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Study Documents and Management Tools - Templates & Logs

The study logs and templates are intended to help research teams organize study documents, document required information and track study procedures with the aim to prevent common study errors and mistakes.

Study Start-up

Checklist of Activities for Pre-Study Qualification Visit

NorDx Laboratory - Support for Clinical Research Study (Green Sheet)

Operating Room Investigational Device Procedures

Pre-study/Qualification Visit Follow Up

Protocol Assessment Checklist

Research Use of an Investigational Device -Sign off Sheet

Roles and Responsibility Log

Staff Signature Log

Study Training Log

Training Documentation Log

Study Management

Adverse Event Log

Communication Log

Delegation of Responsibility Log

Device Log

Drug Log

IRB Correspondence

Memo to File Template

Minor Protocol Deviation Documentation Log

Remuneration Receipt

Screening/ Enrollment Log

Study Visit Checklist

Study Document Checklist

Subject Eligbility Checklist

Study Close

Audit Checklist

Self-study Review Worksheet

Study Closeout Checklist