Prospective Clinical Trials Involving the Consent Process: Study Personnel Education/Training

All personnel involved in research with human subjects must complete the following: 

Link to CITI website

            CITI Course in the Protection of Human Research Subjects

                        Human Subjects Training

                        To access the “Biomedical Course” choose group 1 under question 1

                        To access optional courses (Good Clinical Practice and ICH”, Responsible conduct of Research) choose the course(s) you would like to take under Question 3.

                        Lab Animal Welfare Training

                        From Question 2 please select “Working with the IACUC” as well as the appropriate courses relevant to the species you are working with

Link to complete set of instructions

Link to  “Linking training and credentials to IRBNet”

This section should include a copy of your signed and up to date CV (within 2 years), medical/nursing license and a copy of your CITI completion certificate and documentation of any training required by the sponsor.  BMC requires renewing CITI training every 3 years.

Link to FDA Investigator Responsibilities Guidance

All personnel involved in research with human subjects must complete the following: 

CITI Course in the Protection of Human Research Subjects (CITI website)

1. Human Subjects Training

• To access the “Biomedical Course” choose group 1 under question 1
• To access optional courses (Good Clinical Practice and ICH”, Responsible conduct of Research) choose the course(s) you would like to take under Question 3.

2. Lab Animal Welfare Training

• From Question 2 please select “Working with the IACUC” as well as the appropriate courses relevant to the species you are working with
• This section should include a copy of your signed and up to date CV (within 2 years), medical/nursing license and a copy of your CITI completion certificate and documentation of any training required by the sponsor.  BMC requires renewing CITI training every 3 years.

Links

• FDA Investigator Responsibilities Guidance