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.
Recruitment	Recruitment Advertisement Log Recruitment Pre-Screening Log	Tracks research study advertisements and pre-screening during recruitment.