Closing Your Study
All studies must submit a Study Closure Report at the conclusion of the study.
At the time of this submission, the following criteria must be met:
- All human subject interactions and/or interventions should be complete
- There should be no active subjects enrolled or intent to enroll new subjects
- All data should be managed accordingly as indicated in the approved protocol
The link below will take you to a guide we have created to help you locate the form in IRBManager.
Guide: Submitting a Study Closure Report
Changes to Research Personnel
Changes to research personnel can be made by submitting a Key Personnel Change form.
This form can be used to add or delete the following personnel from your study:
- Principal Investigator (PI)
- Co-Principal Investigator (Co-PI)
- Coordinator
- Faculty Advisor
- Research Assistants
Until the IRB has approved the proposed changes to key personnel, any newly added personnel SHOULD NOT engage in the research.
The link below will take you to a guide we have created to help you locate the form in IRBManager.
Guide: Submitting a Key Personnel Change Form
Unanticipated Problems, Violations, or Adverse Events
All unanticipated problems, violations, or adverse events must be reported to the IRB within 48 hours. If it was not possible to submit the report within 48 hours, please provide a justification to the IRB as to why.
Please use the the Unanticipated Problem/Violation Report found in IRBManager.
The link below will take you to a guide we have created to help you locate the form in IRBManager.
Guide: Submitting an Unanticipated Problem/Violation Report
Adding CITI Training Certificates For Faculty Advisors and Other Personnel
Faculty Advisors supervising student research may need to attach their CITI training certificate to a student's IRB protocol.
This can be done by submitting a form in IRBManager.
Do not use this form if you are a student, faculty, or staff researcher who has or who will submit an IRB application for review.
The link below will take you to a guide we have created to help you locate the form in IRBManager.
Guide: Submitting a CITI Training Certificate for Faculty Advisors and Other Personnel
Renewing Your Study
Most studies expire one year after IRB approval. If you wish to continue the research for another year, you will need to submit a Continuing Review Form to the IRB for review.
The link below will take you to a guide we have created to help you locate the form in IRBManager.
Guide: Continuing Review Form
Making Changes to Your Study
Please note: Any changes to key research personnel should be done with the Key Research Personnel Change Form. Do not use an amendment form to make changes to research personnel.
If you have already received IRB approval for your study and now need to make a change to the protocol, you will need to submit an Amendment.
Amendments must be submitted through IRBManager.
We've created a guide with screen captures and hints for submitting an amendment.
Guide: Submitting an Amendment
Registering a New IRBManager Account
NOTE: If you already have an account and are unable to login, please do not create a new account.
If you have a Swarthmore ID, login by clicking the above link and entering your Swarthmore credentials (i.e., Swarthmore User ID and password). If you are not able to log in, please contact the ITS help desk directly.
If you do not NOT have a Swarthmore ID, send an email to the IRB Office at irb@swarthmore.edu to receive a user name and password.
Please include the following:
- First and Last Name
- Email Address (provide an address you frequently check)
- Affiliated Institution
- Department
- Mailing Address
- Contact Phone Number
You will receive an email from the IRB containing the following information:
- Your username (This will be your Email Address)
- Your password (You will be asked to change your password upon login)
- Your client - Swarthmore
If you are unable to login after being issued a user name and password, go to the IRBManager login page, select the ‘click here’ option to log in using the IRBManager issued login and click ‘Forgot Password’ and enter your email address to receive a new password. If you are still unable to login, please send an email to irb@swarthmore.edu to receive help.
Your IRBManager Dashboard
Click image to enlarge
Submitting an Initial Application Form
1) New IRB application forms can be started from your IRBManager Dashboard. Click here to see where.
2) A new application form will open and you can begin to enter information.
3) If there will be others working on the IRB application, you can add them as collaborators. Click here to see where to do that.
4) You do not need to complete this form in one sitting. Any form you have started but not submitted can be accessed on your Dashboard for editing.
5) Once you have completed the form, you will need to "Sign" and submit it.
IRBManager Access
