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Clinical Research Curriculum Certificate (CRCC) - NIH ONLY

The NIH Office of Clinical Research Education and Collaboration Outreach will issue a formal certificate to those successfully completing the required components of the following Clinical Research Curriculum. This program is currently only open to those employed at the NIH in Maryland (as staff, trainee or contractor).

The Clinical Research Curriculum Certificate (CRCC) program was developed for individuals engaged or interested in clinical or translational research. Participants will acquire in-depth knowledge of clinical trial design, ethical concerns and human subject protections, regulatory aspects of clinical research, and responsibilities of the clinical investigator.

To Receive a Clinical Research Curriculum Certificate

REQUIRED Regular Certificate	OPTIONAL Certificate with Commendation
Complete all of the following components of the CRCC: A. Introduction to the Principles and Practice of Clinical Research course with a passing score (80% or greater) on final examination. B. Successful participation in the Ethical and Regulatory Aspects of Clinical Research course by completion of 6 out of 7 quizzes. C. Successful completion of specific modules in the Good Clinical Practice Course (US FDA Focus) of the NIH CITI Training: CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Devices Conducting Investigator-Initiated Studies According to FDA Regulations and GCP Investigator Obligations in FDA-Regulated Research Audits and Inspections of Clinical Trials Detecting and Evaluating Adverse Events D. Attendance at an IRB meeting as a guest observer. With the permission of the IRB, you will be provided copies of the new protocols and consent forms to review prior to the meetings to provide a better understanding of the issues under discussion by the IRB while maintaining confidentiality. To set up your attendance at an IRB meeting as a guest observer, please contact Rebecca Hwang at crcc@mail.nih.gov.	Complete all required components of the CRCC and at least one of the following elective components: A. Principles of Clinical Pharmacology course with a passing score (70% or greater) on final examination within the last 2 years. B. Successful completion of an FAES course in statistics or epidemiology in the last 5 years, verified by an unofficial transcript showing no withdrawal or drop of the course.
All components must be completed within the last 2 years. Completion of the above must be confirmed by certificates and/or other documentation. Please email proof of completion to crcc@mail.nih.gov.	Completion of the above must be confirmed by certificates and/or other documentation. Please email proof of completion to crcc@mail.nih.gov.

REQUIRED

Regular Certificate

OPTIONAL

Certificate with Commendation

Complete all of the following components of the CRCC:

A. Introduction to the Principles and Practice of Clinical Research course with a passing score (80% or greater) on final examination.

B. Successful participation in the Ethical and Regulatory Aspects of Clinical Research course by completion of 6 out of 7 quizzes.

C. Successful completion of specific modules in the Good Clinical Practice Course (US FDA Focus) of the NIH CITI Training:

CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Devices
Conducting Investigator-Initiated Studies According to FDA Regulations and GCP
Investigator Obligations in FDA-Regulated Research
Audits and Inspections of Clinical Trials
Detecting and Evaluating Adverse Events

D. Attendance at an IRB meeting as a guest observer. With the permission of the IRB, you will be provided copies of the new protocols and consent forms to review prior to the meetings to provide a better understanding of the issues under discussion by the IRB while maintaining confidentiality.

To set up your attendance at an IRB meeting as a guest observer, please contact Rebecca Hwang at crcc@mail.nih.gov.

Complete all required components of the CRCC and at least one of the following elective components:

A. Principles of Clinical Pharmacology course with a passing score (70% or greater) on final examination within the last 2 years.

B. Successful completion of an FAES course in statistics or epidemiology in the last 5 years, verified by an unofficial transcript showing no withdrawal or drop of the course.

All components must be completed within the last 2 years. Completion of the above must be confirmed by certificates and/or other documentation. Please email proof of completion to crcc@mail.nih.gov.

Completion of the above must be confirmed by certificates and/or other documentation. Please email proof of completion to crcc@mail.nih.gov.