Dear Drs. <XXX>,

As the copyright holder of an important assessment instrument <instrument name> used in clinical trials, we request your permission to represent your instrument in an industry standard metadata format that has been defined by the Clinical Data Interchange Standards Consortium (CDISC), a non-profit standards organization( CDISC works with the FDA, US National Institutes of Health (NIH), and global organizations conducting clinical research to represent data collected in clinical trials in a standards format that can be more consistently analyzed and reviewed. Your consent and participation in this process will ensure that when incorporated in future clinical trials, your instrument is accurately and efficiently represented in a CDISC standard format. Please note that you and all instrument owners will maintain full copyright status when granting this permission to CDISC. The National Cancer Institute Enterprise Vocabulary Services (NCI-EVS) maintains CDISC controlled terminology as part of NCI Thesaurus.

We want to emphasize that having your instrument available in CDISC standard format will not in any way affect your licensing fees or procedures. In fact, we expect that making your instrument compatible with our standards could increase its use, especially for clinical trials that are being submitted to the FDA and conducted by research institutions.

CDISC standards for your instrument will include standardized variable names and controlled terminology for database values. If agreeable we would also like to include an annotated Case Report Form version of your instrument. This information will be maintained on the CDISC website where you may access it directly.

We hope that you will agree to work with us so your instrument can provide even greater value to medical research for the development of new therapies and help patients in need. We would appreciate your response by <month, day> so we can determine when to include this into our future development schedule. Please do not hesitate to contact us if you have any questions or would like to discuss this request and opportunity further.

With best regards,

Bernice Yost

CDISC

610-827-1368 office

610-420-0331 mobile

If agreeable please return one copy of this document with your signature indicating approval.

Printed Name:______

Signature:______

Date:______

401 W. 15th Street, Suite 975

Austin, TX 78701 USA