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)
Research site administrator
Regulatory compliance managers
Investigator initiated trial managers
Glenda Guest is Vice President of Norwich Clinical Research Associates Ltd. (NCRA), a full service Clinical Contract Research Organization (CRO) located in central NY State, USA. She has been involved in regulated research since 1997 and specializes in medical device monitoring and project management; GCP, vendor and third party auditing as well as training on US regulated research and Good Clinical Practice.
Ms. Guest is an active member of the Association of Clinical Research Professionals (ACRP) and is a regular speaker at their local events and global conferences. She has also presented at a number of other industry-related events and enjoys sharing her expertise with colleagues in the clinical research arena.
Ms. Guest has maintained her status as an ACRP Certified Clinical Research Associate since April of 2002. She is also recognized by the Society of Quality Assurance as a Registered Quality Assurance Professional - Good Clinical Practices (RQAP-GCP),having successfully passed the first exam for this designation offered by SQA in April 2007.
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