Templates and guidance for essential documents

Template to construct a new study budget or use as a guide for existing study budget spreadsheets.

Template for writing a research protocol involving participants. Describes how the study will be conducted.

Outline of key elements in a research proposal.

Self-evaluation checklist.

Documents study-specific training completed by staff exhibiting their qualifications to perform tasks involved in the clinical research study. Other training may also be listed on this log.

Used to list research subjects/participants screened; includes those who fail screening and those who are enrolled.

Documents all study product disposition and accountability on the site level.

Track clinical specimen, purpose and location of storage. Also document if the subject/participant consented for the sample to be retained for future research.

Completed by the clinical site monitor to document dates and purpose of clinical site monitoring visits.

Document the subject/participant study identification number, name, and other identifying information. Must be stored securely and separately from research records since it is the link between a study ID and the subject’s/participant’s name.

Used to document pertinent study-related telephone conversations with regulatory bodies. Not intended to document conversations with study subjects/participants.

Used to document study-specific conversations with a study subject/participant.

Used to record all protocol deviations that occur at a study site.

Validation requirements for use of Meditech to obtain electronic health record data.

Provides instruction on how to number draft and final documents. Version control should be used for clinical research documents, including the protocol, consent document and case report forms.

To be used to assist with a pre-study/site qualification visit.

Topics, tasks, and operations that are discussed during a site initiation meeting to ensure all staff, facilities, and procedures are in place to conduct the clinical research study.

Documents the site initiation visit.

Use this site feasibility questionnaire sample for your research 

Each monitoring visit should have this form completed ensuring that both the site and sponsor are aware of mutual responsibilities.

Provides a timeframe for projected visits and the dates of the actual study visits.

Used by clinical site staff to document a discrepancy or problem with the conduct of the clinical research study, and plans to resolve and prevent the problem from recurring. May be used to document a corrective and preventive action plan.

Provides a framework for documenting the consent process. May be modified to suit the needs of the clinical research study.

Documents all the consent versions signed by all study patients.

Helps the investigator plan the orderly closure of study documents, data and publication.