Study Tools and Templates

The following logs, templates, and guidances are provided to assist researchers with study organization, tracking, best practices and compliance. Check back periodically for additional documents or revisions. The use of these documents is not mandatory. Researchers are strongly encouraged to use the documents or create similar documents to use. Once you have a template selected, customize the form to fit the specific needs of the study and research team.

Guidance and Checklists

  • Guidelines to Good Clinical Research Documentation
    This guideline will describe the necessary key components for adequate documentation in research records.
  • QA/QI Review Self-Assessment Checklist
    Use this checklist to assess compliance with federal regulations and guidance’s, MHC HRPP policies, ICH GCP guidelines, and overall conduct of study activities.
  • Site Preparation for QA/QI Review Guidance
    Use this guidance to help you understand what will occur at a QA/QI site review and steps to prepare.
  • Organizing your study binder (COMING SOON)
    This guidance is designed especially for investigator-initiated studies. It outlines how to store and organize required and useful study documents and correspondences.
  • Are you conducting research?
    This is a booklet guide for resident and student Principal Investigators

Templates, Logs, and Worksheets

  • Consenting Process
    Use this checklist to ensure the consent process was performed and documented.
  • Note-to-File
    Use this template and guidance document to learn how to write a note-to-file to explain discrepancies in study data or processes.
  • Delegation of Duty
    Use this log to document study personnel who are delegated tasks on a protocol by the Principal Investigator
  • Subject Eligibility Confirmation
    Use this checklist to document the evaluation and confirmation that inclusion/exclusion criteria was met prior to subject enrollment.
  • Clinical Research Training Log
    Use this worksheet to document protocol specific and other training provided to study team members.