Institutional Review Board

Good Clinical Practice (GCP) Education

The training of investigators and research teams to conduct clinical research is crucial to successful translation of novel drugs, devices and interventions. In order to secure comprehensive competency-based training for clinical research personnel, we will require certification of training in Good Clinical Practices (GCP) for all investigators and personnel directly involved in new and ongoing clinical studies that involve the testing of drugs or devices, including all FDA-registered studies as well as investigator-initiated protocols. This requirement applies to studies reviewed by both the Einstein IRB, and approved external IRBs (e.g. BRANY, NCI CIRB, etc.).

Effective January 1, 2017, all Montefiore, Einstein and PAGNY employees who participate in clinical research must have certification of completion of GCP training that has been taken or renewed within the past three years in order to submit a protocol to the IRB for review and approval.  This was changed from our previous renewal requirement of 5 years in response to a recent NIH policy on clinical trials (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html).  As a result, if you completed the CITI GCP course prior to January 1, 2017 the 5 year expiration date noted on your completion report is no longer valid and the new expiration date is now 2 years earlier.  

GCP training for investigators and clinical trial staff must be renewed every three years.  You may check the status of your GCP training in CITI by logging into https://www.citiprogram.org.  You may renew your GCP training in CITI at any time by logging into CITI (https://www.citiprogram.org).  When you log onto CITI: 

  • Click on "Add a Course".    
  • Under Question 3 select "Yes, I would like take the Refresher GCP course (I previously completed the Initial GCP course at Einstein. NOTE: Completion of this course does NOT satisfy the Human Subjects Education requirement.)"  
  • If you need assistance with renewing your training, please e-mail iris-support@einstein.yu.edu. 

On September 16, 2016, the NIH announced that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).  A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.   

Investigators and clinical trial staff (individuals, identified by the investigator, who are responsible for study coordination, data collection and data management) on NIH-funded clinical trials must complete this training. This requirement applies to studies reviewed by both the Einstein IRB, and approved external IRBs (e.g. BRANY, NCI CIRB, etc.). 

Do you have an  NIH-funded clinical trial that does NOT involve drugs or devices that was submitted to the Einstein IRB prior to January 1, 2017? 

Please contact the Einstein IRB for guidance on submitting an amendment to update your IRB application so GCP requirements may be automatically checked by the Einstein IRB.

Effective January 1, 2015, all Montefiore, Einstein and PAGNY employees who participate in clinical research (including faculty investigators) must have certification of completion of GCP training in order to submit a protocol to the IRB for review and approval. Please note:

  1. All members of the research team who are identified as key personnel on the protocol’s IRB submission must have GCP certification;
  2. GCP certification from a variety of approved programs* will suffice;
  3. Those who do not have current GCP certification must complete the on-line program offered by the Collaborative Institutional Training Initiative (CITI) provided at no charge to investigators or staff (https://www.citiprogram.org), or one of the other approved courses;

    Note: Effective March 2015, CITI will only support Internet Explorer (IE) 8.0+, or use a current version of Chrome, Firefox, or Safari. Users at Montefiore whose computers only have IE 7.0 or earlier may contact the EHIT helpdesk to request that Firefox be installed on their computers.

  4. Certification of successful CITI GCP course completion will be tracked automatically in iRIS, but if you have completed GCP training with any other approved programs, you will need to submit your completion certificate or other documentation for incorporation into the iRIS database (email to irb@einstein.yu.edu or fax to 718-430-8817);
  5. Satisfactory completion of this requirement will be checked during the submission/review of new studies, amendments, and progress reports.

*Valid GCP certification must have been completed within 3 calendar years of the submission of the new IRB protocol. Any of the following GCP programs will qualify:

  • Collaborative Institutional Training Initiative (CITI);
  • Academy of Physicians In Clinical Research (APCR);
  • FDA Investigator Course;
  • TransCelerate Biopharma, Inc. approved courses;
  • National Institute of Allergy and Infectious Disease (NIAID) Program;
  • GCP courses offered by ACRP or SOCRA.

It is your responsibility to submit proof of valid and current certification by any of these programs (other than CITI certification which is automatically sent to the IRB).

Have additional questions? See our GCP Frequently Asked Questions (FAQ).

 

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