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.
|Enrollment||Tracks participant enrollment in real-time (including screening and withdrawals).|
|Delegation of Authority (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||Documents the consent process for individual participants in real-time.|
|Participant Eligibility||Documents participant eligibility (whether they have been included or excluded appropriately).|
|Drug or Device||Tracks study product dispositions and/or device utilization.|
|Regulatory Binder or Research Record||Ensures complete regulatory files or research records. Essential documentation assists in the successful management of a protocol.|
|Participant Documentation||Stores participant identifiers, track in real-time participant payments, or document an individual participant’s study visit cycle.|
|Protocol Adherence||Provides context, additional information, or justification for items that may need clarity within the record.|
|Recruitment||Tracks research study advertisements and pre-screening during recruitment.|