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Applications

CERVANT
CTO's custom reporting application on clincial trials.
RETA
RETA is utilized to track staff effort and manage personnel resources on CTO coordinated trials.
Velos
Velos eResearch is the primary clinical trials management system for the CTO.

Applications - Assistance

EMERSE: Access Request & Training Video
EMERSE (Electronic Medical Record Search Engine) enables users to search across the free text (e.g., dictated or typed) clinical notes from our electronic health record system, including both CareWeb and Michart documents (as well as radiology, pathology,
EMERSE / i2b2 Research Account Request Form
EMERSE / i2b2 Research Account Request Form

Committees

Cancer Center Committees

PRC: Protocol Review Committee
The PRC provides peer review of the scientific merit, prioritization and progress of all cancer clinical research to be conducted at the Medical Center. Make sure to log into your UofM google acount. Example: uniqname@umich.edu
DSMC: Data and Safety Monitoring Committee
The DSMC monitors the data integrity and patient safety of appropriate research protocols. Make sure to log into your UofM google acount. Example: uniqname@umich.edu

CTO Committees

Great Committee
Clinical Trials Office Recognition Committee
Mentors
Clinical Trials Office Mentorship Committee

Department Documents

CTO Fax Coversheet
CTO fax form that should be used for all faxes.
CTO Leave Request Process
The process in order to request and record leave requests
CTO Letter Head
CTO Letter Head Electronic Template
CTO Map and Directions
Map and directions for CTO visitors.
CTO Memo Form
CTO memorandum form that should be used for all memos.
CTO Organizational Chart (Overview)
Organizational structure of the Clinical Trials Office.

Job Descriptions

Core Staff
Job descriptions

Newsletters

O-CTSU Times - January 2017
In this issue: New Staff and Kids at Work
CTO Times, July 2015
In this issue: Physicians, Managers and Kids ….
CTO Times, April 2015
In this issue: A Look Behind, A Look Ahead and Neoplaasms ….
CTO Times, January 2015
In this issue: Mhealthy, CRC-Data, Photos, etc…
CTO Times, August 2014
In this issue: Mystery, Mhealthy, & Munchkins
CTO Times, April 2014
In this issue: Everything changes, nothing looks the same …
CTO InSite, June 2013
In this issue: CTO Staff change roles and we welcome in the next generation
CTO InSite, December 2012
In this issue: Mentors launch Resident Experts and Janet Retires
CTO InSite, October 2012
In this issue: Wall of Health and New Additions
CTO InSite, May 2012
In this issue: SOCO, Study and Goslings?
CTO InSite, March 2012
In this issue: Appreciation and Recognition
CTO InSite, January 2012
In this issue: Quality Team, Mhealthy Program, Great and More ….
CTO InSite, November 2011
In this issue: Research Palooza, Open Houses, Moustaches and more….
CTO InSite, August 2011
In this issue: Quack Squad, Kit Magic,…
CTO InSite, July 2011
In this issue: Solid Tumor Open House, CTO Mother Goos, SOCRA Groups,…
CTO InSite, April 2011
In this issue: New CTO Group to Recognize Employees, Reg Team Open House,…

Forms

Forms: Study

Transfer of Study Participant Between Investigational Sites
This form should be completed when transferring a UM study participant to another institutional site; or when a study participant from another site is transferring to a UM investigator.
Clinical Research Team (CRT) - Protocol Peer Review Form
This form should be completed by chair assigned reviewers when CRTs are reviewing protocols prior to PRC submission.
Clinical Research Team (CRT) - CTSU Feasibility Review Form
This form should be completed by CTSU personnel when CRTs are reviewing protocols prior to PRC submission.

References

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

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

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
ECHO, Lower limit of normal documentation for the LVEF for research reporting purposes
INR
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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