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Clinical
Trials Administrative Start-Up Handbook
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SECTION 12
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Clinical
Trials Administrative Start-Up Handbook
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All of the following tools/checklists are samples and will need to be adapted to your study. Over time, and with your help, we will add more tools to this section of the Handbook. If you have similar tools and would like to share them - or if you know of other Web site references with useful tools - please send them to Gigi Streidl in the Office of Research and Graduate Education, UW School of Medicine. We will edit the tools so that they are generalizable to the broader UW research community, delete study-specific or department-specific information, then post them in the Handbook.
Completing Case Report Forms (CRFs)- Rules of Thumb: Industry-sponsored studies normally provide detailed instructions for CRF data entry, but for investigator-initiated studies, you'll need to create your own data entry conventions. This document shows some of the most common conventions.
Concomitant Medication Log: This log can be useful for identifying all subject medications (Rx and OTC) at baseline and then for tracking changes at each study visit.
Data and Safety Monitoring Board (DSMB) Charter: A DSMB is an independent panel of experts charged with the responsibility of monitoring the progress of trials, the safety of participants, and the efficacy of treatments being tested. The purpose of a DSMB charter is to define the responsibilities of a particular DSMB, its procedures, and its membership. Many sample DSMB charters are available on the Web. This sample charter is from the Fred Hutchinson Cancer Research Center.
Drug Inventory and Accountability Log - If you are not using one of the investigational drug pharmacies, use this log to record drug dispensation, inventory, and return.
Feasibility Checklist: In determining whether a particular protocol is feasible, researchers need to assess many factors. For example, is the protocol well designed? Is the workload manageable? Are the sponsor's timelines reasonable? As you weigh your interest in the trial, you may wish to use this feasibility checklist to guide.
GCP Checklist: Researchers should be fully aware of their obligations and responsibilities required by the University of Washington and applicable regulatory agencies prior to conducting research. This checklist provides a summary and self-check of researcher responsibilities pertinent to data and document management in accordance with Good Clinical Practice (GCP) Guidance.
Internal Adverse Event Report Tracking Form: Use this log to document that you appropriately monitored all adverse events and submitted all required adverse event reports.
Meeting Record: Add this record to your study files.
Protocol Design Template - Consult this link for access to the University of Pennsylvania's Protocol Design Template. Scroll down on the linked page to the "External Version" (the non-U-Penn version) of the template. Note the guidelines and the tips for completing the template. This template is designed for a drug study and provides guidelines for developing study protocols that are compliant with Good Clinical Practice standards.
Readability Toolkit (Group Health Center for Health Studies): This tool is a guide for creating printed materials that can prospective research participants can easily read and understand. As stated by the authors, many of the guidelines and strategies presented in the Toolkit can be applied to print materials in any health care setting - not only a research setting. The Toolkit "provides a detailed description of 'plain language' principles as well as concrete guidelines, tools, examples, and resources." Don't let the length of the document deter you from using it. Especially interesting are the sections on "Alternative wording suggestions" and "Examples of improved readability" and "Examples of improved formatting."
Self Assessment Form (University of Kentucky): This comprehensive self-assessment form was developed by the University of Kentucky with funding from an NIH grant. Parts of the form are University of Kentucky-specific but can easily be adapted to your needs. Use this form before external or internal monitoring visits to ensue that you are prepared.
Staff Task Lists: Pre-Study Tasks, On-Study Tasks, Post-Study Tasks: Use these multi-purpose tools when planning staffing levels, job descriptions, budgets, training needs, or simply as reminder checklists.
Staff Training Log: Customize this log to your study and use it to enable verification/tracking of staff training requirements.
Study Closeout Checklist: Use this checklist for assurance that you have remembered all of the tasks involved in closing out a study.
Study Coordinator Time Tracking Log: Useful for coordinators, especially for those who are working on multiple studies and need to account for their time.
Study Site Signature and Delegation of Responsibility Log - Read the Section 10. of the Handbook, Investigator Responsibilities, and then adapt this log to your own needs.
Subject Enrollment Log: Use this log to document the status (e.g., enrolled, active, completed, withdrawn, terminated) of research participants.
Telephone Communication Record: Add this record to your study files.
Virtual Regulatory Binder Developed for the research community at Partners' HealthCare System and referenced with their permission, this binder is full of invaluable information for helping sites to achieve and maintain regulatory compliance.
Clinical Research Toolbox (NIH/National Institute on Aging) This Toolbox is a comprehensive resource that includes more templates, sample forms, guidelines, regulations, and other materials. Especially valuable are the Manual of Procedures (for multi-site studies) and the data and safety monitoring information (DSMP Template and Guidelines, DSMP Checklist, DSMB Charter, Budgeting for DSM Activities, Conflict of Interest for DSMB members, and DSMB Reports and Templates).