All adult Cooperative Group regulatory submissions (excluding STAR, SELECT, BCPT, PCPT, and GOG-0190) must be faxed or mailed to the CTSU Central Regulatory Office located in Philadelphia. The CTSU and the Adult Cooperative Groups have developed a central repository for Cooperative Groups' regulatory documents. The submission of data to the CTSU Central Regulatory Office will streamline the process for all Adult Cooperative Groups members who currently provide regulatory documentation to several addresses, depending on their group affiliations.

The CTSU Regulatory Office not only offers a centralized storage facility for regulatory documents, but also a point-of-entry for pre-established regulatory document data points to be entered into the RSS database. These pre-established data points listed below will ensure accuracy and increase the integrity of data when entered into the RSS system.

In order to capture the necessary data points that are routinely submitted on regulatory documents into an organized and sequential format, the IRB Certification Form was developed for entering data. The CTSU Regulatory Office at the Coalition strongly recommends that adult Cooperative Group sites utilize this form to ensure the accuracy and integrity of data keyed into the RSS database. The following data points will be captured on this form for accuracy:

• Protocol Number
• Protocol Version Date (required for amendments)
• Protocol Title
• Institution Name(s)
• NCI Institution Code
• OHRP Assurance Number
• Principal Investigator
• NCI Investigator Number
• Review Type (original, amendment, renewal)
• Approval Type (full, expedited, facilitated)
• Date of Local IRB Review
• IRB Number
• Expiration Date
• Comments