IND/IDE/CTA Sponsor Training

As of July 2016, all Perelman School of Medicine (PSOM) Sponsors of INDs, IDEs, or Comparable International Regulatory Filings (CTAs) are required to complete Sponsor Registration as outlined in the following SOP006. In addition, Sponsors are required to complete Sponsor training.

First, please register your protocol.

Investigational New Drug (IND) Sponsor Training 

The first step in training for IND sponsors is to take the online IND Sponsor Training module via the Workday Learning system. This training includes an introduction to basic terms, sponsor responsibilities, vendor qualification and financial and is to be completed prior to in-person training. 

As a follow up to the online training, an in-person training is available to address any questions and to provide additional training as needed based on  the sponsor’s experience and the specific IND. The Office of Clinical Research will contact the Sponsor to schedule this training, but the sponsor may also email the Office of Clinical Research to schedule as well.

Investigational Device Exemption (IDE) Sponsor Training

The first step in training for IDE Sponsors is to take the online IDE Sponsor Training module via the Workday Learning system. This training includes an introduction to basic terms, sponsor responsibilities, vendor qualification and financial information and is to be completed prior to in-person training. 

As a follow up to the online training, an in-person training is available to address any questions and to provide additional training as needed based on the Sponsor’s experience and the specific IDE. The Office of Clinical Research will contact the Sponsor to schedule this training, but the Sponsor may also email the Office of Clinical Research to schedule as well.

Comparable International Regulatory Filing (CTA) Sponsor Training

Training for Clinical Trial Application Sponsors (sponsors of international clinical trials using investigational products) is conducted in person by the Office of Clinical Research. Once the study is registered, the Office of Clinical Research will contact the Sponsor to schedule this training. The Sponsor may also email the Office of Clinical Research to schedule as well.