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Resources for Clinical Research
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Good Clinical Practice — SOPs for Investigative Sites
Standard Operating Procedures (SOPs) for Good Clinical Practice are your site's blueprint for
compliance; they highlight critical standards valued by sponsors, CROs, and, above all, your
research team. The Center for Clinical Research Practice has
developed a set of templates for Investigative Sites based on the principles found in GCP
Consolidated Guideline, ICH and the Code of Federal Regulations. The templates are in an
easy-to-read format that is clear, precise and pertinent to the day-to-day conduct of clinical
research. You can use them to make your own!
UW School of Medicine faculty and staff may obtain a license for the Investigative Site set of
SOP templates for a network user fee (Second Edition, 2001). Once licensed, the templates should be adapted
to reflect each research facility's practices. Please read the full licensing
information below. The Standard Operating Procedures Electronic Template (SOPET) software
requires Microsoft Windows and Word 97 or higher.
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SOPET for Investigative Sites: Table of Contents
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General Administration |
- SOP on SOPs: Preparing, Maintaining & Training
- Responsibilities of the Research Team
- Training and Education
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Study Start-Up
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- Assessing Project Feasibility
- Prestudy Site Visit
- Investigator and Site Initiation Meetings
- Project Start-Up
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Project Management |
- Site-Sponsor/CRO Communications
- Interactions with the Institutional Review Board
- Regulatory Files and Subject Records
- Sponsor/CRO Monitoring Visits
- Study Termination Visit
- Investigational Drug Accountability, Storage, Dispensing and Return
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Subject Management |
- Informed Consent Development and Implementation
- Subject Recruitment and Screening
- Subject Management While on Study
- Adverse Event Reporting
- Specimen Collection and Handling
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Data Management |
- Data Management
- Management of Electronic Records and Signatures
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Quality Assurance |
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Licensing
Please read and honor the terms of the
full License Agreement. For your convenience, we are
providing a working summary of the UW License Agreement in the next paragraph.
Use of the SOP software constitutes complete and
unconditional acceptance of the terms and conditions of use set forth in the full License
Agreement.
In summary, UW School of Medicine faculty/staff may obtain a network user license for the SOP
software for network user fee per network user. "Network-users" are defined as those who wish to
use and customize the software and have a copy of the software on their computers. Network
users can customize the Templates to meet the requirements and standards for conducting
clinical trials in their group. Network users may make copies of their customized electronic
and printed SOP documents and forms and may distribute these copies for use by other UW
personnel. Users of the customized forms created from the SOP templates do not need to
license the software. Only those individuals who want a copy of the SOP software need to
obtain the network user license.
To obtain a password, send an email to
restudy@u.washington.edu.
In the message, please include the following information.
- State specifically that you are requesting the SOPs for Investigative Sites so we will know to send you the correct password
- Your Name
- Department/Division
- Telephone/Fax Numbers
- Email Address
- Box Number
- Budget Number (to be charged the network user fee)
- Budget authorization signature (send this message for budget authorization in your department via electronic sign-off, then forward the message to the above address)
The Office of Clinical
Research will charge your budget and email you a password within one business day. Please
note that School of Medicine faculty/staff without UW budget numbers may send checks made out
to the University of Washington to the Clinical Research Office, Box 356340, Attn: Caroline
Murphy.
Installation of the SOPET software
After obtaining a license and receiving a password, follow these instructions:
- Read these instructions carefully, then download the SOPET installation program, sop_site.exe (UW NetID required). Make sure to save it to an easy to find location on your hard drive.
- Locate sop_site.exe on your computer, then double-click on it to start it. Next, click on "Finish." You will be prompted for the password that you received when you purchased your license. After you enter the password, the program will create a new folder named sop_site on your C: drive (or in the location you specify).
- Locate the sop_site folder on your hard drive ( c:\sop_site ). Double-click on setup.exe. Follow the onscreen instructions to install your copy of "Standard Operating Procedures for Good Clinical Practice at the Investigative Site."
- When the installation program notifies you that the installation process is complete, you can open the SOPET via the Windows Start Menu. In the Start Menu Programs list, you'll find a new entry for "Center for Clinical Research Practice." Click on it, select "Standard Operating Procedures Manual," and the SOPET will open into Microsoft Word.
Notes
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You must have Microsoft Word 95 version 7.0, Microsoft Word 97 or Microsoft Word 2000
installed on your computer in order to use the SOPET.
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You may need to adjust the formatting of the template after you have loaded it on to your
computer. The Standard Operating Procedures Electronic Template (SOPET) contains bullets,
tables, and other formatting features found in Microsoft Word, but everyone's
configurations for document formatting are different. For example, font settings are
controlled by the type of printer you have and the software on your computer. While
an effort has been made to configure the SOPET settings to be widely compatible, there
is no guarantee that the SOPET will match the printed version of the SOP template exactly.
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