Study Tools and Templates | EQuIP | Research Administration | Research

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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

Research Staff and Training

Study Organization Tools

Study Tracking and Documentation Tools

Research Staff and Training
Roles & Responsibilities Log Template Guidance	Outlines each staff member's roles and responsibilities, including time on study and contact information.
Staff Training Log V1 Staff Training Log V2	Lists all approved staff, documents their signature and the time frame each staff member was delegated specific tasks for the study.
Staff Signature Log Template Guidance	Lists all approved staff, documents their signature and the time frame each staff member was delegated specific tasks for the study.
Clinical Trial Tasks	Outline of common study tasks involved in the execution of a study

Study Tracking and Documentation
Subject Screening Log Guidance for Subject Screening Log	Tracks and documents all potential subjects screened.
Subject Enrollment Log Guidance for Subject Enrollment Log	Tracks and documents progress of enrolled subjects.
Subject Eligibility Checklist	Documents that approved inclusion/exclusion criteria is evaluated and verifies all inclusion criteria is met prior to enrolling the subject
Study Visit Checklist Guidance for Study Visit Checklist	Documents what study activities were completed at each visit.
Informed Consent Checklist	Checklist to ensure all required steps taken when obtaining consent; and to provide secondary documentation of the process.
Memo-to-File Guidance for Memo-to-File	Documents and explains any discrepancies in study data or processes.
Monitoring Log Guidance for Monitoring Log	Documents all reviews of the study from outside monitors (e.g. site visits, sponsor monitors, FDA audits, etc.).
Communication Log Template	Documents pertinent conversations regarding the study.
Recruitment Activity Log Guidance for Recruitment Activity Log	Tracks recruitment activities and used to evaluate which activities are most successful.
Remuneration Log Remuneration Vouchers	Tracks all remuneration obtained by study staff and distributed to research subjects
Deviation Log V1 Deviation Log V2	Documents and explains protocol deviations, and may be used to submit accumulated minor deviations to the IRB at the time of continuing review
Drug Accountability Log V1 Drug Accountability Log V2 Guidance for Drug Accountability Log	Documents and tracks investigational drug dispensation and accountability.
Device Accountability Log V1 Device Accountability Log V2	Documents and tracks investigational device and accountability.
IRB Tracking Log V1 IRB Tracking Log V2 Guidance for IRB Tracking Log	Tracks IRB submissions, actions, PI responses and other pertinent correspondence.
Consent Revision Log Guidance for Consent Revision Log	Documents and tracks revisions made to the consent and assent forms.
Clinical Trial Study Documents V1 Clinical Trial Study Documents V2	List of common study documents that the research team are responsible for maintaining throughout the research trial
Study Document Retention Inventory	Tracks study document storage, retention and destruction.
CRF-Source Document Log	Lists study Case Report Forms (CRF)/data points and the corresponding source documents that will be used to verify.

General Guidance and Information
Subject Case History	Guidance on creating comprehensive and complete subject case histories.
Electronic Storage of Study Data and Documents	Provides guidance to ensure study data stored electronically meet the same fundamental elements of quality that are expected of paper records.
FAQs: Storing Consents in Medical Records	How to store signed research consent and assent forms in subject’s medical records

Research | Study Tools and Templates

Study Tools and Templates | Overview

Research Staff and Training

Study Tracking and Documentation

General Guidance and Information