Clinical Research Operations

• When do I need to fill out a planned enrollment form?
• How do I fill out a cumulative enrollment form for a continuing review (CR)?

When do I need to fill out a planned enrollment form?

You need to complete and fill out the planned enrollment form when you are submitting a new (initial) review or submitting an amendment that changes your accrual ceiling.

How do I fill out a cumulative enrollment form for a continuing review (CR)?

For a CR, you will need to complete the pdf version of the cumulative enrollment form and attach it to your application under “other study documents.”  Note that you will need to complete a pdf separately for the NIH CC site, for other domestic sites combined, and for other foreign sites combined. Many of the totals on this form will pre-populate as you start to fill in the numbers. The CRO office will be able to provide you with the numbers for this.

I am not recruiting subjects to my protocol. Do I still have to submit a planned enrollment form?

You must submit a planned enrollment form for all protocols except: training protocols and screening protocols.

In my amendment, I am changing my accrual ceiling. Do I need to submit a new planned enrollment form?

Yes, but only if your protocol is a FY 14 protocol and forward.

I am a bit confused about how the top section (cumulative totals) should be completed for multi-center studies being conducted both domestically and in foreign countries where NIH is the coordinating center. Should the top section be completed the same way for both of the forms being submitted, with the demographics being completed separately for foreign vs. domestic sites?

Yes, even though this seems duplicative, fill out the total accrual information on each form in the top section then list the demographics separately on each form in the gender/ethnicity table section.

I am planning to recruit or am recruiting individuals whose sex at birth does not align with their gender identity. How do I address this on the Planned Enrollment and/or Cumulative Inclusion Enrollment Report forms?

When collecting and reporting information about sex/gender, it’s important to consider what is most relevant to the scientific question under study (e.g., sex at birth, current gender identity, etc.).   The NIH encourages information reported on the Cumulative Inclusion Enrollment Report to be based on self-report of the participants whenever feasible.  Therefore, how the question is asked of the participants is important.  The information obtained from the participants should then be used to complete the table.  Participants always have the option not to identify, in which case they would be reported under “Unknown/Not Reported” category on the Cumulative Inclusion Enrollment Report. 

FAQs for Routing in iRIS

FAQs for Study Application

FAQs for Continuing Review Submission Form

FAQs for Amendment Submission Form

FAQs for Study Closure Form

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These pages will continue to be updated as more information becomes available.

Note: If you have a submission procedure question that isn’t answered within these pages, please contact: nciprotocolsupportoffice@mail.nih.gov