We thank you for your interest for inclusion in our ever growing network of highly qualified and enthusiastic clinical investigators. Sponsors/CROs demand highly capable and qualified Principal Investigators and we must therefore insure that the physicians we welcome to our network encompass those criteria. Below are some basic minimal requirements we require in those Investigators and Sites seeking to participate in our network:

• PI must provide a copy of current CV and medical license.
• PI must not have been debarred or currently under investigation by FDA or any medical licensure board or have any limitations placed on his/her ability to practice medicine.
• Understands the role and responsibilities of a PI and is willing to undertake such responsibilities (provided by MCRCA) as well as a working knowledge of Good Clinical Practices.
• If PI or study site has been audited by the FDA, a copy of FDA Form 483 must be provided.

Site Requirements:

• Dedicated exam rooms.
• Dedicated office for MCRCA staff and study related files.
• Locked and limited access drug and supply storage facilities.
• Basic lab and equipment facilities for specimen and diagnostic collection. All lab and equipment facilities must be calibrated and certified as required by law.
• Refrigeration and freezer capabilities or accessibility specific to the needs of the study drug.
• Prefer a dedicated area for storage of study binders that has limited access and is secure.
• Dedicated area for Sponsor monitoring visits that is well lit , comfortable and appropriate for monitoring staff.
• Assign a dedicated staff person to be trained as the Study Coordinator.
• Assign a dedicated lab technician to conduct study related lab requirements for all assigned studies
• Maintain a system for quickly identifying patients by diagnosis or condition (preferable a dedicated staff member who could conduct chart reviews during pre-screening/screening process for qualified patients).

In an effort to better understand your qualifications, capabilities and interests, we ask that you fully complete and submit a Site Information Form. Upon our receipt and evaluation of your information, we will follow up with you to discuss your inclusion in our network.

The site information form can be downloaded as a MS word document or a PDF file, click your preference to download.