Continuing Review

Continuing Review of previously approved research is to be conducted at intervals appropriate to the degree of risk, but not less than once per year [21 CFR 56.108(a)(1), 45 CFR 46.109(e) and 56.109(f)].

Depending on the type of research, Continuing Review may be performed by expedited review or by convened IRB review.

Note: Continuing review is still required by institutional policy for non-FDA, expedited studies.

Both the Office for Human Research Protection (OHRP) agency’s 10 November 2010 Guidance on IRB Continuing Review of Research and the Food and Drug Administration’s (FDA) February 2012 Guidance for IRB’s Clinical Investigators and Sponsors IRB Continuing Review after Clinical Investigation Approval have reiterated that the key issues to focus on at Continuing Review are:

  • Risk assessment and monitoring;
  • Adequacy of the process for obtaining informed consent;
  • Local issues/Investigator and institutional issues; and
  • Research progress

To submit a Continuing Review, please complete a “Modification and Continuing Review” (MODCR) submission through the electronic IRB (eIRB) system. A MODCR is required to be submitted at least 2 months prior to the study’s expiration date to allow enough time for IRB review, accounting for any changes that may be required of the study team prior to approval.

If there are no modifications being made to the study at the time of Continuing Review, a MODCR submission is still required. You may simply indicate that no changes are being made in the “Summarize the Modifications” section of the submission.

Please refer to the following tip sheet to guide you through this Continuing Review submission process:

How to Report Continuing Review (CR) Data when Tufts Health Sciences IRB is the IRB of Record for Participating Site(s) (pSites) under an IRB Authorization Agreement(s) (IAA).

At the time of continuing review, in addition to submitting a MODCR (Modification and Continuing Review) for a study, the Tufts PI is required to Report Continuing Review (CR) Data through eIRB for each participating site (pSite) where Tufts HS IRB serves as the IRB of record (also referred to as a relying site). The Tufts PI is to communicate with each Site PI to gather the information needed prior to completing this report on their behalf.

This Continuing Review Data report will ask for the following information relating to each pSite:

  1. Enrollment Totals (since the last review, initial or continuing, and to-date)
  2. Study activity since the last IRB approval (initial or continuing review)

Space will also be provided to attach supporting documents and add any comments, as necessary.

This ‘Report CR Data’ button is located on the left hand side of the study workspace on the individual pSite page(s). To get to the pSite page(s):

  1. Find your study in eIRB
  2. Select the “Sites” tab
  3. Select ‘Report Continuing Review Data’ on the left hand side of the workspace

Note: This ‘Report Continuing Review Data’ button will only be visible to the study’s Principal Investigator

For assistance on how to “Report Continuing Review Data” for each pSite, please refer to this step-by-step walkthrough here.

In addition to Reporting CR Data:

Based on your monitoring plan outlined in the protocol, at the time of continuing review, the Site Principal Investigator(s) (PIs) are required to provide an update on their monitoring plan. At minimum, this will include the completion of the following self-audit tools to the Tufts PI from each pSite. These two checklists must be completed and retained in your study records, but are not required to be uploaded to eIRB with your continuing review submission.  

However, the Tufts PI is to include a brief summary of the completed self-audit for each pSite with their continuing review submission.

This summary should describe any issues identified during the self-audit. We strongly encourage the use of the Tufts HS IRB self-audit Summary Template , which is also available for download in the eIRB Library. This summary can be uploaded under the “Local Site Documents: Other Attachments” section within the eIRB submission. The original self-audit checklists must be available upon request from the Tufts Health Sciences IRB.

If any issues identified meet the criteria for Reportable New Information, please submit Reportable New Information through eIRB.

Other Guidance related to pSites at the time of Continuing Review:

For a brief overview of key policies, see Expectations when Tufts Health Sciences IRB serves as the IRB of record for a non-Tufts site.

If you want to add a new site with your Continuing Review, follow the instructions on the Single-IRB Guidance Checklist for Lead Principal Investigator & Study Team to include this request in your MODCR submission.

For more information, refer to the “Assuming review over participating sites” section of the Single IRB Review for Multisite Research page.

1) When is the CR submission due for my study?

To find out when the CR for your study is due, please refer to our Continuing Review Submission Deadlines page.

If the IRB office does not receive a CR submission by the deadline, you may not receive IRB approval prior to the study’s expiration date. In the event that your study expires, all research activity must stop until IRB approval is granted.

2) Can the IRB send CR reminder notices to my study coordinator as well?

Yes, the eIRB will send up to 3 automatic Continuing Review reminder notices to the study’s Principal Investigator (PI), Primary Contact, and PI Proxy (if one is assigned). If the study coordinator is listed as the Primary Contact and/or PI Proxy for the study in eIRB then they will receive these reminder notices.

The PI is encouraged to assign their study coordinator/research team member as the Primary Contact and/or PI Proxy to allow enough time to prepare the submission before the study’s deadline. It is also recommended that coordinators put the CR Submission Deadlines in their calendars and set reminders for each of the studies they work on to ensure timely submissions.

Courtesy Continuing Review reminder notices will be sent out as follows:

  • First Notice: 90 days prior to the study’s expiration date and submissions are due 60 days prior to the study’s expiration date. Please submit your Continuing Review application before the deadline in order to ensure prompt review of your study.
  • Second Notice: 60 days prior to the study’s expiration date (if a Continuing Review has not been received).
  • Third Notice: 30 days prior to the study’s expiration date (if a Continuing Review has not been received).

3) I want to amend my study, but the CR for my study is due. Can I submit an amendment/modification along with my CR?

Yes, you can submit Amendments (Modifications) with your CR submission. Please note that any modification included with the CR submission will be reviewed in combination with the CR (which can be as long as one month after the time of submission).

Therefore, if a modification is urgent and you choose to submit it separately and prior to your CR submission, please communicate this to the IRB over the phone or email and include this as a comment in the eIRB.

NOTE: eIRB does not allow you to have a separate Modification and Modification/Continuing Review submission pending at the same time on the same study. (Note that if your study has external pSites, eIRB does allow you to open Site Modifications at the same time as other submissions.)

4) I forgot to submit my CR and the IRB approval of my study has expired. Can I still conduct research activity on my study?

No, if IRB approval for your study has lapsed, you are no longer approved to conduct any research activity for this study. Research activities may not occur until IRB approval is granted. All research activities involving human subjects must stop after IRB approval expires, including enrollment of new subjects.  In the rare event that it is in the best interests of already enrolled subjects to continue participating in the research, for example, when the research interventions hold out the prospect of direct benefit to the subjects or when withholding those interventions poses increased risk to the subjects, please contact the IRB Office about the best way to proceed.

5) My study is due for CR but I want to close it out with the IRB. What do I do?

In order for a study to be closed out with the IRB, all four of the following criteria must apply to the remaining research activities:

  1. Study is permanently closed to enrollment OR was never open for enrollment,
  2. All subjects have completed all study-related interventions OR not applicable (e.g. study did not include interventions, no subjects were enrolled),
  3. Collection of private identifiable information is complete OR not applicable (no subjects were enrolled), and
  4. Analysis of private identifiable information is complete OR not applicable (no subjects were enrolled)

If the above criteria are met but you would still like to keep the study active with the IRB, contact the IRB office staff to discuss.

NOTE: If remaining research activities consist of writing a manuscript, you may still close the study out with the IRB, as long as the above criteria are met.

If your study meets eligibility for close out, action is still required in eIRB. Please follow these step by step instructions:

If your study does not meet eligibility for close out, a continuing review submission is still required. Otherwise, the study may risk a lapse in IRB approval. 

6) I’m getting Continuing Review reminders for a study that uses an External IRB. Do I need to do anything?

No, you do not need to do anything in eIRB for these studies. Make sure to submit your CR to the external IRB according to its requirements. Once the external IRB completes its continuing review, you can optionally forward the approval letter to the IRB staff to have the expiration date updated in eIRB.

Additional Resources for Researchers:

Feel free to contact the IRB Office for assistance with any questions.

Please refer to the Tufts Health Sciences IRB Policies on our website for assistance.