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Basic Folder Information

https://eirb.healthsciencessc.org/HSSC/sd/Doc/0/1DFHOA2GQDTKDE6G3G664BGP1F/FAQs%20image%203.png

 

Welcome to Health Sciences South Carolina (HSSC) electronic Institutional Review Board (eIRB) human research application Frequently Asked Questions (FAQs).
 

Select from the below content to answer some of the most common questions about using the system.  


QUICK TIP:  Completed CITI training records not appearing for study personnel? Make sure the user's first name, last name and email addresses are EXACT MATCHES in eIRB and CITI.  Updates will appear for successful matches after system nightly data synchronization. If there's still an issue, you may have multiple eIRB or CITI accounts interfering with the matching processContact your institution's eIRB administrator for assistance.

 
For other possible issues, access the Education and Training section document 'eIRB & CITI: Troubleshooting issues with training record displays', or otherwise contact your eIRB administrator for assistance. 
 
 


eIRB Frequently Asked Questions

 

CONTENTS*
Login User Roles Completing Applications Notifications
Studies IRB Change Requests Approved Documents Amendments
CITI Training Reportable Events Continuing Reviews Status Changes
SCResearch.org      

Please contact your institutional eIRB administrator for additional support, or the eIRB Education & Training* section.

*Referenced links on this page may require system login to access its content.


 

 

Login

  • Why am I not able to log in?
    • When going to http://eIRB.healthsciencessc.org, make sure you are selecting the correct institution of your affiliation and you are entering your current and active credentials (username and password) issued by that institution.  Contact your institutional eIRB administrator if you need help with your login information.
    • If you successfully get past your institution’s login screen and are receiving another type of error or message, contact your institutional eIRB administrator for assistance.
  • What can I expect the first time I access eIRB?
    • When accessing http://eIRB.healthsciencessc.org, select your affiliated institution from the drop down screen and login with the current and active credentials assigned to you by that institution.  If you experience issues at this point, see the information in the above section ‘Why am I not able to log in?’.
    • The first time you log into the system, a registration screen will be displayed. Fully complete the requested information and submit the registration form.  
    • An email will be sent to the institutional eIRB account manager(s), who will verify your account, assign user roles appropriate to your research activities and activate your account.
    • You will receive an email notification of account activation.

Contact your institutional eIRB administrator with any questions about this process, including expected account activation turn-around time.

  • I have moved from one eIRB institution to another one.  Does this affect how I log into eIRB?
    • Yes, moving from one eIRB institution to another one will require you to log into eIRB with your credentials from your new institutional affiliation.  However, it is very important that you do not have multiple eIRB accounts.  This scenario presents a number of issues, such as ensuring proper login, having access to associated studies and matching eIRB and CITI records. Therefore, before accessing eIRB, contact your new institutional eIRB administrator for guidance on their requirement and process to transfer your eIRB account from the previous institution to the new one.

 

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User Roles

  • What functions do various personnel listed on a study application have within the eIRB system?
    • Personnel listed on the eIRB study application as Principal Investigator (PI), Co-Investigators, and Study Coordinators automatically have read and edit rights to the study.  These personnel can create and edit study projects, respond to IRB change requests and are able to be listed on the study's eIRB communication coordinator list to receive system email notices of study activities.  Only the PI can submit new projects to the IRB. 
    • Study application personnel listed as Other Study Staff also have the ability to create, edit and respond to IRB change requests if they are added with having edit rights on the study application.  Otherwise, they will have read only access to the study.  Other Study Staff can also be included on the study's eIRB communication coordinator list whether or not they have edit rights on the study. 
    • Collaborating PIs added as a result of an HSSC Cooperative Review study receive access similar to a Co-Investigator.
    • Study Mentors have read only access to the study, but can be included on the study's eIRB communication coordinator list. A Mentor is required for studies where the PI is a student or is not otherwise a faculty member.  The Mentor gains access to the study only after it's been submitted by the PI.  Therefore, if you want the Mentor to have study access before submission (e.g., in the Pre Submission state), you should also add the Mentor to another study personnel role.
    • Users listed as Guests have read only access to the study.
  • I have logged into eIRB and I am on the "My Home" page, but I still do not see any of my studies.
    • In the navigation column on the left side of the page, ensure that you are in the correct “Role” (i.e. Study Staff, Mentor, IRB Member, etc.). To see your studies, you must be in the Study Staff role. Select the correct tab that speaks to the status of the study or type of application you are attempting to view. The ‘Studies’ tab will also display all studies.  If you do not have the Study Staff role, contact your institutional eIRB administrator.
  • I’m trying to add personnel to the study, but I cannot find the names in the system.  Why aren't they appearing?
    • Personnel must have an eIRB account and have been assigned appropriate roles in the system to appear in pick lists.  Contact your institutional eIRB administrator to discuss the personnel’s eIRB account and update role assignments, if needed.

 

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Notifications

  • I’m not receiving any emails about my study from eIRB.  What may be the problem?
    • Be sure that any email from eIRB is not in your Junk E-Mail folder.  All emails from the eIRB system use the domain ‘@eirb.healthsciencessc.org’. One method to ensure delivery of these emails is to add ‘@eirb.healthsciencessc.org’ as a safe domain in your email client.  To do this through Microsoft Outlook:
      • Click on one of the eIRB email messages that you may have moved into your inbox
      • Click Actions (at the top of the screen)
      • Select Junk E-Mail
      • Select Add Senders Domain (@example.com) to the Safe Senders List.

This should allow all email coming from @eirb.healthsciencessc.org to arrive in your inbox. 

  • Make sure you are listed as one of the eIRB communication coordinators in the study at the time the communication went out from eIRB.   A communication coordinator or lead means you are set up on the study to receive emails about application activity.
  • If all of the above checks out, contact your institutional eIRB administrator for assistance.

 

  • How do I change who can receive automated study notices from eIRB?
    • This can be done on the study by selecting the activity ‘Edit Communication Leads’ in the My Activities section and making edits there.  All personnel appearing with a check next to their name currently receive these types of communication.  This action does not require an amendment submission to complete. 

 

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Completing Applications

  • I am not able to advance beyond the page of the application I was editing.  Why is the system stopping me from moving forward?
    • There may be required content needed on that page before you can move on to another one.  Required content is generally indicated by a red asterisk and an error message when you save the page, noting an answer is needed.  Using the 'Continue' button will stop advancement because the system is trying to save the page and then advance to the next page.  It stops because the system cannot save the page without the required content.  The ‘Jump To’ drop down menu on each page is one way to go to different pages if all of the content on one page is not complete. However, there are some pages where this option will not work because of system automated programming. This prevention, however, does not apply to the majority of the pages. If you are also experiencing a stoppage with ‘Jump To’, to continue working, you may want to include information to satisfy the question, such as ‘REMEMBER TO FILL THIS IN’, being sure to enter in ‘true’ content when it's available before the application is submitted.
  • I’m trying to add personnel to the study, but I cannot find the names in the system.  Why aren't they appearing?
    • Personnel must have an eIRB account and have been assigned appropriate roles in the system to appear in pick lists.  Contact your institutional eIRB administrator to discuss the personnel’s eIRB account and update role assignments, if needed.
  • I was adding/revising the personnel list and clicked the continue button. Now I don't have access to continue editing the study.  What happened?
    • You may have removed/replaced yourself on the Study Team members listing within the eIRB Smartform page. Because of this, the system no longer recognizes you as someone with rights to the study (you may also have been logged out of the system with no access to that protocol). You can request someone who’s listed as personnel with edit rights to add you back onto the study. Otherwise, you will need to contact your institutional eIRB administrator for assistance.
  • Where should I upload any extra documents for my applications?
    • This documentation can be uploaded in the “General Comments” section.  However, be sure that these documents do not apply instead to other parts of the application, such as options under the “Application Checklist” or “Amendment Requests”.  If you have not chosen an appropriate option within application pages, then the corresponding Smartforms will not populate to allow you to upload the applicable documents.
  • How can I revise a document I uploaded?
    • If you are revising a document when you are creating a study and BEFORE you have sent it to the IRB, delete the document and add a new one.  However, if you are revising a document that has already been sent to IRB at any point (i.e., changing a document in response to IRB comments for a new study or you are changing a document through an amendment request), select the Upload Revision option next to the document name and add the revised form.  In this way, the system will re-number the version date to make it consistent with the previous versions.  Do not use ‘ADD’ to upload a revised document because the system does not recognize that the uploaded document is an update to a prior version.
  • I have completed the application. However, I don’t see where I can submit it to the IRB.  Where is the submission option?
    • Study personnel may create applications to the point of completion, but the PI must submit it. The eIRB is designed as a paperless environment, incorporating automated routing for approval and on-line access to study documents. The ability to have this process is based on the on-line authentication of individual users.  To ensure research integrity, the PI’s login is authenticated and submission is assured by the PI performing the action to send applications to IRB.  Because of this electronic verification mechanism, the eIRB system will only allow the Principal Investigator to submit the initial study, amendment, continuing review /statuses & reportable event applications.  The PI should use the 'Submit' option available under the application's homepage My Activities section that's on the left side of the screen.   If you are the PI and don’t see the ability to submit the application, contact your institutional eIRB administrator for assistance.
  • I have completed the application and it says it’s in a “Pre-Submission” state?  What does this mean?
    • When your study is in “Pre-Submission,” the application has not yet been submitted to the IRB for review.  When complete, it should be submitted to IRB by the PI.
  • I am not the PI, but have completed an application. Is the PI notified that it's ready to be sent to the IRB?
    • No, the system will not send a notice to the PI that an application is ready for IRB submission. This communication must occur outside of the eIRB system through your routine notification methods.
  • How can I find out the status of my application's approval?
    • The eIRB system is state-based, which means it displays a 'Current State' that tells you where the application is in the review process at any point in time.  Each application will transition through various states from Pre Submission to final states such as Approved, Acknowledged, Withdrawn and Completed. The Current State is viewable within the column called ‘State’ on your homepage or when searching for projects, or on the upper left hand side of the project's workspace.  Users with access to the application can log into the eIRB system and see in which state the application resides, as well as view the history showing when actions were taken on the application.  To see a listing of all the available states and their definitions, go to the Education & Training section of eIRB and select the ‘States Chart’ document.

 

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Studies

  • I don’t see the option to create a “New Study.”
  • My study has multiple PI’s (e.g. Co-Is on a grant).  How do I indicate multiple PI’s in eIRB?
    • eIRB only permits naming one PI. The other investigators will be required to be listed as Co-Investigators within the system.  Check with your IRB for other requirements of who can be listed as a PI for the study. 
  • I was adding/revising the personnel list and clicked the continue button. Now I don't have access to continue editing the study.  What happened?
    • You may have removed/replaced yourself on the Study Team members listing within the eIRB Smartform page. Because of this, the system no longer recognizes you as someone with rights to the study (you may also have been logged out of the system with no access to that protocol). You can request someone who’s listed as personnel with edit rights to add you back onto the study. Otherwise, you will need to contact your institutional eIRB administrator for assistance.
  • Where do I upload a current copy of the investigator’s CVs?
    • This type of documentation can be uploaded in the “General Comments” section.  Contact your IRB for additional instruction on other locations to include CVs, as required.
  • The PI has submitted the study, but it doesn’t seem to have gone through to the IRB.  What is the hold-up?
    • Studies may require mentor, department or other ancillary reviews before it will route to the IRB.  In these cases, the eIRB system automatically routes the study to the approving individuals along with a notification email. If required approvals are incomplete, the current state of the study will read “Department Review”.  To check on an approval required, locate the “Pre-Review Status” tab on the protocol’s main page.  This will display an update of pending and received approvals.  You can also check the study’s History tab to see who in a department or ancillary group was sent an email with a request to review the study.  These details are accessible by clicking on the particular history line that documents a submission to IRB or notice to a department group and accessing the Notification tab within that history line.  A study is not considered ‘submitted’ to the IRB unless all of the necessary prior approvals have been completed.
  • I am working with a service department on campus & understand the department will receive notice of my study.  Does this complete my submission to that department?
    • No, eIRB only provides a notice that the study has requested or involves this service and does not complete any submission review requirements of the service department.  You must contact that department for application requirements.
  • How can I find out the status of my study's approval?
    • The eIRB system is state-based, which means it displays a 'Current State' that tells you where the study is in the review process at any point in time.  The study will transition through various states from Pre Submission to final states such as Approved, Acknowledged, Withdrawn and Completed. The Current State is viewable within the column called ‘State’ on your homepage or when searching for the study, or on the upper left hand side of the study's workspace.  Users with access to the study can log into the eIRB system and see in which state it resides, as well as view the history showing when actions were taken on the study.  To see a listing of all the available states and their definitions, go to the Education & Training section of eIRB and select the ‘States Chart’ document.

 

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Amendments

  • How do I complete a new amendment?
    • First, you will have to choose “Create New Amendment” from the study homepage.  The eIRB system will ask a series of questions related to your amendment.  There are two sections in the system to submitting an amendment.  One section includes the amendment Smartforms and the other includes the study Smartforms.  After completing the amendment Smartforms, you must go to the study Smartforms and make any corrections to the study itself that would occur from the amendment.  The link to access the study Smartforms is within the amendment Smartforms page ‘Instructions for Completing Amendments’.  To see a video tutorial about completing amendments, go to the Education & Training->Researchers & Staff->Amendments section of eIRB.
  • I want to create a new amendment, but the “Create New Amendment” option is not visible on my home page.  Why not?
    • There could be a few reasons why you are not able to create a new amendment. 
      • The study is not yet IRB approved.
      • There is already an amendment open.  Only one amendment request can be submitted to the IRB at a time.  Once the previous amendment has been approved, the system will allow you to submit a new amendment.  However, several changes can be combined into one amendment.
      • You do not have edit rights on the study to be able to create new projects.  If you need edit rights, contact the PI to update the study for appropriate rights. 
  • Where do I submit a tracked changes and clean version of my revised documents?
    • There are two sections in the system to submitting an amendment.  One section includes the amendment Smartforms and the other includes the study Smartforms. Upload all track changes/red-lined versions of documents to the amendment smartforms.  Upload all clean versions of documents to the study smartforms. The link to access the study Smartforms is within the amendment Smartforms page ‘Instructions for Completing Amendments’.  To see a video tutorial about completing amendments, go to the Education & Training->Researchers & Staff->Amendments section of eIRB.
  • How do I upload a clean version of my study documents?
    • Once you access the appropriate study smartforms, click “Upload Revision” next to the document’s name to upload a revised version of a document previously approved by IRB. User the “ADD” option to upload documents that have not been previously approved.
  • I have completed the amendment.  Why won’t the system allow me to submit?
    • The PI is the only person who can submit an amendment.  You must notify the PI that the amendment is ready for submission through routine communication.
  • I just withdrew my amendment.  How can I re-open it to edit and submit?
    • After an amendment has been withdrawn, it is not editable or able to be copied.  You must create a new amendment.
  • I made a mistake on my amendment but it’s already been submitted to the IRB.  Is it possible for me to go back to make the necessary edit?
    • If you have withdrawn the amendment, it is no longer editable.  However, if the amendment is not withdrawn, you can contact the IRB for further assistance where the IRB may be agreeable with sending the amendment back to you via a change request.
  • I’m trying to add personnel to the amended study smartforms, but I cannot find their names in the system.
    • Personnel must have an eIRB account and have been assigned appropriate roles to appear in pick lists.  Contact your institutional eIRB administrator to discuss the personnel’s eIRB account and update role assignment, if needed.
  • I was adding/revising the personnel list and clicked the continue button. Now I don't have access to continue editing the study.  What happened?
    • You may have removed/replaced yourself on the Study Team members listing within the eIRB Smartform page. Because of this, the system no longer recognizes you as someone with rights to the study (you may also have been logged out of the system with no access to that protocol). You can request someone who’s listed as personnel with edit rights to add you back onto the study. Otherwise, you will need to contact your institutional eIRB administrator for assistance.

 

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Reportable Events

  • What are examples of reportable events to be submitted in this section?
    • Reportable events are classified by adverse events, unanticipated problems, protocol deviations, and other reports/events.  Other reportable events include Data Safety Monitoring Board reports, other safety reports, or audits from internal sources or the FDA.  You should contact your IRB for reporting requirements of any of these types of events.  To see a video tutorial about completing Reportable Events, go to the Education & Training->Researchers & Staff->Reportable Events section of eIRB.
  • The reportable event has caused a change in the protocol due to safety reasons.  How do I submit the protocol change?
    • Any changes in protocol, informed consent, or other documents will require a separate amendment to be submitted in addition to the reportable event.  To see video tutorials about completing applications, go to the Education & Training->Researchers & Staff section of eIRB and select the particular application type.
  • How will I know when my reportable event has been approved by the IRB?
    • Under the “Reportable Events” tab, you will find your reportable event, and it will say “Acknowledged” under “State.”  You can also access the study and Reportable Events tab to see all events for the study.

 

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Continuing Reviews

  • My continuing review requires a change to the currently approved study documents.  Can I submit the changes together with the continuing review?
  • The Conflict of Interest (COI) has changed since the last continuing review.  What do I do?
    • You must submit a new amendment summarizing the change on the COI Smartform page.  Contact the IRB with other questions and requirements of reporting COI, if needed.  To see a video tutorial about completing Amendments, go to the Education & Training->Researchers & Staff->Amendments section of eIRB if desired.
  • How do I report a study has been completed or terminated?
    • Create a “New Continuing Review’ or 'New Study Status Update' and on “Current Study Status” page, select “Permanently Closed – All study activities are complete”.  Navigate through the remaining screens to complete the application pages, after which the PI can review and submit it to IRB. 
  • I don’t see the option to create a New Continuing Review or Status Update application.  Why is it not there?
    • There could be a few reasons why you are not able to create a new continuing review or status update application. 
      • The study is not yet IRB approved.
      • There is already a continuing review or status update application open.  Only one of these types of requests can be open and submitted to the IRB at a time.  Once the previous application has been approved, the system will allow you to submit a new one. 
      • You do not have edit rights on the study to be able to create new projects.  If you need edit rights, contact the PI to update the study for appropriate rights.

To see a video tutorial about completing continuing review applications, go to the Education & Training->Researchers & Staff->Continuing Reviews/Status Changes section of eIRB.

 

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Study Status Changes

  • I’m not sure if my study is considered changing statuses.  What are some of the options for study status changes?
    • Status changes should only be submitted to report interim status changes outside a routinely scheduled continuing review application.  The possible statuses include enrolling subjects/collecting data, enrolling subjects – no accrual/enrollment to date, enrollment closed - subjects continue to receive study treatment/intervention, enrollment closed - follow-up and collecting data only, data analysis, or enrollment temporarily suspended.  To see a video tutorial about completing status changes, go to the Education & Training->Researchers & Staff->Continuing Reviews/Status Changes section of eIRB.
  • How do I report status change that completes or terminates a study?
    • You cannot report study closures through a Status Change application.  You must create a “New Continuing Review’ or 'New Study Status Update' application.  On the first page, “Current Study Status”, select “Permanently Closed – All study activities are complete”.  Navigate through the remaining screens to complete the application pages, after which the PI can review and submit it to IRB. 
  • I have to change the status of my study due to a reportable event (e.g., serious adverse event).  Is it enough for me to submit information regarding the reportable event in with the study status change?
    • No, you must submit a separate reportable event.  Any other changes that cause a study status change must be submitted as a separate amendment as well.  To see video tutorials about completing status changes or other required applications, go to the Education & Training->Researchers & Staff section of eIRB.

 

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IRB Change Requests

  • How will I know that there are changes to my application required by the IRB after submission?
    • If you are listed as one of the applications’ eIRB communication coordinators, you will receive an email notifying you of the changes required.  Another way is to navigate to your eIRB MY Home page, and under “Inbox”, a list of projects requiring editing and a response will appear.  These projects, for instance, may say “Changes required by IRB” or “Contingencies Pending” under the “State” column.
  • What are the steps in responding to IRB comments?
    • The first step is to access the project, go to the Reviewer Notes tab and click on the hyperlink next to the “Jump to” option to go to the Smartform page.  Make any necessary changes that may be required by the IRB to the Smartform.  Next, respond on that page to the IRB’s comments with the changes that were made by clicking “Click here to respond” and saving the response.  Exit out of the application page and click 'Submit Changes' on the study home page workspace to send the response to IRB.  Any listed eIRB study personnel who can edit the application can also submit the response to IRB, with the exception of studies in certain states that require PI submission (e.g. Not Ready for Review).  Contact your institutional eIRB administrator for assistance if needed.  To see a video tutorial about responding to reviewer comments, go to the Education & Training->Researchers & Staff ->Reviewer Comments section of eIRB.

 

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Approved documents

  • Which documents are IRB approved and stamped?
    • Stamping in the eIRB system is through a process termed as “watermarking.”  Common IRB-stamped documents include consents, HIPAA authorizations, information sheets associated with the consent process, and recruitment/advertisement materials.  Check with your IRB on the specific type of documents required for stamping.
  • What is a watermark?  When is it needed?
    • eIRB requires all IRB-stamped approvable MS WORD documents to contain specifically programmed merge fields in the document. These fields are contained within a text box template called the ‘watermark.’ A watermark is generally required for information provided to research participants, such as informed consents, assent documents and HIPAA authorizations.  For WORD documents, the watermark must be placed in the document before submitting it to IRB, usually in the footer of the form but this may vary for your institution.  These documents that have not been created with or modified to include the appropriate watermark template will not be properly approved.  Contact your IRB to find out the process and where to access the watermark template for your institution.  After you submit your application with these documents uploaded, eIRB automatically adds information to these fields during the review and approval process creating an electronic “Approval” stamp.  Documents submitted as PDFs do not require this watermark template, as the system will automatically add approval details in the footer of the document. Therefore, you should submit PDFs with no content in the mid, footer section and with no watermark template.  After approval, all stamped documents become read-only.  To see a video tutorial about watermarking, go to the Education & Training->Researchers & Staff->Documents section of eIRB.
  • Where is a copy of my stamped approved documents such as informed consent, assent forms, HIPAA authorization, advertisements, surveys, etc?
    • Stamped copies of informed consent/assent are found under a separate study tab labeled “Stamped ICF.”  The currently approved versions of consent forms are listed here. The previously approved versions are also located within this tab by clicking on the History icon next to the consent’s name. The draft versions of these document are located in the ‘Attachments’ tab on the study’s main page, within the Consent Process section.
    • Stamped copies of separate HIPAA authorizations, as well as other stamped documents such as recruitment materials and surveys are found under the study’s “Attachments” tab, by scrolling to the bottom to the section labeled “Ancillary Documents.”  The previously approved versions of these documents are also available by clicking on the History icon next to the documents’ name.  The draft versions of these document are also located in the ‘Attachments’ tab, within the study Smartform section of the document.
  • Where is the approval letter for my study?
    • The current ‘Letter of Approval’ is located on the main page of your study.  For other types of projects (e.g., amendments, reportable events, continuing reviews, status changes), a similar title or one called ‘Letter’ can be accessed from the projects main page.
  • Where can I locate my study's original approval letter?
    • If your study has not yet been approved through a continuing review, you can access the letter by selecting the ‘View’ link in the Letter of Approval field on the main study workspace page. If your study has had at least one continuing review, you can still access the original approval letter from the Amendments tab on the protocol’s workspace and selecting the link under the title ‘Originally Approved Version’. The approval letter appears as the ‘View’ link in the Letter of Approval field.  If an amendment is open on the study, the letter will be accessible instead on the study’s History tab under the title ‘Originally Approved Version’.  

 

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CITI Training Records

  • I don't see study personnel training records on the study.  Why are they missing?

The CITI Training Records Smartform page appears on human subjects research studies and display records individual HSSC eIRB sites have reported as required for research personnel to complete.  If research training records are not displayed for particular personnel:

  • Make sure the personnel's first name, last name and email addresses are exact matches in eIRB and CITI.  Updates will appear for successful matches after system nightly data synchronization.
  • Required CITI training courses may not have been completed in affiliation with one of the HSSC sites. The user should log into CITI to make sure the CITI profile has been associated to the correct institutions and required training has been completed.  Updates will appear for successful matches after system nightly data synchronization
  • The personnel may have multiple eIRB and/or CITI accounts interfering with the matching process.  Contact your institutional eIRB administrator for assistance.
  • The personnel's eIRB profile may not be completed filled out to associate the user with an institutional department. Contact your institutional eIRB administrator for assistance.

For additional information, access troubleshooting and other resources in the Education and Training->Researchers and Staff->CITI Training Records section of eIRB, or otherwise contact your institutional eIRB administrator for assistance. 

 

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SCResearch.org

  • How can I include or remove my study from SCresearch.org?
    • There are certain types of studies where online posting is not available, such as studies approved as exempt applications or those that are only recruiting from retrospective data.  For eligible studies, when first preparing a study for submission, make sure the checkbox for the question ‘INCLUDE study in S.C. Research Studies Directory’ is checked on the SCResearch Smartform page and the next page includes the recruitment details.  When the study is approved, it will be automatically posted on SCresearch.org and will remain online until the study is no longer approved, its status is no longer recruiting or until you have changed the posting status.  To change the posting status after IRB approval, go to the study and use the activity ‘Edit SC Research Studies Directory Posting’ to include a check or remove the check for posting.  The SCresearch.org website is refreshed nightly and the change will appear the next day. 
  • What information about my study will be displayed in SCresearch.org?
    • The study PI, Title, Pro#, approval date, lay summary, recruitment contact and keywords will appear online as included on the study application.  The lay summary will be taken from the “Brief Study Summary” section under “Study Identification Information” in the study smartforms.
  • How do I change the summary of my study in SCresearch.org?
    • Any changes to the lay summary seen by interested participants will need to be changed by submitting an amendment.  In the amendment, the “Brief Study Summary” in the study Smartforms will need to be changed.
  • How do I change the Recruitment Coordinator and contact or listed Keywords?
    • These details can be changed without an amendment.  Access the study and use the activity ‘Edit SC Research Studies Directory Posting’ to edit the information.

 

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