GCP Tool Kit
These study tools are not intended to burden research staff with unnecessary work, so it is important to implement only those tools that will benefit your study. Before you implement a study template, please take the time to tailor it to capture only information that is pertinent for your study and to format it so it is user-friendly for the entire research team.
To use any of our study templates below, click on the template name to open the document in MS Word format.
- Delegation of Responsibilities Log (DOC)
Outlines each staff member's roles and responsibilities, including time on study and contact information.
- Subject Enrollment Log (DOC)
Documents and tracks the progress of enrolled subjects.
- Subject Eligibility Checklist (DOC)
Documents that approved inclusion/exclusion criteria is evaluated and verifies all inclusion criteria is met prior to enrolling the subject
- Study Visit Checklist (DOC)
Ensure consistency and documentation of study visits
- Monitoring Log (DOC)
Documents all reviews of the study from outside monitors (e.g. site visits, sponsor monitors, FDA audits, etc.)
- Note-to-File Template (DOC)
Documents and explains any discrepancies in study data or processes
- Adverse Event Tracking Log (DOC)
Documents adverse events that have occurred on the study and well as their seriousness, causality in relation to investigational agent, expectedness and when they were reported to the IRB or study sponsor (if indicated)
- Drug Accountability Log (DOC)
Documents and tracks drug dispensation and accountability
- Device Accountability Log (DOC)
Documents and tracks device dispensation and accountability
- Temperature Log (DOC)
Documents temperature at which investigational agent is stored.
- Regulatory File Checklist (PDF)
A checklist of documentation required for study regulatory files
- Clinical Protocol Template (DOC)
- Find a Clinical Trial
- New Study Start Up
- Contracting Office
- Managing a Study
- Protocol Amendments
- Closing a Study
- Investigational Pharmacy
- Education & Training
- Clinical Research Compliance Program
- Regulatory Information
- Research Links
- Frequently Asked Questions
- Contact Information