Protocol Development

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.

Protocol Templates

These protocol templates are based on the IRB protocol requirements for research at the Tufts University School of Dental Medicine. The templates also include some example language for each required section in the protocol.  Please note that they are not necessarily comprehensive, and will need to be tailored to your specific study.

Informed Consent Forms

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 8th 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.

Supporting Documents

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

Study Materials

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

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 Nicolette Kafasis 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 Nicolette Kafasis with any questions.