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How to Determine if a GCP Course Meets TransCelerate BioPharma Minimum Criteria

Ten of CITI Program's Good Clinical Practice (GCP) courses 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.

Study monitors or site administrators can confirm that a learner has completed one of these courses by checking the description field on the Completion Report's Transcript Report page (see examples below). A course containing all of the modules and completed after the course's effective date for mutual recognition will contain a statement in the description field that identifies:

  • Course Name
  • Version

This statement will also include that the learner has completed all the attested CITI Program modules from the course to meet the minimum criteria for ICH GCP training identified by TransCelerate BioPharma.

In addition, study monitors or site administrators may also cross-reference the module ID numbers listed on the learner's Completion Report to the course listings below, or via the TransCelerate Biopharma website.

Please note, however, that a course may have more modules than listed in the approved course.
 

TransCelerate GCP Basic Courses

  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
    • Version 1 Effective Date - 7 May 2015
    • Version 2 Effective Date - 20 Jan 2017
  • ​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

TransCelerate GCP Refresher Courses
 
  • GCP FDA Refresher
    • Version 1 Effective Date - 11 Mar 2016
    • Version 2 Effective Date - 25 Jan 2017
  • ​GCP ICH Refresher
    • Version 1 Effective Date - 19 Mar 2015
    • Version 2 Effective Date - 25 Jan 2017


CITI Canada's TransCelerate GCP Courses

  • Good Clinical Practice (GCP) - Canada
    • Version 1 Effective Date - 28 Mar 2014
    • Version 2 Effective Date - Pending
  • ​CITI Canada GCP Refresher
    • Version 1 Effective Date - 19 Mar 2015
    • Version 2 Effective Date - 25 Jan 2017


Translations of TransCelerate GCP Courses

  • ​GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) Course - Spanish
    • Version 1 Effective Date - 16 Dec 2015
    • Version 2 Effective Date - 25 July 2017
  • GCP for Clinical Trials with Investigational Drugs and Biologics (International / ICH Focus) - Spanish
    • Version 1 Effective Date - 18 Mar 2015
    • Version 2 Effective Date - 13 July 2017
  • ​GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) Course - Portuguese
    • Version 1 Effective Date - 1 Jan 2016
  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) - Portuguese
    • Version 1 Effective Date - 1 Jan 2016

Example Transcript Report:

Description Example:

Note: The description field will only show if the learner completed the required modules within the effective period of time.
 

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

  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

  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 in FDA-Regulated Research (ID: 14615)

  6. Managing Investigational Agents According to GCP Requirements (ID: 14617)

  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 - 11 Mar 2016

  • Version 2 Effective Date - 25 Jan 2017 

  1. GCP Refresher - International Conference on Harmonisation (ICH): GCP Requirements (ID: 16779)

  2. GCP Refresher - Investigator's Responsibilities and GCP (ID: 16780)

  3. GCP Refresher - Informed Consent (ID: 16781)

  4. GCP Refresher - Safety Management (ID: 16782)

  5. GCP Refresher - Investigational Product (Drug) Management (ID: 16783)

  6. GCP Refresher - Audits, Inspection, and Monitoring of Research Studies (ID: 16784)

  7. GCP Refresher - Sponsor Responsibilities and GCP (ID: 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)

 

GCP ICH Refresher
 
  • Version 1 Effective Date - 19 Mar 2015

  • Version 2 Effective Date - 25 Jan 2017

  1. GCP Refresher - International Conference on Harmonisation (ICH): GCP Requirements (ID: 16779)

  2. GCP Refresher - Investigator’s Responsibilities and GCP (ID: 16780)

  3. GCP Refresher - Informed Consent (ID: 16781)

  4. GCP Refresher - Safety Management (ID: 16782)

  5. GCP Refresher - Investigational Product (Drug) Management (ID: 16783)

  6. GCP Refresher - Audits, Inspection, and Monitoring of Research Studies (ID: 16784)

  7. GCP Refresher - Sponsor Responsibilities and GCP (ID: 16785)


Good Clinical Practice (GCP) - Canada

  • Version 1 Effective Date - 28 Mar 2014

  • Version 2 Effective Date - Pending

  1. Overview of New Drug Development (ID: 14047)

  2. International Conference on Harmonisation (ICH): GCP Requirements    (ID: 14048)

  3. Health Canada and U.S. FDA Regulated Research    (ID: 14049)

  4. Conducting Investigator-Initiated Studies According to Health Canada and FDA Regulations and Good Clinical Practices    (ID: 14050)

  5. Investigator Obligations in Health Canada and FDA-Regulated Clinical Research     (ID: 14051)

  6. Investigator's Responsibilities and GCP    (ID: 16501)

  7. Managing Investigational Agents According to GCP Requirements (ID: 14056)

  8. Informed Consent (ID: 14062)

  9. Detection and Evaluation of Adverse Events (ID: 14063)

  10. Reporting Serious Adverse Events    (ID: 14066)

  11. Monitoring of Clinical Trials by Industry Sponsors    (ID: 14068)

  12. 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

  1. GCP Refresher - International Conference on Harmonisation (ICH): GCP Requirements (ID: 16779)

  2. GCP Refresher - Investigator's Responsibilities and GCP (ID: 16780)

  3. GCP Refresher - Informed Consent  (ID: 16781)

  4. GCP Refresher - Safety Management (ID: 16782)

  5. GCP Refresher - Investigational Product (Drug) Management (ID: 16783)

  6. GCP Refresher - Audits, Inspection, and Monitoring of Research Studies (ID: 16784)

  7. GCP Refresher - Sponsor Responsibilities and GCP (ID: 16785)


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 - Pending

  1. Generalidades del desarrollo de nuevos fármacos (ID: 12159)

  2. ICH - Comparación entre la directriz E6 de las GCP de la ICH y las regulaciones de la FDA de los Estados Unidos (ID: 12153)

  3. Realización de estudios iniciados por el investigador según las regulaciones de la FDA y las GCP  (ID: 12154)

  4. Obligaciones del investigador en la investigación regulada por la FDA  (ID: 12155)

  5. Administración de los agentes en fase de investigación según los requisitos de las GCP (ID: 12156)

  6. Descripción general de las regulaciones de la FDA para dispositivos médicos  (ID: 12151)

  7. Consentimiento informado en ensayos clínicos de fármacos, productos biológicos y dispositivos (ID: 12194)

  8. Detección y evaluación de eventos adversos (ID: 12152)

  9. Informe de eventos adversos graves (ID: 12158)

  10. Auditorías e inspecciones en ensayos clínicos (ID: 12150)

  11. Monitoreo de ensayos clínicos por patrocinadores de la industria (ID: 12157)


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

  • Version 1 Effective Date - 18 Mar 2015

  • Version 2 Effective Date - Pending

  1. Realización de estudios iniciados por el investigador según las regulaciones de la FDA y las Buenas Prácticas Clínicas (ID: 15274)

  2. Obligaciones del investigador en la investigación clínica regulada por la FDA (ID: 15275)

  3. Administración de los agentes en fase de investigación clínica según los requisitos de las GCP     (ID: 15276)

  4. Consentimiento informado en estudios clínicos de fármacos (ID: 15277)

  5. Monitoreo de ensayos clínicos de fármacos por patrocinadores de la industria (ID: 15278)

  6. Auditorías e inspecciones en ensayos clínicos de fármacos (ID: 15279)

  7. Generalidades del desarrollo de nuevos fármacos     (ID: 15280)

  8. Generalidades de la ICH (ID: 15281)

  9. Comparación entre la guía E6 de la ICH para las GCP y las regulaciones de la FDA de los Estados Unidos (ID: 15282)

  10. Detección y evaluación de eventos adversos    (ID: 15283)

  11. Informe de eventos adversos serios en las investigaciones de fármacos y productos biológicos (ID: 15284)

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

  • Version 1 Effective Date - 1 Jan 2016

  • Version 2 Effective Date - Pending

  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

  • Version 2 Effective Date - Pending  

  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)

Last Updated: 01-Aug-2017 2:01 p.m. EDT

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