Submitting a Study

Studies for review may be submitted via electronic mail (e-mail), via fax, FedEx, UPS, DHL, or via the United States Postal Service.

E-mail address: rclunie@asentralirb.com

Fax: 978-462-6416

Mail: Asentral, Inc. IRB
       15 Main Street, Suite 203
       Salisbury, MA 01952
       978-462-6415

Required information and forms to be included in your IRB submission packet include the following:

	ASENTRAL Institutional Review Board STUDY APPLICATION FORM (Note: application forms may be accessed from the Home Page and clicking on the FORMS button or by clicking on this link: FORMS)
	The Investigational Drug Brochure or Package Insert
	The Study Protocol (2 copies)
	The Informed Consent Form(s) (hard copy and electronic-Microsoft Word compatible)
	Proposed Subject Information (if any)
	Copy of the signed Form FDA 1572 or Investigator Statement
	Satellite Site Application(s) for each site listed in section #3 of the Form FDA 1572 (if applicable)
	Shipping and Invoicing Information Form
	Proposed Advertising/Recruitment material (if any)
	Any patient instructions, medical device user manuals, patient diaries or any other forms designed to be used by patients during the study
	Curriculum vitae (CV) of the Principal Investigator and all Sub-Investigators (CV’s must be current within 1 year, include any medical license information, research license information, and be signed and dated). Massachusetts sites please include the Massachusetts Research Registration Number from the Department of Public Health for the Principal Investigator The Board will send all original correspondence to the Principal Investigator. Upon written request, Asentral IRB will provide a copy of the approval documentation directly to the Sponsor/CRO/SMO managing the study.