IND/IDE/CTA Sponsor Registration and Training

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

First, please complete Sponsor Registration online here: http://tinyurl.com/z7frse6.

Investigational New Drug (IND) Sponsor Training 

The first step in training for IND Sponsors is to take the online IND Sponsor Training module via KnowledgeLink here.  This training includes an introduction to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP) and is to be completed prior to in-person training.  We recommend you log in to Knowledgelink before clicking the link to the learning module.

The second step in training is for the Sponsor to complete in-person IND training. In-person training will be tailored to 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 contact OCR to schedule as well.

Investigational Device Exemption (IDE) Sponsor Training

The first step in training for IND Sponsors is to take the online IND Sponsor Training module via KnowledgeLink here .  This training includes an introduction to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP) and is to be completed prior to in-person training.  

We recommend you log in to Knowledgelink before clicking the link to the learning module.

The second step in training is for the Sponsor to complete in-person IDE training. In-person training will be tailored to 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 contact OCR to schedule as well.

 

Comparable International Regulatory Filing (CTA) Sponsor Training

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