Office of Research Integrity / Office of Sponsored Projects IACUC PROTOCOL SUBMISSION GUIDE

Transcription

1 Office of Research Integrity / Office of Sponsored Projects IACUC PROTOCOL SUBMISSION GUIDE Coeus Lite Px Document Version 3 Updated May 2016

2 Table of Contents ABOUT COEUS... 3 o About the Coeus Lite Iacuc Protocol User Guide... 3 o Conventions Used in this Guide... 3 o Before you Begin... 4 I. GETTING STARTED... 5 o Iacuc Protocol Module Overview... 5 o Logging into Coeus Lite... 6 o Getting Help in Coeus... 7 o Accessing Coeus Lite Iacuc Protocol Module... 9 o Overview of the Coeus Lite My Iacuc Protocols Interface II. CREATING A NEW PROTOCOL o Navigating Coeus Lite o Creating the Protocol Shell III. ASSIGNING PROTOCOL ROLES o Adding a User to a Role o Removing a User From a Role IV. COMPLETING THE REMAINING PROTOCOL DETAILS SECTIONS o Completing the Organization Section o Completing the Investigators/Study Personnel Section o Adding a Funding Source o Adding Species/Groups o Adding Protocol Procedures o Completing the Alternative Search Section (amendments only) o Completing the Biosafety Review Section V. COMPLETING THE ATTACHMENTS SECTION o Completing the Attachment Section VI. VIEWING OTHER ATTACHMENTS SECTION VII. FINALIZING AND SUBMITTING THE PROTOCOL o Protocol Validations o Internal Validations (Brown Specific) o Submitting the Protocol VIII. CREATING AND SUBMITTING AN AMENDMENT o Creating an Amendment o Changing the protocol Px IACUC Submission Guide V.3 - Updated May 2016 Page 1 of 76

3 o Amending Existing Attachments o Completing the Alternative Search Section (amendments only) o Submitting the Amendment IX. CREATING AND SUBMITTING A CONTINUATION o Creating a Continuation o Submitting the Continuation X. CREATING AND SUBMITTING A DENOVO SUBMISSION (previously known as a 3 YEAR RENEWAL) o To copy an existing Active Protocol XI. RESUBMITTING A PROTOCOL THAT IS RETURNED IN ROUTING o Resubmitting a Protocol Submission Px IACUC Submission Guide V.3 - Updated May 2016 Page 2 of 76

4 ABOUT COEUS Coeus is a research administration and grant management system developed by the Massachusetts Institute of Technology's Office of Sponsored Programs and implemented by the University in April The system centralizes stored information about proposals, protocols, awards, & subawards and is the system of record for all research activities for the University. In addition, it contains interfaces for proposal-development and IACUC protocol submissions that are electronically routed and approved within Coeus. The IACUC Module in Coeus has been designed to allow Departmental Administrators and Investigators to construct full IACUC Protocols from the desktop and route the protocol online for internal approvals. The IACUC Module also serves as a database of all protocols developed by the department and is a central source to view the most current version of a protocol in progress. Coeus Lite is the web-based version of the Coeus application. The IACUC Module in Coeus Lite allows users to prepare and view protocols then route the completed application for IACUC review. o ABOUT THE COEUS LITE IACUC PROTOCOL USER GUIDE The Coeus Lite IACUC User Guide provides step-by-step instructions for creating and completing the protocol in Coeus Lite including uploading attachments, adding animal and procedure information and routing the submission for review. Chapter Getting Started Navigating Coeus Lite Starting the Protocol Record Assigning Protocol Roles Completing the Protocol Details Section Attachments Completing the Protocol Submitting and Approving Protocols Printing the Protocol Other Coeus Functions Description Provides an overview of the Protocol Development process, logging into Coeus and getting help. How to navigate the Coeus system. How to create the Protocol record and enter the general attributes. How grant other individuals access to the protocol. How to complete the remaining sections of the Protocol Details Section. How to upload protocol documents. Answering the Yes/No Questions, Answering the Questionnaire, Completing the Investigator Certifications, and Validating Protocol. Submitting protocols for approval and maintaining the Inbox. Printing the Brown Custom Forms. Viewing and Sending Comments. o CONVENTIONS USED IN THIS GUIDE These typographical conventions are used throughout this guide. Item Convention Example Menu and List item name / Icon that represents the same Bold, separated by function Select Edit Persons - Section or Screen of protocol record Bold, red Narratives Section Window or tab name Dotted underline IACUC Protocol List Window Field, checkbox, option icon, or key name Bold and underline, blue Protocol No. field Note of interest Tip Note image Light bulb image Px IACUC Submission Guide V.3 - Updated May 2016 Page 3 of 76

5 Item Convention Example New Functionality/Enhancement New sign Start of each procedure Bold and highlighted, grey PROCEDURE End of each procedure Bold and highlighted, grey End of Procedure Field Definition Field Name, blue Protocol No. Link Bold, blue LAUNCH COEUS LITE Button Bold and in brackets, blue [LOGIN] o BEFORE YOU BEGIN To create protocols in Coeus, you must have access to Coeus and you need to be assigned the Protocol Creator role in your home department. In order to access Coeus you must complete the Coeus Request for Access form - found on the Computing Accounts & Passwords Webpage. This form can take up to 10 days to process Px IACUC Submission Guide V.3 - Updated May 2016 Page 4 of 76

6 I. GETTING STARTED This section will introduce you the IACUC Protocol Module in Coeus Lite, instruct you how to login to Coeus, and demonstrate how to get help in Coeus. o IACUC PROTOCOL MODULE OVERVIEW The IACUC Protocol Module in Coeus has been designed to allow Departmental Administrators and Investigators to develop complete protocols from the desktop, electronically route protocols for IACUC review, and use active protocols as a foundation for annual and 3yr submissions along with Amendments. The use of Coeus IACUC Module supports Brown s efforts to comply with the electronic routing and approvals of Research Administration Compliance requirements. The IACUC Protocol Module has been designed to allow Departmental Administrators and Investigators to perform the following functions: Develop complete protocols from the desktop Route the protocol electronically for internal reviews and IACUC approval Access their portfolio of Protocols anywhere by logging in via webvpn Protocol Roles can be assigned at the departmental level. These assigned role(s) define the users rights to the protocols within that department. In addition, Protocol Roles can also be assigned to a specific protocol. The rights within each role are one or any combination of the following: For details about the functions that each Role can perform, please see Department Roles and Rights Document available on the Coeus website. Coeus Protocol Roles that can be assigned to a user are: Protocol Creator IACUC Protocol Aggregator IACUC Protocol Approver (assigned by business rules / maps) IACUC Protocol Viewer The Protocol Creator/IACUC Protocol Aggregator creates a protocol shell by entering the basic details of the protocol. Once the required Protocol Detail fields are entered and the record is saved, collaborative work on the protocol can be distributed to Investigators and/or Administrators to complete the required protocol components necessary for submission. The 4 main components to the IACUC Protocol Submission process are: 1. Protocol Details Entry 2. Animal and Procedure information 3. Attachments 4. Routing / Approvals / Submission Px IACUC Submission Guide V.3 - Updated May 2016 Page 5 of 76

7 o LOGGING INTO COEUS LITE In order to access Coeus you must complete the Coeus Request for Access form - found on the Computing Accounts & Passwords Webpage ( The Coeus application authenticates using your Brown User ID and Password. PROCEDURE 1. To begin, use your internet browser to access the URL for the Coeus download page: OR Go to the Coeus Support Webpage at to access the link to Coeus Lite. 2. To open Coeus Lite; Open your browser and navigate to the Coeus page or copy and paste the Coeus link into your browser address bar. Click on the LAUNCH COEUS LITE link. 3. You will be directed to this Coeus Login Page after you click the LAUNCH COEUS LITE link. The Coeus application requires your Brown User Name and Password for login Px IACUC Submission Guide V.3 - Updated May 2016 Page 6 of 76

8 Click in the User Name field and enter your Brown User Name. Click in the Password field and enter your Brown Password. Click on the [LOGIN] button The Coeus Lite Homepage will open where you can access your protocols. End of Procedure o GETTING HELP IN COEUS The Coeus Lite application contains a help link which directs the user to the Coeus Support Webpage. PROCEDURE To get to the Coeus Support Webpage from the Coeus Lite application: 1. While in the Welcome to Coeus Lite Page, click on the COEUS SUPPORT PAGE link on the left hand side of the page. The Coeus Support Webpage will open Px IACUC Submission Guide V.3 - Updated May 2016 Page 7 of 76

9 2. Click on the COEUS IACUC PROTOCOL SUBMISSION link on the left-side navigation to get to the IACUC Protocol documentation. There are various topics to choose from the left-side navigation. The right-side navigation provides additional quick resources and training information. 3. To close the Coeus Support Webpage and return to the Coeus Application, click on the red [X] button in the top right hand corner of the window browser. End of Procedure Px IACUC Submission Guide V.3 - Updated May 2016 Page 8 of 76

10 o ACCESSING COEUS LITE IACUC PROTOCOL MODULE In this topic you will learn how to access the IACUC Protocol Module. PROCEDURE After logging in as described earlier, the first screen you will see if the Welcome to Coeus Lite Page. Welcome to Coeus Lite Page contains the following links in the toolbar (Tabs that are greyed out are currently not Used): Coeus Home My Negotiations My Proposals My Awards My COI My IRB Protocols My IACUC Protocols Inbox My AARA Logout Brings you back to the Coeus Lite Welcome Screen Currently not used Proposal Development Module Currently not used Currently not used Currently not used IACUC Module Coeus Lite Inbox stores the messages related to your Coeus Applications Currently not used Use to logout of the system 1. Click on the MY IACUC PROTOCOLS link to access the module. A new screen with a series of links will open with the default view to the Pending Protocols Screen Px IACUC Submission Guide V.3 - Updated May 2016 Page 9 of 76

11 o OVERVIEW OF THE COEUS LITE MY IACUC PROTOCOLS INTERFACE Elements of the Coeus Lite My IACUC Protocol Screen are called out in the illustration below and described in the table that follows. 1. All Protocols 2. Protocols pending 3. Protocols that need a PI Action 4. All Amendments, Continuations, and Renewals 5. Start a New Protocol 6. Search all protocols 7. Items waiting for Review 8. IACUC meeting schedule Element All Protocols Pending Protocols Pending PI Action Amendments & Renewals Create New Protocol Protocol Search All My Reviews Schedules Description Lists all Coeus Protocols that you have a role on ( In Progress, Routing in Progress, Submitted to IACUC, etc.) Displays all non-approved protocols that you hold a view or modify role on. Lists protocol submissions that were returned to the PI for corrections. (Minor Revisions Required, Major Revisions Required or Expiring Protocols) Lists all Amendments, Continuations, and 3yr Renewals that are not yet approved. Allows you to start a New protocol in Coeus. Allows you to search for a specific protocol. Only active to IACUC committee members, this screen will list all submissions waiting for this member s review. Only active to IACUC committee members, this screen will list protocols submitted to the IACUC meeting for review, and a PDF copy of the Agenda Px IACUC Submission Guide V.3 - Updated May 2016 Page 10 of 76

12 II. CREATING A NEW PROTOCOL This section will explain how to create a new protocol. PROCEDURE In order to create a protocol, you must be assigned the role of Protocol Creator for your department. 1. While in the Welcome to Coeus Lite Page, click on the MY IACUC PROTOCOL link. 2. A new screen with a series of tabs will open with the default view to the Pending Protocols Screen. 3. To create a new protocol, click on the CREATE NEW PROTOCOL link Px IACUC Submission Guide V.3 - Updated May 2016 Page 11 of 76

13 4. The IACUC Protocol record opens to the General Info Screen. End of Procedure o NAVIGATING COEUS LITE There are numerous sections on this page where information about the protocol is entered. Use the Navigation Panel Links to navigate your protocol. Do not use your Browser s Back or Forward buttons these functions are not supported for use in navigation in Coeus Lite Px IACUC Submission Guide V.3 - Updated May 2016 Page 12 of 76

14 Use the following Navigation Panel links to navigate your protocol: GENERAL INFO ORGANIZATION INVESTIGATORS/KEY PERSONNEL FUNDING SOURCE SPECIES/GROUPS PROCEDURES ALTERNATIVE SEARCH BIOSAFETY REVIEW NOTES ATTACHMENTS OTHER ATTACHMENTS VALIDATE SUBMIT TO IACUC AMENDMENT/RENEWALS HISTORY VIEW HISTORY SEND ACCESS PERMISSIONS COPY PROTOCOL PRINT SUMMARY Enter specific details required to create and save a proposal. This panel will always be the first screen presented when a protocol is selected. Displays the contact information of the submitting organization, performing organization, and allows users to add performing sites of additional locations. Add Investigators and Study Personnel and customize their roles, and contact information. Contains the entity responsible for funding the protocol. Identifies species, number requested, pain category and exception information that will be submitted for approval. Identifies the procedures proposed, organized by species group, and the locations where proposed procedures will take place. Contains Alternative Search information for protocols that request animals to be used under pain category D or E (for amendments only) Indicates that the proposed protocol requires Institutional Biosafety Committee or Radiation Safety Committee approval or that approval is already in place. Currently Not Used Navigates to the file upload section, for all protocol attachments. Contains Attachments uploaded by the IACUC office. Allows user to manually run validation checks on the protocol at any time. Routes protocols for internal approval. Lists all Amendment, Continuations and 3yr Renewals that have been created for this protocol. Lists all actions taken on the protocol, date, and system generated comments. Navigates to the notification function that allows users to generate and send messages through Coeus. Add or Remove user access to your protocol. Allows users to copy all or part of the protocol to a new protocol. Allow users to generate all of the information in the protocol, including attachments into a PDF document Px IACUC Submission Guide V.3 - Updated May 2016 Page 13 of 76

15 o CREATING THE PROTOCOL SHELL To create a new IACUC Protocol record in Coeus Lite you need to enter a few basic details in order to create and save the protocol record. Once the protocol record is created, it can be updated and modified at any time. The General Info Screen is the default view upon opening a protocol. PROCEDURE The General Info Screen has four mandatory fields that need to be completed on the Protocol record. The red asterisk (*) indicates fields that need to be completed to save the record: Protocol Type Project Type (system default) Title Application Date ( system default) 1. Complete the required fields: a. Protocol Type Select the appropriate type to describe the purpose of animal use from the list of values by clicking on the arrow button to the right of the Protocol Type field to generate the drop-down menu. The Protocol Types are as follows: Protocol Type Research - Domestic Holding Training Sentinel Program Research/Training MOU/IIA Research - International Description Basic or applied research projects. For ACF use only to be used for the central University holding protocol. Project provides research training in a particular concept or area of science. For ACF- use only to be used for the central University sentinel program. Project includes components of basic or applied research and research training. For IACUC office use only Basic or applied research with international collaboration. b. Project Type System default; no action is required by the user Px IACUC Submission Guide V.3 - Updated May 2016 Page 14 of 76

16 c. Title - Click on the Title field and enter the protocol title. This title can be modified at any point while the status of the protocol is In Progress. d. Application Date Application date is the date the protocol was created and saved in COEUS. This date will default by the system; no action is required by the user. The following fields are not used on the General Info Screen: Reference Num 1 Reference Num 2 2. When the required fields are completed, save the record by clicking on the [SAVE] button at the bottom of the screen. 3. When you click [SAVE], the following information will appear at the top of your Protocol Record indicating that the base protocol record has been created: End of Procedure III. ASSIGNING PROTOCOL ROLES The Protocol Creator/Aggregator for a given protocol by default has the rights to modify all parts of the protocol. There are times, however, when another user, i.e. Investigator, will need to be granted access to the protocol in order to either modify or view it. The Aggregator(s) for the protocol may grant access to any other users who may collaborate on the development of the protocol by assigning users to specific roles on the protocol. Any roles assigned to a user apply only to the current protocol they are assigned to, NOT all protocols for the department. In this topic you will learn how to grant/assign individuals view or modify access to your protocol by assigning them to IACUC Protocol Roles. Roles can be assigned at any point once the IACUC Protocol shell is created. PROCEDURE You have the ability to grant individuals view only or modify access to your protocol. To open the Access Permission Section: Px IACUC Submission Guide V.3 - Updated May 2016 Page 15 of 76

17 1. Select the ACCESS PERMISSION link in the Navigation Pane on the left side of the screen. 2. The Protocol Roles Screen will open. The Protocol Roles are as follows: IACUC Protocol Aggregator IACUC Protocol Approver IACUC Protocol Viewer See document available on Coeus Website Department Roles & Rights - for definitions of each role. Any roles you assign to a user apply only to the current protocol. If you copy a protocol, access rights do not carry over. Access rights apply only to the specific protocol number in which they are granted Px IACUC Submission Guide V.3 - Updated May 2016 Page 16 of 76

18 o ADDING A USER TO A ROLE To assign users to protocol roles: 1. Click on the ADD USER link located right to each of the available Protocol Roles. The Employee Search Window will open: 2. Enter the search criteria for the user you want to add in the Employee Search Window and click on the [SEARCH] button. You can search by User ID, User Name, Unit Name, etc. 3. The search results will be displayed in the User Search Result Window. To add the individual to that particular role, just click on the name Px IACUC Submission Guide V.3 - Updated May 2016 Page 17 of 76

19 4. The user you have selected will appear in the Protocol Roles Screen under the role you selected the ADD USER link for. You can add any number of users to a role. End of Procedure o REMOVING A USER FROM A ROLE PROCEDURE 1. If necessary, click on the plus button to expand the list of users under the role from which you want to remove a user. 2. Click on the REMOVE link next to the user you want to remove. 3. Click on the [OK] button when you get the following message: Px IACUC Submission Guide V.3 - Updated May 2016 Page 18 of 76

20 The selected user will be deleted. End of Procedure IV. COMPLETING THE REMAINING PROTOCOL DETAILS SECTIONS This section will explain how to complete the remaining Protocol Details Sections. There are several sections within Coeus Lite where information about the proposed protocol is entered. The information entered in these sections is used to create a protocol submission that will be submitted electronically for IACUC approval. Once a Protocol record is initiated, the Protocol Roles assigned, and the General Info Section saved; the remaining sections need to be completed. These sections are: 1. General Info - (Completed in a previous topic) 2. Organization 3. Investigators/Study Personnel 4. Funding Source 5. Species/Groups 6. Procedures 7. Alternative Search (applies to AMENDMENTS ONLY) 8. Biosafety Review 9. Attachments In this topic you will complete the above mentioned sections Px IACUC Submission Guide V.3 - Updated May 2016 Page 19 of 76

21 o COMPLETING THE ORGANIZATION SECTION The Organization Section contains the contact information for Brown University, other Organizations and Performing Locations/Sites for the project. Protocol Organization Specifies the Performing Organization and additional locations of the protocol. The Performing Organization will default to Brown University. The Organization/Location Types are as follows: Required: Performing Organization The organization responsible for the review of this protocol, defaults to Brown University. Not Required: Facilities Use Agreement Should be selected if there is or will be an agreement in place with another Non-Brown entity using Brown s facilities Formal agreement is required, click the ADD ORGANIZATION/LOCATION link and select Facilities Use Agreement as the Type. Brown Owned Animals at Org This type should be selected if Brown owned animals are being used in this location. Click on the ADD ORGANIZATION/LOCATION link and select Brown Owned Animals at Org. Non Brown Animals at Brown This type should be selected if animals are used at Brown but are owned by another institution and are not covered under a Facilities Use Agreement. MOU/IIA This type should be selected if there is or if there will be a Memorandum of Understanding or an Inter-Institutional Agreement in place. Address The Address Section will default to the official address of the selected Organization entered in Coeus; you cannot modify the address information for the Performing or Other Organization types Px IACUC Submission Guide V.3 - Updated May 2016 Page 20 of 76

22 PROCEDURE 1. To navigate to the Organization Section by selecting the ORGANIZATION link in the Navigation Pane on the left side of the screen. The Organization Section will open: 2. To enter Other Organizations in the Organization Screen, click on the ADD ORGANIZATION link located at the top of the screen. A new Protocol Organization panel will be created above the default Organization data. a. Select the desired Type from the drop-down list: Px IACUC Submission Guide V.3 - Updated May 2016 Page 21 of 76

23 b. Add the Organization click on SEARCH link to open the Organization Search Window. Type in your search criteria and click on the [SEARCH] button. c. In the Organization Search Window, type in your search criteria and click on the [SEARCH] button. If you cannot find the location, contact to have the organization added to Coeus. Search Criteria d. Your results will be displayed in the Organization Search Result Window. Select and click on the Organization you want to add Px IACUC Submission Guide V.3 - Updated May 2016 Page 22 of 76

24 The entry will become listed in the Organization field. e. Click the [SAVE] button to save the organization and add it to the record. The default address of the organization you selected will populate the Protocol Organization Screen of the Protocol record. 3. Repeat this process to add as many Organizations and Organization Types to the record as needed. End of Procedure Px IACUC Submission Guide V.3 - Updated May 2016 Page 23 of 76

25 o COMPLETING THE INVESTIGATORS/STUDY PERSONNEL SECTION The Investigators/Study Personnel Section identifies the Principal Investigator (PI), Co-Investigators, and Study Personnel of the protocol. Individuals included in the Investigators/Study Personnel Section: Principal Investigator (PI) Individual primarily responsible for the design, conduct and reporting of a project Co-Investigator (Co-I) Individual involved with the design, conduct and report of a project Study Personnel Individuals working on the project other than the PI and Co-Investigator o Types of Study Personnel: Protocol Personnel Lab or dept staff working on the protocol Animal Care Staff Animal Care Staff members performing specific protocol functions Lab Manager Individual to whom responsibility is delegated for laboratory management Faculty Mentor Required faculty oversight for postdoctoral PI s In this topic you will enter all Investigators and Study Personnel. PROCEDURE 1. To navigate to the Investigators/Study Personnel Section, select the INVESTIGATORS/STUDY PERSONNEL link in the Navigation Pane on the left side of the screen. The Investigators/Study Personnel Screen has two database tables that can be searched to add Investigators to the Investigator Tab. The Person Table EMPLOYEE SEARCH link Searches all Brown employees - populated with info from Brown's Human Resources Database. The Rolodex Table NON EMPLOYEE SEARCH link Searches all Non-Brown employees - manually entered in the Rolodex. (New faculty may be located in the Rolodex until they have an official record in the Human Resources database.) 2. To enter the Principal Investigator, Co-Investigators, and Study Personnel who are Brown employees, click on the EMPLOYEE SEARCH link to search for them Px IACUC Submission Guide V.3 - Updated May 2016 Page 24 of 76

26 A Red message will appear and notify the user that has navigated to the Investigator/ Study Personnel Section, that by default their names will populate the Name field in this section. This does not mean they are added to the protocol. Click the EMPLOYEE SEARCH link to search the Brown directory for the Investigator or Study Personnel you would like to add or click the NON-EMPLOYEE SEARCH link to search the rolodex. This default will only appear when you click in this section for the first time. The Person Search Window will open. a. You can search by Last Name, First Name, and Full Name, or by User Name. It is recommended to search the Last Name field and to use the asterisks (*) before and after all or part of the last name. For example, enter "*lastname*". (You can narrow your search by entering *firstname* of the individual in the first name field when searching.) b. Click the [SEARCH] button to conduct your search. A listing of all individuals that meet the search criteria will display in the Person Search Result Window. Select and click on the individual you want to add. c. The information for the individual selected will be displayed in the Investigator/Study Personnel Details Section Px IACUC Submission Guide V.3 - Updated May 2016 Page 25 of 76

27 d. Complete the information in the above screen Protocol Role Person Role Affiliation Select the individual s role on the protocol (Principal Investigator, Co-Investigator, Study Personnel) If Study Personnel is selected as the Protocol Role, select the Person Role from the drop-down (Protocol Personnel, Animal Care Staff, Lab Manager, Faculty Mentor) Select the correct affiliation type for the individual selected (Faculty, Non-Faculty, Post- Doctoral, Graduate Student, Undergraduate, Non-Brown) e. Click on the [SAVE] button to save your entry. f. Upon clicking the [SAVE] button; the Individual will appear in the List of Investigators/Study Personnel Details Section at the bottom portion of the screen. To add another individual, click the ADD INVESTIGATOR/STUDY PERSONNEL INFORMATION link to create a blank field. 3. To enter the Principal Investigator, Co-Investigators, and Key Personnel who are non-brown employees, click on the NON EMPLOYEE SEARCH link to search for them. A PI could be a Non-Brown employee if he/she is coming to Brown, but has not yet been added to the HR system Px IACUC Submission Guide V.3 - Updated May 2016 Page 26 of 76

28 The Person Search Window - Rolodex will open. a. You can search by Rolodex Id, Sponsor Code, Sponsor Name, Last Name, First Name, and Middle Name. It is recommended to search the Last Name field and to use the asterisks (*) before and after all or part of the last name. For example, enter "*lastname*". (You can narrow your search by entering *firstname* of the individual in the first name field when searching.) If you do NOT find the person in the Rolodex, you will need to COEUS-IACUC-Help@brown.edu for the information to be entered into COEUS. Be sure to include the name, address, phone, and organization or sponsor they are associated with. b. Once the search criteria have been entered, click on the [SEARCH] button to conduct your search. A listing of all individuals that meet the search criteria will display in the Person Search Result Window. Select and click on the individual you want to add Px IACUC Submission Guide V.3 - Updated May 2016 Page 27 of 76

29 c. The information for the individual selected will be displayed in the Investigator/ Study Personnel Details Screen. d. Complete the information in the above screen (the fields that are editable are displayed in white; the noneditable fields are grayed out). Unit Protocol Role Person Role Affiliation If the Rolodex entry is for a PI or Co-I, click on the SEARCH link to search for the department that will be the home unit for the protocol. Required Select the individual s role on the protocol (Principal Investigator, Co-Investigator, Study Personnel) If Study Personnel is selected as the Protocol Role, select the Person Role from the drop-down (Protocol Personnel, Animal Care Staff, Lab Manager, Faculty Mentor) Select the correct affiliation type for the individual selected (Faculty, Non-Faculty, Post- Doctoral, Graduate Student, Undergraduate, Non Brown) e. Click on the [SAVE] button to save your entry. Upon clicking the [SAVE] button; the individual will appear in the list of Investigators/Key Study Personnel Details at the bottom portion of the screen 4. Repeat the above steps to add additional Investigators and Study Personnel. End of Procedure o ADDING A FUNDING SOURCE The Funding Source tab stores information about related Sponsors & Proposals. Each protocol must have at least one sponsor listed in the protocol. If the protocol is not associated with an external sponsor, list Brown University for internal/department funding. PROCEDURE List the Sponsor responsible for funding the protocol. If the protocol is externally funded then the Institute Proposal must be link so that the reviewers can access that information. To add a Sponsor to a protocol record: Px IACUC Submission Guide V.3 - Updated May 2016 Page 28 of 76

30 1. Select the FUNDING SOURCE link in the Navigation Pane on the left side of the screen. The Funding Source Screen will open: 2. Click on the ADD FUNDING SOURCE link at the top of the screen to open new fields. 3. Select Sponsor from the Type drop-down list. a. Click on the SEARCH link to open the Search Window of the Sponsor Table. b. Use the search fields to locate the Sponsor that will fund the project and click on the [SEARCH] button to return results Px IACUC Submission Guide V.3 - Updated May 2016 Page 29 of 76

31 c. In the Sponsor Search Results Window, click on the name of the Sponsor that you want to add as the funding source to the protocol. 4. Click on the [SAVE] button to add the Sponsor to the protocol. Once the Sponsor is saved it will be listed in the bottom section of the screen. 5. Repeat these steps to add more sponsors if required. To add an Institute Proposal to a protocol record: 5. Click on the ADD FUNDING SOURCE link at the top of the screen to open a new field. 6. Select Institute Proposal from the Type drop-down list Px IACUC Submission Guide V.3 - Updated May 2016 Page 30 of 76

32 a. Click on the SEARCH link, this will open the Proposal Search Window for the Institute Proposal table. b. Use the search criteria to locate the proposal that will be funding the protocol. Click on the name to add the proposal to the protocol record. c. In the Select Proposal Results Window, click on the name of the IP you want to add to the protocol record. 7. Click on the [SAVE] button to add the Institute Proposal to the record. When the record is save the Institute Proposal will appear under the Sponsor in the Funding Source Screen. End of Procedure Px IACUC Submission Guide V.3 - Updated May 2016 Page 31 of 76

33 o ADDING SPECIES/GROUPS Animals should be added to the protocol in groups based on species and pain category, and should be entered in the Species/Groups Screen. Information added in the Species/Groups Screen will automatically flow into the Procedures Screen and will auto populate certain fields in this section. PROCEDURE Each species groups will need a unique name to help organize the information. This naming convention is up to the PI developing the protocol. To enter Species/Group information: 1. Select the SPECIES/GROUPS link in the Navigation Pane on the left side of the screen. 2. Click on the ADD SPECIES/GROUPS link to open the Species / Groups Screen. 3. In the Group field, enter the Group Name. (Group is an open text field) The Group name must be a unique identified for each group listed. Keep in mind that only one species and one pain category can be assigned per each group you add. That may help you determine how many groups you will need to add and how they should be named Px IACUC Submission Guide V.3 - Updated May 2016 Page 32 of 76

34 4. From the Species drop-down, select the species that corresponds to the group you added. Species are listed in alphabetical order. If there is (USDA) next to the Species name, the USDA Covered Type checkbox will automatically be checked. 5. In the Species Strain field, enter a Species Strain A group of individuals which share a presumed common ancestry and have clear-cut physiological but not usually morphological distinctions. (Not a Required Field) 6. From the Pain Category drop-down, select a Pain Category All vertebrate animals used for research or teaching must be assigned to a USDA Pain and Distress Category. Only one pain category per group can be assigned Px IACUC Submission Guide V.3 - Updated May 2016 Page 33 of 76

35 7. From the Count Type drop-down defaults to Animals, if not correct, select the unit of measure. 8. In the Count field enter the number of units requested; Count field is a text field. 9. If there is an Exception on the protocol for the group you added which means that the protocol included a departure from the Guide for the Care and Use of Laboratory Animals, the Exception checkbox will automatically get checked, upon selecting an Exception checkbox, from the list. 10. If selecting Other as the Exception, Enter the description in the box provided (required) 11. When all Exceptions have been enter for this group, click on the [SAVE] button to add the information to the record. 12. Repeat these steps to add more Species/Groups. End of Procedure Px IACUC Submission Guide V.3 - Updated May 2016 Page 34 of 76

36 o ADDING PROTOCOL PROCEDURES Procedure must be identified for each species group added to your protocol. This information gets captured in the Procedures Section where a list of procedures performed on the species is identified along with the location and responsible persons. PROCEDURE To add Procedures to a Protocol: 1. Select the PROCEDURES link in the Navigation Pane on the left side of the screen. The Procedures Section will open and contain 4 new tabs located within this section. Protocol Procedure Procedure Location View All Screen where procedures are assigned to the protocol. Screen where specific location can be assigned to specific procedures or to all procedures for a group. Summary screen containing information from all other tabs within the procedure sections. 2. In the Protocol Procedure Tab, click on the ADD PROCEDURES link for a selected group. The Procedures list will open in a window above the procedures screen. Expand the list of Procedure Categories by clicking on the symbol and select the specific procedures. This is a multi-select box Check all procedures that apply to this group. When finished, click on the [OK] button. The procedures will be listed under the Group name in the Protocol Procedures Tab Px IACUC Submission Guide V.3 - Updated May 2016 Page 35 of 76

37 a. Repeat these steps for each group on the protocol. There are several new fields that appear next to the procedure name: Count Remove Locations Additional Information This should always be noted as 0. It is not required to note counts by procedure category. Link will remove the procedure from the group. Displays the locations assigned to the procedure, once information is set up in the Procedure Locations Tab. Provides ability to add additional information to the protocol about the specific procedure. This information is required, if the link is present. b. To add additional information, click on the ADDITIONAL INFORMATION link and new fields will open. Add the information as it applies to the protocol Additional Information is only required for procedures listed under the Procedure Categories of Drugs, Hazardous Agent Use & Surgery. Example: For Procedures listed under the Drug procedure category Enter the Name of Drug and select the Class, if controlled. c. When all additional information has been entered, click on the [SAVE] button to add information to the record Px IACUC Submission Guide V.3 - Updated May 2016 Page 36 of 76

38 Once all Procedures have been assigned and all additional information has been completed, move on to adding procedure locations. 3. Click on the Procedure Location Tab of the Procedures Screen to add location(s) to each procedure identified. The Protocol Procedures Screen will open. a. Click the ADD LOCATION link, to display new fields. b. Select the Location Type from the drop-down list. Location Type Brown Non Brown Description Locations on the Brown University Campus Locations at other Institutions c. Select the Location Name from the drop down list. If Brown is selected as the Location Type, only Brown facilities will be listed Px IACUC Submission Guide V.3 - Updated May 2016 Page 37 of 76

39 If Non Brown is selected as the Location Type, only Non Brown facilities will be listed. d. Enter the Room number. e. Enter the Description. This information is optional and applies to non-brown locations. f. Assign Procedure to the Location. You can assign specific procedures to a location, you can assign all procedures on the protocol or you can view which procedures have been assigned and which have not. ADD PROCEDURES Link: the Procedures List Window will open and you can select specific procedures to assign to a location. ASSIGN ALL PROCEDURES Link will assign all procedures listed on a protocol to the location selected. Upon clicking on the ASSIGN ALL PROCEDURES link, a confirmation window will open. Click on the [OK] button to assign all procedures to the selected location Px IACUC Submission Guide V.3 - Updated May 2016 Page 38 of 76

40 VIEW ASSIGNED PROCEDURES Link will indicate which procedures have been assigned to a location. g. Once all locations have been assigned to procedures, click on the [OK] button. h. To remove a location from the record, click on the REMOVE PROCEDURE LOCATION link. i. A warning message will appear asking if you want to remove the location. Click on the [OK] button and the location will be removed from the protocol. 5. Now that all the information has been entered there are 2 ways to view the Procedure information: Protocol Procedure Tab - Now that information has been entered when you click on the PERSONS link or the LOCATION link, information will appear on the screen Px IACUC Submission Guide V.3 - Updated May 2016 Page 39 of 76

41 View All Tab This screen will give a complete summary of all information added to the Procedures Section. Click on the symbol to expand the group to display all the information listed. End of Procedure Px IACUC Submission Guide V.3 - Updated May 2016 Page 40 of 76

42 o COMPLETING THE ALTERNATIVE SEARCH SECTION (AMENDMENTS ONLY) During this time of transition, please DO NOT complete this information for new or de novo (renewal) protocols. Alternative search information should only be provided if you are submitting an amendment. o COMPLETING THE BIOSAFETY REVIEW SECTION The Biosafety Review Section is used to note and track other protocol related information that must be acted on by the Institution s IACUC. Protocol specific Institutional Biosafety Committee review is an example of a special review that must be entered (if applicable). In this topic you will complete the information regarding the Institutional Biosafety Committee or Radiation Safety Committee. You should only complete this information if IBC or RSC approval is required for the protocol. If IBC or RSC approval is not required, then omit this section. PROCEDURE 1. To navigate to the Biosafety Review Section, select the BIOSAFETY REVIEW link in the Navigation Panel on the left side of the screen. 2. Click the ADD BIOSAFETY REVIEW link 3. To indicate that Institutional Biosafety Committee review/approval is required, select Institutional Biosafety Committee from the Biosafety Review drop-down Px IACUC Submission Guide V.3 - Updated May 2016 Page 41 of 76

43 4. Click the drop-down box in the field labeled Approval and select a status appropriate to the review. If you select Pending status, then all required information has been entered. (Leave approval date blank if pending) If you select Approved status, then enter a date into the Approval Date field. The Application Date field and the Expiration Date field are not required. Coeus does not store or track Institutional Biosafety Committee date information. 5. Click on the [SAVE] button to save your entry. Upon clicking the [SAVE] button; the Biosafety Review will appear on the List of Biosafety Review Section at the bottom portion of the screen. End of Procedure Px IACUC Submission Guide V.3 - Updated May 2016 Page 42 of 76

44 V. COMPLETING THE ATTACHMENTS SECTION The Attachments section stores the scientific documents, Study Personnel, Certifications, etc. pertinent to the Protocol. *The required forms for the different Protocol Submission types are located on the IACUC Protocol Forms Webpage. o COMPLETING THE ATTACHMENT SECTION The Attachments Section is the section of the protocol that will contain all of the uploaded documents. In this topic you will learn which attachments are required for each protocol and how to upload them into a protocol submission. All Uploaded attachments need to be a PDF document. No other types are accepted. PROCEDURE 1. To navigate to the Attachment Section, select the ATTACHMENTS link in the left hand Navigation Pane on the left side of the screen. 2. Click on the ADD NEW DOCUMENT link. New fields will become available. 3. Select the document you want to upload from the Document Type drop-down list Px IACUC Submission Guide V.3 - Updated May 2016 Page 43 of 76

45 a. Document Types will be used to define the type of document that is attached. Document Type Animal Use Document Amendment Document Other Protocol Attachments Description The Animal Use document is required for all Initial Protocol Submissions (new protocols and three year renewals). Complete appendices as they apply to the study. The amendment form is required for all amendments. Complete appendices as they apply the amendment. Other Protocol Attachments can be used if the aggregator would like to attach additional information. (Not Required) 4. Enter the Description of the document in the provided field. For multiple documents type add a specific description for each one. For example if there are several investigators that each need their CV uploaded. Each description should begin with the individual s last name. 5. Click on the [BROWSE] to search for your document. 6. Search for the file on your computer and click on the [OPEN] button to select it. 7. Click on the [SAVE] button to add the attachment to the protocol record Px IACUC Submission Guide V.3 - Updated May 2016 Page 44 of 76

46 All Files will be listed in the New/Changed Attachments Section of the Attachments Screen. 1. Repeat these steps to add other required/optional attachments. End of Procedure Px IACUC Submission Guide V.3 - Updated May 2016 Page 45 of 76

47 VI. VIEWING OTHER ATTACHMENTS SECTION The Others Attachments Section will be used by the IACUC Administrator to upload Revision letters that are ed to the Investigator/department or store the original protocol submission if submitted prior to Coeus. This screen requires NO DATA ENTRY from the Investigator or department. PROCEDURE 1. To navigate to the Others Attachment Section, select the OTHERS ATTACHMENT link in the Navigation Pane on the left side of the screen. 2. To view the document, click on the VIEW link and the PDF document will open. End of Procedure Px IACUC Submission Guide V.3 - Updated May 2016 Page 46 of 76

48 VII. FINALIZING AND SUBMITTING THE PROTOCOL This section will explain how to validate the protocol and submit it electronically for approval. o PROTOCOL VALIDATIONS When you run the Coeus Validation Check, it will notify you if you have missed or failed to complete any required elements of your protocol. The validations review your protocol data and will check Coeus specific and Brown specific requirements. About Validations : Coeus contains 2 different validations that are used to verify that the data you entered in the protocol meets the criteria of the selected validation that is run against the protocol. There are two unique validation mechanisms pertaining to IACUC in Coeus: 1) Internal Validations (Brown Specific) 2) Coeus Validations In Coeus Lite, all the different validations will be run at the same time. o INTERNAL VALIDATIONS (BROWN SPECIFIC) This type of validation checks for completion of all the required data that is needed for a complete protocol. PROCEDURE 1. To perform the Validation check, click on the VALIDATE link located in the left hand navigation panel. 2. Once you click on the VALIDATE link, the validations will run. If data is missing, the Validation Screen will open displaying items that did not meet the requirements for the protocol Px IACUC Submission Guide V.3 - Updated May 2016 Page 47 of 76

49 Errors listed in Red must be fixed before the protocol can be submitted for routing. Warnings are listed in Blue. These are items that should be considered based on information entered in the protocol, but will not stop a protocol from being submitted. 3. Once the Errors/Warnings have been addressed, click on the VALIDATE link again. You should receive the following message: All Coeus Valuation rules were passed successfully If this is the case you can now submit the protocol for routing. If you forget to click on the VALIDATE link, all validation will automatically run when you click on the SUBMIT TO IACUC link. Click the [OK] button to continue with the protocol submission. End of Procedure o SUBMITTING THE PROTOCOL When the Protocol submission is complete it is ready to be electronically routed to the Research Protections Office (RPO). PROCEDURE 1. Click on the SUBMIT TO IACUC link located in the left hand navigation panel. Coeus will check once again if all Validation Rules were passed or not Px IACUC Submission Guide V.3 - Updated May 2016 Page 48 of 76

50 2. Click on the SUBMIT FOR REVIEW link located in the Protocol Actions Screen. The Validations will run again, but should be passed unless there are warnings. Click on the [OK] button to continue. A message will appear asking Do you want to submit the Protocol? Click on the [OK] button to continue with the protocol submission. The Protocol Submission Screen will open. 3. In the Protocol Submission Screen select: a. The appropriate Type (Submission Type). (Required field) Submission Type Initial Submission Response to Previous IACUC Notification Request to Deactivate Request to Lift Hold FYI Amendment Renewal Continuation/Continuing Review Description An original protocol submission. First submission of a project. Currently Not Used. Currently Not Used. Currently Not Used. Currently Not Used. An amendment to a currently active protocol. 3 year submission, used to re-evaluate the project. Submission of annual progress reports that are required for the continuation of IACUC approval. b. The Review Type Administrative Review. (Required field) The Type Qualifier field is Currently Not Used Px IACUC Submission Guide V.3 - Updated May 2016 Page 49 of 76

51 4. After selections are made, click on the [SUBMIT] button. A warning message will come up asking if you wish to submit the protocol. 5. Click on the [OK] button for the final submission action. Once the Protocol has been successful submitted you will receive a confirmation message in the protocol screen. The status of the protocol is now Routing in Progress and the individuals listed on the routing map have been electronically notified that there is a submission waiting for review. The Protocol is also locked down and cannot be modified by the department. End of Procedure Px IACUC Submission Guide V.3 - Updated May 2016 Page 50 of 76

52 VIII. CREATING AND SUBMITTING AN AMENDMENT This section will explain how to create and submit an Amendment to an Active protocol. Amendment can only be made to a protocol that is Active, meaning it is approved by the IACUC. Any type of change to the active protocol needs to be approved prior to implementing. If you have any questions about whether a change requires an amendment, contact the Animal Research Protection Program. (Examples of most common changes are: adding personnel, adding animals, adding procedures and/or adding/changing locations) Any change that is implemented before obtaining approval could jeopardize the approval of the project as a whole and/or disrupt funding of a grant. When in doubt submit an amendment. *The required forms for the different Protocol Submission types are located on the IACUC Protocol Forms Webpage. o CREATING AN AMENDMENT PROCEDURE 1. Follow steps in section I. Getting Started Logging into Coeus Lite of this guide to log into Coeus Lite using your Brown username and password. 2. Once logged in, from the Home Screen click on the MY IACUC PROTOCOLS link at the top of the page Px IACUC Submission Guide V.3 - Updated May 2016 Page 51 of 76

53 Now that you are in the IACUC Module, Coeus will by default display all of the Pending Protocols, these are protocols submission that you are in the process of working on or that have been submitted to the Research Protections Office and are waiting for approval. 3. To view all of your Active or Approved protocols, click the ALL PROTOCOLS link, in the IACUC navigation. All of your protocols will be displayed regardless of their status: 4. Locate the Active protocol that you want to amend and click directly on the link. The protocol will open in display mode, meaning no changes can be made to the protocol record. 5. To request an amendment to the protocol, click on the NEW AMENDMENT link from the left hand navigation Px IACUC Submission Guide V.3 - Updated May 2016 Page 52 of 76

54 A New Amendment will open where you will be able to enter the required information to complete the amendment request. 6. In the New Amendment Screen, complete the following: a. In the Amendment Summary textbox, enter the following: Amendment Requested b. Check the checkboxes for each section of your protocol that you want to change. Remember to check the Add/Modify Attachments box in addition to any other section. You will need to upload the Amendment document along with any changes to the COEUS screens Px IACUC Submission Guide V.3 - Updated May 2016 Page 53 of 76

55 The Amendment upload document can be found on the IACUC website. When complete save as a PDF file. Only PDF s can be uploaded into COEUS. c. Click on the [SAVE] button, to save your entries. Once the Amendment is saved, the protocol number will display an extension (A001) which stands for the type of submission (A = Amendment) and the number is the number of the submission on the protocol (001 = is the Amendment #1) The Status of the submission also changes to Pending/In Progress this is for the submission only the approved protocol is still listed as Active. End of Procedure Px IACUC Submission Guide V.3 - Updated May 2016 Page 54 of 76

56 o CHANGING THE PROTOCOL PROCEDURE 1. Navigate to the screens that are checked off and saved on the Summary Screen, these screens are now open and editable. 2. Follow the prior section s instructions to update the information. When the screens in Coeus are updated and the Amendment document is complete and saved as a PDF, upload the document into the Attachments Section of the protocol record. 3. To add the Amendment document, click the ATTACHMENTS link in the left hand navigation. Listed will be all of the attachments that were submitted in the original protocol. 4. Click on the ADD NEW DOCUMENT link located at the top of the screen. New fields will open. 5. Complete the required fields: a. Select Amendment Document from the Document Type drop-down list Px IACUC Submission Guide V.3 - Updated May 2016 Page 55 of 76

57 b. Add a Description this is a text indicator. (Required field) c. Click on the [BROWSE] button to search your computer for the PDF file. Search for the file on your computer and click on the [OPEN] button to select it. d. Click on the [SAVE] button to save your file. The document will be added to the Attachments Screen listed under New/Changed Attachments. End of Procedure Px IACUC Submission Guide V.3 - Updated May 2016 Page 56 of 76

58 o AMENDING EXISTING ATTACHMENTS This process is required if your amendment includes an update to an attachment that is already uploaded to the protocol. (For Example: a CV change) PROCEDURE 1. Locate the attachment you want to amend in the screen and click the AMEND link. The details of this attachment will then populate the top of the screen under the heading Upload a New Version of the Document. 2. Click on the [BROWSE] button to attach a new PDF document. Search for the file on your computer and click on the [OPEN] button to select it. 3. Click on the [SAVE] button when finished Px IACUC Submission Guide V.3 - Updated May 2016 Page 57 of 76

59 The updated attachment will be listed under the New/Changed Attachments heading along with the Amendment document. End of Procedure o COMPLETING THE ALTERNATIVE SEARCH SECTION (AMENDMENTS ONLY) For amendments that have species of animals assigned to a pain category of D or E, alternative search information must be added to prove to the committee that a thorough search was done to find any existing research that would nullify a need to do the proposed experiment. Alternative search allows the researcher to specify the database searched, the years the search was conducted, and the keywords and strategies used to perform the search. PROCEDURE Alternative search is only required on amendments that have groups of animals assigned to the D or E pain category. To add Alternative Search information: 2. Select the ALTERNATIVE SEARCH link in the Navigation Pane on the left side of the screen. 3. Click on the ADD ALTERNATIVE SEARCH link at the top of the screen to open new data fields. 4. Complete the required fields: Px IACUC Submission Guide V.3 - Updated May 2016 Page 58 of 76

60 Enter the Search Date The date the database was searched. Check the boxes of the Database Search (more than one can be selected) Name of Database Searched. Enter the Years Searched List the years or range of years searched. Enter Keywords Searched Keywords used to conduct the search. Enter Comments When other is selected as the database, enter the name in the comments section. 5. When the information is complete, click on the [SAVE] button and the information will be added to the record. 6. To remove an Alternative Search that was entered incorrectly, click on the REMOVE link. 7. To modify a saved Alternative Search, click on the MODIFY link and the screen will become editable. 8. To add additional Alternative Searches, repeat the steps outlined in this section. End of Procedure Px IACUC Submission Guide V.3 - Updated May 2016 Page 59 of 76

61 o SUBMITTING THE AMENDMENT When all required information has been changed in the Coeus and required documents have been uploaded, the next step is to submit the amendment electronically for approval. PROCEDURE 1. Click the SUBMIT TO IACUC link located in the left hand navigation. The Protocol Actions Screen will open. 2. Click on the SUBMIT FOR REVIEW link located within the Protocol Actions Screen. Validations will run for the Amendment submission. 3. Fix all red errors and review/address the blue warnings. When complete, continue with the submission process. 4. In the Protocol Submission Screen, select Amendment from the Type drop-down list. 5. Select Administrative Review from the Review Type drop-down list. The Type Qualifier field is Currently Not Used. 6. When both fields are completed, click on the [SUBMIT] button Px IACUC Submission Guide V.3 - Updated May 2016 Page 60 of 76

62 7. A confirmation message will come up asking if you want to submit the protocol. Click on the [OK] button to continue with the submission. The Amendment is now electronically routed for review. The status of this submission has changed to Routing in Progress and is no longer editable. End of Procedure Px IACUC Submission Guide V.3 - Updated May 2016 Page 61 of 76

63 IX. CREATING AND SUBMITTING A CONTINUATION This section will explain how to create and submit a continuation on an active protocol. Continuation is the Coeus term for annual progress report submission needed to continue approval for an IACUC protocol. Reminder s will be sent out to your department to help prompt timely submissions to avoid lapse in approval. *The required forms for the different Protocol Submission types are located on the IACUC Protocol Forms Webpage. o CREATING A CONTINUATION PROCEDURE 1. Follow steps in section I. Getting Started - Logging into Coeus Lite of this guide to login using your Brown username and password. 2. Once logged in, from the Home Screen, click on the MY IACUC PROTOCOLS link at the top of the page Px IACUC Submission Guide V.3 - Updated May 2016 Page 62 of 76

64 Now that you are in the IACUC Module, Coeus will by default display all of the Pending Protocols these are protocol submissions that you are in the process of working on or that have been submitted to the Research Protections Office and are waiting for approval. 3. To view all of you Active or Approved protocols, click on the ALL PROTOCOLS link in the IACUC navigation. All of your Protocols will be displayed regardless of their status. 4. Locate the Active protocol that is about to expire and click directly on the link. The protocol will open in display mode, meaning no changes can be made to the protocol record. 5. To create a Continuation, click on the NEW CONTINUATION link located in the left hand navigation Px IACUC Submission Guide V.3 - Updated May 2016 Page 63 of 76

65 A new Continuation Screen will open. You can now complete a continuation from within the protocol record. 6. Complete the required fields: In the Continuation/Continuing Review Summary box Enter text to describe the status of the Project. o o The text should be Continuation Requested for projects that are continuing for another year OR The text should be Project Complete for projects that have ended. 7. Enter the text and click on the [SAVE] button Px IACUC Submission Guide V.3 - Updated May 2016 Page 64 of 76

66 The record will then open in display mode; no edits can be made to the attributes of the protocol. Once the Continuation is saved The protocol number will display an extension (C001) which stands for the type of submission (C = Continuation) and the number is the number of the submission on the protocol (001 = is Continuation #1) The Status of the submission also changes to Pending/In Progress this is for the submission only the approved protocol is still listed as Active. 8. Click on the ATTACHMENTS link in the left hand navigation. The Attachments Screen will open listing all of the documents submitted with the original protocol. 9. Click on the ADD NEW DOCUMENT link located at the top of the Attachments Screen. New fields will open Px IACUC Submission Guide V.3 - Updated May 2016 Page 65 of 76

67 10. Complete the required fields: a. Select Continuation Document from the Document Type drop-down list. b. Add a Description text indicator. (Required field) c. Click on the [BROWSE] to upload the PDF document. (The Continuation Document that must be completed can be found on the IACUC website.) Search for the file on your computer and click on the [OPEN] button to select it. 11. When finished, click on the [SAVE] button. The new document will be listed under the heading New/Changed Attachments. End of Procedure o SUBMITTING THE CONTINUATION When all attachments have been added to the Coeus protocol record, the next step is to submit the Continuation electronically for approval. PROCEDURE 1. To submit the Continuation, click the SUBMIT TO IACUC link located in the left hand navigation. The Protocol Actions Screen will open: Px IACUC Submission Guide V.3 - Updated May 2016 Page 66 of 76

68 2. Click on the SUBMIT FOR REVIEW link located in the Protocol Actions Screen. Validations will run for the Continuation submission. 3. Fix all red errors and review/address blue warnings. When complete, continue with the submission process. 4. In the protocol Submission Screen, select Continuation/Continuing Review from the Type drop-down list. 5. Select Administrative Review from the Review Type drop-down list. The Type Qualifier field is Currently Not Used. 6. When both items are selected, click on the [SUBMIT] button Px IACUC Submission Guide V.3 - Updated May 2016 Page 67 of 76

69 7. A confirmation message will come up asking if you want to submit the protocol. Click on the [OK] button in the confirmation window to continue with the submission. The Continuation is now electronically routed for review. The status of this submission has changed to Routing in Progress and the protocol is no longer editable. End of Procedure Px IACUC Submission Guide V.3 - Updated May 2016 Page 68 of 76

70 X. CREATING AND SUBMITTING A DENOVO SUBMISSION (previously known as a 3 YEAR RENEWAL) *At the current time all DeNovo submissions will be submitted and reviewed as a new protocol or Initial Submission, and will require that you upload the same documents required for Initial submissions; Animal Use form, Investigator / Study Personnel Form, and PI Certification. The required forms for the different Protocol Submission types are located on the IACUC Protocol Forms Webpage. *This section will explain how to copy an existing Active record, to use as the base for your new protocol. *Reminder s will be sent out to your department to help prompt timely submissions to avoid lapse in approval. o TO COPY AN EXISTING ACTIVE PROTOCOL PROCEDURE 1. Follow steps in section I. Getting Started- Logging into Coeus Lite of this guide to login using your Brown username and password. 2. Once logged in, from the Home Screen, click the MY IACUC PROTOCOLS link at the top of the page Px IACUC Submission Guide V.3 - Updated May 2016 Page 69 of 76

71 Now that you are in the IACUC Module, Coeus will by default display all of the Pending Protocols. These are protocol submissions that you are in the process of working on or that have been submitted to the Research Protections Office and are waiting for approval. 3. To view all of you Active or Approved protocols, click on the ALL PROTOCOLS link, in the IACUC navigation. All of your protocols will display regardless of their status Locate the Active protocol that is about to expire and click directly on the link. The protocol will open in display mode, meaning no changes can be made to the protocol record. 6. To create a New Protocol, click on the Copy Protocol link located in the left hand navigation Px IACUC Submission Guide V.3 - Updated May 2016 Page 70 of 76

72 A new Protocol Record will open. There will be a new protocol number and the status will be Pending In Progress. 7. For some older protocols the Old or Copied Protocol number will automatically prepopulate in the Reference 1 field. If it does not do this automatically, please enter the Old or Copied Protocol number in the Reference 1 field and click save Px IACUC Submission Guide V.3 - Updated May 2016 Page 71 of 76

73 Complete the protocol as you would an Initial Protocol submission (for details see page 11-56); update any necessary fields, upload the attachment and submit for approval. Be sure to review all copied information to confirm that is accurate and consistent with actual study procedures and information. End of Procedure XI. RESUBMITTING A PROTOCOL THAT IS RETURNED IN ROUTING This section will explain how to make revisions to a protocol that has been returned while in routing and resubmit it for Administrative Review. o RESUBMITTING A PROTOCOL SUBMISSION Once a protocol submission has been submitted in Routing for Administrative Review, the Research Protections Office will work with you to make sure all of the elements needed for committee review are present. If a piece is missing or other revisions are needed, the protocol submission will be returned in routing, and the aggregator will be able to edit the submission. PROCEDURE 1. If a submission is returned, all aggregators on the protocol submission will receive an notification titled: IACUC Submission needs Revisions 2. To make the necessary revisions to the protocol, click on the link provided in the Px IACUC Submission Guide V.3 - Updated May 2016 Page 72 of 76

74 The Coeus Lite Login Page will open. 3. Login using your Brown username and password. Once logged in, Coeus will open directly to the Summary Screen. 4. Click on the APPROVAL ROUTING link in the left side navigation to view the comments and attachments from the Research Protections Office. Once in the Routing Screen you will see 2 links: COMMENTS link ATTACHMENTS link If information is entered and/or attachments uploaded you will see a green check mark next to the COMMENTS and/or ATTACHMENTS link Px IACUC Submission Guide V.3 - Updated May 2016 Page 73 of 76

75 5. To view the comments, click on the COMMENTS link and a new Comments Window will open. 6. To view the attachments, click on the ATTACHMENTS link and a new Attachments Window will open displaying the PDF attachments. Double click on the PDF to open. 7. To make corrections to the record, click on the PROTOCOL DETAILS link from within the Routing Screen, the record will become editable Px IACUC Submission Guide V.3 - Updated May 2016 Page 74 of 76

76 Getting to the Protocol from the Pending Protocol Screen: If you are already logged into Coeus Lite, you can click on the PENDING PROTOCOLS link to find the protocol that needs revisions. The status of the protocol has been changed to Pending/In Progress. 8. Make any revisions necessary by using the left hand navigation panel. 9. Once the revisions have been made, click on the SUBMIT TO IACUC link from the left hand navigation to open the Protocol Actions Screen Px IACUC Submission Guide V.3 - Updated May 2016 Page 75 of 76

77 10. Click the SUBMIT FOR REVIEW link in the Protocol Actions Screen. The Protocol Submission Section will open. from the Type drop-down list select the type of submission you are requesting (same type as originally submitted and select the Review Type from the drop-down. 11. From the Type drop-down list select the type of submission you are requesting (same type as original submission). 12. From the Review Type drop-down list select the appropriate review type. 13. Click on the [SUBMIT] button. 14. You submission will then be submitted for Administrative Review. The Status will be changed to Routing in Progress Px IACUC Submission Guide V.3 - Updated May 2016 Page 76 of 76