for\none reason or another. There must be a way to mitigate and resolve conflicts.<\/p>\n\n\n\n<h2><strong>Dissecting the Protocol<\/strong><\/h2>\n\n\n\n<p>At Nationwide Children\u2019s\nHospital, every study with procedures that are being done outside of the\nstandard of care or that are paid on a per-subject per-procedure basis is\nrequired to go through the mandatory feasibility process managed by Clinical\nResearch Services. This was put in place after the institution had a deficit\nbecause some investigators had taken on studies that were under-performing or\nhad accepted budgets that were inadequately paying for study procedures. Nationwide\nChildren\u2019s Hospital has a mandatory study feasibility process focused on\nensuring that procedures being done for research purposes are clearly defined,\nthe study budget covers the cost of conducting the study, and the study can\noperationally be conducted at NCH. The investigators are responsible for\ndetermining the scientific adequacy of the study. <\/p>\n\n\n\n<p>One of the first steps after\nthe feasibility process is to ensure that the study team understands the\nprotocol. This is also part of feasibility. However, it is necessary to dissect\nthe protocol to ensure that the budget is sound and the study can be operationalized\nin an effective way (Table 3). <\/p>\n\n\n\n<p>The study team must know: <\/p>\n\n\n\n<ul><li>Where the subjects will be recruited and enrolled<\/li><li>Where the subjects will be seen for their study visits<\/li><li>Whether study visits will be combined with standard of care visits.<\/li><\/ul>\n\n\n\n<p>It is also necessary to know\nwhether the clinical research team has prior experience and contacts in the\narea. If so, knowing how other study(ies) performed will help the study team\nunderstand the necessary resources for the study being evaluated. All of this\ninformation is also required for the development of adequate budgets.<\/p>\n\n\n\n<p>The study team must know\nwhich procedures will be done during a study and when they will be done. This\npart of the evaluation includes determining whether additional\nstaffing\/resources will be necessary to conduct a study. For example, one study\nat Nationwide Children\u2019s Hospital has bi-weekly infusions and requires the\nclinical research nurse to be in the pediatric intensive care unit for the\nentire eight-hour infusion. When evaluating studies, it is important to review all\nthe information in the schedule of events, which can be missed. <\/p>\n\n\n\n<p>Another key question is\nwhether the clinical research site has, or the sponsor will supply, the right\nequipment for the study. In another study at Nationwide Children\u2019s Hospital, weekly\ninfusions were given to five children. The supplies, which were not part of the\nbudget, cost $55 for every infusion.<\/p>\n\n\n\n<p>Determining which ancillary\nservice providers will be needed for a study is another consideration in\ndissecting the protocol. The study team must know this and have the buy-in of ancillary\nservice providers. This requires discussing the study with staff in ancillary\ndepartments during the protocol dissection process, not after IRB approval.<\/p>\n\n\n\n<p>The study team must also\nconsider how the procedures required by the study will impact the number of\npotential enrollees. At Nationwide Children\u2019s Hospital, if the science is worth\nit, Clinical Research Services will find a way to make the study work. It is\ncrucial, however, to identify potential barriers and ways to manage them early,\nnot after the study has started. IRB submission and budget and contract approval\nmay occur simultaneously, or each process may be dependent upon other processes\nbeing completed, depending on institutional procedures. <\/p>\n\n\n\n<p>Nationwide Children\u2019s\nHospital has established a study start-up team and has developed tools to lead clinical\nresearch nurses and study coordinators through the protocol implementation\nprocess and facilitate protocol compliance. These tools are very helpful to clinical\nresearch nurses and study coordinators who are working on other protocols and\nseeing subjects for study visits who tend to delay study start-up activities. <\/p>\n\n\n\n<p>In 2015, Nationwide\nChildren\u2019s Hospital created a study start-up team comprised of three people in\nClinical Research Services who are highly organized, very processed-oriented,\nand very technology-savvy. The team members are also non-confrontational, so\nwhen they work with clinical research nurses and study coordinators, it is\nclear that they are there to assist them through this process. They are not\nseen as threatening when they check in on what is happening with a study to\nensure that timelines are met. A member of the study start-up team is assigned\nto each study.<\/p>\n\n\n\n<p>Study start-up tools are a protocol\nimplementation checklist, a study start-up timeline, and a study start-up calendar.\nThe protocol implementation checklist is useful in both investigator-initiated\nstudies and industry-sponsored studies, but it may be more helpful for\ninvestigator-initiated projects. When turning a grant application into a\nprotocol, many things are missed. The checklist helps the study team identify\nwhat questions must be answered in order to operationalize a study. Even for industry-sponsored\nstudies, the checklist helps the study team identify questions to ask the\nsponsor or contract research organization. The checklist covers:<\/p>\n\n\n\n<ul><li>Type of study<\/li><li>Responsibilities:<ul><li>Study-specific procedures<\/li><li>Ancillary departments<\/li><\/ul><\/li><li>Source documents, including whether the sponsor is providing them\n     or the clinical research site needs to develop them<\/li><li>Laboratory kits and processing requirements<\/li><\/ul>\n\n\n\n<p>Using the checklist enables\nthe study team to determine what study start-up will involve, how long it will\ntake, and whether additional staff will be needed to conduct a study.<\/p>\n\n\n\n<p>The study start-up timeline starts\nwith the date when Nationwide Children\u2019s Hospital receives the study, followed\nby the date when a study start-up team member is assigned to the study. Next,\nthe date for completion of the protocol dissection is added, and a meeting with\nthe study team lead is scheduled if there are questions about the protocol.\nIdentifying how the inclusion\/exclusion criteria will be reported and\ndocumented is the next step in the timeline. Nationwide Children\u2019s Hospital\nrecruits many subjects who live in other countries and states, which requires\nobtaining medical records from those places.<\/p>\n\n\n\n<p>Clinical Research Services\noffers a la carte services. Principal investigators can use some or all available\nservices. Multiple meetings are held with the principal investigator so that\nstaff members in Clinical Research Services understand which services the\nprincipal investigator plans to use for a study. Any meetings with the sponsor\nthat might be required are also on the timeline.<\/p>\n\n\n\n<p>The study start-up calendar works\nbackwards from the target enrollment date. It includes activities that must\noccur each week and is used to track completion of those activities.<\/p>\n\n\n\n<h2><strong>Compliance Checks<\/strong><\/h2>\n\n\n\n<p>Clinical research tends to be\nreactive. Every time that a study process went wrong at Nationwide Children\u2019s\nHospital, processes were changed to ensure that the problem would not repeat. Challenges\nwith protocol adherence exist at every site. Quality improvement and quality\nassurance processes can be implemented before the first subject is enrolled in\norder to reduce risks during study implementation and conduct (Table 4).<\/p>\n\n\n\n<p>The study start-up team\nmember assigned to a study also does a final comparison of the source documents,\nthe protocol, the case report forms, and the informed consent form. Launch\nmeetings will uncover issues about 50% of the time. By reviewing and comparing\nthe study documents ahead of time, mistakes can be corrected, compliance can be\nachieved, and all of the study documents will be as clear and concise as possible.<\/p>\n\n\n\n<p>The inclusion\/exclusion criteria\nsource document is designed to prove that the subject meets the criteria for a study.\nThis document contains a line for every calculation that is required and a\ncheckbox for every document that requires back-up documentation. It also\nincludes the start and stop dates for medications when necessary as per the\nprotocol.<\/p>\n\n\n\n<p>The research chart includes a\nprint out of all of the withdrawal and stopping criteria. The study coordinator\nand the principal investigator can refer to this at each visit. This ensures\nthat they do not miss the withdrawal and stopping criteria or have to refer to\nthe protocol to find that criteria during a visit.<\/p>\n\n\n\n<p>At least one week prior to the\nstart date for enrollment, a mock visit is conducted and the launch meeting is\nheld. The launch meeting helps identify the financial and operational aspects\nof the study and tries to clear up any issues before the first subject is\nenrolled.<\/p>\n\n\n\n<h2><strong>Conclusion<\/strong><\/h2>\n\n\n\n<p>The study start-up process sets a study up for ultimate success or failure, and there are key components that have the ability to make the conduct of the study more efficient and effective. Feasibility assessment is a best practice for all clinical research sites in order to fully evaluate the desirability and feasibility of new studies. Evaluating the feasibility of new studies to ensure accepting the \u201cright\u201d studies for the investigator and the institution allows for the success of not only that particular study, but potentially all studies being conducted at the institution. Other best practices include establishing a communication plan, dissecting the protocol as a team, creation and use of study start-up tools and checklists, and methods to evaluate any potential issues with protocol adherence.<\/p>\n\n\n\n<hr class=\"wp-block-separator\"\/>\n\n\n\n<h3><strong>TABLE 1<\/strong><\/h3>\n\n\n\n<p><strong>Reasons\nto Assess Feasibility<\/strong><\/p>\n\n\n\n<ul><li>Saves time and money<\/li><li>Proactively identifies and addresses competing priorities<\/li><li>Avoids surprises and overpromising<\/li><li>Promotes better relationships between sponsors and clinical\n     research sites<\/li><li>Makes the best use of staff time and possibly creates efficiencies<\/li><li>Enables staff to conduct the study effectively and compliantly<\/li><\/ul>\n\n\n\n<h3><strong>TABLE 2 <\/strong><\/h3>\n\n\n\n<p><strong>First-line\nStudy Feasibility Questions at Children\u2019s Hospital of Philadelphia <\/strong><\/p>\n\n\n\n<ul><li>When is enrollment scheduled to end?<\/li><li>How much time will it take to:<ul><li>Obtain IRB approval?<\/li><li>Finalize the contract?<\/li><li>Be ready to enroll subjects?<\/li><\/ul><\/li><li>What is the anticipated date of enrollment of the first subject?<\/li><li>How much time will be available for enrollment?<\/li><li>How many study subjects are needed (contracted number)?<\/li><li>How many potential study subjects who meet eligibility criteria\n     does the clinical research site have access to, if known?<\/li><li>Are enough study staff members currently available to fully staff\n     the study? Will it be necessary to hire new staff or transition staff from\n     other studies?<\/li><\/ul>\n\n\n\n<h3><strong>TABLE 3<\/strong><\/h3>\n\n\n\n<p><strong>Dissecting\nthe Protocol at Nationwide Children\u2019s Hospital<\/strong><\/p>\n\n\n\n<ul><li>Where will subjects be recruited and enrolled?<\/li><li>Where will they be seen for their study visits?<\/li><li>Are study visits combined with standard of care visits?<\/li><li>Will marketing tools be needed?<\/li><li>Does the study team have prior experience and other contacts in the\n     area? <\/li><li>Which procedures will be done and when?<ul><li>Does the site have the right equipment?<\/li><li>Does the site need additional staffing\/resources?<\/li><li>Is the equipment being supplied? Does it meet the institution\u2019s\n      standards?<\/li><li>Does the team need additional training?<\/li><li>What ancillary service providers will be needed?<\/li><li>Will the procedures impact the number of potential enrollees?<\/li><\/ul><\/li><\/ul>\n\n\n\n<h3><strong>TABLE 4 <\/strong><\/h3>\n\n\n\n<p><strong>Compliance\nChecks at Nationwide Children\u2019s Hospital<\/strong><\/p>\n\n\n\n<ul><li>Study start-up team<\/li><li>Comparison of documents:<ul><li>Source documents <\/li><li>Protocol <\/li><li>Case report forms <\/li><li>Informed consent form<\/li><\/ul><\/li><li>Inclusion\/exclusion source document designed to prove that the\n     subject meets the criteria:<ul><li>Lines for calculations to be made <\/li><li>Start\/stop dates for medications<\/li><li>Identification of when back-up documentation should be printed<\/li><\/ul><\/li><li>Source document in the research chart with withdrawal\/stopping\n     criteria:<ul><li>Reviewed at each visit<\/li><\/ul><\/li><li>Mock visit at least 1 week prior to start date<\/li><li>Launch meeting<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Jennifer Goldfarb, CCRPSenior Director, Clinical Research Support OfficeChildren&#8217;s Hospital of Philadelphia&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Grace Wentzel, CCRPDirector, Clinical Research ServicesThe Research Institute at Nationwide Children&#8217;s Hospital Abstract: The study start-up process sets a study up for success or failure. This article provides an overview of study start-up, the players on the study team, and the infrastructure required for &hellip; <\/p>\n<p><a href=\"https:\/\/www.socra.org\/blog\/developing-effective-study-start-up-processes\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Developing Effective Study Start-up Processes<\/span> &rarr;<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0},"categories":[67],"tags":[68],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v15.6.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Developing Effective Study Start-up Processes - SOCRA Blog<\/title>\n<meta name=\"description\" content=\"This article provides an overview of study start-up, the players on the study team, and the infrastructure required for successful study start-up.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.socra.org\/blog\/developing-effective-study-start-up-processes\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Developing Effective Study Start-up Processes - 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