Study Tools and Templates | Overview
SOME OF THE TOOLS AND TEMPLATES ON THIS SITE MAY NOT BE THE MOST RECENT VERSION. CONTACT THE EQUIP OFFICE AT 617-355-5308 IF YOU HAVE QUESTIONS ABOUT WHETHER A NEWER VERSION IS AVAILABLE.
The study tools and templates provided are intended to help research teams:
- Document required information
- Organize study documents
- Track study procedures
First, take the time to think about what data is required, and only then should you select a template to build from. Do not let a template influence what data you will collect, but rather modify the template to collect the data you need. Once you have a template selected, customize the form to fit the specific needs of the study and research team. When tailoring the template, remember to:
- Use a legible font and font size
- Provide ample space to enter complete and legible data
- Only collect data that is required and useful for the study and staff (remove fields if they will not be used)
- Design the form to be user-friendly -- easy to update, understand and maintain
- Consider where the form will be filed and how it will be updated (electronically or paper) - must be safe and secure, but accessible for updating and reference.
To use any of our study templates below, click on the template name to open the document in MS Word format. For more detailed description and ideas on how to use the template, click on the corresponding Guidance document (if available).
Pre-Study Set-Up
Study Organization Tools
Study Tracking and Documentation Tools
Research Staff and Training |
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Outlines each staff member's roles and responsibilities, including time on study and contact information. |
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Lists all approved staff, documents their signature and the time frame each staff member was delegated specific tasks for the study. |
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Lists all approved staff, documents their signature and the time frame each staff member was delegated specific tasks for the study. |
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Outline of common study tasks involved in the execution of a study |
Study Tracking and Documentation |
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Tracks and documents all potential subjects screened. |
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Tracks and documents progress of enrolled subjects. |
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Documents that approved inclusion/exclusion criteria is evaluated and verifies all inclusion criteria is met prior to enrolling the subject |
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Documents what study activities were completed at each visit. |
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Checklist to ensure all required steps taken when obtaining consent; and to provide secondary documentation of the process. |
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Documents and explains any discrepancies in study data or processes. |
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Documents all reviews of the study from outside monitors (e.g. site visits, sponsor monitors, FDA audits, etc.). |
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Documents pertinent conversations regarding the study. |
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Tracks recruitment activities and used to evaluate which activities are most successful. |
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Tracks all remuneration obtained by study staff and distributed to research subjects |
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Documents and explains protocol deviations, and may be used to submit accumulated minor deviations to the IRB at the time of continuing review |
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Documents and tracks investigational drug dispensation and accountability. |
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Documents and tracks investigational device and accountability. |
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Tracks IRB submissions, actions, PI responses and other pertinent correspondence. |
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Documents and tracks revisions made to the consent and assent forms. |
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List of common study documents that the research team are responsible for maintaining throughout the research trial |
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Tracks study document storage, retention and destruction. |
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Lists study Case Report Forms (CRF)/data points and the corresponding source documents that will be used to verify. |
General Guidance and Information |
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Guidance on creating comprehensive and complete subject case histories. |
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Provides guidance to ensure study data stored electronically meet the same fundamental elements of quality that are expected of paper records. |
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FAQs: |
How to store signed research consent and assent forms in subject’s medical records |