E7-8137. Defining and Implementing Quality in Clinical Investigations: From Design to Completion; Public Workshop; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop; request for comments.

The Food and Drug Administration (FDA) is announcing a public workshop cosponsored with the Drug Information Association (DIA) entitled “Defining and Implementing Quality in Clinical Investigations: From Design to Completion.” The purpose of the public workshop is to solicit constructive information on identifying attributes of quality in clinical investigations, approaches to quality from design to completion, and methods for measuring quality and ensuring data integrity during the conduct of clinical investigations. The public workshop will discuss the definition of quality, mechanisms for implementing quality in clinical investigations, and methods to improve the accuracy and reliability of collected data, which will enhance human subject protection. FDA also is requesting comments on these topics.

Dates and Time: The public workshop will be held on May 10 and May 11, 2007, from 8 a.m. to 5 p.m.

Location: The public workshop will be held at the Washington Marriott Hotel, 1221 22d St. NW., Washington, DC 20037.

Contact Person: Kathleen Donner, DIA, 215-293-5810, FAX: [phone], or e-mail: [e-mail].

Registration: Registration will be accepted by mail, fax, or e-mail until May 10, 2007, and also onsite. Mail, fax, or e-mail your registration information (including name, title, firm name, address, telephone, and fax numbers) to the contact person (see Contact Person). You may also register online at www.diahome.org (“Educational Offerings,” keyword 07013). (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) There is a registration fee for the workshop: $1,165.00 for industry, $475.00 for charitable nonprofit organizations or academia, and $200.00 for Federal Government employees. The registration fees will be used to cover costs of the workshop, including program materials and food.

If you need special accommodations due to a disability, please contact Kathleen Donner (see Contact Person) at least 7 days in advance.

Comments: The deadline for submitting comments regarding this public workshop is July 10, 2007.

Interested persons may submit written or electronic comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

SUPPLEMENTARY INFORMATION:

The purpose of the public workshop entitled “Defining and Implementing Quality in Clinical Investigations: From Design to Completion” is to solicit constructive information on identifying attributes of quality in clinical investigations, approaches to quality from design to completion, and methods for measuring quality and ensuring data integrity during the conduct of clinical investigations.

Over time, clinical investigations have evolved dramatically. In particular, clinical investigations are no longer primarily conducted at a single center; the use of electronic recordkeeping in the studies has increased dramatically; and the conduct of clinical investigations has become more complex. The public workshop will address the challenges of and potential solutions for maintaining quality during the conduct of clinical investigations to protect human subjects. The following topics will be discussed: (1) The definition of quality, (2) mechanisms for implementing quality in clinical investigations, and (3) methods to improve the accuracy and reliability of collected data. As part of the Human Subject Protection/Bioresearch Monitoring Initiative (http://www.fda.gov/​oc/​initiatives/​criticalpath/​ ), this public workshop will help improve the safe conduct of clinical investigations and maximize efficiency in clinical investigations without compromising quality.

Dated: April 23, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.