Glenda Guest 2012 - The Investigator Agreement: How and When to Complete FDA Form 1572

If you read FDA warning letters (and you should!), you are aware that the number of citations for failure to correctly complete the required FDA Form 1572 are increasing. An FDA Form 1572 is required for drug or biologic studies conducted under an IND, whether in the U.S. or abroad. Similarly, medical device trials require a signed agreement from each investigator that contains information similar to that requested in the 1572.

There has been long standing confusion and disagreement over who should be listed as a sub-investigator on the 1572. Even experienced clinical investigators continue to struggle with 1572 completion questions and this challenge is further complicated by the growing complexity of clinical trials, which may involve multiple ‘satellite sites’ or distributing other study functions.

Why should you Attend:

There has been long standing confusion and disagreement over who should be listed as a sub-investigator on the 1572. Even experienced clinical investigators continue to struggle with 1572 completion questions and this challenge is further complicated by the growing complexity of clinical trials, which may involve multiple ‘satellite sites’ or distributing other study functions. Learning more about the use of and proper completion of this form will help ensure regulatory compliance with this important document.

Web Seminars Includes:

- Q/A Session with Expert.

- Attendees will get a free document on FDA Guidance document & sample medical device investigator agreement after attending this session..

Areas Covered in the Session:

Review of Frequently Asked Questions from the Guidance and from the GCP Helpdesk web site.

Other regulatory implications for those listed on the 1572 (e.g., Financial Disclosure obligations)

Understanding the intent of the Form 1572

Who will benefit: (Titles)

CRA, monitor

CRC

Research coordinator

Research site administrator

Project manager

Research center

Regulatory compliance managers

Physician investigators

Investigator initiated trial managers

https://compliance2go.com/index.php?option=com_tra...