Tools, Templates, and Resources
This set of documents is intended to provide an organized resource for the tools, templates, and other resources needed to conduct clinical and translational research at OHSU. Let the OCTRI Navigator know if there is anything else that would be helpful for you to see here: octri@ohsu.edu.
General Study Start Up Information
As you begin your clinical research project, you may also want to familiarize yourself with these process maps outlining the general pre and post award process at OHSU as well as the clinical research billing workflow map and the lifecycle of a research billing charge.
OHSU institutional contracting information (for industry sponsored research)
OHSU research pharmacy services general information sheet
IRB review board membership and FWA information
OHSU institutional information for grants/contracts
Information about process and billing aspects for device studies
OHSU Clinical Engineering form to review medical devices and equipment
Aeroscout Equipment Monitoring - how to order tags for your freezers
Information about OHSU's electronic health record system
Lab information and normal ranges:
Proposal Development
As you begin to develop your grant proposal and create your clinical research protocol these resources may be useful. Be sure to give ample consideration and time to ensuring your project is feasible.
Proposal Development:
- OCTRI's Clinical Research Development Team or Design Studio
- Data and safety monitoring plan assistance - contact OCTRI's Regulatory Knowledge and Support
- Data and safety monitoring plan for OHSU's IRB
- Data and safety monitoring board training guide, provided by Tufts CTSI
- NIH Division of Human Subjects Research (DHSR) Resources on Human Subjects, Clinical Trials and Inclusion
- NIH Data Management & Sharing Policy help through the OHSU Library
- NIH Sample Data Management & Sharing Plans
- OHSU Library resources related to working with data
Protocol Development:
- Protocol feasibility checklist
- Clinical trial protocol example outline
- Clinical trial protocol example checklist
- OHSU's IRB protocol templates - open the accordion titled "Protocol Templates"
Protocol examples
A sample of OCTRI's boiler plate template for inclusion in funding proposals can be downloaded below.
If you are submitting a funding application with specific OCTRI resources, you must request a cost estimate to include in the proposal budget. Without a cost estimate on file we cannot guarantee the resources you plan on using will be available or feasible for your project.
Please complete our Resource Request Form to submit a request for a cost estimate and letter of support.
Budgeting
Budgeting for a clinical research study can be a complicated high contact activity. Here we have assembled some templates, tools and links to assist in the budgeting process.
Budget development — administrative guidance on developing a budget for grants
Industry budget and payment terms guidelines
Industry-sponsored clinical trial budget checklist
OHSU Fixed Fee Memo for Industry studies
Increase in IDC for Industry Sponsored Studies, Memo 3/15/2023
Research Staff Effort Calculator
OHSU research rates approval process and account request
OHSU Research Administration Training and Education (RATE) shared document library
Study Conduct
To make the conduct of your study go a bit smoother, we have compiled a collection of information, tools and templates for your day to day activities. If you have a great tool that you would like to share please contact us.
Scope of practice for research assistants/associates
Scope of practice for support staff in ambulatory care settings
Research coordinator training requirement checklist
Acronym and General Clinical Research Contacts guide
General OHSU Abbreviations Guide
Study Management:
- Study management checklist — an example of a checklist of tasks required for the management of a clinical study
- Clinical trial regulatory file checklist
- Study-specific training sign-in log — an example of an in-service document log
- Delegation of authority log
- 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
- Specimen log — an example of a form to track the collection and distribution of study-related biological specimens
- Protocol violation documentation form — an example of a form that can be used to document protocol violations and deviations
- Research Participant Payment Options and information about ClinCard
- Image Library - request images and anonymized images
- Consent form scanning options for Research Consents - options and tools for scanning research consents into Epic.
- Emails to Participants - Using the OHSU Secure server for Emails with participants; See FAQ here
Study Subject Tracking Templates and Examples:
- Study subject schedule tracker
- Study subject screening tracker
- Comprehensive subject tracker
- Subject drug log — an example of a log to be used for a research subject to track taking their study drug
- Subject ID card template — used for subjects to know contact information and where research is being conducted
- Adverse Event (AE) tracking log example
Using Epic for Research:
- Epic For Research Sharepoint site including forms and tools
- Epic access for OHSU research staff request form (Note: Epic research class required prior to access)
- Epic access for research monitors/auditors request form - please email this to ResearchCrdHIMclbtn@ohsu.edu for more information and questions see the Health Information Management page. Once given access Auditors and Monitors can access OHSU Connect. Also visit the O2 page with information on process for Escorted Visitors.
- Care Everywhere FAQ for use guidance related to research
- Scheduling Research Patients in Epic, see Tip Sheet on the Epic for Research Bridge Site
- Acceptable use of MyChart for Research Coordinators (policy)
- Genetic Opt-Out Training and Access to the Genetic Opt-Out Database (provided after training is complete)
Clinical Trial Registration:
- Clinical trials registration (CT.gov) quality control checklist
- ClinicalTrials.gov OHSU Sharepoint for resources and information
FDA Audits:
Knight Cancer Institute
Clinical Research Policies, Procedures and Central Offices
Under the following accordions you will find a listing of policies and procedures you should be aware of when conducting clinical research at OHSU. Note that this list may not be comprehensive.
OHSU policy manual — 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
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
OHSU healthcare policy database (Ellucide or MCN)— includes all healthcare-related policies
Adverse drug reaction reporting (HC-MMM-100-POL)
Authorization to Handle, Transport and Administer Medication Policy (HC-MMM-145-POL)
Uses and disclosure of protected health information which require written authorization (IPP-11)
Charges for research support (HC-FSM-125-POL)
Innovative procedures for therapies (HC-PC-125-POL)
Investigational agents consisting of recombinant DNA for infectious agents (Policy number 04-06-001)
Permitted uses and disclosures of protected health information (IPP-09)
Uses of protected health care information that require written authorization (IPP-11)
Research documentation in the integrated health record (HC-MRM-123-POL)
Right to an accounting disclosures of health information (IPP-21)
Right to request access to inspect or obtain a copy of protected health information (IPP-18)
Use of research devices and equipment (HC-PE-724-POL)
Research study participant registration (HC-LD-138-POL)
Privacy and Security Policies and the Privacy and Security Policy List
OHSU Institutional Review Board (IRB)
OHSU Clinical Research Services Office (CRSO)
OHSU Clinical Research Contracting Office (CTO Contracting)
OHSU Clinical Research Billing Office (CRBO)
Office of Proposal and Award Management (OPAM)
OHSU Affiliate Research Program
OHSU Health Information Management (HIM)
Chief Research Information Office (CRIO)
Contact an OCTRI Navigator to connect with research resources
Find Training and Education for Clinical Research Staff
Does your study need a Data Use Agreement (DUA)? Find the DUA intake form and dashboard here.