Update to Click SmartForm

September 29, 2019

An enhancement has been added to the Click™ Research Compliance System to help streamline the IRB review process. Several questions on the “HRP-503 – Template – Protocol” form that are frequently updated by researchers have been incorporated into the online Click SmartForm. This change was made because we anticipate that it will be faster for researchers to update the questions on the Click SmartForm rather than having to make the change in the HRP-503 and upload the revised document when submitting a modification that impacts these questions. Incorporating the questions in the Click SmartForm will also allow individuals to use the “View Differences” function in Click to see updates made to these questions. 

The questions that have been moved from the HRP-503 to the Click SmartForm include:

  • Research procedures

  • Subject population and age range

  • Subject compensation

  • Inclusion and exclusion criteria

  • Recruitment materials

Several new questions were also added to the Click SmartForm and include:

  • Research conducted outside the United States

  • Research conducted on American Indian or Alaskan Native tribal lands or research that will use an American Indian or Alaskan Native tribal identifiers

Impact to Researchers

This change does not impact researchers’ continuing review submissions (with no modification), modifications to study team members, or ongoing exempt determinations.

For ongoing non-exempt studies: At the time of the next modification to other parts of the study, researchers will be asked to copy the questions’ answers from the HRP-503 to the Click SmartForm, and then delete the answers from the HRP-503.

For submitted new study and modification to other parts of the study submissions:  If a clarification is requested, researchers will be asked to copy the questions’ answers from the HRP-503 to the Click SmartForm, and then delete the answers from the HRP-503.

New study submissions that are in pre-submission or have not been started yet: Researchers will need to answer the new questions in the Click SmartForm.  The HRP-503 – Template – Protocol has been updated to remove these questions and the new version is available at http://hrpp.msu.edu/templates/index.html Older versions of the HRP-503 will be accepted until November 1, 2019; if researchers used an older version, they will need to delete the answers to the questions from the HRP-503.