{"id":717,"date":"2020-12-16T08:31:14","date_gmt":"2020-12-16T08:31:14","guid":{"rendered":"http:\/\/clinicaltrialrisk.org\/prevention\/"},"modified":"2023-06-26T08:50:02","modified_gmt":"2023-06-26T08:50:02","slug":"faq","status":"publish","type":"page","link":"https:\/\/clinicaltrialrisk.org\/faq\/","title":{"rendered":"FAQ"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"717\" class=\"elementor elementor-717\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-34988a2 elementor-section-content-middle elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"34988a2\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6f4b106\" data-id=\"6f4b106\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-453d3b8 elementor-widget elementor-widget-heading\" data-id=\"453d3b8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.15.0 - 20-08-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h2 class=\"elementor-heading-title elementor-size-default\">Frequently Asked Questions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-512ca02 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"512ca02\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6c54461\" data-id=\"6c54461\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-31c1253 elementor-section-content-middle elementor-reverse-tablet elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"31c1253\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-0204469\" data-id=\"0204469\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a310b89 elementor-widget elementor-widget-heading\" data-id=\"a310b89\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">FAQ<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-bf603eb elementor-widget elementor-widget-accordion\" data-id=\"bf603eb\" data-element_type=\"widget\" data-widget_type=\"accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.15.0 - 20-08-2023 *\/\n.elementor-accordion{text-align:left}.elementor-accordion .elementor-accordion-item{border:1px solid #d5d8dc}.elementor-accordion .elementor-accordion-item+.elementor-accordion-item{border-top:none}.elementor-accordion .elementor-tab-title{margin:0;padding:15px 20px;font-weight:700;line-height:1;cursor:pointer;outline:none}.elementor-accordion .elementor-tab-title .elementor-accordion-icon{display:inline-block;width:1.5em}.elementor-accordion .elementor-tab-title .elementor-accordion-icon svg{width:1em;height:1em}.elementor-accordion .elementor-tab-title .elementor-accordion-icon.elementor-accordion-icon-right{float:right;text-align:right}.elementor-accordion .elementor-tab-title .elementor-accordion-icon.elementor-accordion-icon-left{float:left;text-align:left}.elementor-accordion .elementor-tab-title .elementor-accordion-icon .elementor-accordion-icon-closed{display:block}.elementor-accordion .elementor-tab-title .elementor-accordion-icon .elementor-accordion-icon-opened,.elementor-accordion .elementor-tab-title.elementor-active .elementor-accordion-icon-closed{display:none}.elementor-accordion .elementor-tab-title.elementor-active .elementor-accordion-icon-opened{display:block}.elementor-accordion .elementor-tab-content{display:none;padding:15px 20px;border-top:1px solid #d5d8dc}@media (max-width:767px){.elementor-accordion .elementor-tab-title{padding:12px 15px}.elementor-accordion .elementor-tab-title .elementor-accordion-icon{width:1.2em}.elementor-accordion .elementor-tab-content{padding:7px 15px}}.e-con-inner>.elementor-widget-accordion,.e-con>.elementor-widget-accordion{width:var(--container-widget-width);--flex-grow:var(--container-widget-flex-grow)}<\/style>\t\t<div class=\"elementor-accordion\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2001\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2001\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">What is a clinical trial protocol?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2001\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2001\"><p>When a pharmaceutical company develops a drug, it needs to pass through several phases of clinical trials before it can be approved by regulators.<\/p><p>Before the trial is run, the drug developer writes a document called a protocol. This contains key information about how long the trial will run for, what is the risk to participants, what kind of treatment is being investigated, etc.<\/p><p>The problem is that each protocol is up to 200 pages long and the structure can vary. There is not a standardised way of noting the intervention, number of participants, locations, and so on, although there exist in-house standards within many pharma companies.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2002\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-2002\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">What does the Clinical Trial Risk Tool do?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2002\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-2002\"><p>The Clinical Trial Risk tool is a tool that helps funders and pharma companies identify risk factors in a trial protocol using natural language processing and rate the trial as high, medium or low risk.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2003\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-2003\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">How do I cite the Clinical Trial Risk Tool?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2003\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-2003\"><p>Wood TA and McNair D. Clinical Trial Risk Tool: software application using natural language processing to identify the risk of trial uninformativeness [version 1; peer review: awaiting peer review]. Gates Open Res 2023, 7:56 (https:\/\/doi.org\/10.12688\/gatesopenres.14416.1)<\/p><p>A BibTeX entry for LaTeX users is<\/p><pre>@article{Wood_2023,\n\tdoi = {10.12688\/gatesopenres.14416.1},\n\turl = {https:\/\/doi.org\/10.12688%2Fgatesopenres.14416.1},\n\tyear = 2023,\n\tmonth = {apr},\n\tpublisher = {F1000 Research Ltd},\n\tvolume = {7},\n\tpages = {56},\n\tauthor = {Thomas A Wood and Douglas McNair},\n\ttitle = {Clinical Trial Risk Tool: software application using natural language processing to identify the risk of trial uninformativeness},\n\tjournal = {Gates Open Research}\n}<\/pre><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2004\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-2004\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Does the Clinical Trial Risk Tool store my data?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2004\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-2004\"><p>If you upload a protocol, the Clinical Trial Risk Tool does not store or save it. You can read more on our <a href=\"https:\/\/clinicaltrialrisk.org\/privacy-policy\/\">Privacy Policy page<\/a>.<\/p><p>If you choose to create a user account on app.clinicaltrialrisk.org, you can click Login and you will be directed to create an account and\/or authenticate on the third party authentication provider Auth0.com. Your email address is stored as your unique identifier while on the app. Our reason for storing your email address is that it is needed for optional user authentication. If you want to use the application anonymously, all functionality is still available without logging in, only that you will not be able to save and retrieve profiles at a later date.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2005\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-2005\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">I want you to delete all data you hold about me<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2005\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-2005\"><div dir=\"auto\">You can delete any configuration you have saved on the server using the Delete button on the application at\u00a0<a href=\"http:\/\/app.clinicaltrialrisk.org\/\" target=\"_blank\" rel=\"noopener\" data-saferedirecturl=\"https:\/\/www.google.com\/url?q=http:\/\/app.clinicaltrialrisk.org&amp;source=gmail&amp;ust=1676240940542000&amp;usg=AOvVaw2ZKUInHay6rROv_iBhT24T\">app.clinicaltrialrisk.org<\/a>.\u00a0 You can also delete your account on our third party authentication provider Auth0.com by logging into that service. In accordance with the Right to Be Forgotten (please see our <a href=\"https:\/\/clinicaltrialrisk.org\/privacy-policy\/\">Privacy Policy<\/a>), you can also send a message via the contact form to ensure complete deletion of your data.<\/div><div dir=\"auto\">\u00a0<\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2006\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"button\" aria-controls=\"elementor-tab-content-2006\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">How does the Clinical Trial Risk Tool work?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2006\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"region\" aria-labelledby=\"elementor-tab-title-2006\"><p>The Clinical Trial Risk Tool allows a user to upload a trial protocol in PDF format. The tool processes the PDF into plain text and identifies features which indicate high or low risk of uninformativeness.<\/p><p>The tool uses a series of machine learning algorithms, such as Convolutional Neural Networks, combined with rule-based components, to identify key features of a protocol. You can download and run the source code on <a href=\"https:\/\/github.com\/fastdatascience\/clinical_trial_risk\">Github.<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2007\" class=\"elementor-tab-title\" data-tab=\"7\" role=\"button\" aria-controls=\"elementor-tab-content-2007\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">How reliable is the Clinical Trial Risk Tool?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2007\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"7\" role=\"region\" aria-labelledby=\"elementor-tab-title-2007\"><p>Please see <a href=\"https:\/\/clinicaltrialrisk.org\/accurate-clinical-trial-risk-tool\/\">this blog post<\/a> for a summary of the tool&#8217;s accuracy in the different areas.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2008\" class=\"elementor-tab-title\" data-tab=\"8\" role=\"button\" aria-controls=\"elementor-tab-content-2008\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">What do the numbers mean?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2008\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"8\" role=\"region\" aria-labelledby=\"elementor-tab-title-2008\"><p>The tool gives a broad sense of risk using a traffic light system (red\/amber\/green for high\/medium\/low risk respectively). To see a finer definition of the risk, the tool internally scores protocols between 0 and 100. These scores are derived from a linear model. For example, a trial gains 20 points if it has a completed statistical analysis plan, 10 extra points if it has a large sample size, and so on. These are summed in an easy-to-understand way. You can adjust the weights (coefficients) of the different parameters extracted by the tool under the right-hand tab entitled &#8220;Configure thresholds and parameters&#8221;.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2009\" class=\"elementor-tab-title\" data-tab=\"9\" role=\"button\" aria-controls=\"elementor-tab-content-2009\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Does the Clinical Trial Risk Tool give p-values?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2009\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"9\" role=\"region\" aria-labelledby=\"elementor-tab-title-2009\"><p>At this time the Clinical Trial Risk Tool does not give p-values. In future we hope to provide more statistical data to the Clinical Trial Risk Tool\u2019s users.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-20010\" class=\"elementor-tab-title\" data-tab=\"10\" role=\"button\" aria-controls=\"elementor-tab-content-20010\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Who made the Clinical Trial Risk Tool?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-20010\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"10\" role=\"region\" aria-labelledby=\"elementor-tab-title-20010\"><p>The Python code of the Clinical Trial Risk Tool was written by <a href=\"https:\/\/freelancedatascientist.net\/\">Thomas Wood<\/a> (<a href=\"https:\/\/fastdatascience.com\/\">Fast Data Science<\/a>).<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-20011\" class=\"elementor-tab-title\" data-tab=\"11\" role=\"button\" aria-controls=\"elementor-tab-content-20011\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">I would like to improve the tool<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-20011\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"11\" role=\"region\" aria-labelledby=\"elementor-tab-title-20011\"><p>Our source code is on <a href=\"https:\/\/github.com\/fastdatascience\/clinical_trial_risk\">Github<\/a>. If you would like to improve the tool you are welcome to submit any changes you may have using a pull request. Please contact us to discuss.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-20012\" class=\"elementor-tab-title\" data-tab=\"12\" role=\"button\" aria-controls=\"elementor-tab-content-20012\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">My protocol is several separate PDFs and the SAP is also a separate PDF, can the tool handle this?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-20012\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"12\" role=\"region\" aria-labelledby=\"elementor-tab-title-20012\"><p>At present the tool is designed to handle single documents only, but a future improvement may allow batch processing of multiple PDFs.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-20013\" class=\"elementor-tab-title\" data-tab=\"13\" role=\"button\" aria-controls=\"elementor-tab-content-20013\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">My trial is not HIV or TB, can the tool help?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-20013\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"13\" role=\"region\" aria-labelledby=\"elementor-tab-title-20013\"><p>You are welcome to upload a protocol for a different pathology. Just please be aware that the thresholds for what is a small, medium or large trial may be different in a different area such as oncology, and the tool was developed with a focus on HIV and TB in particular. A future direction of the project could involve expansion to more pathologies.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-20014\" class=\"elementor-tab-title\" data-tab=\"14\" role=\"button\" aria-controls=\"elementor-tab-content-20014\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">What license does the tool have?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-20014\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"14\" role=\"region\" aria-labelledby=\"elementor-tab-title-20014\"><p>The tool is <a href=\"https:\/\/github.com\/fastdatascience\/clinical_trial_risk\/blob\/main\/LICENSE\">open-sourced under the MIT License<\/a>.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-20015\" class=\"elementor-tab-title\" data-tab=\"15\" role=\"button\" aria-controls=\"elementor-tab-content-20015\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Is the Clinical Trial Risk Tool GDPR or HIPAA compliant?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-20015\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"15\" role=\"region\" aria-labelledby=\"elementor-tab-title-20015\"><p>The tool does not save personal data, except for your email address if you create an account, and is GDPR and HIPAA compliant. More information on our <a href=\"https:\/\/clinicaltrialrisk.org\/privacy-policy\/\">Privacy Policy<\/a>.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Frequently Asked Questions FAQ What is a clinical trial protocol? When a pharmaceutical company develops a drug, it needs to pass through several phases of clinical trials before it can be approved by regulators. Before the trial is run, the drug developer writes a document called a protocol. This contains key information about how long [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FAQ - CLINICAL TRIAL RISK TOOL<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/clinicaltrialrisk.org\/faq\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FAQ - CLINICAL TRIAL RISK TOOL\" \/>\n<meta property=\"og:description\" content=\"Frequently Asked Questions FAQ What is a clinical trial protocol? When a pharmaceutical company develops a drug, it needs to pass through several phases of clinical trials before it can be approved by regulators. Before the trial is run, the drug developer writes a document called a protocol. 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