Dear Gene Therapy Investigator:

As you are aware the FDA is requiring archiving of clinical samples from all patients enrolled in gene therapy trials using retroviral or other integrating vector systems. To aid investigators in this effort, Indiana University was asked to establish a National Resource for archiving and clonality testing of samples. This Sample Repository operates through the existing NCRR-supported National Gene Vector Laboratory program.

Samples will be bar-coded and entered into the repository tracking system. DNA will be prepared and aliquoted for testing, archiving and back-up. For samples that are found to contain a predominant clone, notification will be sent to the investigator with the appropriate testing recommendations.

While the subjects submitting samples to the archive are part of a research protocol, the act of archiving or performing an FDA required test is not a research activity. The samples will remain the property of the investigator and will not be available to Indiana University or others for testing without written direction from the investigator (or their institutional designee). As Indiana University will not be performing analysis of insertion sites or other research questions, we believe that archiving and clonality testing can be performed in conjunction with the investigators protocol and does not require review at our institution. Therefore, we do not intend to obtain permission from the Indiana University, Investigational Review Board (IRB) as we are providing a laboratory service.

We will require that investigators submitting samples provide written assurance that the subject has been informed that samples are being archived in compliance with FDA regulations. The disposition of sample once submitted will be solely at the discretion of the submitting investigator or their institutional designee. If research questions arise that require access to archived samples, the samples will only be released to the submitting investigator or the institutional designee. It will be the responsibility of the investigator and their institution to insure proper compliance with institutional regulations concerning human research subjects.

We look forward to working with you to facilitate compliance with federal regulations in an attempt to insure the safety of research subjects.

Sincerely,

Kenneth Cornetta, M.D.
Joe C. Christian Professor and Chairman
Department of Medical and Molecular Genetics Coordinating Director, National Gene Vector Laboratories (NGVL)

Please follow the instructions below and then download and complete the submission and request forms given in PDF format.

INSTRUCTIONS/NOTE REGARDING THE SAMPLE SUBMISSION AND REQUEST FORMS:

The forms you are about to download are in the PDF format. You must have the Adobe Acrobat Reader installed on your computer in order to open the forms. Get the Adobe Acrobat Reader here if you do not already have it.

• Once the form is open it can only be filled out on the computer (you can't print the form and fill it out).
• All required fields must be filled in order to print the form.
• You must use the print button on the form (using any other method to print the form will result in blank pages).
• Patient information will not appear on the printed form but it must be filled in.
• The person who completed the form must sign as indicated and mail to the address on the form as indicated.
• The form will contain a barcode when printed. Do NOT deface the bar code in any way. If the barcode is defaced/damaged or does not print clearly (i.e. printer ink is low/clogged), print another form.
• Once filled out, the data in the form will NOT be saved. If you save the form on your computer it will NOT contain the data. Be certain to keep a copy of the printed form for your records.
• The form may be printed on any type of printer but do not use "low", "economy" or "draft" mode print settings. Default quality settings should be adequate.

In order to request material from a sample previously submitted, download and fill out the sample request form according to the instructions. Fill out one form for each sample requested.
Click here to download the IUVPF Sample Request Form

In order to submit a new sample to the repository, download and fill out the sample submission form according to the instructions. Fill out one form for each sample submitted.
Click here to download the IUVPF Sample Submission Form