Protocol & Consent Writing Assistance

Free Consultations Available:  Protocol Development, Statistical Plans, Data Management

Protocol Builder Assistance

Guidance for answering questions in protocol templates developed by Protocol Builder

Protocol Templates (Required for studies in which the UVA PI will be the overall PI of a multi-site study)

Lay Terminology
Radiation Risk Language

Learning Shots

Background Information


Free Consultations Available:  Protocol Development, Statistical Plans, Data Management

Free consultations are available for protocol development, statistical plans and data management from Public Health and Sciences @ the Library

Protocol Builder Assistance

Protocol Builder is an online program that must be used by investigators who wish to submit a new study to the IRB-HSR that meets the criteria for review by any of the following review types: full board, expedited, exempt or non-engaged.  For additional information on review types see:  Submission Types.   Protocol Builder will asks a series of questions which it uses to build the templates for the protocol and consent form that are specific to the study.

If you need additional assistance with the Protocol Builder Program, please
contact IRB-HSR Staff

Guidance for answering questions in protocol templates developed by Protocol Builder

Examples of how to answer the following questions may be found by clicking on the question below.

Protocol Templates (non-oncology)

If you are writing a protocol that will serve as the protocol for a multi-site study, we strongly suggest you use one of the templates below to write the protocol.  The template provided by Protocol Builder will not be accepted by the IRB-HSR.  

Protocol Templates (oncology)

If you will be the PI of an oncology protocol (single site or multi-site), please use one of the templates on the PRC website: https://med.virginia.edu/cancer-research/research-resources/office-of-clinical-research/protocol-review-committee/. If you are required to use an alternative template (e.g.,  by a funding source), please check with the Protocol Development Team (Protocol Development Team - UVA Comprehensive Cancer Center (virginia.edu)) before getting started.

The IRB protocol template provided by Protocol Builder does not address all of the sections that are required for PRC review and should not be used for oncology protocols.


 

Learning Shots

Lay Terminology

Radiation Risk Language