Research

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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 857-355-5308 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

 

Pre-Study Set-Up: Checklists
Clinical Trial Study Documents: List of common study documents that the research team are generally responsible for creating, maintaining and updating
Clinical Trial Tasks: Outline of common study tasks involved in the execution of a study
Research Staff and Training

Staff Signature Log: Lists all approved staff, documents their signature and the time frame each staff member was delegated specific tasks for the study. For guidance in using this template, click here.

Roles & Responsibilities Log: Outlines each staff member's roles and responsibilities, including time on study and contact information.  An alternate version of template is available.  For guidance in using templates, click here.

Staff Training Log: Documents the protocol specific research training provided to and received by members of the research staff.  An alternate version of template is available.  For guidance in using templates, click here.

Study Organization Tools

CCI/IRB Tracking Log: Tracks CCI submissions, actions, PI responses and other pertinent correspondence.  An alternate version of template is available.  For guidance in using templates, click here.

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.

Document Log: Lists study documents and specifies location if not stored in the study regulatory binder.  For guidance in using template, click here

Consent Revision Log: Documents and tracks revisions made to the consent and assent forms.  For guidance in using template, click here

Subject Case History: Guidance on creating comprehensive and complete subject case histories

Study Tracking and Documentation Tools

Subject Screening Log: Tracks and documents all potential subjects screened.  The CRP version of template is also available.  For guidance in using templates, click here.

Subject Enrollment Log: Documents and tracks the progress of enrolled subjects.  The CRP version of the template is also available.  For guidance in using these templates, click here.

Subject Eligibility Checklist: Documents that approved inclusion/exclusion criteria is evaluated and verifies all inclusion criteria is met prior to enrolling the subject.  The CRP version of this checklist is also available.

Subject Visit Documentation: Outlines different methods to document a subject visit.  A progress note template and subject visit checklist are available.

Monitoring Log: Documents all reviews of the study from outside monitors (e.g. site visits, sponsor monitors, FDA audits, etc.).  For guidance in using this template, click here.

Memo-to-File: Documents and explains any discrepencies in study data or processes.  For guidance in using this template, click here.

Study Communication Log: Documents pertinent conversations regarding the protocol

Recruitment Log: Tracks recruitment activities and used to evaluate which activities are most successful.  For guidance in using template, click here.

Remuneration Log: Tracks all remuneration obtained by study staff and distributed to research subjects. Clinical Trial Subject Remuneration Vouchers can be found here.

Deviation Log: Documents and explains protocol deviations, and may be used to submit accumulated minor deviations to the CCI/IRB at the time of continuing review.  An alternate version of template is available.

Exception Log: Documents and explains protocol exceptions, and may be used to submit accumulated minor exception to the CCI/IRB at the time of continuing review.  An alternate version of template is available.

Drug and Device Accountability: Documents and tracks drug/device dispensation and accountability.  Templates are available to track drug accountability (for alternate version, click here) and device accountability (for an alternate version, click here). 

Adverse Event Summary Log: Documents and explains adverse events, including documentation of whether the event meets IRB reporting criteria.  An alternate version of template is available.

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