Below is a collection of forms and tools collected to assist in the conduct of clinical research. Feel free to email Darlene Kitterman at kitterma@ohsu.edu any tools you wish to share.
OHSU Tools & Forms
Audit Medical Record Request
To request printed LCR records from HIS to support audits of research studies.
Data and Safety Monitoring Plan Templates
Templates to use to create data and safety monitoring plans for NIH clinical trials conducted at OHSU.
Industrial Account Request Form
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 List
An example of a form to document the laboratories used in a study and the contact information at each laboratory.
Laboratory Requisition
The OHSU Clinical Laboratory Requisition to order research laboratory services.
LCR Access and Training Instructions
Instructions on how to obtain access to and be training on LCR.
Medical Record Number (MRN) Request Form
To request an MRN from Health Information Services (HIS)
Pre-award Flowcharts
Links to various flowcharts created to guide those starting research studies through OHSU Pre-award processes.
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 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.
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 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.