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Streamlining Study Start-Up and Continuing ReviewTo streamline its submission processes, Quorum has reduced its initial site submission documentation requirements and combined two of its forms into one. Please see below for more information. Decreased Documentation for Site Submissions
Instead, Quorum now requests the key data from these documents on Quorum's Site Information Questionnaire. By eliminating the requirement that these items be submitted separately in hard copy, Quorum expects to facilitate the submission of complete site applications that can be reviewed by the Board without delay. Quorum also no longer requires that sites submit revised 1572's during the course of the study. If your site moves, changes the Principal Investigator, or makes other significant changes we will need more information than is found on the 1572 form. We ask that you report changes as described at: http://www.quorumreview.com/investigators_general_topic.asp#site_changes. As sites will no longer be required to submit the FDA form 1572 Quorum will no longer send acknowledgements for any 1572 forms received. If your site monitor needs documentation of this policy you can print a statement from our website. The statement can be found with our Investigator Frequently Asked Questions under the question, "How do I submit a change of address or a new facility?" Site Status Report You can also find these changes in our online Handbook at www.quorumreview.com. Hard copies of the revised Handbook will be available later in the year. |
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