{"id":5900,"date":"2020-08-25T12:32:13","date_gmt":"2020-08-25T12:32:13","guid":{"rendered":"https:\/\/demo.theisn.org\/?page_id=5900"},"modified":"2026-03-11T15:33:40","modified_gmt":"2026-03-11T15:33:40","slug":"being-a-trial-site","status":"publish","type":"page","link":"https:\/\/www.theisn.org\/in-action\/research\/clinical-trials-isn-act\/isn-act-toolkit\/being-a-trial-site\/","title":{"rendered":"Being a trial site"},"content":{"rendered":"<p>[vc_row][vc_column][vc_column_text]<\/p>\n<h2>Being a Trial Site<\/h2>\n<p>Being part of clinical trials can be a rewarding part of medicine. While it does take some effort, it potentially provides you and your patients with access to novel treatments and methods. It is also a great way to learn about the research process and offers the opportunity to collaborate with peers. The skills and systems you develop from trial participation can even help you in planning your own studies.<\/p>\n<p>Before becoming a trial site it is important to be aware of what you and your site will require. We have presented a summary of the requirements below. Remember that trial investigators will always be willing to problem solve if it means a motivated site joins their study \u2013 so if you don\u2019t have all of the following items in place it is still worth expressing interest as others may be able to help you to get your site ready to go.[\/vc_column_text][vc_tta_accordion style=&#8221;flat&#8221; spacing=&#8221;5&#8243; c_position=&#8221;right&#8221; active_section=&#8221;0&#8243; collapsible_all=&#8221;true&#8221; el_class=&#8221;accordion-isn&#8221;][vc_tta_section title=&#8221;To become a trial site, you should have:&#8221; tab_id=&#8221;trial-site-have&#8221;][vc_column_text]<i class=\"fa fa-check-circle red\"><\/i> A leader \u2013 Principal investigator<\/p>\n<p><i class=\"fa fa-check-circle red\"><\/i> A team \u2013 which might include co-investigator(s), study coordinators, a pharmacist and\/or study-nurse(s)<\/p>\n<p><i class=\"fa fa-check-circle red\"><\/i> Good Clinical Practice (GCP) training and certificates for all trial site staff<\/p>\n<p><i class=\"fa fa-check-circle red\"><\/i> Basic equipment for handling drugs and laboratory specimens \u2013 centrifuge, refrigerator(s) etc.<\/p>\n<p><i class=\"fa fa-check-circle red\"><\/i> Access to local laboratory, radiology and\/or pharmacy services<\/p>\n<p><i class=\"fa fa-check-circle red\"><\/i> An appropriate place for study documentation storage, for Investigational Medicinal Product (IMP) (i.e. the study drug) storage and dispensing<\/p>\n<p><i class=\"fa fa-check-circle red\"><\/i> Appropriate place to see the patients and administer the treatment<\/p>\n<p><i class=\"fa fa-check-circle red\"><\/i> Access to the internet<\/p>\n<p><i class=\"fa fa-check-circle red\"><\/i> Enough time to conduct the trial (it may be more time-consuming than you first think)<\/p>\n<p><i class=\"fa fa-check-circle red\"><\/i> For international trials, sufficient English or support from a translator to understand the Protocol and Investigators Brochure and Manuals, communicate with Contract Research Organization (CRO) and Study Team, and manage the electronic Case Report Forms (eCRF) (all trial site staff)[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Starting as a trial site &#8211; once you are approached by the study team, you will have to:&#8221; tab_id=&#8221;starting-have-to&#8221;][vc_column_text]<\/p>\n<ul class=\"list list-icons list-icons-sm\">\n<li><i class=\"fa fa-check-circle red\"><\/i>Review the study protocol, especially the site and patient eligibility criteria. Your aim here is to consider whether you have sufficient patients that would meet the study eligibility criteria and the resources to conduct the study<\/li>\n<li><i class=\"fa fa-check-circle red\"><\/i> Make sure you have sufficient staff, room and equipment to conduct the study<\/li>\n<li><i class=\"fa fa-check-circle red\"><\/i> Make sure that the specific patient population is available in your institution, or you have contacts with other institutions which can refer the patients<\/li>\n<li><i class=\"fa fa-check-circle red\"><\/i> Make sure you are able to follow the screening and recruitment schedule, and study protocol procedures<\/li>\n<li><i class=\"fa fa-check-circle red\"><\/i> Make sure your institution has an appropriate license for all procedures outlined in the study protocol<\/li>\n<li><i class=\"fa fa-check-circle red\"><\/i> Make sure you have an access to an accredited Institutional Review Board (IRB) or Independent Ethics Committee (IEC)<\/li>\n<li><i class=\"fa fa-check-circle red\"><\/i> Make sure the head of your institution will sign the Study Agreement<\/li>\n<li><i class=\"fa fa-check-circle red\"><\/i> Consider if the financial or other support provided by the study sponsor is sufficient to cover the costs of running the study at your site<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Once you are a trial site, you have to be ready to:&#8221; tab_id=&#8221;once-trial-be-ready&#8221;][vc_column_text]<\/p>\n<ul class=\"list list-icons list-icons-sm\">\n<li><i class=\"fa fa-check-circle red\"><\/i> Undergo specific training, most of which is online<\/li>\n<li><i class=\"fa fa-check-circle red\"><\/i> Receive and manage multiple correspondence from the monitors and study team<\/li>\n<li><i class=\"fa fa-check-circle red\"><\/i> Receive and manage multiple protocol versions and amendments<\/li>\n<li><i class=\"fa fa-check-circle red\"><\/i> Spend time talking to the patients about the trial before they sign Informed Consent<\/li>\n<li><i class=\"fa fa-check-circle red\"><\/i> Expect challenges in pre-screening and screening patients \u2013 it may be harder than anticipated to find eligible patients<\/li>\n<li><i class=\"fa fa-check-circle red\"><\/i> Timely obtain, handle and ship samples from the patients<\/li>\n<li><i class=\"fa fa-check-circle red\"><\/i> Monitor and timely report Adverse Events (AEs) and Serious Adverse Events (SAEs)<\/li>\n<li><i class=\"fa fa-check-circle red\"><\/i> Undergo monitor\u2019s visits \u2013 which may not happen as often as you need<\/li>\n<li><i class=\"fa fa-check-circle red\"><\/i> Be audited<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Useful links&#8221; tab_id=&#8221;useful-links&#8221;][vc_column_text]<\/p>\n<ul>\n<li><a href=\"https:\/\/ictr.wisc.edu\/\" target=\"_blank\" rel=\"noopener noreferrer\">UWM Clinical Toolkit<\/a><\/li>\n<li><a href=\"https:\/\/www.hra.nhs.uk\/planning-and-improving-research\/research-planning\/planning-working-with-sites\/\" target=\"_blank\" rel=\"noopener noreferrer\">Planning and working with sites<\/a> (NHS Health Research Authority)<\/li>\n<li><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK305499\/\" target=\"_blank\" rel=\"noopener noreferrer\">Field Trials of Health Interventions<\/a>\u00a0(see Chapter 7: Trial Governance) from\u00a0<a href=\"http:\/\/ieaweb.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">International Epidemiological Association\\Resources\\Publications<\/a><\/li>\n<li><a href=\"http:\/\/www.ct-toolkit.ac.uk\/\" target=\"_blank\" rel=\"noopener noreferrer\">NHS Clinical Trials Toolkit<\/a><\/li>\n<li><a href=\"http:\/\/ascopubs.org\/doi\/full\/10.1200\/jco.2007.15.6398\" target=\"_blank\" rel=\"noopener noreferrer\">ASCO Statement on Minimum Standards and Exemplary Attributes of Clinical Trial Sites<\/a><\/li>\n<li><a href=\"https:\/\/about.citiprogram.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">CITI Program online training courses in research skills, including in GCP (payment required for courses unless a member of a participating university).<\/a><\/li>\n<li><a href=\"https:\/\/globalhealthtrainingcentre.tghn.org\/elearning\/\" target=\"_blank\" rel=\"noopener noreferrer\">Global Health Training Centre online training courses in research skills, including in GCP \u2013 courses are FREE<\/a><\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_column_text] Being a Trial Site Being part of clinical trials can be a rewarding part of medicine. While it does take some effort, it potentially provides you and your patients with access to novel treatments and methods. It is also a great way to learn about the research process and offers the opportunity to collaborate [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":4020,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-5900","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.theisn.org\/wp-json\/wp\/v2\/pages\/5900"}],"collection":[{"href":"https:\/\/www.theisn.org\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.theisn.org\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.theisn.org\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.theisn.org\/wp-json\/wp\/v2\/comments?post=5900"}],"version-history":[{"count":7,"href":"https:\/\/www.theisn.org\/wp-json\/wp\/v2\/pages\/5900\/revisions"}],"predecessor-version":[{"id":52794,"href":"https:\/\/www.theisn.org\/wp-json\/wp\/v2\/pages\/5900\/revisions\/52794"}],"up":[{"embeddable":true,"href":"https:\/\/www.theisn.org\/wp-json\/wp\/v2\/pages\/4020"}],"wp:attachment":[{"href":"https:\/\/www.theisn.org\/wp-json\/wp\/v2\/media?parent=5900"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}