Protocol Templates & Forms - Northwestern University
Consult our Protocol Conversion Guide 11-9-2014 for important information about using templates with new submissions or converting templates for previously approved research. When developing the recruitment sections of your protocols please refer to our Recruitment Materials and Guidelines webpage.
Nov 9, 2014 · The IRB Office has developed three new protocol templates for use by the Northwestern University research community to describe human research activities: • Template Local Protocol Addendum (HRP-503) : This document contains local
Resources & Guidance: Institutional Review Board (IRB) Office ...
Protocol templates and forms are ready-to-use documents that will guide you through the process of writing protocols and other supporting documents for your studies. It is important to use the correct template or form to ensure pertinent information is included.
Modifications - Northwestern University
Making modifications to your current study may require additional changes to study procedures or study documents housed in eIRB+, including the protocol, consent form, and recruitment materials. Only one Modification may be under review …
Reportable New Information (RNI) - Northwestern University
Reference the Study Support Resources page for templates and tools to help maintain compliant research (such as the Protocol Deviation Log and Note to File Template).
Biomedical & Social Behavioral Consent Templates - Northwestern …
If you are planning to obtain online or verbal consent, the end of the social behavioral consent template (HRP-582) has instructions for altering the template for use with online or verbal consent. The Suggested Consent Language webpage has additional template language.
Initial Studies - Northwestern University
The IRB Office has many protocol templates for use by the Northwestern University research community to describe human research activities. You are encouraged to reference the Investigator Manual when developing your protocol.
Checklists & Worksheets - Northwestern University
Study teams are encouraged to review worksheets as they write their protocols to address the criteria for approval but they are not required.
Corrective and Preventive Action (CAPA) Plans - Northwestern …
An example, create and document a process or standard operating procedure (SOP). Then, train on the process, implement the process, evaluate the process, and amend the process as necessary. Consider whether you need to revise the protocol or …
Recruitment Materials & Guidelines - Northwestern University
You will be asked to include a description of your recruitment methods in either the protocol or the local addendum to the sponsor’s protocol. Certain restrictions apply to studies that will use or disclose Protected Health Information (PHI) in the identification and recruitment of participants.