eRA IRB Submissions FAQ


Questions about eRA Access

I receive an error message when I attempt to log into eRA.

I receive an error message when I attempt to log into eRA.

Error 102:

Error: 102 (Unable to authenticate)
Login failed. Please double-check your username and password.

If you see the above error message, then please double check your Accessnet Username and TUsecure Password. If you have difficulties or have forgotten your password then please go here.

Error 201:

Error: 201 (Unauthorised ERA login)
Login failed. You are not authorised to use the application.

If you see the above error message, then please contact us at era@temple.edu and provide your TUID and Accessnet Username to us. Please DO NOT provide us any passwords.

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I do not have a Temple Accessnet account. How can I log onto eRA?

If you are affiliated with Temple University as an employee, student, or various other capacities, you may obtain an Accessnet account by following the steps outlined here.

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When I log in to eRA, I do not see a My Human Subjects tab.

If you do not have access to a My Human Subjects tab when you log into eRA, please send an email to era@temple.edu.

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How do I obtain eRA Access if I am a TUHS Employee?

Before you begin you will need a valid TUHS network account. Your manager also needs a valid TUHS account and needs to be listed as a manager in TUHS. If your manager is not, you should find a TUHS manager/administrator that can approve the SARF for you.

For further instructions please go here.

Your new account will have a different TUID and username because TU and TUHS use 2 different HR systems (Banner and Peoplesoft). The account is good for 1 year and can be renewed. Please call the Client Support Help Desk at 2-7008 (215-707-7008) if you have any issues with the Online SARF or the TU Help Desk at 4-HELP (4-4357) if you have issues with your TU Guest Account after it has been issued.

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How do I obtain eRA Access if I am a Temple University faculty, staff, or a student?

Email your full name, 9-digit TUID, and Department to era@temple.edu. In the subject line, write "Requesting eRA Access".

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I forgot my Accessnet username and/or password, or do not know my account information.

If you need more information on your TU Accessnet account, or forgot your username or password, please visit Temple's Account Management website. Several frequently asked questions about Accessnet accounts are listed on the right hand side of the page: https://accounts.temple.edu/selfcare/login.jsp

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Questions Involving the PI

How do I submit IRB items on behalf of someone else who is the PI?

There are three ways to submit items on behalf of someone else who is the PI: 1) as a Study Coordinator, 2) as a Student Investigator, and 3) as a Delegate. Delegate authorization is a distinct role that should be reserved for high-level, trusted, full time research staff who submit both IRB protocols and Grant Proposals. Please see the following. For more on the Student Investigator or Study Coordinator roles, please see the following.

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If as PI, I assign research personnel as my delegates, what information do they have access to in eRA?

It is important to be aware that a delegate in eRA will have access to everything you own across all modules in eRA. Essentially, your assigned delegate can access all your protocols (Human Subjects and Lab Animals) and all your proposals and associated financial information. Please be extremely careful in who you assign as a delegate as they will be privy to sensitive information.

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How do I submit research on behalf of a PI if I am the Study Coordinator or a Student Investigator?

Research submitted by students is required to have a full-time faculty advisor listed as PI. Study Coordinators will often be responsible for submitting items to the IRB on behalf of a PI. In order to submit research in eRA, on behalf of a PI and without being a Delegate, users must follow a special process outlined in the "Student Investigator and Study Coordinator Roles" section on page 40 of the Human Subjects Development Guide. This process involves starting a new application, then adding the Study Coordinator or Student Investigator after the shell of the application is in place. If you have any questions about what type of research involves the Student Investigator or Study Coordinator role, please contact the IRB at 215-707-3390 or irb@temple.edu. You can also add a Student Investigator or a Study Coordinator to an existing, IRB approved protocol by submitting a Modification request to the IRB.

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Questions About Other Resources

Are there eRA training resources available?

Yes. Please visit the eRA Documentation and Training page to view video tutorials and written guides for submitting items to the IRB. You will need to sign in with your Accessnet ID and TUsecure password to view this page. Additionally, the IRB staff is available to provide in-person training if needed. Please contact La'Shay Cobb at lashay.cobb@temple.edu or 215-707-7145.

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How can I find out more about eRA?

eRA is the working name for the electronic Research Administration (eRA) project at Temple University. The project is part of the larger, University-wide initiative redefining and reengineering many of the current administrative systems at the University. eRA is the term used to describe the philosophy of conducting Research Administration in an integrated and automated environment. In its broadest definition, it encompasses both pre- and post-award processes that involve the administrative and regulatory aspects of grants, contracts, and human subjects research, including clinical trials.

The Human Subjects Module is the "IRB part" of eRA. This is everything contained in the My Human Subjects tab when you log into eRA. This is where you can submit items to the IRB and access past submissions. The Proposal Module in eRA is related to project grants and finances and is completely separate and distinct from the Human Subjects Module. However, delegates of PIs can access all modules across eRA.

For more information on eRA@TU, please visit: http://www.temple.edu/research/researchadmin/era/index.html

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Questions about Drugs/Devices

How do I add a Drug or Device Appendix to the Application for Human Research e-form?

If you are trying to add a drug or device to appendix B or C of the Application for Human Research, you must answer YES to the appropriate question in Section II of the application. This will add the appropriate appendix to the application e-form, which you should then complete. Select your drug or device by clicking the yellow plus sign in the appendix, and then filling out any additional information, as applicable.

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The drug or device that I want to add is not on the list. What do I do?

If you do not see the drug you would like to add on this list, please email lashay.cobb@temple.edu the following information:

  1. The drug's generic name
  2. The drug's investigational name
  3. Is the drug FDA approved (yes or no)?
  4. If the drug is FDA approved, the date of FDA approval.
If you do not see the device you would like to add on this list, please email lashay.cobb@temple.edu the following information:
  1. The device name.
  2. The short name of the device.
  3. Is it a Significant Risk Device (yes or no)?

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Questions About Submissions

How do I include Research Personnel in my application if they have no affiliation with Temple, TUHS, or Shriner's Hospital for Children (beyond participation in the research)?

Complete and sign the Research Personnel Signature Form on the IRB's website: http://www.temple.edu/research/regaffairs/irb/irb_forms.html. This form is to be used only to collect authorization for Research Personnel who are not affiliated with Temple University, Temple University Health System, or Shriner's Hospital for Children. Affiliated individuals should be added to the eRA system and provide electronic authorization. The PI must always be listed and authorize via eRA, not on this signature form. Un-affiliated Research Personnel should provide their authorization of participation by completing the information below. Include a scanned copy of this document with your IRB submission in eRA.

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Which forms are mandatory?

There are certain e-forms that are mandatory for each type of submission. They are as follows:

  • Initial Submission (new application) - either the Application for Classroom Project OR the Application for Human Research e-form.
  • Continuing Review - Continuing Review e-form.
  • Modification - Modification of Approved Human Research e-form.
  • Reportable New Information - Reportable New Information e-form.
  • Close Protocol - Final Report e-form.

For all submissions other than Initial Submissions, the e-forms are automatically added to the Components of your submission, and you must click “Edit” to complete the form.

For Initial Submissions, you must choose either the Application for Classroom Project OR the Application for Human Research e-form. If you submit an Initial Submission without one of the two e-form Applications, it will be returned to you.

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How do I find templates for supplemental documents such as investigator protocols, HIPAA authorizations, consent forms, etc.?

All supplemental documents (protocols, consent forms, HIPAA forms, etc.) are available as downloadable templates on the IRB's website at http://www.temple.edu/research/regaffairs/irb/irb_forms.html. Visit the website to download the templates, modify them, save them to your computer, and then upload them as a Component of your submission by clicking Add Institutional Forms/Supporting Documents from the Components screen, then adding them in the Upload section (see below):

How do I add a Drug or Device Appendix to the Application for Human Research e-form?

If you are trying to add a drug or device to appendix B or C of the Application for Human Research, you must answer YES to the appropriate question in Section II of the application. This will add the appropriate appendix to the application e-form, which you should then complete. Select your drug or device by clicking the yellow plus sign in the appendix, and then filling out any additional information, as applicable.

The Drug or Device that I want to add is not on the list. What do I do?

If you do not see the drug you would like to add on this list, please email lashay.cobb@temple.edu the following information:

  1. The drug's generic name
  2. The drug's investigational name
  3. Is the drug FDA approved (yes or no)?
  4. If the drug is FDA approved, the date of FDA approval.
If you do not see the device you would like to add on this list, please email lashay.cobb@temple.edu the following information:
  1. The device name.
  2. The short name of the device.
  3. Is it a Significant Risk Device (yes or no)?

I am trying to add Research Personnel to my Application for Human Research e-form, but the individual that I am searching for is not on the list in eRA. What do I do?

Every individual involved in the conduct, design, or reporting of the research must be listed in the Personnel section, and must approve the submission. If you are attempting to add someone who does not appear on the list, please visit the eRA FAQs section of the IRB's website for instructions on how to proceed. *Reminder - when an individual is added to the Personnel section of an e-form Application in eRA, they are automatically added to the approval route. They must approve the submission in order for it to move on to the next step in the approval route, and for it to ultimately reach the IRB for review.

How can I avoid losing my work?

Always remember to hit "Save" throughout the submission process. When you are finished with a particular page, after hitting "Submit" or "Save", hit the "Done" button rather than closing a window in your internet browser.

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Do I have to complete a submission in one sitting?

No. To return to a submission in progress at a later time, ensure that you save your work by hitting "Save", do not hit "Submit" at any point, and close all pages by clicking on "Done" rather than closing the windows in your internet browser.

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How do I find a submission that is saved in progress, but not submitted yet?

Under the My Human Subjects tab, search for the submission using the temporary protocol number. A temporary protocol number will start with TEMP and is followed by a hyphen and four numbers (i.e. TEMP- 0001). If you are the PI, you can see all of your items by clicking on Show/List in the My Human Subjects tab.

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Can multiple users edit one submission?

Yes. Users must be delegates under the PI to access the submission. Users can check a form out and complete their own edits by clicking on Check In/Out (see red arrow below) within the application form itself. Once a form is check out, the user can make their edits, hit Save, then hit Check In/Out again to check the form back in. By clicking on Form Hist (see blue arrow below), you can view the history of edits to the form by clicking on Show All Edits in Form Hist.

If using the Check In/Out feature, make sure that when finished, you Check the form back IN so that other users may access the form.

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How do I know that my item has been submitted?

On the main Components page of your submission, the thumbs up Submit icon will have been replaced by a Scroll icon (see red arrow below). Clicking on the Scroll icon will allow you to view the progress of the submission route. You can also see the progress within the components page itself (see blue arrow below). When the "IRB Check In" step of the route is listed as completed, the IRB has received and begun processing your submission.

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Does the PI have to approve all submissions?

YES! PIs are required to approve every submission on which they are listed as PI. This applies even if the PI is making the submission. PI approval is required because the electronic review/approval takes the place of the PI's hard copy signature, and authorizes the submission. PIs have the ultimate responsibility for the oversight and conduct of their research, so their approval is required before any item can be reviewed or approved by the IRB. When an item is submitted, the PI will receive an email notifying them that their approval is required. Please see the PI Approval section on page 38 of the Human Subjects Development Guide for more information.

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What other approvals are required for IRB submissions?

In addition to the PI, every individual listed on the approval route on an IRB submission is required to approve the submission before it can reach the IRB for review. The electronic approval takes the place of a hard copy signature. Department Heads and all research personnel are required to approval Initial Submissions. Individuals can also be manually added to the approval route. Everyone listed on the approval route must view and approve the submission in order for it to reach the IRB. Please see the instructions for Providing Approval in eRA on the IRB’s website.

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I submitted an item, but it was returned to me for PI Clarification. What do I do now?

The IRB office will return submissions that are incomplete and therefore unable to be reviewed. This happens when a significant portion of the submission, such as an Application Form, is not included. The PI (and Delegate(s) if cc'd) will receive an email from the IRB office. Click on Open Submission Package to review the comments from the IRB. Based on the comments, you can make edits to e-forms, add new documents, and remove or replace previously submitted documents from the Components page of your submission. Click Submit when finished to return to your submission to the IRB office for review.

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I submitted an item, and received a notice from the IRB that Modifications are Required to Secure Approval. How do I submit a response?

Open your protocol by searching by protocol number or by selecting Show/List. When you open the protocol, you will see the Submissions screen indicating the status as Mods Required to Secure Approval. Click on the blue hyperlink to Respond. Choose Mods Required to Secure Approval, and click Save and Close. You will then be returned to the Components page, where you can edit your previously submitted e-forms, add new documents, and remove or replace previously submitted documents. Please see the full instructions on p. 32 of the Human Subjects Development Guide available on the IRB eRA Documentation and Training website here.

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My protocol has been approved and I need to access my stamped consent form. How do I access stamped documents?

IRB-approved, stamped documents such as consent forms are saved as PDF files within your eRA submission. To find a document, open your protocol. Open the submission most recently approved. From the Components page for that submission, click the View icon next to the document(s) labeled as stamped consents (see blue arrow below). A PDF version of the stamped document will open. You may save the PDF to your computer, or come back to eRA anytime to access it.

*Note: electronic versions of stamped IRB-approved documents are only available on eRA if the item (initial submission, modification, continuing review) containing the documents was submitted via eRA. If the initial submission or continuing review was submitted on paper, you will not have access to the stamped consent version in eRA.

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Can I use the eRA system for any IRB item - whether I originally submitted it on paper or not?

No. While you can submit new items such as continuing reviews, modifications, or closures for IRB protocols originally approved on paper, you cannot submit responses to modifications required by the IRB if the original item to which you are responding was submitted on paper. For example, if you have an IRBapproved protocol that was originally submitted on paper and approved in June 2012, then you may submit your continuing review for that protocol in eRA. However, if you submitted a modification request for that protocol on paper in January 2013, and the IRB has asked you to submit additional information to secure approval, you must submit that information on paper. A good rule of thumb: if the item (not the protocol) was initiated on paper, all follow up responses and communications should also be on paper, not through eRA.

If you are unsure how to respond, please contact La'Shay Cobb at lashay.cobb@temple.edu or 215-707- 7145.

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Can I submit initial WIRB studies through eRA?

Yes, initial WIRB studies can be submitted through eRA. As you would with paper applications, only the initial WIRB study should be submitted to the IRB. Once a study is approved by WIRB, the investigator submits all modifications and other post-approve items directly to WIRB. These items cannot be submitted through eRA. WIRB keeps the Temple IRB informed of all changes. Please follow the instructions on the "WIRB Forms" document on the References page of the IRB's website.

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How do I add new personnel to an existing, approved protocol?

First, the new personnel have to be added to the eRA system:

Next, the PI or the PI's designee should submit a Modification in eRA. Please see Creating a New Submission in an IRB-Approved Protocol for further instructions. After you hit Submit on the Modification and reach the screen displaying the Approval Route of the submission, you must add the new personnel to the route so that they can approve and "sign off" on their participation. Please see Viewing and Editing the Approval Route of a Submission for further instructions.

*Please note that that all research personnel must have current CITI training to be approved by the IRB.

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I am searching for an individual (a PI, myself, a student, etc.), and they are not listed in eRA. What do I do?

  • If the individual is Temple University faculty, staff, or a student, email their full name, 9-digit TUID, and Department to era@temple.edu. In the subject line, write "Requesting eRA Access".
  • If the individual is a TUHS employee, please see How do I obtain eRA Access if I am a TUHS employee?
  • If they are not affiliated with the university or health system, they will not be in eRA and cannot be entered. If you wish to add unaffiliated personnel to an application or a modification, include a completed Research Personnel Signature form with the submission.

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The approval route on my submission shows it was Accepted/Approved at the IRB. Does that mean my submission has been approved and I can proceed with my activity?

NO! The approval route displays the progress of a submission only up to the point that it is received by the IRB and accepted in for review. The review by the IRB starts after this point. When the IRB review is completed, the PI receives an official memo from the IRB stating the result of the review. As an example, the Routing Progress on the below submission shows that it was Accepted in Step 6 - IRB Check-In. This means it has been received by the IRB, and will undergo review. This is the last step on the route. If you need to know more information on the status of a submission (i.e. 'has my submission been approved?'), you must contact the IRB directly.

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