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Mandatory training and education for NICHD Clinical Investigators
The Office of the Clinical Director has instituted a formal program of mandatory training and education for NICHD clinical investigators. This program involves training in Good Clinical Practice (GCP), covering the scientific and ethical standards of human subject research, including FDA and HHS policies, guidelines, and regulations. In addition, PowerPoint slide presentations and other new information relevant to clinical research compliance will be distributed regularly to NICHD clinical investigators and protocol study staff. The Office of the Clinical Director maintains documentation of completion for the training and education. Continued participation in the NICHD Intramural Clinical Research Program is dependent on fulfilling these training activities.
Required of all NICHD PI’s and AI’s:
GCP training modules: This course is offered on-line through NIAID (http://gcplearningcenter.niaid.nih.gov). Individuals taking this course should sign in as a NIAID collaborator, as NIAID has opened this course to our institute. Please use Internet Explorer. Once completed, please email to Maryellen Rechen in the OCD office the certificates of completion for the 4 course modules.
As part of the continuing education program for NICHD clinical investigators, review of the following:
- Updated - 21 CFR Part 312 - FDA Safety Reporting Requirements for INDs
- Understanding Unanticipated Problems
- FDA Sponsor and Investigator Checklist
- FDA Guidance for Safety Reporting (Optional)
For viewable copies of these presentations, go to the Office of the Clinical Director’s Mandatory Training page.
Please send the documentation of this review to Maryellen Rechen (firstname.lastname@example.org) in the OCD office by emailing the following: "I reviewed the information contained in the (state the name of the educational reading/power point) on (enter date), and I understand the implications for my clinical research activity. I have retained an electronic or hard copy for my records."