Research-Related Forms

OHSU TOOLS & FORMS

To request printed EPIC records from HIS to support audits of research studies.

Summary of training requirements for Clinical Research Coordinators formatted to document training as completed.

Data and Safety Monitoring Plan Templates
Templates to use to create data and safety monitoring plans for NIH clinical trials conducted.

ECG/ECHO Research Exam Order Form
To order research ECGs and ECHOS.

EPIC Access 
EPIC access request from.  EPIC research class is required for research access.

The form to request an industrial account to enable hospital services to be charged to a research study Oracle Grants Accounting (OGA) Project Number.

Laboratory Requisition
The OHSU Clinical Laboratory Requisition to order research laboratory services.

Medical Record Number (MRN) Request Form
To request an MRN from Health Information Services (HIS)

Radiology Research Requisition
The forms required to order OHSU Radiology Services for research subjects.

Request For Research Admission
Form to request the admission of a research subject to the hospital.

Research Billing Related Forms
Clinical Research Billing Office (CRBO) forms page.

Research Outpatient Scheduling Request
Form to request a scheduler in an OHSU practice set up an appointment for a research subject.

Research Rates Request Form
Form for rate approval and departmental review of hospital services delivered in research studies.

General Tools & Forms

Clinical Trial Budget Checklist
A list of items to consider including when creating a clinical budget.

Clinical Trial Regulatory File Checklist
An example of a checklist for clinical trial regulatory file contents.

Drug Accountability Logs
Below are several versions of logs that can be used for tracking investigational drug dispensing and accountability.

• Drug Accountability Form
• Generic Drug Accountability Form
  

FDA Audit Checklist
An example of a checklist for clinical study site preparation for an FDA audit.

Inservice Documentation Log
An example of a form to document the study specific training of study personnel.

Laboratory List
An example of a form to document the laboratories used in a study and the contact information at each laboratory.

Medication Log Form
An example of a form to document the medication taken by a research subject during a study.

Protocol Feasibility Checklist
This is a checklist to assist with determining whether a protocol can be successfully conducted.

Protocol Templates

• Clinical Trial Protocol Outline: An outline to consider using when creating a clinical trial protocol.
• Protocol Template
  A general protocol template.
• Spirit 2013 Example Template: Example template of recommended content for the schedule of enrollment, interventions and assessments.
• Spirit 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.

Protocol Violation Documentation Form
This is an example of a form that can be used to document protocol violations and deviations.

Safety Reporting Flowchart
A flowchart representing the decision tree for determining the minimum required expedited reporting of adverse events to the FDA for IND studies.

Specimen Log
An example of a form to track the collection and distribution of study related biological specimens.

Standard Operating Procedures (SOPs)
Examples of different SOPs utilized by units on campus to assist with units developing their own SOPs.

Study Budget Template
A template that can be used to create industry sponsored clinical trial budgets.

Study Management Checklist
An example of a checklist of tasks required for the management of a clinical study.

Study Subject Schedule
An example of a form to track the visit dates of each subject on a study.

Study Subject Screening Tracking Form
An example of a form that can be used to track study subject screening and enrollment for a clinical study.

Study Tracking Workbook
A workbook to track; study subject screening, enrollment, study visits and other study activity for a clinical study