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ACRIN Biospecimen Application Review Process Overview

This document outlines the step-by-step process of the ACRIN Biospecimen Application Review, led by Rosa Medina. It details the pre-application phase, including revisions requested by the Ad Hoc Review Committee, the review timeline, and the submission of the full application by investigators. The process also covers the roles of the Review Committee in scientific assessment and biostatistics, approval notifications, and the logistical review by the Data Access Committee. Lastly, the document highlights data management and eventual mailing of samples to principal investigators.

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ACRIN Biospecimen Application Review Process Overview

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  1. NLST ACRIN Process Model for Biospecimen Application Review ACRIN | Rosa Medina Receives PRE-Application Week 0 REVISIONS REQUESTED * Ad Hoc Review Committee constituted Review Committee Preliminary scientific review Biostatistics Determine adequacy of specimen numbers & costs ACRIN | Rosa Medina Forwards results of PRE-Application review to investigators Week 8 Investigators Submit FULL application Week 12 RC Scientific Review | Forward decision to Rosa Medina APPROVED NOT APPROVED Rosa Medina Forwards Scientific Review to ACRIN Data Access Committee (DAC) Rose Medina Notify PI | Forward RC comments DAC Logistical Review REVISIONS REQUESTED * Rosa Medina Forwards decision and review comments to investigator Investigator Signs Material Transfer Agreement Week 26 Statistics Identify the samples Week 30 Biorepository Mails samples to PI | Update database Week 38 * In most instances, the revised application will be considered at the time of resubmission for the same application cycle

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