{"id":735,"date":"2018-05-03T08:21:19","date_gmt":"2018-05-03T08:21:19","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/international-council-harmonisation-good-clinical-practice-ich-gcp\/"},"modified":"2026-03-06T14:46:49","modified_gmt":"2026-03-06T19:46:49","slug":"international-council-harmonisation-good-clinical-practice-ich-gcp","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/international-council-harmonisation-good-clinical-practice-ich-gcp\/","title":{"rendered":"International Council for Harmonisation: Good Clinical Practice (ICH-GCP)"},"template":"","categories":[24],"tags":[],"content-type":[41],"topic":[81,66,75],"update-type":[],"class_list":["post-735","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","content-type-guidance","topic-international-research","topic-investigator-study-team-responsibilities","topic-regulations-policies-federal-state-local"],"acf":{"use_legacy_editor":true,"updated_date":"2026-03-06 14:30:00","update_notice":false,"author":"IRBMED","summary":"The following information applies to the conduct of clinical research at the University of Michigan under ICH-GCP E6(R2) Guidelines.<\/em>\r\n\r\nInternational Council for Harmonisation (ICH)<\/a>\u00a0Good Clinical Practice (GCP<\/a>) standards (ICH-GCP) standards are fully described in an ICH efficacy<\/a> guideline document entitled E6(R2): Good Clinical Practice.<\/a>","button_links":null,"related_content":"","legacy_path":"international-council-harmonisation-good-clinical-practice-ich-gcp","legacy_node_id":264,"legacy_related_nids":"","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"About the ICH-GCP E6(R2) Efficacy Guideline","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"The ICH-GCP<\/a>\u00a0E6 Efficacy Guideline<\/a> applies only to\u00a0drug<\/strong>\u00a0clinical trials<\/a>, and does not represent a regulatory requirement in the United States; but may be required by industry sponsors<\/a>, especially for multi-site<\/a> or international\r\ntrials. The ICH-GCP Guideline is an international standard established to promote the ethical and scientifically sound design, conduct, recording, and reporting of human clinical trials.\r\n\r\nThe ICH-GCP E6(R2) on GCP Guideline in many points mirrors U.S. regulations and University of Michigan policy, but imposes several additional responsibilities on investigators<\/a>.\u00a0 When U-M agrees to a research<\/a> contract indicating a study will be conducted in full compliance<\/a> with ICH-GCP guidelines, the sponsor, oversight agencies such as\u00a0FDA<\/a>, and U-M will apply ICH-GCP requirements in their compliance review of that study.\r\n\r\nTo assist investigators with identifying full ICH-GCP responsibilities, IRBMED developed an\u00a0ICH GCP checklist<\/a>. The checklist is provided for informational purposes only. It is the principal investigator\u2019s responsibility to meet the elements of ICH-GCP E6 as outlined in the checklist. There is no requirement to upload the checklist into the eResearch<\/a> application. Completion of the checklist does not meet the requirements under NIH\u00a0Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; <\/a>U-M HRPP offers training<\/a> to fulfill this requirement.\r\n\r\nThe IRBMED Standard Informed Consent Template<\/a>\u00a0includes special instructions and template language in a unique\r\ncolor to represent elements specific to ICH-GCP. When applicable, IRB staff will verify the consent includes these elements as part of application processing. Furthermore, the\u00a0eResearch application system<\/a> includes a question with accompanying help text to\u00a0identify studies\u00a0requiring ICH-GCP compliance.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Further Information","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"U-M HRPP offers<\/a> two options for basic good clinical practice (GCP) training for clinical trial study team members:\r\n
    \r\n \t
  1. For biomedical clinical trials, U-M offers GCP training through the CITI Program<\/a><\/u>. \u00a0To access the CITI GCP course, you must first create a CITI account (free) and affiliate with the University of Michigan within CITI. See the CITI step-by-step instructions for details<\/a>.<\/li>\r\n \t
  2. For social\/behavioral clinical trials, the Michigan Institute for Clinical & Health Research (MICHR) offers the NCATS\u00a0Social and Behavioral Best Practices\u00a0course\u00a0in My LINC<\/a>. \u00a0All U-M employees and students have access to U-M's My LINC training system through their uniqname and UMICH (Level 1) password.<\/li>\r\n<\/ol>\r\nFor further information about ICH-GCP compliance at the University of Michigan, see\r\n