CIRBI User's Guide for Principal Investigators and Sites

CIRBI User’s Guide for Principal Investigators and Sites

Introduction

Chesapeake IRB launched a custom-designed, web-based electronic platform to facilitate research study submissions, regulatory compliance, and e-processing and tracking of research studies. The e-system is called “Center for IRB Intelligence” (CIRBI) and allows real-time communication among CRRI customers, research sites, and internal staff and IRB members.

All parts of the IRB process, from initial submission, to notification of IRB action, to study close-out, are supported by CIRBI.

Benefits of Using CIRBI

− Smart-Form Technology. Create submissions by completing Smart-Forms (electronic submission form). Smart-Forms contain logic that directs you to complete sections of the application that are applicable to your research activities. Additionally, you may complete the forms during multiple sessions by saving the forms and accessing them later.

− Following the initial submission, all IRB-required documentation and submissions are readily available in the CIRBI workspace. Modifications and reports required by the IRB are easily created, submitted, and tracked in CIRBI.

− Real time postings regarding the status of a submission, and email notification of changes in submission status.

− Real time notification of and access to IRB correspondence; access to original regulatory documents 24 hours a day, 7 days a week.

− Immediate notification of IRB-approved sponsor protocol changes.

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If you need assistance or have questions, contact the CIRBI Help Desk at 1-866-99CIRBI (1-866-992-4724). All Rights Reserved - Chesapeake Research Review, Inc. v02042009

TABLE OF CONTENTS

1. CIRBI REGISTRATION ............................................................................................. 3

1.1. STEPS TO REGISTER ........................................................................................ 3 1.2. FREQUENTLY ASKED QUESTIONS REGARDING REGISTRATION: ............................ 4

2. LOGGING IN TO CIRBI ............................................................................................. 5 2.1. STEPS FOR LOGGING IN ....................................................................................... 5 2.2. FREQUENTLY ASKED QUESTIONS REGARDING CIRBI LOG IN:................................. 6

3. MY HOME............................................................................................................... 7 4. ACCOUNT PROFILE.................................................................................................. 8 5. PREPARING FOR CIRBI SUBMISSIONS ...................................................................... 9 6. INITIAL SITE SUBMISSION ....................................................................................... 10

6.1. PRELIMINARY STEPS.......................................................................................... 10 6.2. CREATING SUBMISSIONS AND COMPLETING CIRBI SMART-FORMS........................ 10 6.3. SUBMITTING THE COMPLETED SMART-FORM ....................................................... 15 6.4. PRINTING THE COMPLETED SMART-FORM ........................................................... 16

7. ACCESSING SUBMISSIONS WITHIN CIRBI ................................................................ 18 8. INITIAL REVIEW PROCESS OVERVIEW ..................................................................... 19 9. IRB AND ADMINISTRATIVE CLARIFICATIONS............................................................. 19

9.1. ACCESSING CLARIFICATIONS.............................................................................. 20 9.2. RESPONDING TO CLARIFICATIONS....................................................................... 21 9.3. SUBMITTING CLARIFICATIONS ............................................................................. 23

10. APPROVED SUBMISSIONS................................................................................... 24 10.1.ACCESSING THE IRB APPROVAL NOTICE ............................................................ 25 10.2.ACCESSING THE IRB APPROVED INFORMED CONSENT FORM............................... 27

11. SUPPORTING IRB DOCUMENTATION.................................................................... 27 12. POST IRB APPROVAL ACTIVITIES........................................................................ 29

12.1.MODIFICATIONS (INCLUDING RECRUITMENT MATERIALS)...................................... 30 12.2.REPORTABLE EVENTS....................................................................................... 33 12.3.CONTINUING REVIEWS AND TERMINATION REPORTS............................................ 35

13. GLOSSARY OF CIRBI TERMS.............................................................................. 37

CIRBI User’s Guide for Principal Investigators and Sites Page 3 of 41


1. CIRBI Registration

1.1. Steps to Register

You must register prior to accessing the CIRBI system. To register, go to www.cirbi.net, and click “Sign Up.”

Complete the “Registration for CIRBI” form. The red asterisks (*) denote fields that must be completed.



You will be contacted via email with a temporary password. You will need your email address and the temporary password to log into CIRBI for the first time.

1.2. Frequently Asked Questions Regarding Registration:

Who needs to be registered?

o Principal Investigator.

o Anyone who will create (have editor rights) an IRB submission and respond to the IRB’s clarifications.

o Anyone who needs to be copied on all IRB correspondence.

Does each user have to register for themselves?

o Registration for each user at a site may be completed by one individual. The steps outlined above can be completed for each member of the study team.

o Note: Each person who needs access to your submission should be registered before you start your submission.

Can log in information be shared by the study staff?

o No. Each user must have a unique registration/email account.

I have two email addresses, one for work and one personal hotmail address. Can I register two times, once with each address?

o No. You should only register with one email address. Your registration information (i.e. your email address) will be linked to submissions you are involved with. If you register with more than one email address, you may not be able to view or edit your submissions.

o You are encouraged to use your business email address when registering. You will be able to access CIRBI 24/7, even if you do not have access to your work email.



2. Logging in to CIRBI

2.1. Steps for Logging In

Immediately following registration, you will be able to log in to CIRBI 24 hours a day, 7 days a week. To log in:

1. Go to www.cirbi.net and click “Login” in the upper-right-hand corner.

2. Enter your email address and temporary password, and then click “Login”.

3. You will be required to change your password when logging in for the first time. Your password should be at least 8 characters and is case sensitive.



2.2. Frequently Asked Questions Regarding CIRBI Log In:

What happens if I forget my user name?

o Your user name is the email address you provided when you registered.

What happens if I forget my password?

o Return to the CIRBI login screen and click “Forgot password?”

o You will be asked to provide your User Name and E-mail. Enter the email address you provided when you registered into both of these boxes.

o A temporary password will be sent to your email address.



3. My Home

My Home is displayed when you log into CIRBI. My Home shows all the submissions you are associated with. You may return to this page at any time by clicking “My Home” in the top right-hand corner of the screen.

Submissions will be organized under one of the following tabs, based on their status:

− Inbox – submissions that require action on your part (for example: submissions that have been started, but not submitted for IRB review or submissions that require clarifications).

− Submissions Pending IRB Review – submissions in the review process with the IRB or administrative staff.

− IRB Approved Submissions – submissions that have been approved by the IRB.

− Archived Submissions – submissions that are no longer active (for example: submissions that have been terminated or withdrawn).

− Reference Materials – provides access to documents you may need during the conduct of your study including the CIRBI FAQ, CIRBI Glossary, CIRBI User Guide for Principal Investigators and Sites, CRRI Investigator Handbook, Current IRB Meeting Schedule, Current IRB Membership Roster, Experimental Subjects Bill of Rights, Statement of IRB Oversight Waiver, and Terms of IRB Oversight for Sponsors.



(One additional tab – Account Profile – is not related to submissions but to your contact information and the contacts at your site. See Section 4)

The submissions listed under each tab may be sorted by clicking on the column header (i.e. ID, Name, Type, State). In addition, the submissions may be filtered so that only the submissions that meet the filter criteria are listed.

4. Account Profile

Use the Account Profile tab, under My Home, to view your registration information and your contact information.

If your contact information changes, click “Edit Account Information” to update the information.

If changes affect your documents (e.g. informed consent form), you must submit the changes as a Modification so that administrative and IRB review, if appropriate, can occur. If you are the Principal Investigator, you will need to upload your current CV in this section.



5. Preparing for CIRBI Submissions

The following information should help you prepare for your CIRBI submission:

• Register the following people before starting your submission: o The PI. o Anyone who will create (have editor rights) an IRB submission and respond to

the IRB’s clarifications. o Anyone who needs to be copied on all IRB correspondence.

• One person at your site can register all of the necessary people.

o Each person must have a unique email address.

• The IRB requires submission of the following items: o PI’s CV. o FDA 483s and the site’s response to the FDA’s findings. Each audit should be

saved individually. o OHRP audits, if applicable. o Any other pertinent documents (SOPs, IRB Waiver of Oversight, etc.).

**If any documents are password protected; don’t forget to provide us with the applicable passwords when submitting these documents.

• The IRB does not require the following: o FDA Form 1572s o CVs for Sub-Investigators o Financial Disclosure Forms o Medical licenses



6. Initial Site Submission

6.1. Preliminary Steps

Prior to submission to Chesapeake IRB using CIRBI, you should verify that the Sponsor or CRO has submitted the protocol information.

You are also encouraged to register everyone at the site before you begin the submission. The following individuals need to be registered:

Principal Investigator.

Anyone who will create (have editor rights) an IRB submission and respond to the IRB’s clarifications.

Anyone who needs to be copied on all IRB correspondence.

6.2. Creating Submissions and Completing CIRBI Smart-Forms

New submissions may be created and submitted by the Principal Investigator, study coordinator, or other designated, registered, study staff.

To create a new submission:

1. Log into CIRBI and click “Create Initial Submissions”.



2. Click “Create Site Submission Only”. This will take you to the first page of the Smart-Forms (electronic submission forms) you will need to complete in order to submit your site information for a specific protocol. The Sponsor or CRO should have previously submitted the protocol information.



Completing CIRBI Smart-Forms

The CIRBI Smart-Form replaces the Principal Investigator and Site Submission Form. The Smart-Form will guide you to the pages that are appropriate for your specific submission (for example, a submission that includes an investigational drug will not include questions about devices). Questions that must be answered are designated with a red *.

The Smart-Forms are similar in length to the paper submission forms previously required by Chesapeake IRB. The forms do not have to be completed during one session.



As you complete the form, use the “Continue” and “Back” buttons to navigate from one page to the next. Each time you click the “Continue” button, the previous page’s information will be saved.

The “Save” and “Exit” buttons allow you to exit the Smart-Form and return later to complete the submission.



Sections of the Smart-Form include areas for uploading documents associated with the submission. These documents can include CVs, audits, and additional text for the informed consent document.

When uploading documents, CIRBI will instruct you to find the file on your computer or network, similar to the process of attaching documents to an email.



Once the Smart-Form is complete, click “yes” when asked if the application is complete. Then submit the Smart-Form for IRB review.

The Principal Investigator and Site information for the protocol will not be submitted to Chesapeake IRB for review until the Submit Site activity is completed.

6.3. Submitting the Completed Smart-Form

Once the Smart-Form has been completed the Principal Investigator or a designated member of the research team can submit the information to the IRB for review.

The Submit Site activity will submit the Smart-Form and any uploaded documents to Chesapeake IRB and will begin the IRB review process.

The Submit Site activity is not visible, until the Smart-Form is complete.



If a staff member is submitting the Smart-Form, the Principal Investigator still has the following responsibilities:

• Ensure that the research study does not start prior to receiving IRB Approval. • Personally conduct or supervise the described investigation(s). • Ensure that all associates, colleagues, and employees assisting in the conduct of the

research study are informed about their obligations in the conduct of the research. • Utilize only the IRB-approved informed consent form to enroll subjects. • Obtain appropriate informed consent from potential research subjects prior to performing

any procedures done solely for the research (If changes are made due to immediate danger to a subject, immediately report these change to the IRB).

• Make no changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.

• Comply with all federal, state, and local regulations regarding the conduct of research. • Ensure your investigative/research location(s) are conducting this research in compliance

with the policies and procedures outlined in Chesapeake IRB’s Investigator Handbook.

Once submitted, you will not be able to make edits to the submission.

Your submission will be assigned to a Chesapeake IRB team for processing. This team will be your point of contact for questions, or for you to request an activity associated with your submission.

You will be able to check the status of your submission at any time. Simply log into this website and view the submission workspace.

6.4. Printing the Completed Smart-Form

The Smart-Form can be printed at any time after the submission is started.

To print the completed Smart-Form, select the Printer Version button on the left side of the screen.



A single page printable version of the submission Smart-Form will open. Select the Print button at the top of the screen.

If the text is cut off on the printed document, adjust the Scaling for the document under the printer Preferences in your web-browser.



7. Accessing Submissions within CIRBI

When you start completing the Smart-Form, your submission will be assigned a unique identifier beginning with “SSU”. Your submission will appear under the appropriate tab on your My Home page. Use the submission identifier to locate your submission. Click the submission link to access the submission workspace.

The submission workspace will include organizational tabs. Workspace tabs may include the following:

− History – an account of the submission from creation of the Smart-Form through IRB review with determination letters.

− Attachments – a listing of all documents submitted with the Smart-Forms.

− IRB Issued Documents – a listing of IRB-approved consent documents, correspondence letters (including approvals), and recruitment materials, with active links to the documents.

− Clarifications – a listing of all administrative and IRB clarifications sent to the site along with the site responses.

− Mods, PREs, CRs – a listing of all submissions for protocol and site Modifications; Continuing Reviews; Serious Adverse Events, Protocol Violations, Unanticipated Problems involving risks to subjects or others; and other reports made to the IRB, with links to the workspaces for each specific item.



8. Initial Review Process Overview

Once Chesapeake IRB receives the site submission, Chesapeake IRB staff will link the site submission to the specific protocol and perform an administrative review of the submission.

If there are any questions regarding the submission, Chesapeake IRB staff will send administrative clarifications via CIRBI. An email notification will contain a link to the submission, alerting you to log in to CIRBI and respond to the clarifications. You will need to execute the Submit Clarifications activity after responding to the questions, in order for CRRI staff to continue processing the submission.

Once the review is completed, CIRBI will contain the IRB’s determination. If approved, the site will be able to immediately access the approval and informed consent documents.

9. IRB and Administrative Clarifications

Chesapeake staff will communicate questions that arise during the review of your submissions as Clarifications. Questions will be posted on the specific page of the Smart–Form that they pertain to.

When clarifications are required:

You will receive an email notification.

In addition, your CIRBI Inbox will indicate that Administrative Clarifications are required.



9.1. Accessing Clarifications

There are two ways to access clarifications:

1. Select the Clarifications tab to see all required clarifications.

or

2. Open the submission Smart-Form via the “Edit Site Application” button.



You will see a section at the top of the form labeled “Clarifications”. Navigate within this section to get to all of the clarifications. You may have more than one clarification, on multiple pages of the Smart-Form.

9.2. Responding to Clarifications

Click on “Click here to respond…” from the Smart-Form or the Clarifications tab.



The “Respond to Clarifications” window will open. Type your response in the designated section, and then click “OK” (If your response includes modifications to the Smart-Form, indicate that the modifications were made).

Once you have responded, your response will be indicated in the Smart-Form and under the Clarifications tab.



9.3. Submitting Clarifications

Once you have addressed all of the clarifications, click the Submit Clarifications activity button.

The “Submit Clarifications” window will open.

CIRBI will confirm that you have responded to every question. If there are missing responses, you will be instructed to complete the missing clarifications. You will not be able to submit your responses until all clarifications have been addressed.



After responding to the clarifications:

Chesapeake IRB will receive notification that you have responded.

You will be able to see your clarifications at any time.

10. Approved Submissions

Once the IRB has approved your site’s participation in a study, you will be notified via email of the approval. In addition, the submission information will be available under the IRB Approved Submissions tab on your My Home page.

If you click on the submission link, the workspace for the site submission will open, and you will see that the status has changed to Approved.



10.1. Accessing the IRB Approval Notice

There are two ways to access your IRB Approval Notice:

1. Click on the “View Correspondence Letter” link under the History tab.

or



2. Click the link in the Correspondence Letters section under the IRB Issued Documents tab.

The IRB Approval Notice will open so that you can view and print it, if necessary.



10.2. Accessing the IRB Approved Informed Consent Form

1. Click the link in the Informed Consent Documents section under the IRB Issued Documents tab.

11. Supporting IRB Documentation

Supporting IRB documentation, including the IRB Membership Roster, Experimental Bill of Rights and Investigator Handbook, are available for downloading from the Reference Materials tab on your My Home page. To access these documents:

Click on the “Reference Materials” tab.



Click on the “Reference Materials Download Area” link.

The “Reference Materials” screen allows you to select and download the appropriate documents.



12. Post IRB Approval Activities

CIRBI supports the reporting responsibilities of Principal Investigators and sites following IRB approval. This includes site-specific modifications, continuing reviews, and serious adverse event reporting. If you have questions about Chesapeake IRB’s reporting requirements, please reference the Investigator Handbook.

Once your submission has been approved, you will have access to new activities:



12.1. Modifications (including Recruitment Materials):

All changes to the site submission are reported via Modifications. Modifications include:

Recruitment material.

Changes to the IRB approved informed consent documents.

Changes to the investigative site locations (address changes or addition/removal of sites).

Change of Principal Investigator.

To create a modification, go to the appropriate submission workspace (please refer to Section 3) and click on “Modification”. (Note: submissions must have IRB approval before the option to submit a modification is available).



The modification Smart-Form will walk you through the submission requirements. A new workspace will be created for the modification.

Once you have completed the modification Smart-Form, do not forget to submit the modification.



After submitting the modification, the review process will be similar to the initial site submission and review process.

The Smart-Form for the modification is available to view at any time.

The History is posted for all activities related to the modification.

Clarifications will be requested, as necessary.

The IRB Approval Notice and modified IRB approved informed consent form, if applicable, will be posted to the IRB Issued Documents tab.

To find the modification, go to the appropriate site workspace and click on the Mods, PREs, CRs tab. All of the post-approval submissions related to the specific site submission will be listed under this tab. The submissions are organized by type – all modifications are grouped together.

To access a specific modification workspace, click on the modification link.



12.2. Reportable Events:

Reports required during the conduct of the research are reported via “Reportable Events” or “Prompt Reporting Events (PREs)”. Examples include protocol violations, serious adverse events and unanticipated problems involving risks to subjects or others. If you have questions about Chesapeake IRB’s reporting requirements please reference the Investigator Handbook.

To submit a report, go to the appropriate site workspace and click on “Reportable Event”.

The reportable event Smart-Form will walk you through the reporting requirements. A new workspace will be created for the reportable event.



Once you have completed the reportable event Smart-Form, do not forget to submit the reportable event.

Following submission of the report, the process will be similar to the initial site submission and review process.

The Smart-Form for the report is available to view at any time.

The History is posted for all activities related to the report.


IRB related correspondence is posted to the workspace, as applicable.

To find the reportable event, go to the appropriate site workspace and click on the Mods, PREs, CRs tab. All of the post-approval submissions related to the specific site submission will be listed under this tab. The submissions are organized by type – all prompt reporting events (reportable events) are grouped together.

To access a specific reportable event workspace, click on the prompt reporting event link.



12.3. Continuing Reviews and Termination Reports

To submit a continuing review or termination report, go to the appropriate site workspace and click “Continuing Review/Termination”.

The continuing review/termination report Smart-Form will walk you through the reporting requirements.

A new workspace will be created for the continuing review/termination report.



Once you have completed the continuing review/termination Report Smart-Form, do not forget to submit it.

After submitting the continuing review/termination report, the review process will be similar to the initial site submission and review process.

The Smart-Form for the continuing review/termination report is available to view at any time.

The History is posted for all activities related to the continuing review/termination report.


The IRB Approval notice and modified IRB approved informed consent form or Routine Termination notice will be posted to the workspace, as applicable.

To find the continuing review/termination report, go to the appropriate site workspace and click on the Mods, PREs, CRs tab. All of the post-approval submissions related to the specific site submission will be listed under this tab. The submissions are organized by type – all continuing reviews are grouped together. Termination reports are grouped with continuing reviews.

To access a specific continuing review/termination report workspace, click on the continuing review link.

If you need assistance with using CIRBI, contact the CIRBI Help Desk at 1-866-99CIRBI (1-866-992-4724).



13. Glossary of CIRBI Terms

Term Definition

A

Activity An activity in CIRBI is an action that you can perform on a submission. For example, if you want to contact the IRB staff, you would use the ‘Contact IRB’ activity. Activities are available from the submission Workspace. You will have different activities available based on the state of the submission.

Activity Details Every activity has an Activity Details page. This page displays all the information recorded in CIRBI about that activity. After you have completed an activity, the activity is displayed in the history log on the submission Workspace. Clicking the activity name opens the Activity Details page.

Administrative Clarifications Required

A submission is in this state if the IRB Staff administrative reviewer sends the application back to the PI/Research Staff with the requested changes or questions. The PI and any Research Staff that has Edit rights to the application can make any necessary changes and answer any questions. Once the PI or Research Staff member has made the necessary changes and/or responses, the PI uses the Submit Clarifications activity.

Application This is a web-based Smart-Form that routes the PI/Research Staff through the application sections based on answers to the questions. Once the application is completed, then activities can be performed.

Applications in Progress

The In Progress tab displays the submissions that you have rights to see, but for which you do not yet have any required activities to perform.

Approved An Approved state indicates that the submission has been reviewed by the IRB and that an Approval has been issued. Documents are finalized and then available via the history log on the submission Workspace.

IRB Approved Submissions

In your Home Workspace, the IRB Approved Submissions tab displays all submissions that you have rights to see and that are in an Approved state.

Archived Submissions

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

Complete Expired Terminated Withdrawn

Attachments Attachments are any supporting materials / documents that were uploaded with the submission as part of the application. These are available in the Attachments tab in the submissions Workspace.



B Back to Top

Back button CIRBI submission Smart-Forms have a back button that allows you to navigate backwards in the application. This is not the same as the Back button on your browser. Clicking Back on the application saves the current page and moves to the previous logical page of the Smart-Form. You should not use the Back button on your browser when you are completing the application as data loss may occur.

C Back to Top

Client program In CIRBI, your Web browser is the Client software program that works with the CIRBI server.

Contact Contact is a term that describes a person that has been added to an account holder’s profile. A list of these contacts are found in your Home Workspace under the Account Profile tab.

Continue button CIRBI applications 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 page of the 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.

Continuing Review

Periodic review by the IRB of active research for the purpose of re-approving, requiring modifications, disapproving, suspending, or terminating the study.

Correspondence Correspondence is the general term for communications that take place inside CIRBI. Some correspondence activities will include an email notification to let you know when they are posted to CIRBI.

D Back to Top

Deferred Deferral is a decision issued by the IRB. The submission has been put on hold until more information has been received from the submitting party. Once the information requested has been received the submission will be decided on by the IRB.

Disapproved Disapproval is a decision issued by the IRB. The submission is disapproved and the PI/Research Staff can not start or continue the research under that submission. (ex: If a Protocol is disapproved, the study cannot start)

E Back to Top

Exit The Exit link, available on the submission Smart-Form, exits the submission, not CIRBI. 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 Review Review of proposed research by the IRB chair or a designated voting member rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.



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Full Board Review

Review of proposed research at a convened IRB meeting at which a majority of the membership of the IRB is present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.

H Back to Top

Hide / Show Errors

The Hide / Show Errors link checks all the fields in the submission for any required questions that are not answered. The Hide / Show Errors link only checks the fields in the current submission Smart-Form as you are filling it out.

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ID The ID is the unique identifier that is automatically assigned to each submission. Each ID begins with a prefix that identifies what type of submission it is. New Protocol submissions begin with PRO New Site submissions begin with SSU New Continuing Review submissions begin with CR New Modification submissions begin with MOD New Prompt Reporting Event submissions begin with PRE

Inbox Your Inbox is the default page displayed whenever you log into CIRBI. Submissions that appear in your Inbox require action on your part.

Investigator A person responsible for the conduct of research at a research site. If the research is conducted by a team of individuals at the research site, the investigator is the responsible leader of the team and may be called the Principal Investigator.

J Back to Top

Jump-To The Jump-To bar in the submission Smart-Form allows you to jump directly to any section in the Smart-Form. However, you should only use the Jump-To bar if you know that the section that you are jumping to is a section you are required to fill out. Using the Jump-To bar shortcuts the logic built into the Smart-Forms.

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Location(s) of Investigation

A Location of Investigation is any location at which research-related activities occur.



M Back to Top

Modification A change to previously approved research. For example, after approval, any changes to the protocol, supporting materials, Informed Consent Form(s), study contacts, location(s) of investigation, Principal Investigator, as well as any type of recruitment material must be changed through a Modification.

Multi-Site Protocol Sponsors or CROs will complete this form to submit protocol information. The individual investigators who will be conducting the study will complete the "Site Submission".

N Back to Top

Notification CIRBI notifies you of certain events by sending e-mail messages to your normal e-mail inbox. Notifications contain a link that, after you log in, brings you directly to the submission that requires action. Note: Some e-mail programs can break the link in the e-mail message.

P Back to Top

Pre-Submission This state is the default state for any newly-created submission. The Pre-Submission state means that the creator of the submission has not yet submitted it to CIRBI.

Printer-Version A printer-version button or link generates a single page printable version of the submission Smart-Form.

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Routine Termination

A request by the PI to close out the study at their site, indicating that all subject related activities are complete.

S Back to Top

Serious Adverse Event

Any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Serious Non-Compliance

Any action or omission in the conduct or oversight of research involving human subjects that affects the rights and welfare of subjects, increases risk to subjects or compromises the integrity or validity of the research.

Single-Site Protocol

Principal Investigators or Research Staff will complete this form to submit both protocol and site information.

Site Submission Principal Investigators or Research Staff will complete this form to submit site information for a specific protocol. The Sponsor or CRO will be responsible for submitting the protocol information.

Smart-Form Smart-Forms are the applications for submissions in CIRBI. They contain logic to route you through the application. Smart-Forms allow you to complete only the sections that are required.



State State refers to the current status of a submission. When you initially create a new submission, 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 form. Once the submission has gone through all the necessary reviews and is approved, it will move to an Approved State.

Submission Submission refers to any of the application Smart-Forms that can be submitted via CIRBI. These forms are Protocol, Site, Continuing Review, Modifications, and Prompt Reporting Events.

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Unanticipated Problems (UAPs)

Any incidence, experience, or outcome that is unexpected (in terms of nature, severity, or frequency) given the information provided in research-related documents and the characteristics of the subject population being studied; related or possibly related to participation in the research; and suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized.

Upload Uploading is the transferring of files from your computer to CIRBI. In CIRBI, you upload documents via the Add button on a Document Upload.

V Back to Top

View Differences The View Differences button, available on a submission Workspace, displays any changes made to the submission information recorded in the Smart-Form. Any time a change is made to the entered information, the change is tracked and is available for view using the View Differences button.

W Back to Top

Workspace Workspaces are pages that provide overviews of areas within CIRBI. A familiar workspace is your Home Workspace. Your Home Workspace is displayed when you log into CIRBI and shows all the submissions with which you are associated. Workspaces also contain activities you can perform.

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