Click Templates

Below are MS Word templates that are completed and uploaded as part of a submission in the Click^TM Research Compliance System. For help information on IRB submissions, visit the How to Submit page.

The revised Common Rule implemented on January 21, 2019 for new studies. Several templates have been updated to incorporate the revised Common Rule requirements (noted below). Please use the updated templates. If you have started your HRP-503 Protocol using an older version of the template, you will be asked to complete a short supplemental form that includes the revised Common Rule requirements when you submit your study to the IRB. To view more detailed information about the revised Common Rule changes, please visit the Revised Common Rule webpage.

New Study

• HRP-503 - Template - Protocol (Word 61KB) - UPDATED 9/27/2019 (v19-03) (updated for revised Common Rule) (use for new exempt, expedited, or full board studies, includes help information of what documents to upload to Click)
• HRP-503 - Template - Protocol - No Instructions (Word 60KB) UPDATED 9/27/2019 (v19-03) (updated for revised Common Rule) (use for new exempt, expedited, or full board studies)
• HRP-508 - Template - Site Supplement to Sponsor Protocol (Word 42KB) UPDATED 9/27/2019 (v19-03) (updated for revised Common Rule) (use for multi-center sponsored studies that use a sponsor created protocol that is the same for all sites)
• HRP-511 - Template - Request a 45 CFR 46.118 Determination (Word 22KB) (use to request a 45 CFR 46.118 determination)
• HRP-512 - Template - Determination of Human Subject Research (Word 31KB) (updated for revised Common Rule) (use to request a determination of human subject research)
• HRP-513 - Template - External IRB Request (Word 48KB) (use when requesting MSU rely upon an External IRB)
• HRP-514 - Template – Engagement Word (Word 37KB) (use to request an engagement determination)
• HRP-515 - Template - Humanitarian Use Device (Word 26KB) (use to request a Humanitarian Use Device)
• HRP-516 - Template - Expanded Access (Word 21KB) (use when requesting expanded access)
• HRP-562 - Template - Use of a Single IRB (Word 36KB) (use when a federal department or agency grant proposal, including NIH, may invove a sIRB) (updated 2/17/2020)

Continuing Review and Closure

• HRP-510 - Template - Legacy Protocol (Word 25KB) (use for studies that have been transferred from the MSU IRB Online System to Click at the time of first modification or continuing review)
• HRP-527 - Template - Explanation(s) for Items Left Unchecked in Question 4 (Word 20KB) (within the Continuing Review submission, if you left items unchecked in Question 4, complete this template)
• HRP-528 - Template - Closure Report (Word 30KB) (updated for revised Common Rule) (use when requesting closure of study)
• HRP-555 - Template - Appendix to the Closure-Final Report Form for FDA Regulated Studies Conducted Under an IND or IDE (Word 36KB) (include in addition to HRP-528 when requesting closure of a study regulated by the FDA and conducted under an IND or IDE)

Modification

• HRP-510 - Template - Legacy Protocol (Word 25KB) (use for studies that have been transferred from the MSU IRB Online System to Click at the time of first modification or continuing review)
• HRP-529 - Template - Change in Principal Investigator Document (Word 27KB) (updated for revised Common Rule) (use when requesting a change in Principal Investigator)
• HRP-530 - Template - Add or Remove Individuals to FDA Projects Conducted Under an IND or IDE (Word 26KB) (use when adding or removing individuals to FDA projects conducted under an IND or IDE)

Reportable New Information

• HRP-531- Template - Unanticipated Problem Involving Risk to Subjects or Others (Word 26KB) (use when reporting a potential unanticipated problem that may involve risks to subjects or others)
• HRP-532 - Template - Protocol Deviation or Violation (Word 22KB) (use when reporting a protocol deviation / violation)
• HRP-533 - Template - Subject Complaint (Word 22KB) (use to report a subject complaint)
• HRP-534 - Template - Emergency Use of Investigational Drugs or Devices (Word 26KB) (use for notification of emergency use)

MSU Additional Templates

• HRP-535 - Template - Non-MSU Employee Conflict of Interest Disclosure Form (Word 28KB) (use for confict of interest disclosures for non-MSU individuals)
• HRP-536 - Template - Research Match Recruitment Document (use when Research Match is being used; visit the ResearchMatch webpage for instructions on how to use ResearchMatch)
• HRP-537 - Template - Use of Protected Health Information Application (Word 28KB) (use when the study involves HIPAA Protected Health Information, for any covered entity)
• HRP-538 - Template - MSU Authorization to Use or Disclose Health Information (Word 25KB) (use when HIPAA Protected Health Information will be obtained from MSU as the covered entity)
• HRP-571 - Template - MSU Health Care Authorization to Use or Disclosure Health Information (Word 26KB) (use if you plan to obtain HIPAA Protected Health Information from MSU Health Care, Inc. as the covered entity on or after July 1, 2020)
• HRP-539 - Template - Authorization Form Instructions (Word 23KB) (provides help information for the Authorization form)
• HRP-540 - Template - ICH-GCP - For Investigators (Word 43KB) (use when ICH-GCP will be applicable to the study)
• HRP-541 - Template - Involvement of Prisoners in a Research Project (Word 20KB) (use when prisoners are involved in a study)
• HRP-542 - Template - Sample Data and Safety Monitoring Plan (Word 17KB) (provides a sample template for a data and safety monitoring plan)
• HRP-576 - Template - Certificate of Confidentiality (Word 48KB) (use if the study is subject to a Certificate of Confidentiality (CoC) based on funding or an application will be submitted to apply for a CoC)