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- A-Z Index and Glossary
Call for Proposals
Code of Federal Regulations
Chartfields are the building blocks of the University of Michigan's financial reporting structure. The following Chartfield elements are relevant to Sponsored Programs, and provide a common framework for internal and external financial reporting and analysis.
The account is the beginning of a Chartfield string.
A Fund Code is a value that identifies the source and intended purpose of funds and how they should be spent.
A Department is a value that identifies an academic or administrative unit.
Alpha Programs are designed to be used by units throughout the university, and numeric Programs are generally specific to an individual unit.
Class identifies the functional nature of an expense.
Project/Grant is a value used to identify a specific pool of money or activity over a finite period of time.
A Shortcode represents a string of Chartfield values.
Council for International Organizations of Medical Sciences
The class chartfield is used to denote the functional nature of an expense, which is essential for external and internal financial reporting. Codes should be used appropriately and consistently among like transactions. See this list prepared by Cost Reimbursement for the codes relevant to research and sponsored projects. Learn more about this topic and download class code definitions on the Finance website.
The Clinical Trial Routing Form (CTRF) allows study agreement contract negotiations to proceed in parallel with budget negotiations and regulatory approval. The Clinical Trial Routing Form (CTRF) is typically required for all activity in 31200, Clinical Trial Site Activity and for investigator-initiated industry-sponsored clinical trials (in the Research class codes) when there is a draft agreement prior to a PAF routing.
See ITS Clinical Trial Routing Forms Quick Reference Card for the steps to enter a Clinical Trial Routing Form (CTRF) in eRPM.
Clinical Trials is a type of "Other Sponsored Activity."
Clinical Trials fill a key role not only at the U-M Medical School, but with the entire University research enterprise. To streamline the initiation of clinical trials, the Michigan Medicine Office of Research and the Office of Research and Sponsored Projects (ORSP) have developed a program where several steps in the trial contracting process have been clarified and made more efficient.
A major component of the program is a Nondisclosure Agreement (NDA) template that can be signed by the school without routing to ORSP for negotiations if the sponsor agrees to the terms. This NDA is intended to expedite the process for exchanging and protecting a sponsor's confidential information prior to entering into a sponsored clinical trial agreement. Often the parties are simply exploring the possibility of a clinical trial that may or may not result in the University and sponsor establishing an agreement. The goal is to provide a fair and balanced NDA that protects the sponsor's information and also meets the needs of the University as a public body.
Another important component of the program is the use of the Clinical Trial Routing Form (CTRF) which allows study teams to send draft agreements for the trial to ORSP for contract terms review prior to the routing of a PAF with final financial arrangements. Further information on the CTRF is available.
If you have further questions, contact a ORSP Clinical Trials Project Representative for information on Clinical Trial Agreements and Medical School Non-Disclosure Agreements.
Clinical Studies health research at the University of Michigan: https://umclinicalstudies.org/
- ICMJE Clinical Trial Registration Policy
- Clinical Trials Participation - FAQ for Parents
- Clinical Trials Registration & Results Reporting
- ClinicalTrials.gov Support Materials The ClinicalTrials.gov site contains all the information you need to register a study, edit a registration record, and report results from policies to specific procedures to data element definitions, templates, and checklists.
- Final Rule for Clinical Trials Registration and Results Information Submission
- How to Register a Clinical Trial
- How to Report Clinical Trial Results
- Maintaining and Updating ClinicalTrial.gov Records
- NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
- A fillable PDF worksheet with an extraction of some of the questions in FORMS-E for the SF424 forms set. This worksheet is intended to help Research Administrators (RAs) collect the detailed data and scientific questions they will need from their principal investigators (PIs) to more readily complete FORMS-E in the eResearch Proposal Management System.
At the end of a project there are important considerations to make sure the project comes to an orderly close. The University has an obligation to sponsors to submit a final technical and financial report. The necessary closing procedures may vary, depending on the policies of the sponsoring agency and whether the support was in the form of a grant or contract. The requirements may vary from a one-page form to a multi-page document. Perhaps inventions or patents are necessary. Learn more in the Close Out Project section of our website.
Conflict Management Plan
The "Common Rule" is the popular term for the Federal (U.S.) Policy for the Protection of Human Subjects, 45 CFR part 46, which outlines the criteria and mechanisms for IRB review of human subjects research.
- Decision Trees: Exempt Human Subjects Research Decision trees displaying the criteria and potential review paths, including system generated determination, for exempt categories 1 - 4, 7 & 8 under the 2018 Common Rule.
- Tip Sheet: Exemption #1 Provides the full definition and explanation of exemption category #1 (educational exemption) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
- Tip Sheet: Exemption #2 Provides the full definition and explanation of exemption category #2 (surveys, interviews, educational tests, and observations of public behavior exemption) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
- Tip Sheet: Exemption #3 Provides the full definition and explanation of exemption category #3 (benign behavioral intervention) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
A former name for the resources provided by the Ethics, Integrity & Compliance website.
A Michigan law that complements FOIA in exempting proprietary information held by university personnel if certain conditions are met.
- CRIIA Excerpt - MCL Section 390.1553
- Michigan Confidential Research and Investment Information Act (CRIIA) - Act 55 of 1994
- Michigan Freedom of Information Act (FOIA) - Act 442 of 1976 (MCL 15.231, et seq.) Full text of the Michigan Freedom of Information Act (FOIA) - Act 442 of 1976 (MCL 15.231, et seq.)
A conflict of interest (COI) in research is when a U-M investigator's personal, professional, commercial, or financial interests or activities outside the University have the potential of biasing the nature or direction of scholarly research, influencing decisions or behaviors related to their institutional responsibilities, or resulting in a personal or family member's gain or advancement at the expense of the University.
- 3 Key Steps to Disclose in M-Inform Describes and illustrates the top three actions disclosers need to do within M-Inform to successfully submit their outside activity disclosures. (PDF) Last updated: 06/15/2021
- Agencies/Organization Following PHS COI Regulations
- COI Annual Review Process
- COI in Research Policy Effective July 1, 2021 The "COI in Research" policy is the U-M policy that outlines the outside interest disclosure requirements and COI review processes for the Identification and Managment of Conflicts of Interest in Research, Sponsored Projects, and Technology Transfer.
- COI Initial Review Process
- COI Management Examples
- COI Policies
- COI Review: Committee Determination Process
- Conflict of Interest (COI)
- How to determine if you need COI review and approval How to Determine if Your Project or Technology Transfer Activity Needs COI Committee Review and Approval
- ICOI Committee & Schedule
- Institutional Conflicts of Interest (ICOI)
- M-Inform Glossary & FAQ
- Maintaining Department Information in M-Inform Instructions to assign M-Inform roles (e.g., unit reviewers of outside activities disclosures for the unit, division, department, or an individual) and send M-Inform reminder emails to disclose to individuals. (ITS) Last Updated: 06/29/20.
- NIH Conflict of Interest resources page Public Health Service (PHS) regulations, which apply to the National Institute of Health (NIH)C and other PHS agencies
- Non-U-M Investigator Disclosure Process
- NSF COI Policy
- Outside Interest Disclosure Process
- Policy for Institutional Conflicts of Interest in Research Office of the President policy outlining the criteria and processes for the identification, review, and management of conflicts of interest arising when U-M, as an institution, has financial interests that may affect or appear to affect the design, conduct, reporting, review, or oversight of research. Revised October 2020 - all sections in effect except for Section 3.C.2, which will be effective as of February 1, 2021.
- Prepare/Update a Disclosure for Another in M-Inform M-Inform instructions for proxies (i.e., unit assistants) to data enter outside activity disclosures for another U-M discloser. (ITS) Last updated: 06/13/23.
- Principles & Concepts
- Regental Action Requests (RARs) & COI Review
- Respond to a COI Management Plan (for conflicted individual) M-Inform instructions to access and respond to (i.e., accept) a Management Plan for a COI situation.
- Review an Outside Interest Disclosure in M-Inform M-Inform instructions to review outside activity disclosures on behalf of the discloser's U-M unit, division, or department. (ITS) Last Updated: 04/12/23.
- Review and Respond to a COI Management Plan (for ombudsperson, monitor, etc.) M-Inform instructions to view and respond to the COI Management Plan as an individual with an oversight role in the unit for the conflict situtation.
- Sample M-Inform System Email to Disclosers Sample (Word) of the system email sent from M-Inform to those at U-M required to disclose per unit procedures or PHS regulations.
- Start-Up Tipsheet for U-M Employees Approval and disclosure tips for U-M employees thinking of starting or joining a start-up company. (PDF) Last updated 04/10/2023
- Submit an Outside Interest Disclosure in M-Inform Instructions to add a new oustide activity disclosure to M-Inform, edit previous disclosures, remove outside activity disclosures, and restore previously inactive outside activity disclosures. (ITS) Last Updated: 06/22/23.
- Submit Feedback to COI Office Instructions to submit additional feedback and information to a COI Office regarding an outside interest disclosure when the COI Office has identified a potential conflict of interest.
- Submit Information for a Research Initiated Certification Instructions for a discloser to answer a series of follow-up questions regarding an outside interest disclosure from a COI Office using M-Inform.
- Submit Information for the Annual Review of your COI Management Plan (for conflicted individual) M-Inform instructions to access, answer, and submit the Annual Review questionnaire for a conflict of interest situation.
- Submit the Annual Review Response for a COI Management Plan (for ombudsperson, monitor, etc. M-Inform instructions for individuals in an oversight role (e.g., ombudsperson) to access, answer, and submit the Annual Review of a conflict of interest situation.
- The Michigan Conflict of Interest Statute (Public Act 317 of 1968)
- U-M Reviewers: Points to Consider [PDF] U-M guidelines and tips for those who review outside interest disclosures for their unit. Last updated: 05/24/2022.
- U-M Standard Practice Guide (SPG) - 201.65-1
- U-M Start-Up Company Disclosure Process
- UMOR COI Review Committee & Schedule
- Unit COI/COC Plans Unit plans (e.g., LSA, Engineering, UMOR) for Faculty & Staff, posted to Provost web site.
- Update Your Company Profile in M-Inform Instructions to enter information about your start-up company in M-Inform. This information is required for the conflict of interest review at U-M when someone options, licenses, distributes, or commercializes intellectual property developed at the university.
Generally an agreement between university and corporate partners entered into for a specific research project or program.
A participant, either internal or external to the University, whose participation does not require a sub-account or sub-contract, and who is paid via a personal service agreement.
A contract or an agreement involves a promise, or set of promises, for which the performance is recognized as a legal obligation. The contract contains a statement of work or a description of the services provided and has more specificity than a grant. It should be drafted with great care, for failure by the University or contractor to deliver the results anticipated, or to perform what is defined in the statement of work, is a breach of contract.
A U-M researcher can propose research activity with external sponsors/collaborators, but they do not have the authority to negotiate and approve the legal aspects of any research agreement on behalf of U-M.
The use of controlled substances (Schedule I - IV) in research is highly regulated, with strict State of Michigan and federal licensing requirements and guidelines for obtaining, storing, accessing, and documenting the use/disposal of each scheduled substance.
For details, see Controlled Substances in Research.
- Annual Inventory Example Sample of a completed State of Michigan Annual Inventory
- Article 7: Controlled Substances Index of links to the controlled substance policy sections of the Public Health Code Act 368 of 1978
- Authorized Personnel Log Template (Word) to track the individuals, other than the licensee/registrant, who are authorized to handle controlled substances for research use and/or access to the storage location.
- Board of Pharmacy Controlled Substances (R 338.3101 - 338.3199q) Controlled substance policy, including definitions and schedules, from the Department of Licensing and Regulatory Affairs (LARA)
- Controlled Substance Compliance Checklist Checklist (Word) to use to prepare your laboratory and/or the controlled substance storage location for a U.S. Drug Enforcement Administration (DEA) inspection.
- Controlled Substance DEA Inventory Template Template (Word) used to perform a biennial inventory of the controlled substances currently stored at the DEA registered location.
- Controlled Substance Diluted Solution Log Log (Word) used to document the usage details for a controlled substance that has been withdrawn from its original container and mixed with a solution to dilute the concentration.
- Controlled Substance Initial & Closing Inventory Template Template (Word) used to record controlled substances at a new storage location immediately upon receipt of a DEA registration or used to list the controlled substances stored at a registered location upon the closing of that location.
- Controlled Substance Inspection Guidelines Instructions for researchers and lab staff to follow when the State of Michigan or U.S Drug Enforcement Administration (DEA) arrives for a controlled substance inspection.
- Controlled Substance Multiple Dose Log Log (Word) to document the details for each use of any controlled substance amount removed from its original container.
- Controlled Substance Research Requirements
- Controlled Substance SOM Inventory Template Template (Word) used to perform the State of Michigan (SOM) annual inventory of all controlled substances stored at the licensed location.
- Controlled Substances General Inventory Template Template (Word) used to summarize the usage of a controlled substance from the time of acquisition to the end of use (e.g., administration and/or disposal). Also called a “perpetual inventory.”
- Controlled Substances in Research
- DEA Drug Schedules I - V (21 CFR, Part 1308) External link to the federal code, 21 CFR, Chapter II, Part 1308 listing controlled substances by schedule I - V (see parts 1308.11 - 1308.15)
- DEA Form 106 - Report Theft/Loss Link to the online DEA form for use by the DEA Registrant only
- DEA Form 222 - Example Annotated PDF showing how to complete a DEA Order Form 222
- DEA Registration Application & Renewal
- DEA Research Application Instructions Guide to completing the DEA research application.
- DEA Theft/Loss Procedures & Information Link to the DEA website for additional procedural information regarding the reporting of a controlled substance theft or loss
- DEA Update Request Online form to request modifications to an existing DEA controlled substance registration. For use by the registrant only.
- Diluted Solution Log Example Sample of the information that can be found on the controlled substances Diluted Solution Log
- Dispose of Controlled Substances Printable version of the procedure (PDF).
- Dispose of Controlled Substances
- General Inventory Example Sample of a completed general inventory log
- Initial and Closing Inventory Example Sample of the type of information that could be found on a closing inventory using the Intitial & Closing Inventory template.
- Inspection Preparation
- Maintain Controlled Substance Records
- Modify a Controlled Substance License/Registration Printable version of this procedure (PDF)
- Modify a License/Registration
- Multiple Dose Log Example Sample of the information that can be found on the controlled substance Multiple Dose Log
- Online Form 225 Link to the online DEA Controlled Substance Registration Form 225, with instructions, for Schedules II - V only
- Order & Receive Controlled Substances for Research
- Order & Receive Controlled Substances for Research Printable version of the instructions (PDF)
- Report Theft/Significant Loss of Controlled Substances Printable version of this procedure (PDF)
- Report Theft/Significant Loss of Controlled Substances
- Researcher Controlled Substance Request Form Form (PDF) required to order controlled substances for research use from the Michigan Medicine B2 Pharmacy.
- Reverse Distributor Inventory Instructions Instructions to complete the Reverse Distributor Inventory List, also known as the DLD Controlled Substance Inventory List.
- Reverse Distributor Inventory List Inventory template to use when disposing of controlled substances through EHS - Hazardous Materials using U-M's contracted reverse distributor (Drug, & Laboratory, Inc. or DLD.) Also known as the DLD Controlled Substance Inventory List.
- Schedule I and II Controlled Substance Disposal Process Detailed instructions with examples of completed forms for disposing of Schedule I and II controlled substances utilizing the required reverse distributor process offered via Drug & Laboratory Disposal, Inc. (DLD) by U-M Environment, Health & Safety (EHS)
- SOM Data Request Change Form Online form from the State of Michigan (SOM) used to request modifications or updates to an existing controlled substance license. For use by the licensee only.
- SOM License Application & Renewal
- State of Michigan Application Instructions Guide to preparing State of Michigan application for controlled substances research license (Word, download)
- Title 21 Code of Federal Regulations, Part 1300-End Index listing the links to the sections of DEA policy for controlled substance registration
- Title 21 United States Code (USC) Controlled Substance Act U.S. Department of Justice - Drug Enforcement Administration (DEA) outline of the federal Controlled Substance Act
- U-M Authorized Personnel Screening Statement Form Internal attestation form (PDF) for personnel who will handle controlled substances for research purposes and/or have access to the storage location.
- U-M Policy on the Use of Controlled Substances in Research and Education Outlines the investigator and/or department roles and responsibilities when utilizing controlled substances in research at the University of Michigan (revised June 2018)