References: Protocol Templates

Standard Templates
Standard protocol templates provided by the Cancer Center PRC.
Multisite: Process Flow Overview
Overview of the CTO multi-site coordination process.
Multisite: Clinical Monitoring Procedure
Template language for clinical monitoring utilizing CTO Multi-site services.
Multisite: Data Management Procedures
Template language for Data Management procedures utilizing CTO Multi-site services.
Multisite: Data Safety Monitoring Procedure
Template language for data and safety monitoring utilizing CTO Multi-site services.
Multisite: Serious Adverse Event Reporting
Template language for SAE reporting procedures utilizing CTO Multi-site services.
Multisite: Quality Assurance and Audits
Template language for quality assurance and audits utilizing CTO Multi-site services.
Multisite: Screening and Enrollment Procedures
Template language for screening and enrollment procedures utilizing CTO Multi-site services.

References: Regulatory

IDS: Investigational Drug Services
The goal of the IDS is to ensure that investigational drug studies and other drug related research at the Hospitals and Clinics are conducted in a safe and efficient manner.
FDA: Food and Drug Administration
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
GCP: Good Clinical Practice in FDA-Regulated Clinical Trials
Information on the GCP issues arising in human research trials regulated by the FDA.
HIPAA: Health Insurance Portability and Accountability Act
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules 
ICH: International Conference on Harmonisation
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
UMHS Regulatory Affairs Office
UMHS Regulatory Affairs facilitates the prevention/resolution of concerns/disputes/compliance issues related to laws, regulations, institutional policies, accreditation/certification requirements, that impact the activities/reputation of the Med School.

References: Clinical

CTEP's Common Terminology Criteria for Adverse Events and Common Toxicity Criteria
UMHS Medical Abbreviation Listing
Health Information Management's approved medical record abbreviations.
Michart 21 C.F.R. Part 11
UMHS Compliance Checklist for 21 C.F.R. Part 11 – FDA Electronic Records Closed Systems and Electronic Signatures Standards
UM Medical Equipment
UM Medical Equipment Management Plan
ECG Manual
ECG Manual GE Healthcare MAC1200
Urinalysis (Dip)
Urine result comparison with AX sticks and Trace 4+ (+,++,+++)
ECHO, Lower limit of normal documentation for the LVEF for research reporting purposes
INR Normal range documentation for research reporting purposes
UMMS Research Biorepositories Policy
University of Michigan Medical School (UMMS) Policy Governing Tissue Sample Collection, Ownership, Usage, and Disposition Within All UMMS Research Biorepositories
Response Criteria for Lymphoma
This article is reference for response criteria for lymphoma: Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86
RANO Criteria
Response Assessment Criteria for High-Grade Gliomas

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