{"id":36,"date":"2025-11-13T22:15:25","date_gmt":"2025-11-13T22:15:25","guid":{"rendered":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/quality-assurance\/good-clinical-practices-gcp\/"},"modified":"2025-11-13T22:21:21","modified_gmt":"2025-11-13T22:21:21","slug":"good-clinical-practices-gcp","status":"publish","type":"page","link":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/quality-assurance\/qa-services\/good-clinical-practices-gcp\/","title":{"rendered":"Good Clinical Practices (GCP)"},"content":{"rendered":"\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\n<p>The Good Clinical Practices are an international quality standard that describes the conditions and processes under which research using&nbsp;<strong><em>clinical subjects<\/em><\/strong>&nbsp;(both human and animal) is conducted and that define the roles and responsibilities of clinical trial sponsors, investigators and monitors.<\/p>\n\n\n\n<p>In the US, Clinical Trial research must be conducted in accordance with a series of federal regulations that provide for human subjects protection and privacy and ensure the transparency of human subject research results through the publication of trial information and results on an online registry and results database&nbsp;(<strong><a href=\"https:\/\/clinicaltrials.gov\/\" target=\"_blank\" rel=\"noreferrer noopener\">ClinicalTrial.gov<\/a><\/strong>). [Note: to register as a Study Record Manager (user) at ClinicalTrials.gov,&nbsp;<strong><a href=\"mailto:meg.tseveenjav@colostate.edu\">contact the QA<\/a><\/strong>. These regulations have been internationally harmonized through the International Conference on Harmonization (ICH), which has prepared a detailed guidance document for Good Clinical Trials. Additionally, the International Committee of Medical Journal Editors (ICMJE) requires registration of all clinical trials (even non-interventional trials) as a condition of publication.<\/p>\n\n\n\n<p>Additional guidance is also available for laboratories that conduct laboratory analysis in support of a clinical trial, which are known as the Good Clinical Laboratory Practices (GCLP). Links can be found on the GCLP page.<\/p>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\" style=\"margin-bottom:3rem\">\n<h2 class=\"wp-block-heading has-bodoni-font-family\"><em>Medrio.com<\/em><\/h2>\n\n\n\n<ul class=\"wp-block-list is-style-green-border\">\n<li><a href=\"http:\/\/medrio.com\/\">Medrio Clinical Trial Software<\/a> \u2013 M-edu is CFR Part 11 compliant software with CloudEDC\u2122 that is FREE for investigator-initiated trials.<br><br>Founded in San Francisco, CA, Medrio offers an integrated eClinical software platform with a fully hosted Electronic Data Capture (EDC) system for all study phases. Medrio\u2019s revolutionary CloudEDC\u2122 technology features an easy-to-use drag-and-drop interface, allowing study managers to build their studies in days instead of months without any programming knowledge. Via its unique feature set, including event-based data collection, offline data entry, and PRO for the Phase I clinic, Medrio gives a special advantage to those performing early phase trials. It\u2019s no wonder that 12 of the top 20 global pharmaceutical companies choose Medrio for their data collection needs.<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-bodoni-font-family\">GCP Training Opportunities<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.citiprogram.org\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Collaborative Institutional Training Initiative (CITI) [For CSU faculty and students only]<\/strong><\/a><\/li>\n\n\n\n<li><strong><a href=\"https:\/\/grants.nih.gov\/policy\/clinical-trials\/good-clinical-training.htm\">NIH GCP Online Training<\/a><\/strong><\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\" style=\"margin-bottom:3rem\">\n<h2 class=\"wp-block-heading has-bodoni-font-family\">Regulatory Reference<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong><a href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/CFR-2004-title21-vol1\/pdf\/CFR-2004-title21-vol1-part21.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">21 CFR Part 21 \u2013 Protection of Privacy<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/CFR-2004-title21-vol1\/pdf\/CFR-2004-title21-vol1-part50.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">21 CFR Part 50 \u2013 Protection of Human Subjects<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/CFR-2004-title21-vol1\/pdf\/CFR-2004-title21-vol1-part54.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">21 CFR Part 54 \u2013 Financial Disclosure by Clinical Investigators<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/CFR-2004-title21-vol1\/pdf\/CFR-2004-title21-vol1-part56.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">21 CFR Part 56 \u2013 Institutional Review Boards<\/a><\/strong><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-bodoni-font-family\">Guidance Documents and Other Resources<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong><a href=\"https:\/\/www.fda.gov\/media\/93884\/download\" target=\"_blank\" rel=\"noreferrer noopener\">ICH Guidance for Industry E6 (R1) Good Clinical Practice: Consolidated Guidance (March 2018)<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"http:\/\/www.fda.gov\/downloads\/AnimalVeterinary\/GuidanceComplianceEnforcement\/GuidanceforIndustry\/UCM052417.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">FDA Guidance for Industry Good Clinical Practice (Animal Research; VICH GL9 (85))<\/a><\/strong><\/li>\n\n\n\n<li><a href=\"https:\/\/www.fda.gov\/media\/72267\/download\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>FDA Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs \u2014Improving Human Subject Protection<\/strong><\/a><\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\" style=\"margin-bottom:3rem\">\n<h2 class=\"wp-block-heading has-bodoni-font-family\">Helpful Links<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"http:\/\/www.fda.gov\/ScienceResearch\/SpecialTopics\/RunningClinicalTrials\/default.htm\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>FDA Clinical Trials Home Page<\/strong><\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Good Clinical Practices are an international quality standard that describes the conditions and processes under which research using&nbsp;clinical subjects&nbsp;(both human and animal) is conducted and that define the roles and responsibilities of clinical trial sponsors, investigators and monitors. In the US, Clinical Trial research must be conducted in accordance with a series of federal [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"parent":38,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"microsite":[6],"class_list":["post-36","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/pages\/36","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/comments?post=36"}],"version-history":[{"count":0,"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/pages\/36\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/pages\/38"}],"wp:attachment":[{"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/media?parent=36"}],"wp:term":[{"taxonomy":"microsite","embeddable":true,"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/microsite?post=36"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}