{"id":616,"date":"2020-03-11T22:25:04","date_gmt":"2020-03-11T22:25:04","guid":{"rendered":"https:\/\/www.pharmity.com\/?p=616"},"modified":"2020-03-16T13:27:55","modified_gmt":"2020-03-16T13:27:55","slug":"things-you-need-to-know-about-delegation-of-responsibilities-in-clinical-research","status":"publish","type":"post","link":"https:\/\/www.pharmity.com\/staging\/?p=616","title":{"rendered":"Things You Need to Know About Delegation of Responsibilities in Clinical Research"},"content":{"rendered":"\n<h5 style=\"text-align: justify;\"><strong><span style=\"color: #808080;\">Delegation of responsibilities related to a clinical trial is an area that is not always properly understood by the investigators. Incidents with the completion and maintenance of the Delegation Log are repeated over and over across all the research sites which suggest that the investigators did not receive appropriate training. <\/span><\/strong><\/h5>\n<h5 style=\"text-align: justify;\"><strong><span style=\"color: #808080;\">This article will clearly explain what the principles of delegation are and how a Delegation Log must be completed and updated.<\/span><\/strong><\/h5>\n<ul style=\"text-align: justify;\">\n<li>\n<h5><strong><span style=\"color: #04b3b0;\"><em>ICH GCP Section 4.1.5 \u201cThe Investigator should maintain a list\u00a0 of appropriately qualified persons to whom the investigator has delegated significant trial-related duties&#8221;<\/em><\/span><\/strong><\/h5>\n<\/li>\n<\/ul>\n<h5 style=\"text-align: justify;\"><strong><span style=\"color: #999999;\">This article clarifies what &#8220;delegation of trial-related duties&#8221; means and what are the regulatory expectations.<\/span><\/strong><\/h5>\n\n\n\n<hr class=\"wp-block-separator\"\/>\n\n\n\n<h2>\u00a0<\/h2>\n<h2 style=\"text-align: justify;\"><span style=\"color: #04b3b0;\"><strong>Use of Qualified Staff\u00a0<\/strong><\/span><\/h2>\n<h5 style=\"text-align: justify;\">As discussed in one of our previous articles <span style=\"text-decoration: underline;\"><span style=\"color: #0000ff; text-decoration: underline;\"><strong><a style=\"color: #0000ff; text-decoration: underline;\" href=\"https:\/\/www.pharmity.com\/staging\/why-you-should-be-qualified-to-conduct-clinical-trials-as-per-ich-gcp\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u201cWhy you should be qualified to conduct clinical trials as per ICH GCP\u201d<\/a><\/strong><\/span><\/span>, the Principal Investigator (PI) first needs to confirm that their team members are qualified and trained to discharge their roles in the study, and that their qualifications are documented.<\/h5>\n<h5 style=\"text-align: justify;\"><br \/>The PI is required to maintain a list of persons to whom significant study duties have been delegated and it is expected to maintain it throughout the study [ICH GCP E6 (R2) 4.1.5]. Such list is commonly referred to as \u201cSite Delegation Log\u201d or <strong><span style=\"color: #ff9900;\">\u201cSite Signature and Delegation Log\u201d<\/span><\/strong>, moving forward <strong><span style=\"color: #ff9900;\">\u201cDelegation Log\u201d<\/span><\/strong> (DL).<\/h5>\n<h5 style=\"text-align: justify;\"><br \/>A DL provides information such as the staff printed name, initials, date delegation began, date delegation ended, and what tasks were delegated to each study team member.<\/h5>\n<blockquote>\n<h4 style=\"text-align: justify;\"><span style=\"color: #999999;\"><strong>The Delegation Log is an official regulatory document and is always requested during audits and inspections<\/strong><\/span><\/h4>\n<\/blockquote>\n<h5 style=\"text-align: justify;\">\u00a0<\/h5>\n<h5 style=\"text-align: justify;\"><span style=\"text-decoration: underline;\"><span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"https:\/\/www.pharmity.com\/staging\/gcp-course\/\" target=\"_blank\" rel=\"noopener noreferrer\"><strong>View our training on ICH GCP E6 (R2) for<span style=\"color: #0000ff; text-decoration: underline;\"> Investi<\/span>gators and Clinical Research Staff<\/strong><\/a><\/span><\/span><\/h5>\n<p style=\"text-align: justify;\">\u00a0<\/p>\n<h2 style=\"text-align: justify;\"><span style=\"color: #04b3b0;\"><strong>Delegation of Duties: Principles of Delegation<\/strong><\/span><\/h2>\n<h5 style=\"text-align: justify;\">Conducting a study is a team effort with several critical activities running at the same time therefore the PI often needs to delegate certain study related tasks to subordinates, colleagues, or other contracted third parties not under the direct supervision of the PI. <br \/>Let\u2019s gather additional information in how certain study related tasks are delegated to study personnel by the Principal Investigator by reviewing the principles of delegation:<\/h5>\n<ul>\n<li>\n<h5>Some tasks can ONLY be delegated to medical doctors. For example, adverse events and serious adverse events assessments can only be conducted by a medical doctor and not by a study nurse.<\/h5>\n<\/li>\n<li>\n<h5>The PI has to ensure that each individual conducts ONLY the activities delegated to them in the Delegation Log, and ONLY after they have received training on those activities.<\/h5>\n<\/li>\n<li>\n<h5>The PI must also ensure that study staff do not conduct any study activity prior to their recorded start date in the DL.<\/h5>\n<\/li>\n<\/ul>\n<h5>Throughout the study conduct process, the PI remains responsible for the delegated tasks until they are completed, and the study is closed.<\/h5>\n<blockquote>\n<h4><span style=\"color: #999999;\"><strong>The overall responsibility of the study cannot be delegated by the PI<\/strong><\/span><\/h4>\n<\/blockquote>\n<h5>\u00a0<\/h5>\n<h5>Some example of delegated tasks are:<\/h5>\n<ul>\n<li>\n<h5>Obtain\/Conduct informed consent<\/h5>\n<\/li>\n<li>\n<h5>Enter\/correct eCRF data<\/h5>\n<\/li>\n<li>\n<h5>Prepare\/dispense investigational medicinal products<\/h5>\n<\/li>\n<li>\n<h5>Assess adverse events, serious adverse events<\/h5>\n<\/li>\n<\/ul>\n<h2>\u00a0<\/h2>\n<h2><strong><span style=\"color: #04b3b0;\">Site Delegation Log<\/span><\/strong><\/h2>\n<h5>The sponsor can provide a DL template, or the site can use their own template if their log meets all the sponsor\u2019s requirements.<\/h5>\n<h5>A sample of a standard delegation log template can be found at the TransCelerate website: <a href=\"https:\/\/transceleratebiopharmainc.com\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"text-decoration: underline;\"><span style=\"color: #0000ff; text-decoration: underline;\"><strong>www.transceleratebiopharmainc.com<\/strong><\/span><\/span><\/a><\/h5>\n<p><img loading=\"lazy\" class=\"alignnone size-full wp-image-638\" src=\"https:\/\/i0.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2020\/03\/Delegation-of-Tasks_summary.png?resize=676%2C678&#038;ssl=1\" alt=\"\" width=\"676\" height=\"678\" srcset=\"https:\/\/i0.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2020\/03\/Delegation-of-Tasks_summary.png?w=676&amp;ssl=1 676w, https:\/\/i0.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2020\/03\/Delegation-of-Tasks_summary.png?resize=300%2C300&amp;ssl=1 300w, https:\/\/i0.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2020\/03\/Delegation-of-Tasks_summary.png?resize=150%2C150&amp;ssl=1 150w, https:\/\/i0.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2020\/03\/Delegation-of-Tasks_summary.png?resize=146%2C146&amp;ssl=1 146w, https:\/\/i0.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2020\/03\/Delegation-of-Tasks_summary.png?resize=50%2C50&amp;ssl=1 50w, https:\/\/i0.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2020\/03\/Delegation-of-Tasks_summary.png?resize=75%2C75&amp;ssl=1 75w, https:\/\/i0.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2020\/03\/Delegation-of-Tasks_summary.png?resize=85%2C85&amp;ssl=1 85w, https:\/\/i0.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2020\/03\/Delegation-of-Tasks_summary.png?resize=80%2C80&amp;ssl=1 80w\" sizes=\"(max-width: 676px) 100vw, 676px\" data-recalc-dims=\"1\" \/><\/p>\n<h2 style=\"text-align: justify;\"><span style=\"color: #04b3b0;\"><strong>Con<span style=\"color: #04b3b0;\">clus<\/span>ion<\/strong><\/span><\/h2>\n<h5 style=\"text-align: justify;\">The delegation of duties is not just a paper exercise and PIs need to take it seriously.<\/h5>\n<h5 style=\"text-align: justify;\"><br \/>As GCP auditors, we always raise observations related to the delegation of responsibilities at the investigational sites. For example, when reviewing source documents, we sometimes realize that an investigator who was not delegated and who had not received training in the study protocol conducted study specific tasks.<\/h5>\n<h5 style=\"text-align: justify;\"><br \/>It is also quite often seen during site audits, that the PIs delegate the IMP handling to the site\u2019s Pharmacy staff and that they do not keep an adequate oversight. It is like their responsibilities disappear once the tasks are delegated. However, when serious issues arise related to the IMP, the investigators are totally shocked and angry, and a war starts between the PI and the main Pharmacist.<\/h5>\n<h5 style=\"text-align: justify;\"><br \/>All investigators should understand and be reminded on a frequent basis that the delegation of tasks is neither a simple paper exercise nor the hot potato game.<\/h5>\n<p>\u00a0<\/p>\n<h5><span style=\"text-decoration: underline;\"><strong>We have created an engaging ICH GCP E6 (R2) online course covering the delegation of trial-related tasks topic amongst other critical areas that investigators and other clinical research staff conducting clinical trials need to properly understand\u2026<\/strong><\/span><\/h5>\n<p>\u00a0<\/p>\n<h5><strong><span style=\"text-decoration: underline;\"><span style=\"color: #0000ff;\"><a style=\"color: #0000ff; text-decoration: underline;\" href=\"https:\/\/www.pharmity.com\/staging\/gcp-course\/\" target=\"_blank\" rel=\"noopener noreferrer\">Click here to view this course<\/a><\/span><\/span><\/strong><\/h5>\n<p>\u00a0<\/p>\n<h5><span style=\"color: #04b3b0;\"><strong>References<\/strong><\/span><\/h5>\n<h5>Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6(R2). November 2016.<\/h5>\n<h5>\u00a0<\/h5>\n<h5><span style=\"color: #04b3b0;\"><strong>Author: Dr Leire Z\u00fa\u00f1iga, Director and Principal GCP Consultant<\/strong><\/span><\/h5>\n<h4><span style=\"color: #999999;\"><strong>www.pharmity.com<\/strong><\/span><\/h4>\n\n\n","protected":false},"excerpt":{"rendered":"<p>Delegation of responsibilities related to a clinical trial is an area that is not always properly understood by the investigators. Incidents with the completion and maintenance of the Delegation Log are repeated over and over across all the research sites which suggest that the investigators did not receive appropriate training.<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":3,"featured_media":641,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"spay_email":""},"categories":[17],"tags":[23],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v16.0.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Things You Need to Know About Delegation of Responsibilities in Clinical Research - Pharmity<\/title>\n<meta name=\"description\" content=\"Why You Should Be Qualified to Conduct Clinical Trials | This article explains what &quot;To Be Qualified&quot; means in the Clinical Research field as per ICH GCP\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Things You Need to Know About Delegation of Responsibilities in Clinical Research - 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