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Applications

CERVANT
CTO's custom reporting application on clincial trials.
eResearch
eResearch is the UM's site for electronic research admnistration (IRB, IBC, etc.)
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

eResearch Instructions: Cancer Center Program Directors
How to approve Sections 1-3 of an eResearch application (ie, the equivalent to the current PRC form.)
eResearch Instructions: Co-Investigator
Directions on how to accept the role of co-investigator on a study (in lieu of signing the PRC form/IRB submission).
Velos eResearch User Manual, v8.0
User manual for CTO's clinical trials management system.
Velos eResearch Customer Corner
Customer site for Velos eResearch providing additional documentation and training videos. This site is password protected; contact CTO for access.
Guest Access: Friend Accounts
Allows someone who does not have a U-M uniqname and UMICH Kerberos password to authenticate to the U-M computing environment; to log in to the environment and be identified. It does not, however, authorize that person to use any services.
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

CTRAC: Clinical / Translational Resource Allocation Committee
The CTRAC monitors and controls Cancer Center funding for clinical trials infrastructure and translational research. Make sure to log into your UofM google acount. Example: uniqname@umich.edu
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
QARC: Quality Assurance Review Committee
Performs an annual audit of all investigator-initiated therapeutic trials annually according to its guideline to ensure compliance with both the protocol and governmental regulations.
QARC Audit Plan
UMCCC audit plan to assure trials are conducted in compliance with GCP and Regulatory Guidelines.
QARC Chart Audit Form
Audit questionnaire for review of research charts.
QARC IDS Audit Form
Audit questionnaire for Investigational Drug Services

CTO Committees

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

Department Documents

CTO Errands
Cancer Center Errands Worksheet
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: Regulatory

FDA 1572: Statement of Investigator Form (Pre-filled)
The primarly use is to identify qualified investigators and as experts to particpate in clinical investigations at the NCI.
CTEP IDF: Supplemental Investigator Data Form (Pre-filled)
Collection of this information serves two purposes. The first is to identify qualified investigators and associates to participate in the clinical investigations at NCI. The second purpose is to ensure that investigational agents are under the control a
CTEP FDF: Financial Disclosure Form
The use of this information is to disclose or certify information concerning the financial interests of the clinical investigators associated with clinical studies.
MIAP - MICHR IND/IDE Investigator Assistance Program
The MIAP's primary focus is to offer regulatory assistance to sponsor-investigators of a new drug, biologic or medical device to ensure clinical research.excellence and regulatory compliance

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

IRBMED: Institutional Review Board of the Medical School
The IRBMED protects the rights and welfare of human subjects, applying federal and state laws, university policies, ethical principles, particularly those articulated in the Belmont Report.
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 CTC/CTCAE
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
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

References: Groups, Consortiums & Networks

BMT CTN: Bone Marrow Transplant Clinical Trials Network
Established because of a critical need for multi-institutional clinical trials focused directly on improving survival for patients undergoing hematopoietic cell transplantation (HCT).
EDRN: Early Detection Research Network
An initiative of the National Cancer Institute (NCI), brings together dozens of institutions to help accelerate the translation of biomarker information into clinical applications and to evaluate new ways of testing cancer in its earliest stages and for c
MMRC: Multiple Myeloma Research Consortium
Is to accelerate the development of novel and combination treatments for patients with multiple myeloma by promoting and facilitating collaborative research between industry and academia.
NANT: New Approaches to Neuroblastoma Therapy (consortium)
To develop and test new therapies that will be targeted specifically to neuroblastoma cells, and therefore improve the outcome for children with advanced neuroblastoma with fewer side effects.
NCCN: National Comprehensive Cancer Network
A not-for-profit alliance of 21 of the world's leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer.
NCI's Clinical Trails Cooperative Group Program
This program is designed to promote and support clinical trials (research studies) of new cancer treatments, explore methods of cancer prevention and early detection, and study quality-of-life issues and rehabilitation during and after treatment.
SARC: Sarcoma Alliance for Research through Collaboration
A non-profit organization dedicated to the development and support of clinical trial research for the prevention, treatment and cure of sarcomas - a cancer of the bone and connective tissue of the body
TACL:Therapeutic Advances in Childhood Leukemia (consortium)
Established to provide a means for carrying out early studies of new drugs in children with recurrent leukemia or lymphoma.

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