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8.5 Noncompliance by the IRB or Other Components of the HRPP

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

1.0 Purpose The purpose of this policy is to describe the process for reviewing and reporting incidents of noncompliance by the IRB and/or other components of the HRPP. 2.0 Policy It is the policy of the Organization that: 2.1. Reports of noncompliance wi...

8.6 Study Hold, Suspension, and Termination

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

1.0 Purpose The purpose of this policy is to describe the process for study holds, study suspensions, and study termination. 2.0 Policy It is the policy of the Organization that: 2.1. The ORA has the authority to accept a study hold imposed by the PI, spo...

8.7 Reporting Incidents to Institutional Officials and Federal Agencies

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements to ensure prompt reporting of incidents to Institutional Officials, Federal Agencies (including OHRP and FDA) and other Common Rule Departments and Agencies, and to AAHRPP. ...

Table of Contents

HRPP Policies and Procedures

Section 1: General Human Research Protection Program Polices 1.1 Human Research Protection Program 1.2 Authority Granted by the Organization 1.3 UNMC Serving as Central IRB 1.4 UNMC Ceding Review to an External Central IRB 1.5 Requirements for Research Co...

Administrator Billing Statement View

Core Facilities Billing

Administrator Billing Statement Access By default, only those with a role in the service may access billing statements. However, there are a number of instances where a lab manager or administrator may need documentation for ledger transactions. This can be...

Billing Statements and Invoices

Core Facilities Billing

Introduction An invoice for services provided within UNMC are called "billing statements." Traditional invoices are only sent to core facility customers who are not internal to UNMC. Core facilities use an automated process for billing that is completed onc...

About

Core Facilities

About this Guide This user manual and application guide was developed by the Office of the Vice Chancellor for Research for Core Facility users and administrators. Sections in this guide may apply only to people with elevated permissions in the Research Supp...

View the Instrument Schedule

Core Facilities Instrument Scheduler

Introduction The Instrument Scheduler (IS) is a powerful tool that allows researchers and core facility staff to view, create, and manage appointments for machines and instrumentation. View the Schedule To view the schedule for an instrument, access the "...

Create and Update Appointments

Core Facilities Instrument Scheduler

Creating Appointments To create a new appointment on an instrument, access the "CORE" tab in the RSS. Under "Scheduling," select "Instrument Scheduler." Follow the instructions in the view schedule section to navigate to the date you'd like to create the app...

View the Project Tracker

Core Facilities Project Tracker

Introduction The Project Tracker allows core facilities to initiate, monitor progress, and bill research projects that have many steps, use multiple instrument, or that take a longer length of time than can be captured in the instrument scheduler. Researcher...

Introduction

Internal Competitions

For assistance outside the scope of this manual, contact the UNMC NURamp Support Team by email at nuramp-support@unmc.edu. About Internal Competitions Internal Competitions is a module in the NURamp application which can be accessed at nuramp.nebraska.edu. ...

Alternate Approvers

Internal Competitions Accounts and Access

About Alternate Approvers NURamp allows users to delegate other users as their signatory in the form routing process. If you will need another person to electronically sign forms in NURamp on your behalf, add them as an alternate approver. If you will need ...

NURamp Assistants

Internal Competitions Accounts and Access

About NURamp Assistants NURamp allows you to designate other users as "assistants" who will have access to your forms. Access can be granted on a per-module basis, or you can grant an assistant access to all modules. NURamp Assistants have full access to th...

Create New Application

Internal Competitions Applications

Creating the application form There are multiple ways to create a new Internal Competitions application form. This guide will outline the most descriptive method to follow and provide shortcuts below. Step by StepFirst, access the Internal Competitions mo...

Manage Existing Application

Internal Competitions Applications

Attach Files Most NuRamp applications will require additional information to be added to a proposal or review in the form of an attachment. NuRamp accepts files with the following formats: .docx, .doc, .csv, .xls, .xlsx, .jpg, .png, or .pdf. File Upload Fi...

Completing an Application

Internal Competitions Applications

Introduction To complete an application, principal investigators, their collaborators, and assistants may enter the project details into the form fields. This includes the project details, budget, and goals. Each page of the application form has a progress ...

Completing a Review

Internal Competitions Reviewing Applications

Complete Review Assessment After accessing a review request from your system inbox, the review management page will display for the application you've selected. Read the instructions provided in the gray text box for specific review requirements for the comp...

Accessing Reviews

Internal Competitions Reviewing Applications

From time to time, you may be asked to serve on a review committee for an internal competition. When the application is ready for review in the NURamp system, you will receive an email indicating that applications are ready for your review. Log in to the NUR...

6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use

HRPP Policies and Procedures Section 6: FDA Regulated Research/Drugs...

1.0 Purpose 1.1. The purpose of this policy and procedure is to describe the requirements for utilization of an investigational drug or device (test article) for treatment use. This applies to expanded access for individuals or groups of patients with serious...

Login & Access Requests

Core Facilities

Federated Access Users from University of Nebraska institutions may log in to the UNMC Research Support Services application to schedule core services and view billing statements. Click the appropriate logo for your institution of the Research Support Servic...