Skip to main content

Study Support Resources and Templates

The Northwestern University Institutional Review Board (IRB) provides a variety of resources to help investigators conduct compliant human participant research. The tools below were created to support investigators in properly organizing paper based or electronically retained regulatory documentation and research data.

Investigators are encouraged to maintain a real-time accounting of all study related documents and data. Investigators should have all regulatory and participant-related information properly documented, as it plays a crucial role in validating research results throughout the life of the study.

Not all documents in the table below will be applicable to all studies. All study support resources and templates are editable. The user is encouraged to make changes to the tools to suit the study specific needs.

Activity/Process:

Resources:

Instructions:

Enrollment

Assent and Parental Permission Enrollment Log

Screening, Enrollment, & Withdrawal Log

Tracks participant enrollment in real-time (including screening and withdrawals).

Delegation of Authority (DOA)

Biomedical Research DOA

Clinical Trial DOA

Social Behavioral Research DOA

Tracks the roles and responsibilities of study team members over time. With minor edits, you can also track training and CV/resume expiration dates.

Consent Process

Documentation of Consent Process Form (Word)

Consent Form Collection Alternative (Excel)

Documents the consent process for individual participants in real-time.

Participant Eligibility

Biomedical Research Eligibility Checklist

Social Behavioral Research Eligibility Checklist

Documents participant eligibility (whether they have been included or excluded appropriately).

Drug or Device

Device Accountability Log

Drug Accountability Log

Tracks study product dispositions and/or device utilization.

Regulatory Binder or Research Record

Regulatory Binder Checklist

Research Record Components

Ensures complete regulatory files or research records. Essential documentation assists in the successful management of a protocol.

Participant Documentation

Participant Identifier Log

Research Payment Log

Visit Checklist

Stores participant identifiers, track in real-time participant payments, or document an individual participant’s study visit cycle.

Protocol Adherence

Protocol Deviation Log

Note to File Template

Provides context, additional information, or justification for items that may need clarity within the record.