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NIH Policy on Good Clinical Practice (GCP) Training Required Beginning January 1, 2017

The NIH recently issued a Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials

While IU has an existing training requirement with regard to Good Clinical Practices (http://researchcompliance.iu.edu/hso/hs_inv_req.html), the NIH requirement does differ slightly in regards to scope, affected personnel, and training mechanism.

IU has elected to enforce the NIH training requirement as a condition of IRB approval. Consequently, the IU Human Subjects Office (HSO) will be verifying GCP training completion for applicable personnel on NIH-funded clinical trials during the IRB review process.

Important considerations:

  • The GCP training requirement for NIH-funded clinical trials applies to more study personnel than the existing IU GCP training requirement. In particular, Clinical Trial Site Staff are required to have evidence of GCP training for NIH-funded clinical trials.
  • GCP training for affected personnel on NIH-funded clinical trials may be accomplished by various methods (refer to table below).
  • If the training occurred via a mechanism other than the CITI GCP Course, please provide the documentation of training for each affected individual with the IRB study submission.
  • The HSO will verify training for new and renewing (i.e., continuing reviews of) NIH-funded clinical trials.
  • The GCP training must have been completed within the past 3 years. In other words, GCP training must be renewed every 3 years.

REQUIREMENTS FOR GOOD CLINICAL PRACTICE (GCP) TRAINING
IU Requirements NIH Requirements
Scope Interventional clinical trials, irrespective of funding NIH-funded clinical trials
Personnel - Principal Investigators
- Co-Principal Investigators
- Investigators
- Clinical Trial Site Staff responsible for
the conduct, management, and/or oversight of trials (‘Key Personnel’ as defined by the IU IRB)
Training via CITI GCP Course - Class/course
- Academic training program
- Certification from recognized clinical research professional organization
Refresher requirement 3 years 3 years

Please contact the HSO at irb@iu.edu or 317.274.8289 with questions.

Welcome to the Human Subjects Office

The IU Human Subjects Office is the administrative office that supports the Indiana University Institutional Review Boards (IRBs), which are responsible for the review and approval of all research involving human subjects conducted at IU and its affiliated institutions. The HSO administers the human research protection program (HRPP) at IU. IU’s HRPP, which will include the regional campuses effective July 1, 2015, is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

The HSO includes about 30 staff members who support more than 5,000 active human subjects studies, seven IRBs, and the IRB Executive Committee comprised of Chairs and Vice Chairs of each IRB. HSO staff are experts in human subjects protections, and about half have achieved the Certified IRB Professional certification. Staff are divided into three teams, each of which serves a specific set of IU departments. Each department is assigned to a designated staff member who serves as the main contact for that department. Department/team listings are available in HSO Support Teams.

Please see the links below for more information on how to conduct human subjects research at Indiana University (or an affiliated institution).

Lifecycle Basic Steps

1. Level of review

How to decide if your study needs review and how it should be submitted to the IRB

Learn More >

2. Getting started

Information and preparation needed prior to submitting to the IRB

Learn More >

3. Submission

How to submit a study to the IRB

Learn More >

4. Review

What does the IRB do, and how does the process work?

Learn More >

5. Post-Approval

What happens after my study is approved?

Learn More >
Information for Sponsors Information for Subjects

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