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 W9

OHSU institutional contracting information (for industry sponsored research)

OHSU research pharmacy services general information sheet

IRB review board membership and FWA information

Coverage Analysis Information

Coverage Analysis Form

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:

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.

Download OCTRI boilerplate template.

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

Study budget template

Department assessments

Indirect costs

IRB fees

OHSU clinical research rates

Research Staff Effort Calculator

OHSU research rates approval process and account request

Research pharmacy fees

OHSU Research Administration Training and Education (RATE) shared document library

Cost Coverage Letter

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 EpicCare Link. 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:

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

Environmental Health and Radiation Safety