List of TransCelerate Mutually Recognized GCP Training

CITI Program provides GCP courses that meet the minimum criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

This article provides a listing of all mutually recognized GCP courses. Note: The version numbering refers to the version of ICH E6, except for the GCP FDA Refresher course (see the note later in this article for more information). For Version 1, the course meets the ICH E6 minimum criteria. For Version 2, the course meets the ICH E6(R2) minimum criteria. For Version 3, the course meets the ICH E6(R3) minimum criteria.

GCP Basic Courses

GCP Refresher Courses

Note: Version 4 of the GCP FDA Refresher reflects ICH E6(R3) and meets the ICH E6(R3) minimum criteria. However, Version 3 of the GCP FDA Refresher reflects ICH E6(R2) and meets the ICH E6(R2) minimum criteria.

CITI Canada's TransCelerate GCP Courses

Translations of TransCelerate GCP Courses

• Spanish​​

 
The following mutually-recognized courses are no longer offered by CITI Program

• Portuguese

GCP Course List with Module Names and ID#s

GCP for Clinical Trials with Investigational Drugs and Medical Devices (US FDA Focus)

• Version 1 Effective Date - 7 May 2015
• Version 2 Effective Date - 20 Jan 2017
• Version 3 Effective Date - 15 Oct 2025

1. Overview of New Drug Development (ID: 1351)
2. Overview of ICH GCP (ID: 1352)
3. ICH – Comparison Between ICH GCP E6 and U.S. FDA Regulations (ID: 1354)
4. Conducting Investigator-Initiated Studies According to FDA Regulations and GCP (ID: 1355)
5. Investigator Obligations in FDA-Regulated Research (ID: 1356)
6. Managing Investigational Agents According to GCP Requirements (ID: 1357)
7. Overview of U.S. FDA Regulations for Medical Devices (ID: 1358)
8. Informed Consent in Clinical Trials of Drugs, Biologics, and Devices (ID: 1359)
9. Detecting and Evaluating Adverse Events (ID: 1360)
10. Reporting Serious Adverse Events (ID: 1361)
11. Monitoring of Clinical Trials by Industry Sponsors (ID: 1362)
12. Audits and Inspections of Clinical Trials (ID: 1363)

 
GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)

• Version 1 Effective Date - 20 Nov 2013
• Version 2 Effective Date - 20 Jan 2017
• Version 3 Effective Date - 23 Jul 2025

1. Overview of New Drug Development (ID: 14621)
2. Overview of ICH GCP (ID: 14622)
3. ICH - Comparison Between ICH GCP E6 and U.S. FDA Regulations (ID: 14625)
4. Conducting Investigator-Initiated Studies According to FDA Regulations and GCP (ID: 14614)
5. Investigator Obligations (ID: 14615)
• Prior to 23 Jul 2025, this module was titled “Investigator Obligations in FDA-Regulated Research”
6. Managing Investigational Products According to GCP Requirements (ID: 14617)
• Prior to 23 Jul 2025, this module was titled “Managing Investigational Agents According to GCP”
7. Informed Consent in Clinical Trials of Drugs and Biologics (ID: 14618)
8. Monitoring Clinical Trials of Drugs by Industry Sponsors (ID: 14619)
9. Audits and Inspections of Clinical Trials of Drugs and Biologics (ID: 14620)
10. Detecting and Evaluating Adverse Events (ID: 14623)
11. Reporting Serious Adverse Events in Investigations of Drugs and Biologics (ID: 14624) 

GCP FDA Refresher

• Version 1 Effective Date - March 11, 2016
• Version 2 Effective Date - 25 Jan 2017 
• Version 3 Effective Date - 23 Jul 2025
• Version 4 Effective Date - 15 Oct 2025

1. GCP Refresher - International Council for Harmonisation (ICH): GCP Requirements (ID: 21995)
• Prior to 23 Jul 2025, this module was titled “International Conference on Harmonisation (ICH): GCP Requirements.” The module ID was also 16779.
2. GCP Refresher - Investigator's Responsibilities and GCP (ID: 21996)
• Prior to 23 Jul 2025, the module ID was 16780.
3. GCP Refresher - Informed Consent (ID: 21997)
• Prior to 23 Jul 2025, the module ID was 16781.
4. GCP Refresher - Safety Management (ID: 21998)
• Prior to 23 Jul 2025, the module ID was 16782.
5. GCP Refresher - Investigational Product (Drug) Management (ID: 21999)
• Prior to 23 Jul 2025, the module ID was 16783.
6. GCP Refresher - Audits, Inspection, and Monitoring of Research Studies (ID: 22000)
• Prior to 23 Jul 2025, the module ID was 16784.
7. GCP Refresher - Sponsor Responsibilities and GCP (ID: 22001)
• Prior to 23 Jul 2025, the module ID was 16785.
8. GCP Refresher - Conducting Clinical Investigations of Devices (ID: 17205)
9. GCP Refresher - Review of U.S. FDA Regulations for Investigational Devices (ID: 17206)
10. GCP Refresher - Additional GCP Standards for International Clinical Investigations of Devices (ID: 17207)
11. GCP Refresher - Informed Consent and Exceptions to the Requirement for Obtaining Consent for Clinical Investigations of Devices (ID: 17208)
12. GCP Refresher - Oversight of Clinical Investigations of Devices (ID: 17209)
13. GCP Refresher - Reporting Requirements for Clinical Investigations of Devices (ID: 17210)

Note: Version 4 of the GCP FDA Refresher reflects ICH E6(R3) and meets the ICH E6(R3) minimum criteria. However, Version 3 of the GCP FDA Refresher reflects ICH E6(R2) and meets the ICH E6(R2) minimum criteria.

GCP ICH Refresher

• Version 1 Effective Date - 19 Mar 2015
• Version 2 Effective Date - 25 Jan 2017
• Version 3 Effective Date - 23 Jul 2025

1. GCP Refresher - International Council for Harmonisation (ICH): GCP Requirements (ID: 21478)
   • Prior to 23 Jul 2025, this module was titled “International Conference on Harmonisation (ICH): GCP Requirements.” The module ID was also 16779.
2. GCP Refresher - Investigator’s Responsibilities and GCP (ID: 21479)
   • Prior to 23 Jul 2025, the module ID was 16780.
3. GCP Refresher - Informed Consent (ID: 21480)
   • Prior to 23 Jul 2025, the module ID was 16781.
4. GCP Refresher - Safety Management (ID: 21481)
   • Prior to 23 Jul 2025, the module ID was 16782.
5. GCP Refresher - Investigational Product (Drug) Management (ID: 21482)
   • Prior to 23 Jul 2025, the module ID was 16783.
6. GCP Refresher - Audits, Inspection, and Monitoring of Research Studies (ID: 21483)
   • Prior to 23 Jul 2025, the module ID was 16784.
7. GCP Refresher - Sponsor Responsibilities and GCP (ID: 21484)
   • Prior to 23 Jul 2025, the module ID was 16785.

GCP SBR Advanced Refresher

• Version 2 Effective Date - 4 Apr 2018
• Version 3 Effective Date - 23 Jul 2025

1. Overview of ICH E6 GCP for Behavioral Interventions and Social Science Research (ID: 17653)
2. Investigator's Role and Responsibilities in Behavioral Interventions and Social Science Research (ID: 17654)
3. Informed Consent in Behavioral Interventions and Social Science Research (ID: 17655)
4. Monitoring, Audits, Inspections, and Data and Safety Monitoring of Behavioral Interventions and Social Science Research (ID: 17656)
5. ​In-Depth Review of ICH E6 and TransCelerate Minimum Requirements (ID: 17659)

Good Clinical Practice (GCP) - Canada

• Version 1 Effective Date - 28 Mar 2014
• Version 2 Effective Date - 4 Apr 2018 
• Version 3 Effective Date - 27 Oct 2025

1. Overview of ICH GCP (ID: 14048)
   • Prior to 27 Oct 2025, this module was titled “International Conference on Harmonisation (ICH): GCP Requirements.”
2. Institutional Review Board/Independent Ethics Committee/Research Ethics Board (IRB/IEC/REB) (ID: 14049)
   • Prior to 27 Oct 2025, this module was titled “Health Canada and U.S. FDA Regulated Research.”
3. Sponsor Responsibilities and GCP (ID: 14050)
   • Prior to 27 Oct 2025, this module was titled “Conducting Investigator-Initiated Studies According to Health Canada and FDA Regulations and Good Clinical Practices.”
4. Investigator Responsibilities and GCP (ID: 16501)
   • Prior to 27 Oct 2025, this module was titled “Investigator’s Responsibilities and GCP.”
5. Managing Investigational Products According to GCP Requirements (ID: 14056)
   • Prior to 27 Oct 2025, this module was titled “Managing Investigational Agents According to GCP Requirements.”
6. Informed Consent in Clinical Trials of Drugs and Biologics (ID: 14062)
   • Prior to 27 Oct 2025, this module was titled “Informed Consent.”
7. Detection, Evaluation, and Reporting of Adverse and Serious Adverse Events (ID: 14063)
   • Prior to 27 Oct 2025, this module was titled “Detection and Evaluation of Adverse Events.”
8. Administrative Documents (ID: 14066)
   • Prior to 27 Oct 2025, this module was titled “Reporting Serious Adverse Events.”
9. Monitoring Clinical Trials by Sponsors (ID: 14068)
   • Prior to 27 Oct 2025, this module was titled “Monitoring of Clinical Trials by Industry Sponsors.”
10. Audits and Inspections in Clinical Trials (ID: 14141)

CITI Canada GCP Refresher

• Version 1 Effective Date - 19 Mar 2015
• Version 2 Effective Date - 25 Jan 2017
• Version 3 Effective Date - 27 Oct 2025
• GCP Refresher - International Council for Harmonisation (ICH): GCP Requirements (ID: 22102)
  • Prior to 27 Oct 2025, the module ID was 16779.
• GCP Refresher - Investigator's Responsibilities and GCP (ID: 22096)
  • Prior to 27 Oct 2025, the module ID was 16780.
• GCP Refresher - Informed Consent (ID: 22097)
  • Prior to 27 Oct 2025, the module ID was 16781.
• GCP Refresher - Safety Management (ID: 22098)
  • Prior to 27 Oct 2025, the module ID was 16782.
• GCP Refresher - Investigational Product (Drug) Management (ID: 22099)
  • Prior to 27 Oct 2025, the module ID was 16783.
• GCP Refresher - Audits, Inspection, and Monitoring of Research Studies (ID: 22100)
  • Prior to 27 Oct 2025, the module ID was 16784.
• GCP Refresher - Sponsor Responsibilities and GCP (ID: 22101)
  • Prior to 27 Oct 2025, the module ID was 16785.

Good Clinical Practice (GCP) – Canada (French)

• Version 2 Effective Date – 25 Aug 2020 
• Version 3 Effective Date - 27 Oct 2025

1. INTERNATIONAL COUNCIL FOR HARMONISATION (ICH) : EXIGENCES EN MATIÈRE DE BPC (ID: 20045)
2. COMITÉ D’EXAMEN DE L’ÉTABLISSEMENT/COMITÉ D’ÉTHIQUE INDÉPENDANT/COMITÉ D’ÉTHIQUE DE LA RECHERCHE (CEE/CEI/CER) (ID: 20046)
3. RESPONSABILITÉS DU CHERCHEUR ET BPC (ID: 20047)
4. CONSENTEMENT ÉCLAIRÉ (ID: 20048)
5. GESTION DES PRODUITS (MÉDICAMENTS) EXPÉRIMENTAUX SELON LES EXIGENCES EN MATIÈRE DE BPC (ID: 20049)
6. DÉTECTION, ÉVALUATION ET DÉCLARATION DES EFFETS INDÉSIRABLES ET DES EFFETS INDÉSIRABLES GRAVES (ID: 20050)
7. RESPONSABILITÉS DU PROMOTEUR ET BPC (ID: 20051)
8. SURVEILLANCE DES ESSAIS CLINIQUES PAR LES PROMOTEURS (ID: 20052)
9. VÉRIFICATIONS ET INSPECTIONS D’ESSAIS CLINIQUES (ID: 20053)
10. DOCUMENTS ADMINISTRATIFS (ID: 20054)

CITI Canada GCP Refresher (French)

• Version 2 Effective Date - 28 Sept 2019
• Version 3 Effective Date - 27 Oct 2025

1. Mise à jour des connaissances sur les BPC – International Conference for Harmonisation (ICH): Exigences en matière de bonnes pratiques cliniques (BPC) (ID: 17919)
2. Mise à jour des connaissances sur les BPC –– Responsabilités du chercheur et BPC (ID: 17920)
3. Mise à jour des connaissances sur les BPC – Consentement éclairé (ID: 17921)
4. Mise à jour des connaissances sur les BPC – Gestion de la sécurité (ID: 17922)
5. Mise à jour des connaissances sur les BPC – Gestion du produit (médicament) expérimental (ID: 17923)
6. Mise à jour des connaissances sur les BPC – Vérification, inspection et surveillance des études de recherche (ID:17924)
7. Mise à jour des connaissances sur les BPC – Responsabilités du sponsor et BPC (ID: 17925)

GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) - Spanish

• Version 1 Effective Date - 16 Dec 2015
• Version 2 Effective Date - 25 July 2017
• Version 3 Effective Date - 16 Mar 2026

1. Panorama general del desarrollo de nuevos fármacos (ID: 12159)
   • Note: Prior to 16 Mar 2026, the title of this module was “Generalidades del desarrollo de nuevos fármacos.”
2. Panorama general de las GCP según el ICH (ID: 12720)
   • Note: This module is only included in Version 3.
3. ICH - Comparación entre la directriz E6 de las GCP del ICH y las regulaciones de la FDA de los Estados Unidos (ID: 12153)
   • Note: Prior to 16 Mar 2026, the title of this module was “ICH - Comparación entre la directriz E6 de las GCP de la ICH y las regulaciones de la FDA de los Estados Unidos.”
4. Realización de estudios iniciados por el investigador según las regulaciones de la FDA y las GCP (ID: 12154)
5. Obligaciones del investigador en investigaciones reguladas por la FDA (ID: 12155)
   • Note: Prior to 16 Mar 2026, the title of this module was “Obligaciones del investigador en la investigación regulada por la FDA.”
6. Administración de los agentes en fase de investigación según los requisitos de las GCP (ID: 12156)
7. Descripción general de las regulaciones de la FDA para dispositivos médicos (ID: 12151)
8. Consentimiento informado en ensayos clínicos de fármacos, productos biológicos y dispositivos (ID: 12194)
9. Detección y evaluación de eventos adversos (ID: 12152)
10. Informe de eventos adversos graves (ID: 12158)
11. Auditorías e inspecciones en ensayos clínicos (ID: 12150)
12. Supervisión de ensayos clínicos de parte de los patrocinadores de la industria (ID: 12157)
    • Note: Prior to 16 Mar 2026, the title of this module was “Monitoreo de ensayos clínicos por patrocinadores de la industria.”

GCP for Clinical Trials with Investigational Drugs (International / ICH Focus) – Spanish

• Version 1 Effective Date - 18 Mar 2015
• Version 2 Effective Date - 13 July 2017
• Version 3 Effective Date - 16 Mar 2026

1. Realización de estudios iniciados por el investigador según las regulaciones de la FDA y las GCP (ID: 15274)
   • Note: Prior to 16 Mar 2026, the title of this module was “Realización de estudios iniciados por el investigador según las regulaciones de la FDA y las Buenas Prácticas Clínicas.”
2. Obligaciones del investigador (ID: 15275)
   • Note: Prior to 16 Mar 2026, the title of this module was “Obligaciones del investigador en la investigación clínica regulada por la FDA.”
3. Administración de los productos en fase de investigación según los requisitos de las GCP (ID: 15276)
   • Note: Prior to 16 Mar 2026, the title of this module was “Obligaciones del investigador en la investigación clínica regulada por la FDA.”
4. Consentimiento informado en ensayos clínicos con fármacos y productos biológicos (ID: 15277)
   • Note: Prior to 16 Mar 2026, the title of this module was “Consentimiento informado en estudios clínicos de fármacos.”
5. Supervisión de ensayos clínicos con fármacos llevados a cabo por patrocinadores de la industria (ID: 15278)
   • Note: Prior to 16 Mar 2026, the title of this module was “Monitoreo de ensayos clínicos de fármacos por patrocinadores de la industria.”
6. Auditorías e inspecciones de ensayos clínicos con fármacos y productos biológicos (ID: 15279)
   • Note: Prior to 16 Mar 2026, the title of this module was “Auditorías e inspecciones en ensayos clínicos de fármacos.”
7. Panorama general del desarrollo de nuevos fármacos (ID: 15280)
   • Note: Prior to 16 Mar 2026, the title of this module was “Generalidades del desarrollo de nuevos fármacos .”
8. Panorama general de las GCP según el ICH (ID: 15281)
   • Note: Prior to 16 Mar 2026, the title of this module was “Generalidades de la ICH.”
9. ICH - Comparación entre la directriz E6 de las GCP del ICH y las regulaciones de la FDA de los Estados Unidos (ID: 15282)
   • Note: Prior to 16 Mar 2026, the title of this module was “Comparación entre la guía E6 de la ICH para las GCP y las regulaciones de la FDA de los Estados Unidos.”
10. Detección y evaluación de eventos adversos (ID: 15283)
11. Informe de eventos adversos graves en investigaciones con fármacos y productos biológicos (ID: 15284)
    • Note: Prior to 16 Mar 2026, the title of this module was “Informe de eventos adversos serios en las investigaciones de fármacos y productos biológicos.”

The following mutually-recognized courses are no longer offered by CITI Program. 

GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) - Portuguese

• Version 1 Effective Date - 1 Jan 2016

1. Visão geral do desenvolvimento de novos medicamentos (ID: 16336)
2. Visão geral de Boas Práticas Clínicas (GCP) da ICH (ID: 16337)
3. ICH - Comparação entre os tópicos ICH GCP E6 e os regulamentos do FDA (ID: 16338)
4. Realização de estudos iniciados pelo investigador de acordo com a regulamentação do FDA e o GCP (ID: 16339)
5. Obrigações do investigador em pesquisas clínicas regulamentadas pelo FDA (ID: 16340)
6. Gerenciamento de agentes de pesquisa de acordo com os requisitos de GCP (ID: 16341)
7. Visão geral dos regulamentos do FDA para dispositivos médicos (ID: 16342)
8. Consentimento esclarecido (ID: 16343)
9. Detecção e avaliação de eventos adversos (ID: 16344)
10. Relatórios de eventos adversos graves (ID: 16345)
11. Monitoramento de ensaios clínicos por patrocinadores do setor (ID: 16346)
12. Auditorias e inspeções de ensaios clínicos (ID: 16347)

GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) - Portuguese

• Version 1 Effective Date - 1 Jan 2016

1. Realização de estudos iniciados pelo investigador de acordo com a regulamentação do FDA e o GCP (ID: 16360)
2. Visão geral do desenvolvimento de novos medicamentos (ID: 16336)
3. Obrigações do investigador em pesquisas regulamentadas pelo FDA (ID: 16361)
4. Gerenciamento de agentes de pesquisa de acordo com os requisitos de GCP (ID: 16362)
5. Consentimento esclarecido em ensaios clínicos de medicamentos e biofármacos (ID: 16363)
6. Monitoramento de ensaios clínicos de medicamentos pelos patrocinadores (ID: 16364)
7. Auditorias e inspeções de ensaios clínicos de medicamentos e biofármacos (ID: 16365)
8. Visão geral de Boas Práticas Clínicas (GCP) da ICH (ID: 16366)
9. Detecção e avaliação de eventos adversos (ID: 16367)    
10. Relatos de eventos adversos graves em investigações de medicamentos e biofármacos (ID: 16368)    
11. ICH—Comparação entre os tópicos ICH GCP E6 e os regulamentos do FDA (ID: 16369)

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