On Monday, November 23, 2015, The CITI Good Clinical Practice Course for Clinical Trials Involving Investigational Medical Devices was retitled The CITI Good Clinical Practice Course for Clinical Investigations of Devices.
The titles of the modules have also been revised (see chart below for the previous module title and the revised module title). The module ID numbers have not been revised, since the content remains the same.
|Current Title||Revised Title||Module ID|
|The CITI Good Clinical Practice Course for Clinical Trials Involving Investigational Medical Devices (ID: 14633)||The CITI Good Clinical Practice Course for Clinical Investigations Involving Devices||14633|
|Overview of U.S. FDA Regulations for Medical Devices (ID: 14637)||Overview of U.S. FDA Regulations for Investigational Devices||14637|
|Investigator Obligations in FDA-Regulated Clinical Research of Devices (ID: 14635)||Investigator Obligations in FDA-Regulated Clinical Investigations of Devices||14635|
|Conducting Investigator-Initiated Clinical Trials of Devices (ID: 14634)||Conducting Investigator-Initiated Clinical Investigations of Devices||14634|
|Managing Investigational Devices According to GCP Requirements (ID: 14636)||Managing Investigational Devices According to GCP Requirements||14636|
|Informed Consent in Clinical Trials of Devices (ID: 14638)||Informed Consent in Clinical Investigations of Devices||14638|
|Monitoring Clinical Trials of Devices (ID: 14639)||Monitoring Clinical Investigations of Devices||14639|
|Audits and Inspections of Clinical Trials of Devices (ID: 14640)||Audits and Inspections of Clinical Investigations of Devices||14640|
|Reporting Requirements for Device Studies (ID: 14641)||Reporting Requirements for Clinical Investigations of Devices||14641|
|Completing the CITI GCP Course||Completing the CITI Program’s GCP Course for Clinical Investigations of Devices||14642|
Why is the CITI Program revising the titles?
The titles are only being revised to reflect how federal regulations and international standards refer to investigations of devices. For example, the U.S. FDA regulations at 21 CFR 812 refer to device research as “clinical investigations of devices,” and the International Organization for Standardization Guidelines ISO 14155:2011 about device research is entitled “Clinical Investigation of Medical Devices for Human Subjects.”
Key points about this change:
- The content of the modules is not being revised
- The module ID# is not being changed
- This is not a module swap-out
- The course was previously revised to contain information about both U.S. FDA regulations and international standards (revised in 2015)
Please contact the Help Desk if you have any questions.