Please note, several documents are required for upload later in this form, they include:

1. You will need to identify the JHM IRB number of studies for which you served as the Principal Investigator that were subject to FDA inspections. If applicable, you will be asked to upload issued FDA Form 483 with inspection observations.

2. Good Clinical Practice (GCP) training completion certificate. If you have not already completed GCP training, please refer to the Johns Hopkins IRB for information about training requirements and courses. Course options include the JHM IRB certified GCP training, which is located at this link or in myLearning. After logging in, search for the title of the course which is "Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research."

3. Signed letter documenting Department/Divisional leadership approval of your role as Sponsor-Investigator for an IND/IDE. If you are a JHHS-employed part-time faculty, the letter of support must be co-signed by the responsible research lead for the JHHS entity where you hold your primary affiliation. See just below for a draft template.

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