Study Tools and Templates

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:

  1. Document required information
  2. Organize study documents
  3. 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