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Protocol templates and common language

Protocol templates

All Massey investigator initiated trials (IITs) with therapeutic or supportive care intent must be written using the appropriate MCC clinical protocol template. Two versions of the template are available, one with language that is needed for a clinical protocol being conducted under an FDA IND, and one without the FDA IND language. Each template is annotated throughout with prompts for required elements as well as with the ICH GCP guidelines for reference purposes. In addition, each template is also available without annotation for those investigators who would prefer to work with a “clean” template. The current VCU IRB Biomedical Consent Template is also appended to each of the clinical protocol templates for use as a model informed consent template.

IIT Clinical Protocol Template, Without IND Required Language, Annotated
IIT Clinical Protocol Template, Without IND Required Language, Not Annotated
IIT Clinical Protocol Template, With IND Required Language, Annotated
IIT Clinical Protocol Template, With IND Required Language, Not Annotated
Protocol Template Usage Guide

Frequently used tables

The following tables are pre-formatted and can be cut and pasted easily into a protocol template. The tables are revised as needed to keep them current.

Cardiac Status Grading Criteria
Child-Pugh Grading Scale for Liver Disease
ECOG (Zubrod) Performance Scale
IPS Scoring System for MDS
Karnofsky Performance Scale
Lansky Play Performance Scale for Children
Lymphoma – Revised Response Criteria
Menopausal Status Determination
P450 Inhibitors and Inducers
RECIST – Overall Response Evaluation Tables
Torsades de Pointes – Drug Risk List (updated 07/15/2013)

Eligibility guidelines

The following document provides some simple guidelines to facilitate the writing of eligibility criteria.

Eligibility Criteria Guidelines

Scientific writers

Two scientific writers with extensive experience in writing clinical trial protocols are available to assist Massey investigators with the writing, editing, and formatting of their cancer-related protocols. Investigators are encouraged to engage the scientific writers early in the protocol development process.