Research and Development Service - VA Portland HCS
Research & Development - PI Resources
Getting Started
(Info for New Principal Investigators and Their Staff)
Responsibilities of the Principal Investigator (All Research Types) (50MB, MSWord)
Links to Other Services Provided by the R&D Office:
Administrative Staff for R&D
Clinical Trial Agreements
Controlled Substances Ordering
Cooperative Research and Development Agreements (CRADAs)
Education (Training) Requirements
Employees: Hiring Paid and Non-Paid, Appointment Requirements
Forms
Grants: Applying For Grants and Managing Grants
Invention Disclosures
Material Transfer Agreements (MTAs)
Policies
Posters
Presentations and Publications
Purchasing: Purchase Cards, IPAs, IT Purchases
Technology Transfer
Training: Safety and CITI, VMU
Travel
Work Order Requests
Other Resources
The following should be helpful in planning, gaining approval for, conducting clinical research and in training research staff.
If you are writing an investigator initiated protocol, please use the protocol template required protocol template (58KB, MSWord) to be sure that you address all required elements. The protocol template is designed to ensure your protocol, informed consent documents, and other protocol-related documents are consistent and in compliance with VA requirements.
If the protocol you would like to propose was written by a third party (i.e., the sponsor, the coordinating center, etc.), please use the protocol template to create a local protocol addendum that addresses specifically how the required items will be conducted/addressed at the VA Portland Health Care System (VAPORHCS).
The Cooperative Studies Program offers an excellent tutorial for Good Clinical Practice (GCP). Below are documents courtesy of Cooperative Studies Program Site Monitoring Auditing & Review Team (SMART). Research and Development Service of the VA Portland Health Care System (VAPORHCS) is not responsible for the information within the documents. Information contained in the documents should be used as a guide only. It is the Principal Investigator's responsibility to ensure any documents developed using these tools comply with current VA policies and regulations.
General GCP Information
Glossary of Terms (122KB, MSWord)
Listing of Web Sites for GCP and Clinical Trials Information (66KB, MSWord)
Principles of Source Documentation (34KB, MSWord)
Tracking Logs
Central Lab Specimen Tracking Form (43KB, MSWord)
IRB Approved Consent Forms Log (41KB, MSWord)
IRB Submissions Tracking Log (33KB, MSWord)
Non-written Disclosure Log (37KB, MSWord)
Note to File Log (39KB, MSWord)
Record of Consent or Re-consent (52KB, MSWord)
Researcher's Training Log (56KB, MSWord)
Safety Reports Tracking Log (32KB, MSWord)
Serious Adverse Events Log (40KB, MSWord)
Signatures and Delegated Responsibilities Log (36KB, MSWord)
Subject Log (36KB, MSWord)
Visitor's Log (37KB, MSWord)
Templates
Essential Document Templates (199KB, MSWord)
Note to File Form (34KB, MSWord)
Sample IRB Cover Letter for Submitted Items (27KB, MSWord)
Sample IRB Cover Letter for SAE Reporting (28KB, MSWord)
Source Document Templates (136KB, MSWord)
Checklists
Investigator GCP Checklist (319KB, MSWord)
Finally, the audit checklists can assist in assuring you begin research compliant with good clinical practice, VA regulations, and VAPORHCS policies governing human research. You can also use the tools to self-audit any ongoing research and make changes where needed.
Regulatory Audit Checklist (186KB, MSWord)
Informed Consent Audit Checklist (67KB, MSWord)
