Regulatory Management Glossary

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

A

Accept Role

Co-Investigators, Faculty Advisors, Biostatisticians, Research Staff, Consultants, and Others that are added to a study must enter the system and perform the Accept Role activity. By accepting their role in eResearch, these study team members are electronically signing the submission. During the activity, study team members provide a current CV and complete a short conflict of interest section.

Activity

An activity in eResearch is an action that you can take on a submission. For example, if you want to post a correspondence to the study team, you use the Post Correspondence activity. Activities are available from the Study Workspace. You will have different activities available based on the state of the submission and your role.

Activity Details

Each activity has an Activity Details page. This page displays all the information recorded by eResearch about that activity. After you have completed an activity, the activity is displayed in the Study Workspace. Clicking the activity name opens the Activity Details page.

AE

Adverse Event: Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research; or increased the risks of harm from the research; or had an unfavorable impact on the risk/benefit ratio.

Note: The Food and Drug Administration also includes in its definition abnormal preclinical or laboratory findings which may not yet have resulted in direct harm to subjects (e.g. a bacteria is identified in a culture from the same batch of cells used to produce a vaccine which has been administered, even if no cases of infection have been reported).

Amendment

A written description of changes to or formal clarification of a submission. In eResearch, amendments are used to make any change to a submission once that submission has been approved. For example, after approval, any changes to the study team, the study protocol, supporting materials, or any study related information must be changed through an Amendment.

Ancillary Committee

Ancillary Committees are committees that have oversight for specific areas of a submission, such as radiopharmaceuticals, investigational drugs, or devices. These committees do not issue approval for the study, only for their areas of oversight.

eResearch allows study teams to submit one application which is routed to the appropriate Ancillary Committee(s) based on the study application.

Ancillary Committees include:

  • Cellular Therapy
  • Clinical Engineering
  • COI
  • CRAO
  • IBC
  • Research Pharmacy (formerly IDS)
  • MADC
  • MIAP
  • MICHR Biostats
  • MCRU
  • RDRC/SHUR
  • TPC
  • RPC

Application

The Application is the parent submission for all activities in eResearch. The application is a web-based Smart Form that routes study teams through the application sections based on answers to the questions. PI or study team member fill out one application for all Ancillary Committees and the Core Committees. The PI must submit the application.

Application Checklist

The Application Checklist allows study team members to check the progress of a submission in the Pre-submission state. The Application Checklist button is available in the Study Workspace. Clicking the Application Checklist button opens a new window that indicates whether a section of the application is:

  • Complete — All required questions in the section have been answered
  • Incomplete — Required questions in the section still need to be answered
  • Required — The section is required but no questions have been answered
  • Not Required — The section is not required for this submission

Approved

An Approved state indicates that the submission has been reviewed by all the necessary Ancillary and Core Committees and that an Approval has been issued. Documents in an approved study are finalized and then moved to the Approved Documents area of the Documents tab.

Approved (workspace tab)

In your Home Workspace, the Approved tab displays all submissions of which you are a study team member and in an Approved state.

Approved Documents

Approved Documents are documents provided with the submission that have been approved by the necessary Ancillary and Core Committees. Some documents, such as Informed Consent, are time stamped and watermarked when they are finalized. Approved Documents are available in the Documents tab in the Study Workspace.

Archived

Archived submissions appear in your Home Workspace in the Archived Studies tab. Submissions that are archived are in one of the following states:

  • Terminated
  • Expired
  • Withdrawn
  • Suspended

Archived (workspace tab)

In your Home Workspace, the Archived tab displays any submission in any of the archive states.

Authenticate

Authentication is a process that verifies your identity. eResearch authenticates users with their uniqname and UMICH password. For people not affiliated with U-M, authentication is based on their Friend account.

B

Biostatistician

See Study Team Roles

C

Change Tracking

The Change Tracking tab, available in the Study Workspace, displays changes to submission information. Any time a change is made the entered information, the change is tracked in the Change Tracking tab.

Changes Required by Core Staff

A submission is in this state if the core committee staff or reviewer sends the application back to the study team with requested changes. The study team has Edit rights to the application in this state and can make any necessary changes to the submission.

Once the study team has made the necessary changes, the PI or study team uses the Submit Requested Changes activity.

Child submission

See Parent submission

Clinical Engineering (formerly BEU)

Clinical Engineering is an Ancillary Committee in eResearch that reviews any study utilizing biomedical engineering techniques or technology.

COI

The Conflict of Interest (COI) committee is charged with reviewing disclosures submitted to them and rendering reasonable judgments as to whether the financial interests disclosed could directly and significantly affect the design, conduct, or reporting of the proposed project.

Co-Investigator

See Study Team Roles

Committee

In eResearch, Committees are bodies that review and issue approvals on applications or sections of applications. There are two types of committees in eResearch: Ancillary Committees and Core Committees.

Committee Member

Committee Members are people who serve on any of the Ancillary Committees, IRBs, MCRU, or the PRC. In eResearch, people who have Committee Member roles have activities that are available only to them and can correspond with other committee members securely. For example, discussions that take place between users with the Committee Member role are viewable only to other users with that same role.

Also see Core Committee

Consultant

See Study Team Roles

Contact

Contact is a term that describes an account holder in eResearch. Everyone who logs into eResearch is listed as a Contact. You can search for Contacts when you are adding study team members or posting correspondence.

Contingencies

Contingencies are conditions placed on the submission that must be fulfilled before the submission will be approved. Committee Members can communicate with the study team about contingencies before issuing an approval or the committee can issue an Approved with Contingencies decision.

Contingencies Pending

This state returns the submission to the study team where they can address contingencies from reviewers.

Continue (button)

eResearch application forms have a Continue button that allows you to move forward through the application. Clicking Continue saves the current page and moves to the next logical application Smart Form. This is not the same as the Forward button on your browser. You should not use the Forward button on your browser when you are completing the application as data loss may occur.

Core Committee

Core Committees are committees that approve large portions of an application or issue Approvals. The core committees in eResearch are:

Core Committee Staff

Core Committee Staff are members of the Core Committees. They can be reviewers, board members, or office staff.

Correspondence

"Correspondence" is a general term for communications that take place inside eResearch. Viewing Correspondence is limited based on your role in eResearch. For example, Committee Members can communicate securely inside the system.

Some Correspondence activities include a system email notification when they are posted to eResearch.

Cosign

Cosign is the University of Michigan's central authentication system. eResearch uses Cosign to verify users' identity when they log into the system. 

To log in via Cosign, you need to have a uniqname and a UMICH password. Non-UM personnel can obtain a Friend account to use with Cosign.

CTO

The Clinical Trials Office (CTO) coordinates institutional, industrial, cooperative group and externally reviewed (NCI) studies for the Rogel Cancer Center.

D

Deferred

The Deferred activity allows Core Committees to indicate that discussion of a particular submission was deferred to a future meeting. When recording a Deferred activity, Core Committee Staff can indicate why discussion was deferred.

Development

Development refers to the ongoing work being done with the eResearch software. Development of the software is being managed by ITS, with input from UMOR, the IRBs, Core Committees, Ancillary Committees, and many office staff.

Disapproved

This state is based on a decision issued by the applicable Core Committee. The study is disapproved and the study team cannot begin work on the study. The study team does have the option to rebut the decision using the Rebut Decision activity.

Disapproved - Final

This state is based on a decision issued by the applicable Core Committee after the study team has rebutted an initial Disapproved decision. The study team is not able to rebut a "Disapproved - Final" decision, but can submit a new submission. Studies that move into this state are displayed in the Archive tab in the PIs Home Workspace.

Documents

Documents are any supporting materials that are uploaded to eResearch as part of an application. Documents can be any of the recommended file types and file sizes.

E

EAS

Enterprise Application Services (EAS) is a division of U-M Information and Technology Services (ITS). The eResearch team, which develops and supports the eResearch software, is a part of EAS.

Employer

Indicates who employs an eResearch Contact. If this data is incorrect, contact the ITS Service Center.

Engaged

See Performance Site

Environment

Environment refers to a specific instance of the eResearch software. eResearch is the "production environment", which means that it is the official, released version of eResearch. 

When you attend training or log into the Sandbox, you are working in a separate environment than production. This separate environment is a copy of the official eResearch environment, but is not connected to eResearch. In the case of the Sandbox, this means that you can familiarize yourself with the software without having to have any information for a submission.

eRRM

eResearch Regulatory Management

Exempt

The Exempt activity allows Core Staff to send the submission to an Exempt Study reviewer. Core Staff are able to select the Exempt Reviewer, add notes and upload supporting documents before sending the application to the Reviewer

Exempt and Not Regulated (workspace tab)

The Exempt and Not Regulated Studies tab contains all submissions that have been designated as Exempt or have received a Not Regulated decision from Core Staff.

Exit

The Exit link, available in the submission Smart Forms, exits the submission, not eResearch. Clicking the Exit link opens an alert window warning that any unsaved data will be lost when you exit. Always click Save before you click Exit to make sure you don't lose data.

Expedited

The Expedited activity allows Core Staff to send the submission to an Expedited Study reviewer. Core Staff are able to select the Expedited Reviewer, add notes, upload supporting documents, and select an Expedited category before sending the submission to the Reviewer.

F

Faculty Advisor

See Study Team Roles

Fast Find

Fast Find allows you to search for an AE, Amendment, Application, or SCR in eRRM. See Fast Find for details.

Filter

Filters allow you to narrow your search for information available in eResearch. You can filter on studies, names, and other criteria.

Finalize Documents

The Finalize Documents activity embeds information in the Informed Consent documents and places them in the Approved Documents area of the Documents tab in the Study Workspace. The Finalize Documents activity is performed by the Core Staff.

Friend Account

A Friend account allows non-UM affiliated researchers and study team members to have access to eResearch. See Friend Accounts for more information.

H

Hide/Show Errors

The Hide/Show Errors link checks all the links in the submission for any required questions that are not answered. The Hide/Show Errors link only checks the links on the current submission Smart Form.

The PI is not able to submit a submission until all the required questions are answered.

Home Workspace (My Home)

Your Home Workspace is displayed when you log into eResearch and displays all the studies with which you are associated.

Hot Fix

Hot Fixes, like Service Packs, keep the eResearch software current, but are smaller and generally fix critical issues. Generally, users of eResearch do not need to be concerned about service packs, although any system down time will be announced in advance.

Human Subjects Studies

The Human Subjects Studies link in eRRM displays all the submissions in the system that you have rights to view. You can click the tabs in the Human Subjects Studies view to find submissions based on state.

I

IBC

The Institutional Biosafety Committee (IBC) is the ancillary committee charged with overseeing recombinant DNA research. Any study that uses recombinant DNA is reviewed by IBC.

IBCA

IBCA Application (Institutional Biosafety Committee Application) is a submission type available in eRRM for oversight of recombinant DNA (rDNA) and potentially biohazardous research in laboratories. This includes work with:

  • Recombinant DNA (rDNA)
  • Infectious Agents
  • Biological Toxins
  • Blood, body substances, or cells from humans or certain vertebrate animals

ID

The ID is the unique identifier that is automatically assigned to each application, amendment, adverse event (AE), ORIO, scheduled continuations and terminations.

Each ID begins with a prefix that identifies what type of submission it is.

  • New applications begin with HUM
  • New amendments begin with AME
  • New continuing reviews and terminations (SCRs) begin with CR
  • Adverse Events and ORIOs begin with ADV
  • IBC Applications begin with IBCA
  • Repository Applications begin with REP

Inbox

Your Inbox is the default page displayed whenever you log into eResearch. Studies that appear in your Inbox require action, which differs based on your role.

In Progress

The In Progress tab displays submissions which you have rights to see, but for which you don't yet have required actions.

Interested Parties

Interested Parties are people who are not researchers or study staff, but who can view certain aspects of eResearch. Interested Parties can include regulatory bodies, federal oversight committees, or University oversight committees.

ITS

Information and Technology Services. The eResearch Regulatory Management (eRRM) team, which develops and supports the eResearch software, is part of ITS.

J

Jump-To

The Jump-To option allows you to navigate directly to any Smart Form section in a submission. However, you should only use Jump-To if you know that the section you are moving to is required. Using the Jump-To option bypasses the logic built into the Smart Forms.

M

MCRU

A role for the Michigan Clinical Research Unit.

Migration

Migration is the movement of files from one server to another, usually during development. Generally, users of eResearch do not need to be concerned about migrations.

Modification

Modifications to Human Subjects Studies are called Amendments in eRRM.

My Role

The My Role section of your Home Workspace allows you to see all of the roles you have in eResearch. Some users will have multiple roles. Click the desired role in the My Roles section.

It is important to select the correct role as you have different activities available based on your role.

N

Not Regulated

The Not Regulated activity allows Core Staff to prepare a letter to the study team indicating that the study is not regulated by the IRB. Study teams receive notification of the decision and can print the letter.

Notes

There are different types of Notes. Not all Note types are available to all roles, and some Note types are available only in certain states.

  • Study Team Notes
  • IRB Draft Changes Requested
  • IRB Reviewer Checklist
  • IRB Reviewer Notes
  • Reviewer Notes
  • Changes Requested by Core Staff

Notification

eResearch notifies you of certain events by sending email messages to your normal email inbox. When you receive notification differs based on your role in eResearch.

Notifications contain a link that, after you log in, brings you directly to the submission that requires action.

Note: Some email programs can break the link in the email message.

O

Organization

The Organization is the unit within the University which employs the contact. For non-UM employees, this is your employer.

ORIO

Other Reportable Information and Occurrences; ORIOs are Audits, other reports (with IRB issues), protocol deviations, protocol violations, facility/data accidents, or complaints.

To submit an ORIO, click the New Adverse Event/ORIO button in the Study Workspace.

Owner

The Owner is the person in eResearch that is responsible for a study. Normally, the Core Committee assigns an Owner to a study when it is submitted by the PI. This Owner creates Notes and can request changes from the Study Team. The Owner also routes the submission for review and issues letters based on the decision of the Core Committee.

P

Parent submission

Submissions in eResearch have a hierarchal structure. The "parent" submission is the highest level of this hierarchal structure and are the starting point for all "child" submissions.

An example of a parent submission is a new application. The application is the parent submission to all subsequent submissions for the study, such as Amendments, AEs, ORIOs, and SCRs. While each of the subsequent child submissions have their own forms and approval processes, they all related back to the initial submission.

PEERRS

Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS) is a web-based instruction and certification program for members of the University community engaged in or associated with research.

All PIs, Co-Investigators, and Faculty Advisors must complete at least one human research module in PEERRS before the IRB will approve an application.

Performance Site

A Performance Site is any location at which research-related activities occur.

Performance Sites can be "not-engaged" or "engaged". For more information, see the U.S. Department of Health & Human Services website.

Post Correspondence

This activity allows study teams to communicate with the Ancillary Committee(s) and Core Committee(s), or for the committee staff to communicate amongst themselves. Communications between committee staff is secure and cannot be viewed by anyone who is not committee staff.

When you Post Correspondence, anyone you designate in the activity receives a system email notification of the correspondence. Individuals must log into eResearch to view the correspondence.

PRC

PRC, also Protocol Review Committee, is now referred to as the Rogel Cancer Center (formerly PRC). It is a committee responsible for peer review of the scientific merit of all cancer clinical research in the Medical Center.

Pre-submission

This state is the default state for any newly-created submission. The Pre-submission state means that the study staff have not submitted the application, amendment, AE, ORIO, or SCR for review. The submission is editable by the study staff.

Printer-Friendly (inside/outside)

A printer-friendly link generates a single page of the study application that is suitable for printing.

Project

Project in eResearch refers to any of the submissions that can be created. For example, an Adverse Event submission is a project type.

R

RDRC/SHUR

Radioactive Drug Research Committee/Sub-Committee on Human Use of Radiation: This committee has oversight for all studies that utilize radioactive materials.

Refresh

When you submit information in a detail page (such as adding a document), the page that opened the detail page will reload, or Refresh, to display the new information.

You may also hear the term Refresh in reference to development activities. In this context, Refresh means that the eResearch software and data is being updated, which may temporarily make eResearch unavailable. In this event, you will receive notification in advance of system outages.

Release

A Release refers to a specific version of the eResearch software. New releases will occur throughout the year and will be announced in advance. New releases sometimes introduce new functionality, so read release announcements carefully to see if any of your roles are affected.

Renewal

Renewals in eResearch are referred to as Scheduled Continuing Reviews, or SCRs.

Repository Application

Repository Application (REP) is a submission type available in eResearch Regulatory Management (eRRM) for oversight of U-M data/biospecimen research repositories. A research data or tissue bank, or research repository, stores, maintains, and distributes data and/or biospecimens to enable future research. New repositories should request IRB approval through an REP application for intake, storage, maintenance and distribution of data and/or biospecimens.

Research Pharmacy

The ancillary committee charged with reviewing all research projects that utilize investigational drugs.

Reviewer Notes

Reviewer Notes are notes made in eResearch by IRB Reviewers. These notes are viewable only to IRB staff with the proper view rights. Individual Reviewer Notes can also be sent to the study team for clarification, and require a response.

Also see notes

Role

Each person has a Role in eResearch. This role determines what information the person is allowed to enter, edit, view, as well as the activities available to that person.

Some study team members have multiple roles (such as PI and Committee Member). If you have multiple roles, you will see all of your roles listed in your Home Workspace. Be sure you have selected the proper role before continuing in eResearch. If you have the wrong role selected (selecting PI instead of Committee Member) you may not have the proper activities to review or approve a study.

RPC

Research Policies Committee; The Research Policy Committee advises and consults with the Vice President for Research on matters of research and research personnel. Recent Topics include: technology transfer, issues affecting research scientists, research commitments, annual review of regental research policy, research ethics, research computing, UMOR annual report to the Regents.

S

Sandbox

The eResearch Sandbox environment is used for training and informational purposes only. Data entered in the Sandbox will not be reviewed, processed, or approved by the IRBs or other oversight committees. Data will be purged from the Sandbox on a regular basis.

The Sandbox is your place to "play" around with a copy of eResearch, without fear of completing your real application incorrectly. You can upload documents, enter information, add study team members—just like being in eResearch.

You can log into the Sandbox from anywhere you have an internet connection.

SCR

Scheduled Continuing Review (also known as "Continuing Review"): Periodic review by the Institutional Review Board (IRB) of active research for the purpose of re-approving, requiring modifications, disapproving, terminating or suspending the study.

Service Pack

Service packs keep the eResearch software current, and extend and update the system's functionality. Service packs include updates, system administration tools, drivers, and additional components. Generally, users of eResearch do not need to be concerned about service packs, although any system down time will be announced in advance.

Smart Form

Smart Forms are pages in eResearch that contain logic, which route you through the application. Smart Forms allow you to complete only the sections of the application, AE, ORIO, SCR, IBCA, or REP that are required. 

Smart Forms rely on the Continue button to use the logic embedded in them.

Sort

Sorting is a way to display information in eResearch. Many areas, such as your Inbox, display multiple items in a table. You can sort this table by column simply by clicking the column name. All the data in the table is then ordered in ascending or descending order based on the column name clicked. 

You will see an arrow pointing up or down in one of the column names indicating which column the data is being sort by and whether that sort is ascending or descending.

Staff

Staff refers to the office staff in the Core Committees. This includes Rogel Cancer Center, or the IRB directors, specialists, or administrators.

State

State refers to the current status of a project. Upon creation of these forms, the state is Pre-Submission. Once you submit, the state changes. Depending on the state of the submission, you may have edit rights to the forms. 

Once the submission has gone through all the necessary reviews, it moves to an Approved state.

State Change

State changes occur around activities in eResearch. State changes modify the actions available to roles

A common State Change occurs when the PI submits a new study application. The application moves to a review state (which differs depending on the required committees); the study team's ability to edit the application is removed, and the study moves to the applicable Ancillary or Core Committee staff Inbox.

Status

See State

Study Coordinator

See Study Team Roles

Study Team Roles

  • Principal Investigator (PI): the individual with primary responsibility for the conduct and administration of a study. 
  • Co-Investigator (Co-I): an individual who shares responsibility with the investigator for a study. This term is synonymous with sub-investigator.
  • Faculty Advisor: In eResearch, Faculty Advisors are added by student PIs. Faculty Advisors must accept their role in the study before the student PI will be able to submit the study.
  • Study Coordinator: Study Coordinators are staff for the PI that function as a key coordinator for the study staff. Study Coordinators enter, edit, and maintain the information in eResearch.
  • Administrative Staff: Individuals who are NOT involved in the design, conduct, or reporting of research (e.g., unit administrators). These individuals are NOT required to accept their role or complete conflict of interest questions.
  • Research Staff: Individuals who ARE involved in the design, conduct, or reporting of research. These individuals must accept their role and answer conflict of interest questions prior to IRB submission of the application.
  • Biostatistician: Statisticians are study staff that analyze data collected during the study. 
  • Consultant: A consultant is a specialist in a specific area of the study, usually from outside the normal study staff. This role is not used frequently.
  • Other: If the study team member doesn't fit into any of the above categories, you can select Other and then enter the role of the study team member in a text box.

Study Team/Study Staff

See Study Team Roles

Sub-investigator

See Study Team Roles

Submission

Submission refers to any of the forms that can be submitted via eRRM. These forms are Applications, AEs, ORIOs, SCRs, Amendments, IBCAs, and REPs.

Submission Summary

The Submission Summary is an overview of the submission. It provides quick links to submitted documents, outstanding contingencies, sponsor information, oversight information, and committee minutes. 

This view is available only to Reviewers.

Supporting Documents

See Documents

T

Tabled

This is a motion available to Core Committee staff to indicate that the discussion about a submission was tabled during the committee meeting.

TPC

Tissue Procurement Core (TPC) provides researchers with tissue from surgical resection specimens. This tissue is excess, in that it is not sampled for morphologic evaluation and would have been discarded 3-4 months after surgery if not procured for research.

U

UMOR

University of Michigan Office of Research (UMOR) supports and promotes the efforts of U-M faculty, staff, and students to remain in the forefront of research, scholarship, and creative activity; responsible for policies and compliance with ethical conduct of research. UMOR is also a primary sponsor of the eResearch system.

Uniqname

Your uniqname is a unique identifier which identifies you when you use University computing services. Faculty, staff, and students receive a uniqname when they begin at the University. Used with your UMICH password, your uniqname allows you to log into many University systems, including eResearch.

Alumni and Friends of the university can obtain a uniqname and UMICH password from ITS.

Upload

Uploading is the transferring of files from your computer to a server. In eResearch, you upload documents via the Add button. 

Note: Files that are uploaded to new submission are not saved until you click Save or the Continue button.

V

View

Views are used to generate section pages in eResearch. The term "View" is used in development.

W

Workspace

Workspaces are pages that provided overviews of areas within eResearch. A familiar workspace is your Home Workspace. Your Home Workspace is displayed when you log into eResearch and displays all the studies with which you are associated. Project workspaces also contain activities you can perform.