Policies, Forms and Templates
Study Start Up Institutional Information
- OHSU W9
- OHSU Institutional Information
- OHSU Research Pharmacy Services General Information Sheet
- IRB Membership and FWA Information
- Current IRB Membership Roster
- Technical Information Regarding OHSU's Electronic Health Record System - To assist with completing sponsor questionnaires requesting technical information about OHSU's EHR.
- OHSU Certification to FDA of 21CFT part 11 electronic signature - Letter to FDA certifying OHSU's electronic signatures compliance with 21 CFR11.
- Certification of Compliance - eIRB - Letters that can be printed for sponsors to document OHSU's compliance with 21 CFR11.
- Lab Certifications & Lab Director CV's
- Lab Normal Ranges - Test Directory
- Lab Normal Ranges - Infant Coagulation Tests
- Guidance Regarding Clinical Trial Registration
Proposal Development & Protocol Feasibility Information
- Data and Safety Monitoring Plan Templates
- Data and Safety Monitoring Board Training Guide - provided by Tufts CTSI
- Protocol Feasibility Checklist
- Protocol Example Outline and Checklist
- Protocol Example Templates: OCTRI Template, Template from Spirit Study 2013, NIH e-Protocol Writing Tool/Wizard
- Recruitment Resources for Clinical Researchers
- OHSU Administrative Process - Pre Award process flow sheet
- OHSU Administrative Process - Post Award process flow sheet
Budgeting
- Budget Development - Administrative guidance on developing a budget for grants.
- Industry Budget & Payment Terms Guidelines and Information
- Clinical Trial Budget Checklist - a checklist for industry sponsored clinical trial budget creation
- Study Budget Template - a template for clinical trial budget creation
- Department Assessments
- Indirect Costs
- IRB Fees
- OHSU Clinical Research Rates
- OHSU Research Rates Approval Process & Account Request
- Radiology Start-up Fee Justification
- Research Pharmacy Fees
- OHSU Research Administration Training and Education (RATE) Shared Document Library
Study Conduct Resources & Tools
- Good Clinical Practices Training (for Study Coordinators & Research Staff)
- Recruitment Resources for Clinical Researchers
- Scope of Practice for Research Assistants/Associates
- Training Requirement Checklist for Clinical Research Coordinators
- Study Specific Training Documentation - an example of an In-Service Document Log and a Training Sign-in Log
- Delegation of Authority Log
- Epic Access for OHSU Research Staff - Request Form; Note: Epic Research Class Required Prior to Access.
- Epic Access for Research Monitors/Auditors - Request Form
- Clinical Trial Regulatory File Checklist - an example of checklist for clinical trail regulatory file contents.
- Clinical Trials Registration (CT.gov) Quality Control Checklist - a checklist to help researchers with clinical trial registration and reporting compliance.
- FDA Audit Checklist - an example of a checklist for a clinical study site preparation for FDA audit.
- Audit Medical Record Request - To request printed EPIC records from HIS to support audits of research studies.
- Laboratory List/Log - an example of a log to document the laboratories that will be used in a study and the contact information for each laboratory.
- Subject ID - used for subjects to know contact information and where research is being conducted.
- Patient Drug Log - an example of a log to be used for a research subject to track taking their study drug.
- Protocol Violation Documentation Form - an example of a form that can be used to document protocol violations and deviations.
- Research Related Order & Requisition Forms - requisition forms and order templates for ordering research related tests and procedures including EGC/Echo, Laboratory tests and Radiology.
- Safety Reporting Flowchart - a flowchart representing the decision tree for determining the minimum required expediting reporting of adverse events to the FDA and IND studies.
- Specimen Log - an example of a form to track the collection and distribution of study related biological specimens.
- Study Management Checklist - an example of a checklist of tasks required for the management of a clinical study.
- Examples of Study Subject Tracking Workbooks: Schedule Tracker; Screening Tracker; Comprehensive Subject Tracker.
- SOP's - examples of research SOP's used by the Knight
- SOP's - Knight Cancer Institute Toolkits
- Subject reimbursement: ClinCard (reloadable debit card for research participant compensation)
Research Policies & Procedures
- OHSU Policy Manual - This Includes Research Related Policies
- OHSU Distinguishing Gifts from Grants, Contracts and Other Sponsored Projects 04-40-01
- OHSU Sponsored Project Budgets and Cost Coverage 04-40-020
- Research Record Retention Requirement Summary
- Research Development and Administration (RDA) Policies
- Clinical Research Billing Office (CRBO) Policies
- Clinical Trial Office (CTO) Contracting Policies
- Conflict of Interest in Research (COIR) Policies
- Institutional Biosafety Committee (IBC)
- Institutional Review Board (IRB)
- Office of Proposal and Award Management (OPAM) Policies and Guidance
- Clinical Trials Registration for Investigator-Initiated Trials
- Environmental Health and Radiation Safety Policies
Healthcare Policies & Procedures Related to Research
- OHSU Healthcare Policy Database - database including all Healthcare related Policies
- Adverse Drug Reaction Reporting
- Authorization for Use and Disclosure of Protected Health Information
- Charges for Research Support
- Epic for Research
- Innovative Procedures for Therapies
- Investigational Agents Consisting of Recombinant DNA for Infectious Agents
- Permitted Uses and Disclosures of Protected Health Information
- Research Documentation in the Integrated Health Record
- Research Pharmacy Policies
- Billing of Research Related Clinical Services, Research Rates and Research Account Set-up
- Right to an Accounting Disclosures of Health Information
- Right to Request Access to Inspect or Obtain a Copy of Protected Health Information
- Use of Research Devices and Equipment
- Research Study Participant Registration (HC-LD-138-POL)