Study Design Checklists

These checklists are based on the guidelines for research at the Tufts University School of Dental Medicine. By following the checklists, researchers can develop their studies more efficiently. Please note that they are not necessarily comprehensive, and some items might not apply to your specific study, since every study is unique.

• Bench Study
• Chart/Record Review
• Focus Group/Key Informant Interview
• Survey
• Clinical Study

Research Flow and Required Steps

These flow sheets are based on the guidelines for research at the Tufts University School of Dental Medicine. By following the flow sheets, researchers can develop their studies and receive regulatory approval more efficiently. Please note that they are not necessarily comprehensive, and some items might not apply to your specific study, since every study is unique.

• Animal Bench Study
• Case Report (under 3 cases)
• Clinical Study
• Extracted Teeth Bench Study
• Literature/ Systematic Review Project
• Bench Study (no samples from humans)
• Bench Study (with samples from humans)
• Record Review Study (for chart review or academic records review)
• Survey Study (can be used for Focus Groups as well)

Protocol Templates

Please use one of these fully-annotated protocol templates to draft your research protocol. They are based on the IRB protocol requirements for research at TUSDM. The templates include some example language for each required section in the protocol, for additional clarity.  Please note that they will need to be tailored to your specific study. Contact dentalresearchadministration@tufts.edu for questions on how to use these templates. What type of research are you planning?

Literature review:

• Literature Review

Bench study:

• Bench Study (no human tissue samples, extracted teeth okay)
• Bench Study with Human Samples

Chart/Record review:

• Chart/Record Review

Survey:

• Survey Study

Focus Group/Key Informant Interview:

• Focus Groups and Interviews Protocol – Social, Behavioral and Educational Research
• Focus Groups and Interviews Protocol with axiUm Pre-Screening

Mixed Methods Study:

• Record Review + Survey Protocol Template with Validation Language

Clinical Study:

• Interventional Clinical Study
• Non Interventional Observational Study
• Case Report Memo

Informed Consent Forms (DRA will assist)

Informed consent is more than just a signature on a form. It is a process of information exchange that may include, in addition to reading and signing the informed consent document, subject recruitment materials, verbal instructions, question/answer sessions, and measures of subject understanding. The consent document will contain all the information about risks, benefits, and requirements for participation that a potential subject will need to make an informed decision about participating in the study.

The consent document, along with any other written information to be provided to subjects should be written at an 8^th grade reading level or lower, and must be approved by the IRB prior to use. Consent must be obtained PRIOR to a subject’s participation in study activities.

• Adult Informed Consent
• Minor Assent (ages 7+)
• Survey Information Sheet
• Focus Group/Key Informant Interview Information Sheet
• Verbal Script- Consent and HIPAA Authorization
• Short Forms- for consenting Non-English speakers

Supporting Documents (DRA will assist)

All documents that will be provided to, seen or heard by potential participants must be reviewed by the IRB. DRA has developed templates for commonly used supporting documents.

Recruitment Materials

• Advertisement/Flyer
• Referral Email to Colleagues
• Recruitment Email- Focus Groups/Key Informant Interviews
• Recruitment Email- Survey
• Recruitment Email- Content Validity
• Recruitment Email- Face Validity
• Recruitment Email- Test/Retest Reliability
• Verbal Announcement- Survey
• Phone Script

Study Materials

• Content Validity Testing Questions
• Face Validity Testing Questions
• Focus Group/Key Informant Interview Script
• Medical/Dental History Form
• Photo Release Form
• Video Release Form

Letters of Support

Letters of support are needed if:

1. You will be doing study procedures at a non-public location (nursing home, school, etc.) outside of Tufts
2. You will be using records/samples from outside of Tufts
3. You will specifically be recruiting TUSDM faculty, staff or students (considered a vulnerable population)- DRA will help create this based on your study plan

• Letter of Support- providing records
• Letter of Support- providing de-identified, extracted teeth
• Letter of Support- organization where activities will occur

 

Case Report Forms

Case Report Forms (CRFs) are a form of source documentation that capture your study data and all steps that occurred during each study visit. These CRFs provide an audit trail, and when your study is regularly audited for compliance, and outside individual should be able to reconstruct the trial exactly as it happened. DRA will assist with your study team with creating CRFs based on your specific study protocol. Please contact Ann-Marie Billig with any questions.

 

Adjustment Forms

If your study will involve discounted clinic procedures, an adjustment form will need to be created to apply the research discount. The adjustment form will need to be submitted to the business office after the affected procedure, and will ensure that the research participant is not charged the full procedure cost. Please note that any discounted procedures must be approved by your chair, and must be reflected in the study protocol and Informed Consent Form.

DRA will assist with creating adjustment forms based on your study. Please contact Ann-Marie Billig with any questions.